A2 Corporation Limited v New Zealand Dairy Board and JP Hill [2005] NZIPOPAT 15 (4 July 2005)

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IN THE MATTER of an application for Letters Patent No 306584 in the name of A2 CORPORATION LIMITED
Applicant

IN THE MATTER of opposition to said application under section 21 by NEW ZEALAND DAIRY BOARD and JP HILL
Opponents

This application was filed by the PCT route on 9 May 1996 naming Corran Norman Stuart McLachlan as both applicant and inventor. Priority was claimed from New Zealand Application No 272133 which was dated 16 May 1995. The present application (No 306584) was subsequently assigned to Machin Investments Ltd and then to A2 Corporation Ltd. Notice of acceptance of the complete specification was published, pursuant to section 20(2), in Patent Office Journal No 1448 on 28 February 2000.

Two notices of Opposition were filed on 28 June 2000 (by (1) Robert Arthur Elliott and Jeremy Paul Hill, and (2) New Zealand Dairy Board (NZDB) and The National Child Health Research Foundation (NCHRF). Statements of Case were filed on both oppositions on 28 September 2000 and a Supplementary Statement of Case was filed by the NZDB and the NCHRF on 16 September 2002. Grounds (a), (b), (c), (e) (first limb), (f), and (g), as set out in section 21(1) were pleaded by the NZDB, and ground (a) was pleaded by Dr Hill. However, Mr Arthur advised at the hearing that only grounds (a), (e), (f), and (g) are being pursued.

A Counterstatement was filed by the Applicant on 4 December 2000 and was followed by Amended Counterstatements on 5 February 2001 and 18 July 2001. In its amended Counterstatements the Applicant proposed unconditional amendments to claims of the complete specification. These were the subject of a hearing on 20 March 2002 and my subsequent decision on 27 May 2002. Following further correspondence and a Supplementary Counterstatement filed on 26 June 2002, the final allowable version of the claims were set out in a second Supplementary Counterstatement filed on 21 March 2003. The Applicant denies that the two remaining Opponents (NZDB and JP Hill – see below) have locus standi in these proceedings.

The parties agreed in July 2003 that the two oppositions would proceed “in tandem”. Mr Arthur explained at the hearing that Professor Elliott and The National Child Health Research Foundation were not pursuing their oppositions and thus the opponents in the present case are limited to NZDB and JP Hill. Furthermore, in an undated letter received by the Intellectual Property Office (IPONZ) on 15 July 2003 Mr Elliott stated

In a letter dated 18 July 2003, from IPONZ to Professor Elliott, copy to the attorneys for the Applicant and the Opponents, it was stated:

If our understanding is incorrect we ask Professor Elliott to let us know. Otherwise we shall continue on this basis.

Once evidence in the form of a Statutory Declaration has been filed it may only be withdrawn with leave of the Hearing Officer and then only when good reason has been given. A simple wish to withdraw is not, in our submission, a reason for the Hearing Officer to permit evidence to be withdrawn.

We attach* a copy of rule 507(3) of the High Court rules which governs the situation in the High Court. It is our submission that the same principle applies to opposition proceedings at IPONZ.

There was no further correspondence on the matter. However, at the hearing Mr Arthur reiterated his contention that Professor Elliott could not withdraw his evidence without my leave, which should not be given without good reason having been provided. The Applicant raised no objection and, no good grounds having been advanced, I see no reason for allowing the evidence to be removed.

In its second amended Counterstatement, filed on 18 July 2001, the Applicant denies that Dr Hill has locus standi in these proceedings and denies that NZDB has the right to plead the ground of Obtaining. This was reiterated by Mr Lynch at the hearing. He conceded that NZDB has locus standi in all the grounds pursued except that of Obtaining. Furthermore, he submitted that Dr Hill does not have locus standi in the ground of Obtaining, the only ground pleaded by him.

Mr Lynch submitted that it is clear from the Act that the person who can oppose on the ground of Obtaining must be the person from whom the invention was obtained, or that person’s personal representative.

(1) At any time within the period prescribed by subsection (2) of this section any person interested may give notice to the Commissioner of opposition to the grant of the patent on any of the following grounds:

(a) That the applicant for the patent, or the person described in the application as the true and first inventor, obtained the invention or any part thereof from him, or from a person of whom he is the personal representative ... [Emphasis added]

On the other hand, Mr Arthur submitted that the invention can be “obtained” through an agent; what is important is, “who did the invention belong to at the time of the alleged obtaining?”. He referred me to International Carbon Corporation’s Application [1975] RPC 365 wherein Whitford J, in the British Patents Appeal Tribunal, said at pages 369 to 370:

The applicants say that the case on obtaining necessarily involves this, that an opponent must prove that the person who it is alleged obtained the invention "got" the invention from the opponent and that no case lies if in fact the invention was "got" from some third party who, in turn, cannot have "got" it from the opponent. On the facts alleged it is said that the allegation can go to no more than this, that Continental "got" the invention from Mr. Vojkovic, who is named as the true and first inventor.

Next, it is said that Mr. Vojkovic cannot on any view have "got" the invention from the opponents, because he was in fact the true and first inventor. From this it is said it follows that a case of obtaining cannot be established.

The argument is, on the face of it, not without its attractions. I have used the word "got", for it was the submission of counsel on both sides that "obtain" in the context of section 14(l)(a) [New Zealand section 21(1)(a)] means "get". If the facts asserted are established this much must emerge: first, that Mr. Vojkovic is the true and first inventor. He first recorded his invention in the report which, as in duty bound he must, he submitted to the opponents. Now, counsel for the applicants conceded that if some other employee employed on the same terms as Mr. Vojkovic had in fact made the original invention and drafted the original report and Mr. Vojkovic, not being the inventor, had happened to see the report and committed its contents to memory and having done this had communicated the contents to Continental, then the opponents would have a good case on obtaining. The case, counsel said, fails because Mr. Vojkovic was the inventor and cannot accordingly have "got" the invention from the opponents at any time.

For my part, I think the question of obtaining involves deciding first whose invention it was at the time when it is alleged the obtaining took place; next whether the invention, assuming it was the opponents' invention, came from the opponents to the applicants.

At all material times the invention described in the report was an invention which belonged to the opponents, this notwithstanding the fact that it was made by Mr. Vojkovic. If Mr. Vojkovic gave knowledge of the invention enshrined in his report to Continental he was giving Continental that which, as he must have known, was the property of the opponents. At the material time the invention in the report, which I am assuming is the same as the invention in the application, was an invention belonging to the opponents. On the assumed facts it appears to me that Continental got it from the opponents through the agency of Mr. Vojkovic. [Emphasis added]

Mr Arthur also referred me to a decision of Commissioner Burton, Eric Graeme King v Robert Blundell Norgate, New Zealand Patent Office 22 December 1992, in which Mr Burton said at page 11:

To succeed on the ground of obtaining, an opponent must show that some other person (or persons) was (were) the true and first inventor(s), and that the invention subject of an application for protection under challenge, was obtained from that person(s) in contravention of the rights of the opponent. As is established by the case law, this places the burden of proof upon the opponent to establish firstly that some other person than that named by the applicant is the true and first inventor, and secondly that there was some relationship between the parties which gave rise to the act of obtaining.

It is clear from these cases, as pointed out by Mr Arthur, that an invention can be obtained through an agent; it is not necessary, as submitted by Mr Lynch, that the only person(s) who can oppose on the ground of Obtaining is the person from whom the invention was obtained, or that person’s personal representative. In the present case, as will be seen from the discussion below under the heading Obtaining, Dr McLachlan (the named inventor and the applicant in the first instance) did speak to Professor Elliott who could be considered the agent of the NZDB and Mr Hill (just as, as pointed out by Mr Arthur, Mr Vojkovic was the agent in International Carbon Corporation’s Application, discussed above).

The Opponent’s evidence, in the form of Statutory Declarations, is as follows:

The Applicant’s evidence, in the form of Statutory Declarations, is as follows:

Mr Lynch submitted that the evidence of Dr Hill and Dr Crawford should not be considered at all because they are both employees of Fonterra which was formed from NZDB, one of the opponents in these proceedings. Dr Hill is, of course, also the other opponent. Mr Arthur, in reply, pointed out that the Commissioner of Patents functions as a Tribunal and is thus able to receive all probative evidence; strict rules of evidence only apply when the Commissioner is exercising concurrent jurisdiction with the High Court. He referred me to Royal New Zealand Yacht Squadron v Daks Simpson Group PLC, High Court, Wellington, 21 September 2001, AP76/01. This is an appeal from a decision of the Assistant Commissioner of Trade Marks. Ronald Young J said, in relation to the admissibility of evidence which was clearly hearsay:

[16] It is clear, therefore, that the essence of Mr Endean's evidence is hearsay. But is hearsay evidence objectionable in a tribunal such as this?

[17] The Act gives no assistance. It is silent as to whether or not the rules of evidence strictly apply. In contrast see s90(6) of the Accident Rehabilitation Compensation & Insurance Act, s59(d) District Courts Act, and s40 Disputes Tribunals Act.

[18] General principle favours the inapplicability of the ordinary rules of evidence in such circumstances given the desire of administrative tribunals to function informally. See R v Deputy Industrial Injuries Commissioner, Ex parte Moore [1965] 1 All ER 81 at 94 per Diplock LJ (from line (e)):

"The requirement that a person exercising quasi-judicial functions must base his decision on evidence means no more than that it must be based on material which tends logically to show the existence or non-existence of facts relevant to the issue to be determined, or to show the likelihood or unlikelihood of the occurrence of some future event the occurrence of which would be relevant It means that he must not spin a coin or consult an astrologer; but he may take into account any material which, as a matter of reason, has some probative value in the sense mentioned above. If it is capable of having any probative value, the weight to be attached to it is a matter for the person to whom Parliament has entrusted the responsibility of deciding the issue. The supervisory jurisdiction of the High Court does not entitle it to usurp this responsibility and to substitute its own view for his."

[19] And see TA Miller Ltd v Minister of Housing and Local Government & Anor [1969] RPC 91 at 93 per Lord Denning MR when considering a planning inquiry said:

"In my opinion this point is not well founded. A tribunal of this kind is master of its own procedure, provided that the rules of natural justice are applied. Most of the evidence here was on oath, but that is no reason why hearsay should not be admitted where it can fairly be regarded as reliable. Tribunals are entitled to act on any material which is logically probative, even though it is not evidence in a court of law".

[20] It seems clear therefore that a tribunal such as the Assistant Commissioner of Trade Marks constituted here is a tribunal which would ordinarily be free to admit what evidence it considered proper, reliable, logically probative and given in accordance with the rules of natural justice.

The judge then went on to consider the particular circumstances of that case, which were that of concurrent jurisdiction between the High Court and the Commissioner of Trade Marks. He concluded in paragraph 29 that in such a circumstance (concurrent jurisdiction) the Commissioner is bound by the rules of evidence “and in particular the rules of evidence as they relate to hearsay including the Evidence Amendment Act 1980 (No 2) (s7 oral hearsay and s3 documentary hearsay)”. Mr Arthur pointed out that there is no concurrent jurisdiction in patent oppositions such as the present case.

Mr Arthur, however, did draw my attention to the fact that Hammond J, in Rainbow Technologies Inc v Logical Networks Limited, High Court, Wellington, 30 June 2003, CP 136/02, queried Ronald Young J’s decision, but did not reach a different conclusion. He said

[47] I begin with some general observations. In the Yacht Squadron case Young J adopted the approach that a trade mark hearing officer is effectively a "tribunal" and therefore subject to what might be termed as the "tribunals approach" to evidence. In particular, at para [18] it will be recalled that the Judge said:

General principle favours the inapplicability of the ordinary rules of evidence in such circumstances given the desire of administrative tribunals to function informally.

[48] With all due respect I think that is stated much too broadly, and has to be approached with considerable caution.

He concluded in paragraph 58, after a thorough discussion of the matter, by saying, “What can be said with confidence in this case is that whether the test propounded by Young J is adopted, or the “usual” civil principles are applied, the James declaration is unacceptable”.

Mr Arthur, however, submitted that in many cases the Court or the Commissioner receives opinion evidence from employees, although, of course, caution has to be exercised about objectivity. Paragraph 15.11 of Cross on Evidence, New Zealand Edition, states:

A properly qualified expert will not be disqualified by reason of his or her employment by one of the parties. However, it may be important to show that such a witness is aware of the need for objectivity.

Mr Lynch acknowledged that Mr Clarke’s evidence, which provides details of conversations that he had with Dr McLachlan in which Dr McLachlan told him about the discussions he had with Professor Elliott, is hearsay. However, Mr Lynch submitted that it is allowable hearsay evidence in view of Dr McLachlan’s untimely death in July 2003. He referred me to section 7 of the Evidence Amendment Act 1980 (No 2) which states:

In any civil proceeding where direct oral evidence of a fact would be admissible, any oral statement made by a person and tending to establish that fact shall be admissible as evidence of that fact if the maker of the statement had personal knowledge of the matters dealt with in the statement, and is unavailable to give evidence.

The title of the complete specification reads, with the amendments made by the Applicant before and as a result of my decision of 27 May 2002 indicated by overstriking (deletions) and underlining (additions):

The first paragraph on page 1, under the heading “Field of the invention”, reads as follows:

This invention relates to the removal, or the production of immunoglobulins against, immunosuppressant substances present, or, produced from the milk of animals of the genus Bos, and more particularly the domestic dairy species of the group Bos taurus and their crosses with the group Bos Indicus, which are used for milk production, and which contain specific casein alleles.

This invention relates to a method of producing milk free of β-casein A1 by testing genetic material of lactating bovines, selecting bovines based on the results of the testing, and milking the selected bovines. The invention also relates to milk obtained by that method, and to food products and medicaments which contain or are processed from that milk.

There follows, under the main heading “Background of the invention” and the sub-heading “Description of the prior art”:

It has long been understood that the early lactation mammary secretions of certain species, known as colostrum, contains substances that prevent disease, whilst the immune system of the young of the species is developing. This is particularly true of the ruminants, such as the Bos family. However the ingestion of colostrum is not essential in the human. These substances were identified as proteins (globulins) with immune-properties which became known as immunoglobulins, (B L Larsen Immunoglobulins of Mammary Secretions in Advanced Dairy Chemistry Volume 1 Proteins. Ed. PF Fox Elsevier ,1992).

Immunoglobulins are present in the serum and mammary secretions of all mammalian species as part of the immune defence system of the animal. The immunoglobulins are also known as antibodies and are produced by the body's immune system in response to the presence of substances called antigens, including a wide range of molecules, bacteria, viruses, cells and particles that do not express specific markers of 'self’ called histocompatibility antigens. Molecular antigens are largely peptides, proteins and carbohydrates. The classic immune response involves the production of antibodies capable of neutralising these antigens.

The term antigen is now widely used to indicate any molecule that can be specifically recognised by the adaptive elements of the immune system, that is by both B cells, which produce immunoglobulins and T cells which release substances such as cytokines, (Immunology, 3rd Edition ,Ed. I Roitt, J Brostoff, D Male, Mosby, London, 1993).

There are five classes, or isotypes, of immunoglobulins all of which have a similar basic structure, but have differences in their organisational structure as well as the amino acid sequences present and carbohydrate groups present. In addition to the immunoglobulins there are present related immune system proteins. These are known as complement and they are a complex group of proteins which assist the function of antibodies. Their properties are described in the above texts. There are at least 11 proteins in the complement group some of which are expected to be present in milk at the milligram per 100 millilitre level.

1. isolate the immunoglobulins present in mammary secretions, particularly colostrum but also including milk and products derived from milk such as whey. Generally the species involved is the domestic cow, Bos taurus, but it may include sheep or goats.

2. produce an "immune milk" or "health food" incorporating the immunoglobulin proteins, either as a result of stimulating the milk producer's immune system by the addition or injection of substances into the animal's body, either once or systematically, which result in an immune response, or by concentrating the small amounts of immunoglobulins that are naturally present in milk-derived products. In the former case the immunoglobulins may be specific responses to the injection of pathogenic bacteria into the milk-producing animals.

A brief description of the disclosure of several Japanese, United Kingdom, European, and United States patent specifications is followed by the following passage from pages 4 to 10:

Notwithstanding all these patents and the claimed benefits of their products there is a considerable body of evidence that links milk particularly of the Bos taurus, the domestic cow, with allergy problems with young children, asthma, chronic immune disorders such as diabetes mellitis, and atherosclerosis. Recent studies have also linked increased consumption of casein with the formation of hepatic tumours in rats, due it appears to a depressed NK cell cytotoxic activity. Bell RC, et al Nutr Cancr 22:151-162, (1994).

To date it has not been possible to identify any particular fraction or molecule that is responsible for disorders such as atherosclerosis, although the consumption of animal fats and their associated saturated fatty acids have [sic] been claimed to either cause, or contribute to, coronary heart disease, hypertension and obesity as is set out in most medical texts on these subjects and the Surgeon-General's Report on Nutrition and Health, DHHS Publication No 88-50210 (1988).

~~It is an object of this invention to provide an improved food product and/or process or one which will at least provide the public with a useful choice~~.

It is an object of this invention to provide a method of producing milk substantially free of β-casein A1 suitable for use in the prevention or treatment of coronary heart disease, or to at least provide a useful alternative.

"β-casein A1 Allele" is a term used herein in reference to one of the variant forms of the β-casein gene. Expression of the A1 allele results in the production of " β -casein A1".

Where reference is made to the presence of the β-casein A1 allele in an individual or population it encompasses both homozygous and heterozygous genotypes with respect to that allele. Similarly, where reference is made to the presence of β-casein A1 it encompasses phenotypes resulting from either a homozygous or heterozygous state with respect to the β-casein A1 allele.

The term "Immune milk" is used herein reference to milk obtained from an animal that has been immunised to selectively induce for formation of immunoglobulins and other immune proteins, directed against specific bacterial and/or viral pathogens or other foreign antigens that are known to cause diseases, in its milk, such milk being used to prevent disease, within the milk drinker, by fortifying the body's natural resistance against specific disease-causing antigens.

This invention is applicable to all products derived from cattle (live or dead) which products are substantially free of β-casein A1, or contains immune response proteins (including immunoglobulins) to β-casein A1. This includes meat (including offal) blood and blood products (such as black pudding), casein, gelatin, milk and other dairy products, as well as manufactured products containing some or all of the foregoing examples (including whiteners for beverages that include some milk solids).

The term "processed dairy product(s)" is used herein to refer to dairy products derived from a source of bulk milk (ie from milk from more than one animal) and includes, but is not limited to:

(a) bulk milk used to make cheese whether or not the milk has been pasteurised or sterilised prior to cheese making,

(f) pasteurised, sterilised, preserved milks including microfiltered milks, UHT milks,

(k) cheeses including full fat, partial de-fatted and fat-free processed cheeses,

(p) carbonated milk products, including those with added phosphate and/or citrate,

(q) infant formulations which may contain full, partially de-fatted or nonfat milk together with a number of additional supplements,

~~In one aspect the invention provides a food product derived from animals which product is substantially free of the β-casein A1 allele, or β-casein A1 expressed therefrom.~~

~~Preferably the food product is meat or meat related, and more preferably is derived from an animal which is substantially free of the β-casein A1 allele.~~

~~In a particularly preferred form of the invention the food product is milk or other dairy product which is substantially free of β-casein A1.~~

~~In another aspect the invention provides a meat or dairy food product which contains the β-casein A2 allele in preference to the β-casein A1 allele.~~

In another aspect the invention provides a milk or other dairy product capable of minimising the onset of coronary heart disease characterised in that the milk or other dairy product is substantially free of β-casein A1, or its proteolytic or heat produced products.

In a further aspect the invention provides a process for producing milk or other dairy products which does not contain β-casein A1 by testing the individual cows in a herd for the presence of the β-casein A1 allele, or the presence of β-casein A1 in their milk, and selectively culling from the herd those cows that test positive for the presence of the β-casein A1 allele, or β-casein A1, until the bulk milk produced by the herd is substantially free of β-casein A1.

In a related aspect the invention provides a process for producing milk or other dairy products which does not contain β-casein A1 by testing the individual cows in that herd for the presence of the β-casein A1 allele or β-casein A1 in their milk and subsequently employing breeding programmes which select against individual cows testing positive for the presence of the β-casein A1 allele or β-casein A1 until the bulk milk produced by the herd is substantially free of β-casein A1.

In a further related aspect the invention provides a process for producing milk or other dairy products which does not contain β-casein A1 by testing individual cows in a herd for the presence of the β-casein A1 allele or β-casein A1 in their milk and utilising genetic engineering 15 procedures to remove the β-casein A1 allele or inhibit expression of β-casein A1 therefrom.

~~In another aspect the invention provides milk and other dairy products which are substantially free of β-casein A1.~~

~~Optionally the dairy product is casein which is substantially free of β-casein A1. This may be used as a food for animals or humans.~~

In another aspect the invention provides a process for producing immunoglobulins and other immune response proteins, in cow's milk from animals not possessing the β-casein A1 allele, or other commercial milk producing animals, to this allele, to counteract the immunosuppressant substances present that are produced from it, in commercial milking cows such as Holsteins, together with its blending with non-treated milk or the recovery of such immunoproteins.

In another aspect the invention provides immunoglobulins and other immunoproteins produced as a result of inoculating commercial milk producing animals with β-casein A1, its proteolytic hydrolysis products, or fragments thereof produced by other means.

In another aspect the invention provides blended milk obtained from mixing the product of the present invention with milk from animals possessing the β-casein A1 allele as part of their genetic make-up either at the factory or by running a mixed herd of such animals.

In a related aspect the invention provides an immune milk (as herein described), such immune milk being substantially free of β-casein A1 and/or produced from cattle or other commercial milking animals lacking the β-casein A1 allele.

~~Preferably the immunoglobulins active against β-casein A1 and its proteolytic products, are recovered by ultrafiltration, ion exchange chromatography or an immunoadsorbent column.~~

The milk containing immunoglobulins active against β-casein A1 and its proteolytic products may be in the form of whole milk, whole-milk powder, skim milk, skim milk powder, milk whey, yoghurt, cheese, or any other dairy product, or processed dairy product.

In another aspect the invention provides immunoglobulins produced by treating a homozygous β-casein A2, B, or C, or heterozygous mixture of A2, B, and C, cow, with any inoculum to produce immunoglobulins in the milk from a cow that does not contain the immunosuppressant β-casein A1 allele, β-casein A1, proteolytic fragments thereof or fragments thereof produced by other means.

In a yet further aspect the invention provides a method of reducing the onset of disease in an individual or a population which derives some of its food intake from milk or other dairy products by reducing or substantially eliminating the presence of β-casein A1 in the diet of that population. This method is applicable to animals or humans.

~~It is believed that the invention is applicable to reducing the onset of diseases such as:~~

coronary heart disease, cerebrovascular diseases, duodenal ulcer, peptic ulcer, respiratory diseases, such as bronchitis, lung cancer, asthma's and pneumonia, diabetes, polyarthritis, chronica, Psoriasis, renal disease, systemic lupus erythematosus, chronic disorders of the immune system, and any disease where there is a seasonal variation in incidence or death rate.

Preferably the invention provides a method of reducing the onset of coronary heart disease in a human population which derives some of its food intake from milk or other dairy products by reducing or substantially eliminating the presence of β-casein A1 in the diet of that population.

In a yet further aspect the invention provides a method of enhancing the immune response or decreasing the immune suppression of an individual or a population who or which derives some of his/her/its food intake from milk or other dairy products by reducing or substantially eliminating the presence of β-casein A1 in the diet of that individual or that population.

The subject of this invention is the identification of the class of proteins responsible for a number of disorders such as coronary heart disease (and others as described above), their neutralisation in cow's milk and the production of an imunoglobulin capable of partially overcoming some of the deleterious effects they (or it) engender(s) on the human body. This invention is not limited to a specific disease as the molecules concerned appear to act as immunosuppressants to the body's immune system and their removal can only enhance the general well-being of the individual while at the same time providing specific relief to individual's whose genetic make-up is such that contact with these proteins or protein will bring about a specific response such as atherosclerosis or other chronic disorders of the immune system.

- a method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-casein A1 but which contains any one or more of β-caseins A2, A3, B, C, D and E, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding β-casein A1;

(ii) selecting bovines which do not have DNA encoding β-casein A1 to form the herd of lactating bovines;

- a method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-caseins A1, B and C but which contains any one or more of β-caseins A2, A3, D and E, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding any one or more of β-caseins A1, B and C;

(ii) selecting bovines which do not have DNA encoding any one or more of β-caseins A1, B and C to form the herd of lactating bovines;

(i) testing genetic material of lactating bovines for the presence of DNA encoding β-casein A2;

(ii) selecting bovines which do have DNA encoding β-casein A2 to form the herd of lactating bovines;

(i) testing genetic material of the lactating bovines for the presence of DNA encoding any one or more of β-caseins A2, A3, D and E;

(ii) selecting bovines which do have DNA encoding any one or more of β-caseins A2, A3, D and E to form the herd of lactating bovines;

(i) testing genetic material of lactating bovines for the presence of DNA encoding β-casein A1 and DNA encoding β-casein A2;

(ii) separating bovines which have DNA encoding β-casein A2 from bovines which have DNA encoding β-casein A1 or which have DNA encoding both β-casein A1 and β-casein A2 to form the herd of lactating bovines;

(iii) milking the, bovines which have DNA encoding β-casein A2 from the herd to give bulk milk; and

- a method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-caseins A1, B and C but which contains any one or more of β-caseins A2, A3, D and E, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding any one or more of β-caseins A1, B and C and DNA encoding any one or more of β-caseins A2, A3, D and E;

(ii) separating bovines which have DNA encoding any one or more of β-caseins A1, B and C from bovines which have DNA encoding any one or more of β-caseins A2, A3, D and E to form the herd of lactating bovines;

(iii) milking the bovines which have DNA encoding any one or more of β-caseins A2, A3, D and E from the herd to give bulk milk; and

- a method of producing milk as defined above in which the lactating bovines tested in step (i) are, or include, Bos taurus bovines;

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding β-casein A1;

- milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-casein A1, B and C but which contains any one or more of β-caseins A2, A3, D and E, which milk is the product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding any one or more of β-caseins A1, B and C;

(ii) selecting bovines which do not have DNA encoding any one or more of β-caseins A1, B and C; and

- milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-casein A1 but which contains β-casein A2, which milk is the product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding β-casein A2;

- milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-casein A1 but which contains any one or more of β-caseins A2, A3, D and E, which milk is a product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding any one or more of β-caseins A2, A3, D and E;

(ii) selecting bovines which do have DNA encoding any one or more of β-caseins A2, A3, D and E; and

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding β-casein A1 and DNA encoding β-casein A2;

(ii) separating bovines which have DNA encoding β-casein A2 from bovines which have DNA encoding β-casein A1 or which have DNA encoding both β-casein A1 and β-casein A2; and

- milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-caseins A1, B and C but which contains any one or more of β-caseins A2, A3, D and E, which milk is the product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding any one or more of β-caseins A1, B and C and DNA encoding any one or more of β-caseins A2, A3, D and E;

(ii) separating bovines which have DNA encoding any one or more of β-caseins A1, B and C from bovines which have DNA encoding any one or more of β-caseins A2, A3, D and E; and

(iii) milking the bovines which have DNA encoding any one or more of β-caseins A2, A3, D and E;

- a product which contains β-casein but is substantially free of β-casein A1 and which contains or is processed from a milk as defined above;

It has been reported that certain groups of peoples are not subject to the diseases described above, notwithstanding the fact that they consume considerable quantities of milk proteins. These people include the Tibetans, rural Gambians, the Masai and Samburu people of Kenya. The latter peoples are also found not to suffer from obesity, even in old age. The only major difference between the milk consumed by the above people is that it is derived from Zebu, Bos Indicus, and Yak, Bos Mutus. Neither milk contains the casein allele described as β-casein A1. In addition, people such as the Eskimo do not suffer from diseases such as CHD compared with their dairy product consuming Danish countrymen as is illustrated in Table 1:

Table 1. Age adjusted differences in morbidity from chronic diseases between Greenland Eskimos and Danes

Eskimos/Danes
Acute myocardial infarction 1/10
Stroke 2/1
Psoriasis 1/20
Diabetes rare
Bronchial asthma 1/25
Malignant disorders 1/1
Thyrotoxicosis rare
Multiple sclerosis 0
Polyarthritis chronica low

The claims read as follows, with the amendments made by the Applicant before and as a result of my decision of 27 May 2002 indicated by overstriking (deletions) and underlining (additions):

~~1. A product derived from cattle which product is substantially free of the β-casein A1 allele or β-casein A1 expressed therefrom.~~

2. A non diabetogenic product derived from cattle which are substantially free of the β-casein A1 allele or the protein expressed therefrom and which cattle includes β-casein B allele or the protein expressed therefrom.

~~3. A product derived from cattle which product is substantially pure for β-casein A2 allele or β-casein A2 expressed therefrom.~~

~~4. A product derived from cattle as claimed in claim 1 wherein said product is a “processed dairy product” (as herein defined) substantially free of β-casein A1.~~

5. The use of a product derived from cattle which product is substantially free of the β-casein A1 allele or β-casein A1 expressed therefrom in a food or medicine suitable for use in the treatment of coronary heart disease, cerebrovascular diseases, duodenal ulcer, peptic ulcer, respiratory diseases, such as bronchitis, lung cancer, asthma’s and pneumonia, polyarthritis, chronica, Psoriasis, renal disease, systemic lupus erythematosus, and chronic disorders of the immune system.

6. The use of a product derived from cattle which product is substantially pure for the β-casein A2 allele or β-casein A2 expressed therefrom in a food or medicine suitable for use in the treatment of coronary heart disease, cerebrovascular diseases, duodenal ulcer, peptic ulcer, respiratory diseases, such as bronchitis, lung cancer, asthma’s and pneumonia, polyarthritis, chronica, Psoriasis, renal disease, systemic lupus erythematosus, and chronic disorders of the immune system.

~~7. The use of dairy products which are substantially free of β-casein A1 in the preparation of a food or medicine.~~

~~8. The use of “processed dairy products” (as herein defined) which are substantially free of β-casein A1 in the preparation of a food or medicine capable of~~

coronary heart disease, cerebrovascular diseases, duodenal ulcer, peptic ulcer, respiratory diseases, such as bronchitis, lung cancer, asthma’s and pneumonia, polyarthritis, chronica, Psoriasis, renal disease, systemic lupus erythematosus, and chronic disorders of the immune system, and the like.

9. A method of reducing the risk of coronary heart disease, cerebrovascular diseases, duodenal ulcer, peptic ulcer, respiratory diseases, such as bronchitis, lung cancer, asthma’s and pneumonia, polyarthritis, chronica, Psoriasis, renal disease, systemic lupus erythematosus, and chronic disorders of the immune system in a susceptible individual which comprises restricting the dairy product intake of that individual to dairy products as claimed in any one of claims 1, 3 or 4.

10. A process for producing dairy products (including milk) from a herd of cattle which dairy products is or are substantially free of β-casein A1 by testing the individual cows in a herd for the presence of the β-casein A1 allele, or the presence of β-casein A1 in their milk, and selectively culling or breeding those cows showing a positive response to the presence of the β-casein A1 allele, or β-casein A1 from the herd until the bulk milk produced by the herd is substantially free of β-casein A1 and producing the dairy products (including milk for sale) from the bulk milk.

11. A process for producing dairy products (including milk) as claimed in claim 8 wherein the β-casein A1 allele has been removed or the expression of β-casein A1 therefrom inhibited by employing selected genetic engineering techniques.

12. A product derived from commercial milk producing animals which product contains or consists of immune response proteins (including immunoglobulins) to β-casein A1, its proteolytic hydrolysis products or fragments thereof produced by other means.

~~13. A product derived from castle [sic] as claimed in claim 1 wherein said product is a “processed dairy product” (as herein defined) substantially free of β-casein A1.~~

~~14. A bovine animal which after being tested for the presence of the β-casein A1 allele or β-casein A1 has been identified as being free of the β-casein A1 or β-casein A1 expressed therefrom.~~

15. A product derived from commercial milk producing animals as claimed in claim 10 comprising a blended milk product containing milk which may contain β-casein A1 and milk containing immune response proteins (including immunoglobulins) to β-casein A1.

16. A process for producing immune response proteins (including immunoglobulins) to β-casein A1, in cow’s milk from animals not possessing the β-casein A1 allele, or other commercial milk producing animals not processing [sic] the β-casein A1 allele, by inoculating commercial milk producing animals with β-casein A1, its proteolytic hydrolysis products, or fragments thereof produced by other means.

17. A process for producing immune response proteins as claimed in claim 14, wherein immunolglobulins are produced by treating a homozygous β-casein A2, B, or C, or heterozygous mixture of A2, B, and C, cow (or herd of cows), with an inoculum to produce antibodies to β-casein A1, its proteolytic hydrolysis products or fragments thereof produced by other means.

18. A product derived from cattle as claimed in claim 1 wherein the product is derived from a dead animal and the product or the animal has been tested to establish that the product is substantially free of β-casein A1 or the animal from which the product has been derived is substantially free of the β-casein A1 allele.

19. A product derived from cattle as claimed in claim 1 wherein the product is meat (or offal) or a blood product, derived from a slaughtered animal and the product or the animal has been tested to establish that the product is substantially free of β-casein A1 or the animal from which the product has been derived is substantially free of the β-casein A1 allele.

1. A method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-casein A1 but which contains any one or more of β-caseins A2, A3, B, C, D and E, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding β-casein A1;

(ii) selecting bovines which do not have DNA encoding β-casein A1 to form the herd of lactating bovines;

2. A method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-caseins A1, B and C but which contains any one or more of β-caseins A2, A3, D and E, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding any one or more of β-caseins A1, B and C;

(ii) selecting bovines which do not have DNA encoding any one or more of β-caseins A1, B and C to form the herd of lactating bovines;

3. A method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-casein A1 but which contains β-casein A2, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding β-casein A2;

(ii) selecting bovines which do have DNA encoding β-casein A2 to form the herd of lactating bovines;

4. A method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-casein A1 but which contains any one or more of β-caseins A2, A3, D and E, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding any one or more of β-caseins A2, A3, D and E;

(ii) selecting bovines which do have DNA encoding any one or more of β-caseins A2, A3, D and E to form the herd of lactating bovines;

5. A method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-casein A1 but which contains β-casein A2, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding β-casein A1 and DNA encoding β-casein A2;

(iii) milking bovines which have DNA encoding β-casein A2 from the herd to give bulk milk; and

6. A method of producing milk suitable for use in the treatment or prevention of coronary heart disease from a herd of lactating bovines which milk is substantially free of β-caseins A1, B and C but which contains any one or more of β-caseins A2, A3, D and E, the method including the steps of:

(i) testing genetic material of lactating bovines for the presence of DNA encoding any one or more of β-caseins A1, B and C and DNA encoding any one or more of β-caseins A2, A3, D and E;

(iii) milking bovines which have DNA encoding any one or more of β-caseins A2, A3, D and E from the herd to give bulk milk; and

7. A method of producing milk as claimed in any one of claims 1 to 6 in which the lactating bovines tested in step (i) are, or include, Bos taurus bovines.

8. A method as claimed in claim 7 wherein the lactating bovines are Bos taurus bovines.

9. Milk containing β-casein but free of β-casein A1 which is the product of a method as claimed in any one of claims 1 to 8.

10. Milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-casein A1 but which contains any one or more of β-caseins A2, A3, B, C, D and E, which milk is the product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding β-casein A1;

11. Milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-caseins A1, B and C but which contains any one or more of β-caseins A2, A3, D and E, which milk is the product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding any one or more of β-caseins A1, B and C;

(ii) selecting bovines which do not have DNA encoding any one or more of β-caseins A1, B and C; and

12. Milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-casein A1 but which contains β-casein A2, which milk is the product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding β-casein A2;

13. Milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-casein A1 but which contains any one or more of β-caseins A2, A3, D and E, which milk is a product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding any one or more of β-caseins A2, A3, D and E;

(ii) selecting bovines which do have DNA encoding any one or more of β-caseins A2, A3, D and E; and

14. Milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-casein A1 but which contains β-casein A2, which milk is the product of a method including the steps of:

(i) testing genetic material of the one or more lactating bovines for the presence of DNA encoding β-casein A1 and DNA encoding β-casein A2;

(ii) separating bovines which have DNA encoding β-casein A2 from bovines which have DNA encoding β-casein A1 or which have DNA encoding both β-casein A1 and β-casein A2; and

15. Milk suitable for use in the treatment or prevention of coronary heart disease obtained from one or more lactating bovines which milk is substantially free of β-caseins A1, B and C but which contains any one or more of β-caseins A2, A3, D and E, which milk is the product of a method including the steps of:

(ii) separating bovines which have DNA encoding any one or more of β-caseins A1, B and C from bovines which have DNA encoding any one or more of β-caseins A2, A3, D and E; and

(iii) milking the bovines which have DNA encoding any one or more of β-caseins A2, A3, D and E.

16. A product which contains β-casein but is substantially free of β-casein A1 and which contains or is processed from a milk as claimed in any one of claims 10 to 15.

19. The use of a milk as claimed in any one of claims 6 to 15, or of a product as claimed in claim 16, in the preparation of a medicine.

20. The use of claim 19 in which the medicine is for use in the treatment or prevention of coronary heart disease.

a) Shortly after 4 November 1994, the date of filing of NZ 264862 from which NZ 295774 claims priority, Robert Bartlett Elliott (Prof Elliott) met with the Applicant to discuss the possibility of the Applicant developing a process for separating diabetogenic milk and milk products from non-diabetogenic milk and milk products. The first meeting between the applicant and Prof Elliott was arranged by Mr Roy Austin, a board member of the National Child Health Research Foundation referred to in paragraph 1.0 above. Mr Austin had previously worked with the Applicant.

b) There were several further meetings between Prof Elliott and the Applicant before 9 May 1995, the date at which NZ 272133, the priority application for NZ 306584, was filed. During the course of these meetings Prof Elliott disclosed to the Applicant all of the invention of NZ 295774 and the associated research which he and the other Opponent had conducted to confirm the diabetogenic activity of variants of β-casein.

c) The Applicant advised Prof Elliott at the outset that he had no prior knowledge of the existence of variants of β-casein and no knowledge of the different immuno-stimulating activities of those variants.

d) Although there was no written confidentiality agreement between Professor Elliott and the Applicant the circumstances of the negotiations and the potential for a development programme which would have required the maintenance of confidentiality were sufficient to impose obligations of confidentiality on the discussions between Prof Elliott and the Applicant.

That the applicant for the patent, or the person described in the application as the true and first inventor, obtained the invention or any part thereof from him, or from a person of whom he is the personal representative

Mr Lynch reminded me that it is well settled that a high burden of proof is required to establish this ground. For example, in CGC Jowsey and JL Doutre v J Cosio, New Zealand Patent Office, 15 May 1975, Assistant Commissioner Burton said at page 4:

In obtaining cases, not only is the onus of proof upon the Opponent, but the standard, of proof required is high. The reported cases, for example Stuart’s Application 9 R.P.C. 452, confirm that it is not a question merely of the weight of the evidence being on balance in favour of the Opponent.

I consider that the question before me here, is not whether there is a balance of evidence on one side or the other. If there were any evidence on either side to be considered and adjudicated upon, I should not feel it my duty to stop the issue of a patent. I think that the Law Officer is only entitled to stop the issue of a patent, having examined all the evidence given on one side or the other, if he is so clearly of opinion that the Opponent has made out his case that he would, if a jury were to find in favour of the Applicant, refuse to accept it and overrule the decision on the ground that it was perverse and contrary to the obvious weight and effect of the evidence. That is the proposition which I keep before my mind.

Both Mr Lynch and Mr Arthur agreed that the case law has established a two part test for establishing the ground of Obtaining.

The first part of the test is to establish who is the “true and first inventor” of the invention or, as stated by Mr Lynch, “was there some person other than Dr McLachlan who is the true and first inventor of the invention claimed”.

The second part of the test, according to Mr Arthur, is to establish whether the invention was obtained in contravention of the Opponent’s rights (see the quotation from King’s Application (supra)). Mr Lynch worded the second part of the test differently as “Was there a relationship between the parties which gave rise to the act of obtaining?”, this wording being that used by Assistant Commissioner Hazlewood in Hi-Per Wash Limited v EW Schwass, IPONZ, P7/2004, at page 10. As I see it, the true test is that pronounced by Mr Arthur; although it is clear that for the invention to have been obtained “in contravention of the Opponent’s rights” there must have been at some stage “a relationship between the parties which gave rise to [the obtaining]”.

2. Was the invention “obtained” in contravention of the Opponent’s rights?

As pointed out by Mr Arthur, in determining this point one must first identify what is the inventive concept of the claims and determine the contributor or contributors to it. In paragraph 7.53 of Terrell on the Law of Patents, 15th Edition, discussing section 72(1)(b) of the 1977 British Patents Act (which deals with revocation of a patent on the ground that it was granted to a person(s) who was/were not entitled to such a grant), it is stated:

In Henry Brothers (Magherafelt) Ltd v. Ministry of Defence [[1997] RPC 693 and [1999] RPC 442] the scope and limitation of section 72(l)(b) and the related sections were considered. In order to ascertain inventorship, it is necessary to identify the inventive concept of the claim and then to determine the contributor or contributors to it. He or they will be the person(s) entitled to grant

Mr Arthur also submitted that in deciding inventorship it is the invention proposed in the patent which is to be considered and this does not involve an assessment of whether the invention represents a contribution to the art. What is relevant is what is put forward in the patent as inventive. Christopher Lloyd QC, in his judgment in the High Court of Justice Chancery Division Patents Court, said, in paragraphs 17 to 21 of Stanelco Fibre Optics Limited v Bioprogress Technology Limited [2004] EWHC 2263:

17. Two cases were discussed in argument: one where the second worker does no more than exercise his ordinary skill in putting the other worker's concept into effect; and a second where what the second worker does is out of the ordinary or inventive, but nevertheless does not specifically contribute any one feature of the claim. Mr Baldwin QC, who appeared for BioProgress submitted that in the former case, the second worker gets no interest, whereas in the latter case he does or may do.

18. I do not think that this is the correct basis on which to differentiate cases of exclusive ownership from co-ownership. The basic enquiry called for by the Act is to determine the actual deviser(s) of the inventive concept. This enquiry does not involve any assessment of whether the invention represents a contribution to the art, or an inventive contribution (in the obviousness sense) to what the other inventor has come up with. A test for co-inventorship which involves an analysis of whether one party's contribution was truly inventive, or involved more than the exercise of common general knowledge seems wholly at odds with the nature of the overall enquiry: it involves applying a different standard to one co-owner from the other. What is relevant is what is put forward in the patent as inventive. Nevertheless it does seem to me that if the second worker merely does what is suggested to him by the first worker, the second worker is not taking part in the devising of the invention.

19. Mr Miller relied on a judgment of HHJ Fysh QC sitting as a deputy judge of the High court in Markem Corporation v Zipher Limited (No 1) [2004] RPC 10 at paragraphs 66-71. There HHJ Fysh QC recorded that it was common ground in that case that co-inventorship arose in cases where the further activity was of an inventive character. He said:

"Life is not always that simple: the purveyor of even a non-inventive contribution to a working combination may also be a co-inventor".

"The quality of this contribution and its impact on the result must, I think, depend on the facts in each case".

20. I can agree with HHJ Fysh QC that the inventiveness of the contribution cannot be the determining factor. But in my judgment, the crucial question is not the inventiveness (in the obviousness sense) of the second researcher's contribution, but whether the second researcher can be said in substance to be jointly responsible for devising the inventive concept. [Emphasis added]

According to the evidence of Professor Elliott, not contested by the Applicant, he was commissioned by the New Zealand Dairy Board in 1994 to investigate, in conjunction with Dr Hill, whether certain fractions of milk were diabetogenic and others were not. This collaboration led to the discovery that the A2, A3, D and E variants of β-casein are non-diabetogenic while the A1, B, C and F variants are diabetogenic. As a result New Zealand Patent No 295774, with Professor Elliott and Dr Hill named as inventors, was granted to NCHRF and NZDB. This patent (which was published on 24 March 1997, well after the priority date, 16 May 1995, and filing date, 9 May 1996, of the present application) described both the diabetogenic and non-diabetogenic variants and methods of obtaining them by selective breeding.

Shortly after the filing of Provisional Patent Specification No 264862 (the priority document for 295774), on 4 November 1994, Professor Elliott was instructed by the NCHRF to meet with Dr McLachlan, a Chemical Engineer, to explore the possibility of making a physical separation of the two milk fractions as an alternative to separating cattle into herd which produced one or other of the two types of milk. During these discussions it was agreed that such separation was not a commercially practical solution. However, according to Professor Elliott, Dr McLachlan continued to visit him in his laboratory. During this period, in late 1994 or early 1995, Professor Elliott disclosed to Dr McLachlan the immunostimulating properties of the diabetogenic fractions of β-casein. Dr McLachlan clearly had no knowledge, until these discussions, of the immunostimulating properties of the two types of milk.

During these discussions it was Dr McLachlan who raised the question of a correlation between consumption of the β-casein variants and coronary heart disease. Professor Elliott says in paragraph 14 of Elliott 1:

I recall that in one discussion I had with Dr Mclachlan in late 1994 or early 1995, he described his earlier work trying to extract cholesterol from meat. I expressed skepticism about the evidence linking cholesterol and heart disease. At some point in the discussion he asked if the data about differences in consumption of milk of the different variants of beta-casein had ever been compared to the incidence of heart disease. I said that to my knowledge they had not been. I asked what data he might be making the comparison with. He said deaths by heart disease. I said that such data were "soft", i.e. not that reliable, as compared to the incidence of diabetes in children which was usually very accurately recorded. At the time he could not have known about the immunostimulating properties of the diabetogenic fractions of beta-casein except from me, and I had disclosed them to him in confidence. [Emphasis added]

6. As stated-in paragraph 15 of my first declaration, I was surprised and annoyed when I was informed that the Machin patent application had been accepted with claims so broad as to overlap with NZ Patent no. 295774. The Machin patent application appeared to cover information I had revealed to Dr McLachlan in scientific discussions. However, if the Machin patent application had been confined to the link between beta-casein A1 and coronary heart disease (as in the patent specification now amended), I would not have been upset.

7. My research linking beta-casein variants to human disease had entirely concerned itself with Type 1 diabetes in children. A possible link between beta-casein A1 and coronary heart disease arose only when Dr McLachlan asked me whether beta-casein variants could be a risk factor for heart disease. It was he, not me, who asked the question first. I had never considered such a link until Dr McLachlan raised the matter.

8. None of the discussions or meetings I had with Dr McLachlan where we discussed the possibly link between beta-casein A1 and coronary heart disease were part of any request from Mr Austin or the National Child Health Research Foundation. ...

10. Dr Jeremy Hill, my co-inventor for the NZ 295774 patent, was never party to any discussions I had with Dr McLachlan on the possible link between beta-casein A1 and coronary heart disease. At no stage did Dr Hill suggest such a link nor to my knowledge did he support such a link when he later learned of Dr McLachlan's investigations. ...

12. In my opinion, the invention of the Machin patent application as now amended was invented by Dr McLachlan. I do not believe that I was an inventor for that invention as it is specific to the link between beta-casein A1 and coronary heart disease and does not cover any of my research that relates to diabetes.

As I understand it, then, the Applicant does not dispute that Professor Elliott told Dr McLachlan about the immunostimulating and non-diabetogenic properties of the A2 variant of β-casein. What the Applicant contends is that Dr McLachlan discovered the correlation between coronary heart disease and the β-casein variants – this is not disputed by the Opponents.

Mr Arthur argued that the claims as originally accepted (before amendment during the opposition proceedings) were broad and covered a method for removing β-casein A1 from milk, because of its diabetogenic and other immunoactivity, and the product thereof, the invention made by Professor Elliott and Dr Hill. The present, amended, claims are a narrower sub-set limited to the use discovered by Dr McLachlan and to the use of genotyping in the production of the product. Mr Arthur submitted that it is of no moment that the claims have been narrowed – the inventive concept, removing β-casein A1 to avoid its immunoactivity, is unchanged. While Mr Arthur’s argument may not be applicable in all cases – there must be many instances when a new use, which results in the modification of a product, can result in a patentable invention – it seems to me that in the present case, the addition of the words “for use in the treatment or prevention of coronary heart disease” or “suitable for use in the treatment or prevention of coronary heart disease” does not limit the scope of the claims. The milk produced is the same whether or not this “limitation” is present; the milk is still milk which is “substantially free of β-caseins A1, B and C but which contains any one or more of β-caseins A2, A3, D and E”. This is, as I see it, analogous to the situation in the well-known British case Adhesive Dry Mounting Company v Trapp & Co (1910) 27 RPC 341 wherein Parker J, in the High Court of Justice – Chancery Division, said, at page 352-353:

“For carrying into practice the process hereinbefore described, a pellicle which is adhesive when hot and consists of a thin sheet of paper or other carrier 50 is immersed in a solution of gum lac or other gum-resin, in such a manner that the adhesive material is incorporated in the carrier and covers the two faces thereof, substantially as described."

The first question which arises on this Claim is, whether it claims the pellicle therein described, or merely the use of this pellicle in the process claimed in the first Claiming Clause. If the former, the Letters Patent would entitle the Patentees to prevent the use of such a pellicle by others, whatever might be the purpose for which it was used. If the latter, the Letters Patent would only entitle the Patentees to restrain the use of such a pellicle in any process substantially the same as the process referred to in the first Claiming Clause. I think the former is the right construction, for, if the latter be adopted, the second Claiming Clause is already included in the first. On the former construction, the Defendants are undoubtedly infringers, for they have sold such a pellicle. On the second construction, the Defendants are not infringers, for they have not used the pellicle in any such process as referred to in the first Claiming Clause, and, if any relief were given against them, it could only be relief by way of injunction, not against infringing the Patent, but against inviting other persons to infringe it by selling the pellicle expressly for the purpose of being used for mounting photographs. Such an injunction appears to have been granted in Innes v. Short (15 R.P.C. 449), but this case, having regard to the decision of the Court of Appeal in Townsend v. Howarth (L.R. 12 C.D. 830) appears to me to be of somewhat doubtful authority, and no such injunction is asked for in the Statement of Claim. On the other hand, if, according to the true construction of the Specification, it is the pellicle itself which is claimed in the second Claiming Clause, I am unable to see how such Claim has not been anticipated by Jeyes’s Specification No. 2604 of 1867. Jeyes's Specification discloses how a useful material can be made by dipping tissue paper in an alcoholic solution of shellac or other gums, and it cannot be denied that a material so prepared would be identical with, and have all the characteristics of, the Plaintiffs’ pellicle. Of course, Jeyes does not suggest that this material can be used for mounting photographs, or any analogous purpose. He contemplates it being used as tracing paper, or for wrapping tea or tobacco and such like. But after Jeyes's Patent it was open to all the world to make and sell such a material. The idea of using an old material for an entirely new purpose, not being analogous to purposes for which it has theretofore been used, may be good subject-matter, but such idea, however ingenious, can hardly justify a claim for the material itself. I have come to the conclusion, therefore, that the action fails.

However, there is no evidence before me which establishes that either Professor Elliott or Dr Hill (or anyone else for that matter) taught, or even suggested to, Dr McLachlan the method of the present claims, using genotyping in the selection of cows which form the milking herd. Thus, the Opponent (NZDB) has not established that the true and first inventor of the invention claimed is other than Dr McLachlan.

Having reached this conclusion, there is no need for me to address the second question, was the invention “obtained” in contravention of the Opponent’s rights?

Mr Arthur advised that this ground was not being pursued. However, in line with normal practice, I will consider the prior art cited under this ground in the public interest.

The usual test for prior publication is that set forth in the judgment of the English Court of Appeal, delivered by Sachs LJ, in The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited and Others [1972] RPC 457 at 485-486:

If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee's claims if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.

If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented... A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.

Applying this test to the four documents cited by the NZDB under this ground I draw the following conclusions:

The disclosure of this document, which was available in the New Zealand Patent Office Library on 2 March 1984, is adequately summarised by the abstract which reads as follows:

A total enzymatic hydrolysate from whey proteins is disclosed comprising peptidic hydrolysate with substantially no residual proteins, at least 50% of the peptides containing 2 to 5 amino acids. 70 to 90% of the nitrogen present as peptides has a number of amino acids less than 10. A process for obtaining the total enyzmatic [sic] hydrolysate is disclosed comprising hydrolysis of whey proteins with proteolytic enzyme (e.g. pancreatin), which is continued until there is no precipitable nitrogen with 12% trichloroacetic acid. Enzymatic hydrolysis may be carried out continuously. The total enzymatic hydrolysate has uses as food supplement, diet food or intensive care food, and in therapeutic nutrition.

Clearly the document does not describe the method of the present claims which involves testing genetic material of lactating bovines which are then selected to give the desired product.

This document, which was available in the New Zealand Patent Office Library on 25 March 1992, also describes a whey protein hydrolysate. Again there is no disclosure of the method of the present claims which involves testing genetic material of lactating bovines which are then selected to give the desired product.

This document, which was available in the New Zealand Patent Office Library on 10 January 1995, also describes a whey protein hydrolysate. Again there is no disclosure of the method of the present claims which involves testing genetic material of lactating bovines which are then selected to give the desired product.

(d) Nga-Kwai-Hang JF and Grosclaude F “Genetic Polymorhism of Milk Proteins, Advanced Dairy Chemistry Vol 1: Proteins (Ed Fox PF) pp 405-455, Elsevier Scientific Publishers Ltd, London (1992).

The Opponent, NZDB, states, in Paragraph 4.7 of its Statement of Case, that this document was available at the library of the New Zealand Dairy Research Institute, Palmerston North, from 5 April 1993; in paragraph 3.8 of the Applicant’s Supplementary Counterstatement, filed on 21 March 2003, the Applicant states that it “does not deny the statement made in paragraph 4.7 of the Statement of Case alleging the availability date in New Zealand of reference d)”. This document, which is entitled “Genetic Polymorphism of Milk Proteins”, discusses the A1, A2 and A3 variants of milk proteins and states that Bos Grunniens cattle have only the A2 allele of β-casein and only produce milk which is substantially free of the A1 variant. However, as is the case with documents (a), (b), and (c), there is no disclosure of the method of the present claims which involves testing genetic material of lactating bovines which are then selected to give the desired product.

Mr Arthur advised that this ground was not being pursued. However, in line with normal practice, I will consider the prior patent cited under this ground in the public interest.

One document, New Zealand patent specification No 295774, was cited under this ground. This document, which originated as a National Phase entry claiming a priority date of 4 November 1994, has a filing date of 3 November 1995. The Applicant states in its Supplementary Counterstatement filed on 21 March 2003 that it does not accept the entitlement to the priority date claimed. However, I see no need to resolve this question because it seems quite clear to me that the claims of the complete specification in suit are not prior claimed by the cited document. Claims 1 and 17 of the cited document read as follows:

1. A method of selecting milk for the presence of a non-diabetogenic variant of β-casein and the absence of a diabetogenic variant which comprises testing milk from identified cows for the presence of variants of β-casein and selecting those cows whose milk contains any non-diabetogenic variant and does not contain any diabetogenic variant, and milking separately the non-diabetogenic variant milk producing cows and recovering and maintaining their milk separately from milk from any other source.

17. A method of selecting milk for the presence of a non-diabetogenic variant of β-casein and the absence of a diabetogenic variant which comprises testing milk from identified cows for the presence of the hexapeptide Pro-Gly-Pro-Ile-His-Asn, or a protein fragment containing the hexapeptide Pro-Gly-Pro-Ile-His-Asn and selecting those cows whose milk does not contain said hexapeptide or said protein fragment containing said hexapeptide, and milking separately the cows whose milk does not contain the said hexapeptide or said protein fragment containing said hexapeptide and maintaining their milk separately from milk from any other source.

As pointed out by Mr Lynch, these claims (and claims 2 to 16 and 18 to 24 which are dependent on them) relate to phenotyping (testing milk for the protein) rather than genotyping (testing cows for DNA) as is the case for the claims of the present complete specification.

Claims 25 and 26, and the dependent claims 27 to 34, relate to a method of selecting breeding cows and bulls; there are no claims to such a method in the present complete specification.

The remaining claims, claims 35 to 41, of the cited document are either omnibus claims or are dependent to preceding claims.

That the invention, so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step having regard to matter published as mentioned in paragraph (b) of this subsection, or having regard to what was used in New Zealand before the priority date of the applicant’s claim.

Mr Lynch drew my attention to the relevance of the word “clearly” in this subsection. For example, Barker J said, in Beecham Group Ltd v Bristol-Myers Company (No 2)(1980) 1 NZLR 192 at 230:

The word “clearly” in s 21(1)(e) is not found in s 41(1)(f) which provides, as a ground for revocation by the court of a patent in proceedings to that end:

That the invention, so far as claimed in any claim of the complete specification, is obvious and does not involve any inventive step having regard to what was known or used before the priority date of the claim in New Zealand.

The insertion of the word “clearly” in the opposition section indicates a higher onus on an opponent in opposition proceedings who alleges that there is no inventive step; the omission of the word in the revocation section indicates that the onus there is not quite so high.

Both Mr Lynch and Mr Arthur also referred me to Ancare New Zealand Ltd v Cyanamid of NZ Ltd [2000] 3 NZLR 299, wherein the New Zealand Court of Appeal stated:

... the test [for obviousness] is well established. It postulates a person (or, where appropriate, a team) skilled in the field but not inventive, invested with the common general knowledge available in the field at the priority date, presented with the prior knowledge or prior use relied upon. Prior documents may be looked at together if that is what the skilled person or team would do. It asks whether to that person or team the alleged inventive step would be obvious and would be recognised, without bringing to bear any inventiveness, as something that could be done or is at least worth trying. That is a question of fact. If any embodiment within the scope of the claim is obvious the claim is invalid. These propositions are helpfully expanded upon in the recent English cases which are still applicable though under the 1977 Act; see the Windsurfing International case. Hallen Co v Brabantia (UK) Ltd [1991] RPC 195, at p211, and Mölnlycke AB v Procter & Gamble Ltd [1994] RPC 49 at 112.

Both Mr Lynch and Mr Arthur also referred me to the four-step approach set out in the Windsurfing International judgment at pp 73 – 74:

There are, we think, four steps which require to be taken in answering the jury question. The first is to identify the inventive concept embodied in the patent in suit. Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question. The third step is to identify what, if any, differences exist between the matter cited as being ‘known or used’ and the alleged invention. Finally, the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.

As I understand it, in applying the Windsurfing test to the present case, I must:

Mr Lynch also reminded me of the “supplementary principles” which should be considered, as set out by Fisher J in Lucas v Portable Sawing Systems Ltd [2003] NZLR 361 at 377:

A series of supplementary principles then assist. I would summarise them for the purpose of this case as follows:

(a) Where the invention is the combination of features all of which were individually known, the Court must avoid the danger of concentrating on the integers rather than the whole concept: Wood v Gowshall Ltd (1937) 54 RPC 37; Smale at p 43; Sabaf SpA v Meneghetti SpA [2002] EWCA Civ 976; [2003] RPC 264 at p 278, para 40.

(b) The Court must also avoid the danger of falling into ex post facto analysis. It must put out of its mind developments since the invention and view the question of obviousness from the perspective of persons skilled in the art immediately before the priority date: Non-drip Measure Co Ltd v Stranger's Ltd (1943) 60 RPC 135 at p 142; Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346 at p362. The warning against being wise after the event is of special importance in a field, such as the present one, where it is easy to imagine that one is skilled in the art after a relatively brief period looking at a few drawings: Fichera v Flogates Ltd [1983] FSR 198.

(c) There is no inventive step if a known article is applied to a new and analogous purpose: Morgan and Co v Windover and Co (1890) 7 RPC 131 (HL) at p 134; Smale v North Sails at p 43.

(d) Similarly, there is no inventive step if known features are brought together into a single whole in which the component parts continue to "do their own thing": International Paint Co Ltd's Application [1982] RPC 247 at p275. Thus there is no invention if "howsoever juxtaposed to the other ingredients of the mixture or parts of the article, each part performs its own function and would do so even in the absence of the other parts". The converse is true if the collocation of features produces a new or improved function by virtue of the novel relationship established between the known features.

(e) Obviousness relates to the technical subject-matter claimed to be inventive, and not to its commercial worth: Windsurfing at p 72.

(f) The mere fact that the claim is merely to an improvement to a product already on the market does not preclude an inventive step: Hickman v Andrews [1983] RPC 147 at p 189.

(g) In the end, it is impossible to avoid the conclusion that the distinction between novelty and obviousness is a question of degree rather than classification, at least in a case of the present kind.

Mr Lynch further reminded me that evidence is required to establish the ground of Obviousness and referred me to my decision in Sidlaw Flexible Packaging Limited v W R Grace & Co-Conn, IPONZ, 26 March 1999 (P19/1999). At page 8 I said:

Mr Callus also submitted that “it is well established...that [I] cannot consider questions of obviousness, unless [I am] provided with expert testimony to support the allegation”. In the present case, according to Mr Callus, “...there is a complete lack of evidence concerning the contents of these references” although the question of obviousness, in view of the disclosure of these references, has been discussed by the opponent in paragraphs 6.1 to 6.7 of the Amended Statement of Case. I agree.

He also referred me to Conform New Zealand Limited v AEP Industries Limited, IPONZ, 6 April 2000 (P7/2000). I said at page 8:

Mr Arthur pointed out that the only substantive evidence before me is the unchallenged evidence of Mr Port and that the absence of evidence from the applicant raises strong presumptions about the reliability of Mr Port’s evidence. He submitted that in the present case I am entitled to draw the inference that nothing any witness for the applicant could have said would assist the applicant. In support of his submission Mr Arthur referred me to Cross on Evidence, paragraph 2.19:

2.19 Absence of material witness - The absence of a material witness cannot be used to make up any deficiency of evidence. If, however, a witness who had knowledge of the circumstances in issue is not called by the defendant, the tribunal of fact may conclude that the evidence given for the plaintiff may more readily be accepted, as well as any inference open from facts directly proved by the plaintiff. The circumstance that the defendant might have proved the contrary is a proper consideration in favour of drawing the inference. But sometimes the only proper inference is that the evidence of the absent witness would not have helped the party not calling the witness.

I agree with Mr Arthur. However, whether or not obviousness is established is a question for my judgment based on the evidence available. The opponent’s evidence, whether or not any evidence has been provided by the applicant, must be sufficient to convince me that the claims do not involve any inventive step. As discussed above, the burden of proof required is high and the benefit of any doubt must be given to the applicant.

Mr Arthur advised that, although the Statement of Case filed on 28 September 2000 by NZDB and NCHRF relied on four publications for the ground of Obviousness, only one document is now relied upon, Nga-Kwai-Hang JF and Grosclaude F “Genetic Polymorphism of Milk Proteins, Advanced Dairy Chemistry Vol 1: Proteins (Ed Fox PF) pp 405-455, Elsevier Scientific Publishers Ltd, London (1992). The Opponent, NZDB, states, in Paragraph 4.7 of its Statement of Case, that this document was available at the library of the New Zealand Dairy Research Institute, Palmerston North, from 5 April 1993. In paragraph 3.8 of the Applicant’s Supplementary Counterstatement, filed on 21 March 2003, the Applicant states that it “does not deny the statement made in paragraph 4.7 of the Statement of Case alleging the availability date in New Zealand of reference d)”.

Mr Arthur submitted that the inventive concept is “Removing β-casein A1 to avoid its immunoactivity” and went on to say that whether or not Dr McLachlan developed that invention into a different disease, there is no doubt that without that inventive concept from Dr Hill and Professor Elliott, Dr McLachlan would never have achieved the invention now claimed.

Mr Lynch made no specific submissions on the “inventive concept” but, as I understand it, his concept would be along the lines of “The production of milk suitable for the prevention of coronary heart disease by the method claimed in Claim 1”.

I think the latter proposal is nearer the mark, but my comments above on the meaning of “suitable for use ...” in a claim must be considered – as I understand it these words do not substantially, if at all, limit the scope of the claim.

What is disclosed in the cited published matter and what are the differences between the cited published matter and the invention as claimed?

The cited document sets out, on pages 412 to 413, the discovery, at various times between 1961 and 1984, of a number of variants of milk proteins, including β-casein A1, A2, A3, A4, B, C, D, and E, in several dairy cattle breeds. At page 416 it is noted that the A2 variant was the first to be completely sequenced and gives some information on the differences between this variant and variants A1, A3, B, C, D and E. Under the heading “β-casein” on pages 429 to 431, there is a discussion of the distribution of the different variants in various cattle breeds:

Subtyping of β-casin [sic] A into A1, A2 and A3 by acid gel electrophoresis (Peterson &. Kopfler, 1966) was performed in less than half of the published breed investigations. Despite this. there is enough evidence to conclude that: β-CnA1 and β-CnA2 are present in all Bos taurus and Bos indicus populations, while grunniens may only have β-CnA2 (Grosclaude et al., 1982). Variant A2 is predominant in all zebu populations investigated so far and in the majority of taurine breeds, and may thus be considered as the original type of the genus Bos. Among the international breeds, the Guernsey has, by far, the highest frequency of β-CnA2 (0.8 to 0.95 according to Rausch et al., 1967; Kiddy et a/., 1968; Zikakis et al., 1974). In the present state of knowledge on European cattle, the highest concentration of breeds with a high frequency of β-CnA2 (more than 0.7) is in the group of essentially beef breeds of central and southern France, including the Charolais, Limousin, Blonde d'Aquitaine, Salers, Aubrac, Ferrandaise (Grosclaude, 1988). On the other hand. variant β-CnA1 occurs at high frequencies (0.4 to 0.7) in breeds of North European location or origin (Fig. 3) like the Ayrshire ...

The cited publication gives no information on methods of producing milk free of β-casein A1 by any means and certainly not by the use of genotyping as claimed in the present complete specification.

Does this difference constitute steps which would have been obvious to a “normally skilled but unimaginative addressee” in the art of milk production, (who is armed with the common general knowledge of the art at the priority date), or do they require any degree of invention

In answering this question I must put myself in the role of the “normally skilled but unimaginative addressee” in the relevant art. I find this difficult because I appear to have no evidence before me, from either party, which establishes who is the notional skilled addressee or what is the common general knowledge he/she would possess. Mr Arthur referred me to Paragraph 13 of Hill 1 which reads:

What is presented as the novel and inventive discovery in the Opposed Application (for example on page 9) is that it is the consumption of β-casein A1 that causes heart disease rather than simply consumption of β-casein or of milk. Looking at the other features of the Opposed Application, it is clear that there is no novelty in the segregation of cows. The genotyping of cattle for β-casein variants is described in Lien et al (1992) Animal Genetics 23, 333-338. This paper was referred to in example 6 of the aforementioned NZ 295774. What is stated to be the invention is the segregation or selection of cattle which do not have the β-casein A1 variant as this has been linked to CHD. However, in my opinion, the inventor of the opposed application has not established a valid correlation between β-casein A1 consumption and CHD. [Emphasis added]

Dr Hill is certainly an expert in his field. He is General Manager Research and Technical Operations for the Fonterra Co-operative Group Limited and is a biochemist with ten years experience in the field of dairy technology including milk protein chemistry and genetic polymorphism. He is an International Dairy Federation Expert on the subject of milk protein genetic variations and states that he and his team have conducted more extensive research in this area than any other group globally, including the area of health effects of β-casein variants. Thus, he is hardly the “normally skilled but unimaginative addressee” in the field and is not, it seems to me, in a position to provide objective evidence on the common general knowledge such a person possesses. I also note that the Lien article he refers to has not been produced either as evidence or as a document cited under this ground.

In the absence of appropriate evidence I find that the ground of Obviousness has not been made out.

Paragraphs 1.1 to 1.3 of the NZDB’s Supplementary Statement of Case, filed on 16 September 2002, state:

1.1 The Opponent says that claims 1 to 20 of the Opposed Application inserted by the supplementary Counterstatement of 26 June 2001 are not an invention within the meaning of section 2 of the Patents Act 1953.

1.2 The invention claimed in each of claims 1 to 20 is based on an alleged co-relation between the consumption of milk containing the β-casein A1 allele and the incidence of coronary heart disease. Evidence will be adduced that there is no such co-relation.

1.3 In the absence of the alleged co-relation referred to in paragraph 1.2 there is no discovery associated with an industrial application, or, in terms of the definition of invention in section 2 of the Patents Act 1953, there is no manner of new manufacture. There is a failure of consideration from the Applicant and hence no invention.

That the subject of any claim of the complete specification is not an invention within the meaning of this Act

any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies and any new method or process of testing applicable to the improvement or control of manufacture; and includes an alleged invention

Mr Arthur quoted the following modern English version of the Statute of Monopolies:

Provided also and be it declared and enacted, that any declaration, before-mentioned, shall not extend to any letters patent and grants of privilege for the term of fourteen years, or under, hereafter to be made, of the sole working or making of any manner of new manufactures within this realm, to the true and first inventor and inventors of such manufactures, which others at the time of making such letters patent and grants shall not use, so as also they be not contrary to the law, nor mischievous to the state, by raising prices of commodities at home, or hurt of trade, or generally inconvenient. The said fourteen years to be accounted from the date of the first letters patent of grants of such privileges hereafter to be made, but that the same shall be of force as they should be, if this act had never been made, and of none other.

He also referred me to Pfizer Inc v Commissioner of Patents (2004) 60 IPR 624, where the Full Court of the Court of Appeal, reviewing the definition of invention in light of an earlier judgment of the Court of Appeal in Pharmac v Commissioner of Patents [2000] 2 NZLR 529, stated:

[56] While we accept that the interpretation of the Act can be informed by New Zealand's obligations under the TRIPS Agreement, we are also mindful that parliament amended the Patents Act in 1994 only to the extent that it was thought to be necessary to bring New Zealand into compliance with the TRIPS Agreement. No change was made to the definition of "invention" in s 2 (which incorporates by reference s 6 of the Statute of Monopolies), even though, at the time of those amendments, the Wellcome decision was authority for the proposition that methods of medical treatment were not patentable (and one of the grounds on which that decision was based was the "generally inconvenient" wording incorporated into the definition of "invention"). It is notable that Art 27:3(a) specifically provides for exceptions for methods of medical treatment and it is possible that parliament was content to leave the statute unamended in this regard, so that the exception which had applied as a result of the Wellcome decision continued to apply as Art 27:3(a) permitted. ...

[58] We therefore conclude that, notwithstanding New Zealand's obligations under the TRIPS Agreement, the definition of "invention" continues to incorporate the full text of s 6 of the Statute of Monopolies. And we also conclude that the definition as it has been interpreted by the New Zealand courts does not bring methods of medical treatment within the scope of inventions for which patent protection may be obtained. [Emphasis added]

It is generally recognised that patents are a form of social contract which involves the exchange of consideration between the state and the inventor (or applicant). In return for the inventor disclosing his/her invention the state grants a 20 year monopoly of the right to exploit the invention (see page 325 of “Intellectual Property in New Zealand”, Frankel and McLay, Butterworths (2002); Chapter 10 paragraph 10 of the “Report of the Royal Commission on Genetic Engineering (2001)). Mr Arthur contended that if there is no consideration from the inventor (i.e. there is no actual discovery which has been commercially applied), then there is no benefit to the State. It follows that it is "generally inconvenient" to grant a patent where there is no discovery because the patentee is receiving a monopoly but the State is receiving nothing. Applying this argument to the present case, Mr Arthur submitted that, although the inventor asserts that he has discovered that consumption of β-casein A1 causes coronary heart disease, in fact the evidence establishes there is no such causative effect. It follows, therefore, that the inventor has not disclosed any meaningful discovery or commercial application of that discovery to the State and thus the grant of the patent is “generally inconvenient” and thus does not satisfy the statutory criteria for being an invention.

Mr Lynch, on the other hand, submitted that the invention claimed is a manner of new manufacture and therefore is an invention within the definition of section 2. I agree. As discussed above, as I understand it the words “suitable for use...” do not substantially, if at all, limit the scope of the claims. The claims, as pointed out by Mr Lynch, are directed to a method of producing milk and the product (milk substantially free of β-casein A1). None of the grounds of Prior publication, Prior claiming, or Obviousness have been made out and I must therefore assume that the method and product claimed are new. Whether or not the product has the desired properties (the ability to prevent or treat coronary heart disease) is a question of inutility, which is not a ground of opposition before the Commissioner under section 21, although it is a ground for revocation by the Court under section 41(1)(g). For example, in paragraph 4-401 of “Patents for Invention”, TA Blanco White, 4th edition (1974) states:

It is an objection to the validity of a patent in High Court proceedings that "the invention so far as claimed in any claim of the complete specification is not useful." This objection is not available in opposition to grant (Johnson’s Patent (1938) 55 RPC 4 at 17); nor is it one that the Patent Office may take of their own motion (TS’s Application (1924) 41 RPC 530 at 536). (It will, however, often be possible for the objection to be cast into a form in which it can be raised in Patent Office proceedings, such as insufficiency, or unjustified width of claim.)

That the complete specification does not sufficiently and fairly describe the invention or the method by which it is to be performed

In Noton NZ Limited v Alister Bevin Ltd (1979) 1 NZIPR 236 at 238 Davison CJ quoted with approval a passage from the decision by Mr Burton defining the scope of the ground of Insufficiency:

An allegation of Insufficiency is an allegation that the addressee of the complete specification will be unable to produce the subject of the principal or broadest claim by following the directions of the specification without further invention on the part of the addressee.

Graham J, in International Business Machines Corporation’s Application [1970] RPC 533 at 542, in the United Kingdom Patents Appeal Tribunal, set out the scope of this ground as follows:

Sufficiency is a question of fact in each case and the requirement is the same whatever the form of claim. It may well be that one's examination is perhaps on a slightly different basis depending on the particular wording of the claim in question, but in the end the question that must be asked is the same in all cases and that is whether in fact the skilled addressee can from the wording of the specification carry out the invention there described. That has been laid down in a very large number of cases which I need not refer to in detail here.

Similar points are made by Lindley LJ in Edison and Swan Electric Co v Holland (1889) 6 RPC 243 at 280, and in Eastman Kodak’s Application [1970] RPC 548 Whitford J, in the British Patents Appeal Tribunal said at page 564:

I think that, where as here what is alleged in the body of the specification is the disclosure to the public of an invention which will enable them to make solid highly crystalline polypropylenes with tensile strength from 5,500 p.s.i. up to an unlimited value, stiffness from 180,000 p.s.i. up to an unlimited value and a limiting melting point from 180 deg. C. up to an unlimited value and the description tells you no more than will enable you to get a modest increase over the prior art polypropylenes in relation to limiting melting point and stiffness, using the process which the patentees describe as the preferred process, the invention the subject of the complete specification has not been sufficiently or fairly described, nor in my view has there been a sufficient and fair description of the method by which it is to be performed. The applicants are of course entitled to the benefit of the doubt, if doubt there be, but in the present case the specification and evidence do not leave me in any doubt that the description of the invention and 'the method by which it is to be performed is insufficient and unfair within the meaning of the section.

As I understand it, none of the Opponent’s evidence or submissions question the fact that the complete specification contains sufficient information to enable an appropriately skilled addressee to produce milk which is substantially free of β-casein A1. The Opponent’s contention is that the specification does not give sufficient directions to enable such an addressee to produce milk which “is suitable for use in the treatment or prevention of coronary heart disease”.

I have already indicated that I do not think these words limit the scope of the claim. However, because both parties have discussed at length the alleged correlation between β-casein A1 consumption and coronary heart disease, I should consider it at least briefly.

There is a great deal of evidence, from both parties, on this point. Mr Arthur submits, correctly I think, that the evidence of the two parties indicates that there is some correlation, but not necessarily a causative effect, between consumption of β-casein A1 and coronary heart disease. Although this has been contested by some of the Opponent’s witnesses, particularly Professor Truswell, it seems to me that Dr Laugesen presents a fair summary of the evidence. Although he is a witness for the Applicant, he is very well qualified and has no apparent association with either party. He says in his evidence:

5. I am aware that Dr McLachlan had applied for research funds from the National Heart Foundation to investigate the correlation referred to above in paragraph 4. Dr McLachlan's claims, if true, were potentially of great scientific importance. I was asked by Dr Boyd Swinburn, the then director of the National Heart Foundation, to investigate whether there was any merit in claims made by Dr McLachlan that there is a link between the consumption of beta-casein A1 and the incidence of coronary heart disease.

6. Through my own investigations I was able to confirm the correlation found by Dr McLachlan. I rigorously tested his hypothesis in conjunction with Professor R B Elliott. A list of comments on our investigations is attached marked "Exhibit BML-4". ...

7. I used an international database compiled by me to investigate the claimed correlation. My database contains information on food and nutrition supply per capita for the period 1961 to 1995 across more than 20 industrialised countries, including New Zealand. The database also contains information on tobacco and alcohol consumption, both of which are known to affect heart disease. The database enables the comparison of more than 100 items or nutritional measures in the food supply to be made against mortality rates. The investigations with Professor R B Elliott were published in The New Zealand Medical Journal in January 2003 in a paper entitled "Ischaemic heart disease, Type 1 diabetes, and cow milk A1 beta casein". A copy of this paper is attached marked "Exhibit BML-5".

10. I formed the view that there is a significant correlation at the population level between the apparent consumption of beta-casein A1 per capita in fresh milk and cream and the national coronary (ischaemic) heart disease mortality rate. Dr McLachlan had, in my view, uncovered an important correlation with great potential significance. ...

16. Paragraph 10 of Dr Hill's declaration is based on his knowledge that beta-caseins A1, B and C all have a histidine amino acid at position 67. But Dr Hill imposes this single biochemical difference as a prior condition for interpreting whether a correlation exists or not for beta-casein A1 alone. He argues that beta-caseins A1, B and C should be studied for their combined effect on the correlation with heart disease. Professor Elliott and I did this and found that beta-caseins B and C weakened the correlation of beta-casein A1 with heart disease. In doing so, we confirmed what Dr McLachlan had found empirically, i.e. that beta-caseins B and C were unimportant. In other words, data on beta-caseins B and C added nothing to the correlation of beta-casein A1 with heart disease mortality. There are other differences, such as differences between the solubility of beta-caseins A1, B and C, which could explain the differences in correlation with heart disease.

21. In paragraph 19 of his declaration, Dr Hill points to a lack of animal evidence in the Machin patent application supporting a relationship between beta-casein A1 consumption and coronary heart disease. I have read the publication by Professor Julie Campbell appearing in the journal Atherosclerosis in 2003. A copy of that publication is attached marked "Exhibit BML-9". Professor Campbell's team showed increased atheroma in New Zealand rabbits when fed beta-casein A1, but not in those fed beta-casein A2. The conclusion was that beta-casein A1 is atherogenic, compared with beta-casein A2. This is not proof that beta-casein A1 would be atherogenic in humans, but it does substantially increase that possibility.

22. In paragraph 8 of Dr Crawford's declaration, he says that the18 datapoints used in the Machin patent application were insufficient to draw statistically reliable inferences. However, statistically reliable inferences require that like be compared with like. Health care affluent countries need to be compared with similarly health care affluent countries. Dr Crawford did not appear to do this. The populations considered must stand an even chance of surviving once they develop heart disease so that their death rates can be used as a measure of the incidence of heart disease. Beta-casein A1 in the diet may influence the incidence of heart disease, whereas health care determines whether the outcome is fatal in the majority who survive long enough to reach hospital. Comparing like with like limits the numbers of countries that can be validly compared. As mentioned in paragraph 18 above, Professor Elliott and I used 18 countries for milk protein and found a statistically significant correlation with ischaemic heart disease (r=0.60). This is shown in Table 2 of our paper referred to in paragraph 7 above. We considered 20 countries when investigating a correlation between beta-casein A1 consumption and ischaemic heart disease. A statistically more significant correlation was found (r =0.76, p=<0.001) and this is shown in Figure 1 and Table 2 of our paper referred to in paragraph 7 above. There is less than one chance in 1000 that the finding of a correlation was due to chance alone. Thus, again, the correlation between beta-casein A1 and heart disease was confirmed.

23. Exhibit RAC-5 of Dr Crawford's declaration is a table (Table 4). Dr Crawford shows a lack of correlation between heart disease and milk protein for the years 1969-1985. Dr Crawford has not allowed any time lag between milk consumption and heart disease. He should have allowed 5 years for a dietary factor to affect heart disease death rates. Even so, this would not permit one to rule out milk protein as a factor in preventing heart disease. It merely means that other factors may have obscured the relationship between milk protein and heart disease mortality. Paragraph 8 and Table 4 of Dr Crawford's declaration shows percentage decline in the heart disease death rate between 1969 and 1995 across 13 countries, compared to the declines or rises in milk protein consumption per capita. This illustrates the difficulty in explaining falling death rates (without allowing for less smoking, less fatty diet, better medical treatment and surgery) when milk consumption has risen in some cases and fallen in others. Professor Elliott and I also noted this in our paper referred to in paragraph 7 above. This does not invalidate the correlation found between beta-casein A1 consumption and ischaemic heart disease. We found that correlations between average beta-casein A1 consumption and subsequent average ischaemic heart disease mortality rate remained at uniformly high levels whether measured 5, 10, or 20 years later. The lag period between population exposure and elevated ischaemic heart disease death rate did not seem to be influential at all. In other words, it is possible that beta-casein A1 consumption at a much earlier age, as in childhood, may result in a permanent predisposition of a population to ischaemic heart disease in late adulthood, and thus the level of that original exposure varies with the ischaemic heart disease death rate.

24. Dr Crawford rightly refers to the "ecological fallacy" in paragraphs 10 and 11 of his declaration. Dr Crawford correctly considers that population level data may occasionally conceal differences that are nevertheless real. However, population level correlations (ecological studies) frequently do provide useful correlations. Also, strong correlations across 20 countries are quite unusual. Professor Elliott and I found that ischaemic heart disease correlated more strongly with milk protein in the food supply as measured 5 years previously (previous to the year in which the death rate was measured) than with any other dietary correlations we could find. Again, this is shown in our paper referred to in paragraph 7 above.

30. In paragraph 21 of his declaration, Professor Goddard says that the Machin patent application gives no convincing evidence that the correlation with heart disease cannot be simply explained by milk consumption. I found differently. Although beta-casein A1 yields in the milk supply are only known for around 20 health care affluent countries, on re-examining data in the Machin patent application, I found that the correlation was, in fact, as noted above, much stronger (76%) for beta-casein A1 supply, than for milk alone as measured by milk protein (60% correlation), with heart disease rates five years later.

Dr Laugesen’s comments (Exhibit BML-4) on the investigations carried out by him in conjunction with Professor Elliott (who was a witness for both parties) read as follows:

The investigation by Professor Elliott and me of the link between beta-casein A1 consumption and coronary heart disease required consideration of a number of parameters and adjustments. These are outlined as follows.

1. We tracked down every possible reference to beta-casein A1 milk that we could find, with the assistance of the Fonterra library. We found no new data or science that disproved Dr McLachlan's claimed correlation between beta-casein consumption and coronary heart disease.

2. We included information in our investigation on more countries than Dr McLachlan did in his studies. That further information related to the A1 A2 distribution of Italian cow breeds, and also the natural experiments of Jersey and Guernsey where milk low in beta-casein A1 content has been produced and consumed on each island for a hundred years or more and no other milk or breed is imported. Our investigation was based on 20 health services affluent countries, counting the UK as one country only. The correlation remained high and could not now be upset by the inclusion or deletion of any one or two countries.

3. We considered the years 1975,1990 and 1995, in addition to the years 1980 and 1985 considered by Dr McLachlan in the Machin patent application. The correlation remained high. We established that the correlation was not just a lucky chance finding by Dr McLachlan.

4. We used United Nations annual import volume data and the country of origin of those imports, and adjusted for the beta-casein A1 levels of imported milk in those countries that import much of their milk. The beta-casein A1 milk supply estimate therefore reflected the total milk supply. The correlation increased when we made these adjustments.

5. We considered only fresh milk and cream in the milk supply in our investigations. We did not consider butter or cheese. When not factoring in butter or cheese, the correlation increased.

6. When estimating the milk supply per capita, we counted only the fraction of milk produced from cows (not from goats or sheep) which do not produce beta-casein A1 in their milk. The correlation increased on making this adjustment.

7. When estimating the beta-casein A1 content of milk by country, year, and breed, we adjusted for published milk yields per cow and protein concentration in the milk of different breeds by country and year so that we could estimate the average beta-casein A1 content in each national milk supply. This adjustment slightly weakened the correlation, perhaps due to the fact that the data was based only on registered pure breeds and herds.

8. We obtained milk test results for beta-casein A1 for a number of countries - carried out by the Fonterra Research Centre. This provided additional data for some countries.

9. We also obtained data from WHO MONICA studies of non-fatal heart disease. This data showed that rates for non-fatal, as well as fatal, heart disease correlated with beta-casein A1 per capita in the fresh milk and cream supply of the country some five years previous. Thus, beta-casein A1 consumption correlates with heart disease, when rigorously defined under the research conditions of the WHO MONICA project, by the world's leading cardiology researchers, and when applied to both fatal and non-fatal heart disease.

10. We included mortality age standardised for the age group 35-64 years. Above this age, death certificates may be less accurate. We averaged the male and female rates. The correlation was stronger for males.

11. We tested correlations with mortality 5, 10, 15 and 20 years after the reported milk supply availability of beta-casein A1 milk. The correlations were stable across these time periods. This meant that whatever the postulated lag between diet and death (usually taken as 5 to 10 years), the correlation remained high.

Although these investigations by Dr Laugesen and Professor Elliott are criticised in several respects by Professor Truswell, it seems to me, after reading all the evidence, that they provide the clearest indication available to me that there is a very strong likelihood of a correlation between consumption of β-casein A1 and coronary heart disease. That there is little, if any, evidence of a causative relationship is, I think, not of great importance – the onus of proof is on the Opponent and there is, as I understand it, no evidence which proves that there is no correlation or causation. On the contrary, Professor Elliott (who initially gave evidence on behalf of the Opponent), in paragraph 16 of Elliott 2 (on behalf of the Applicant) states:

My view is that whether or not a causative relationship can be established on the basis of the information contained in the specification of the Machin patent application, there is at least the possibility, and even the probability, that the relationship is causative. Proof of a causative relationship could only be established by an appropriately designed intervention study in which beta-casein A1 is withdrawn from a group of individuals and any subsequent coronary heart disease experienced by them, and by an equivalent group who did consume beta-casein A1, studied over a protracted period of many years. Due to the time required for studies of this nature, they are rarely undertaken before recommending dietary intervention for the prevention of disease.

I find that none of the grounds (Obtaining, Prior Publication, Prior Claiming, Obviousness (first limb), Not in Invention, and Insufficiency) have been made out.

Both parties made submissions seeking costs. After considering these submissions I conclude that costs in this case should lie where they fall. Although none of the grounds pleaded by the Opponents have been made out, the opposition resulted in comprehensive amendments being made to the complete specification, resulting in a considerable reduction in the scope of the claims in their final form. Thus, I make no order on costs.

Intellectual Property Office of New Zealand - Patents Decisions

A2 Corporation Limited v New Zealand Dairy Board and JP Hill [2005] NZIPOPAT 15 (4 July 2005)