Patentability of Life Forms

1. Patentability of Life Forms Until 1980, the prevalent legal opinion was that transgenic life forms were not juridical inventions.

2. The Genesis of Patents on Life • In order to fully appreciate Canadian jurisprudence on the patentability or lack thereof of alleged inventions pertaining to life forms, especially, the Supreme Court decision in the Harvard Oncomouse, it is best to start with the US Supreme Court decision in Diamond v. Chakrabarty.

3. Diamond v. Chakrabarty • The majority decision (5-4) of the US Supreme court altered the state of the law on inventions relating to life forms. Prior to Diamond v. Chakrabarty, patents had been issued to processes utilizing life forms. Patent laws rejected product patents on life forms. Diamond’s case was thus the first product patent for a life form.

4. Facts of Diamond case • Anand Chakrabarty, a microbiologist working for GE filed a patent application, assigned to General Electric Co. The application asserted 36 claims related to Anand’s invention of “a bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.”

5. Technical details of the Invention • Plasmids are hereditary units physically separate from the chromosomes of the cell. In his research, Anand and a colleague discovered that plasmids control the oil degradation abilities of certain bacteria. Anand discovered a process by which four different plasmids, capable of degrading four different oil components could be transferred to and maintained stably in a single Pseudomonas bacterium, which itself, has no capacity for degrading oil. In effect, Anand created a new bacterium.

6. Facts of Diamond, Cont’d • The human-made, genetically engineered bacterium is capable of breaking down multiple components of crude oil. This ability, lacking in naturally occurring bacteria is believed to have significant value for the treatment of oil spills.

7. Distinguish Anand From Funk • In the Funk case, however, the patentee had discovered that there existed in nature certain species of root-nodule bacteria which did not exert a mutually inhibitive effect on each other. He used that discovery to produce a mixed culture capable of inoculating the seeds of leguminous plants. In contrast, Anand created a transgenic life form, hitherto unknown to nature.

8. Rationes decidendi in Funk • In rejecting the application, the court reasoned that “each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way.”

9. Nature of the Claims by Anand • Anand’s patent claims were of three types, viz; • Process claims for the method of producing the bacteria, • Second, claims for an inoculum comprised of a carrier material floating on water, such as straw, and the new bacteria, • Third, claims to the new bacteria itself

10. Decision of the USPO • The patent examiner allowed the claims falling into the first two categories but rejected claims for the bacteria. The decision of the USPO rested on the grounds that : • 1. Micro-organisms are products of nature, and • 2. As living things they are not patentable under 35 U.S.C. 101. • These arguments reflected the generally accepted position of the law in many jurisdictions

11. The Appeal by GE/Anand • Anand/GE appealed to the Patent Office Board of Appeals. The Board affirmed the examiner on the second ground. Relying on the legislative history of the US 1930 Plant Patent Act, in which the US Congress extended patent protection to certain asexually reproduced plants, the Board concluded that s.101 was not intended to cover living things such as micro-organisms

12. Appeal Process, cont’d • On further appeal, the Court of Customs and Patent Appeals, by a divided vote, reversed the Appeal Board (on the authority of its prior decision In re Bergy (Bergy held that the fact that micro-organisms…are alive…is without legal significance for purposes of patent law). On appeal to the US Supreme Court, the SC reasoned thus:

13. Majority View in Diamond • Burger, C.J., Stewart, Blackmun, Rehnquist, and Stevens, JJ concurring held that “in choosing such expansive terms as ‘manufacture’ or ‘composition of matter’ …Congress contemplated that the patent laws should be given wide scope, and the relevant legislative history also supports a broad construction.”

14. Majority View in Diamond • The plurality of the court further reasoned that the application was for a non-naturally occurring manufacture of composition of matter-a product of human ingenuity having a distinctive name, character and use. • Further, that contrary to the argument of the USPO, the passage of 1930 Plant Patent Act and the 1970 Plant Variety Protection Act did not exhaust the definition of the phrase “composition of matter” or ‘manufacture.”

15. Majority View in Diamond • The fact that genetic technology was unforeseen when Congress enacted 101 does not require the conclusion that micro-organisms cannot qualify as patentable subject-matter until Congress expressly authorizes such protection. Moreover, that arguments against patentability under 101, based on potential hazards that may generated by genetic research, should be addressed to the Congress and the Executive, not to the judiciary.

16. Law-making process • “It is, of course, correct that Congress, not the courts, must define the limits of patentability; but it is equally true that once Congress has spoken, it is the province and duty of the judicial department to say what the law is. Congress has performed its constitutional role in defining patentable subject matter in 101; we perform ours in construing the language Congress has employed.” Burger, C.J.

17. Dissenting View in Diamond • Speaking for the minority, Brennan J., (joined by White, Marshall, and Powell, JJ.,) conceded that the process patent was not in issue. However, in their opinion “the only question we need decide is whether Congress….intended inventors to secure a monopoly on the living organism itself, no matter how produced or how used. Because I believe the Court has misread the applicable legislation, I dissent.’

18. Dissenting View in Diamond • “given the complexity and legislative nature of this delicate task, we must be careful to extend patent protection no further than Congress has provided. In particular, were there an absence of legislative direction, the courts should leave to Congress the decisions whether and how far to extend the patent privilege into areas where the common understanding has been that patents are not available.”

19. Dissenting View in Diamond • “In this case, however, we do not confront a legislative vacuum…in 1930 Congress enacted the Plant Patent Act…in 1970 Congress enacted the Plant Variety Protection Act…Thus, we are not dealing-as the court would have it-the routine problems of “unanticipated inventions.” In these two Acts Congress has addressed the general problem of patenting animate inventions and has chosen carefully limited language granting protection to some kinds of discoveries, but specifically excluding others.”

20. The Dissent • “If newly developed living organisms not naturally occurring had been patentable under 101, the plants included in the scope of the 1930 and 1970 Acts could have been patented without new legislation. Although the court rejects this line of argument, it does not explain why the Acts were necessary unless to correct a pre-existing situation. I cannot share the Court’s implicit assumption that Congress was engaged in either idle exercises or mere correction of the public record when it enacted the 1930 and 1970 Acts.”

21. The Dissent • “Congress, assuming that animate objects as to which it had not specifically legislated could not be patented, excluded bacteria from the set of patentable organisms. The Court protests that its holding today is dictated by the broad language of 101. But, the Court’s decision does not follow the unavoidable implications of the statute. It is the role of Congress, not this Court, to broaden or narrow the reach of the patent laws. This is is especially true where, as here, the composition uniquely implicates matters of public concern”

22. Chakrabarty Comes to Canada • In Abitibi, the Appeal Board was confronted with the question of whether a somewhat ‘higher’ life form, viz, a mixed fungal yeast culture is a patentable invention. The alleged invention was for a process of biodegrading spent sulfite waste liquor from the manufacture of wood-pulp. While the process claims were allowed, the claims for the mixed fungal yeast were disallowed on the grounds that s.2 did not contemplate living matter as patentable subject matter.

23. Chakrabarty in Canada • Relying heavily on the Chakrabarty decision, the patentee appealed to the Patent Appeal Board. In a rather questionable application of Chakrabarty, the Board allowed the appeal and held that the acclimatized microbial culture was an invention within the meaning of s. 2. • Can you distinguish Funk from In re Abitibi?

24. In Re Abitibi • Applicant sought a patent in respect of two claims directed to a microbial culture system. The invention lay in taking microbial culture from domestic sewage and acclimatized it to sulfite liquor. The acclimatized microbial culture would then be used to digest spent sulfite liquor from pulp plants operated by Abitibi, thereby purifying it, so that the effluent from paper factory can be discarded without contaminating the waste stream.

25. In re Abitibi • The Process claim was allowed but the claims for the yeast culture were disallowed. The applicant appealed to the Patent Appeal Board. • The PAB held that all new life forms which are produced en masse as chemical compounds and are prepared and formed in large numbers that any measurable quantity uniform characteristics and properties are patentable. • The mixed fungal yeast culture system was not a mutant strain of bacteria, and as such, it was not patentable subject matter.

26. Judicial Law Making • “Throughout the world judicial bodies, without changes in legislation, have gradually altered their interpretation of statutory subject-matter to adapt it to new developments on technologies and current concepts of industrial activity. The Canadian courts have not stood entirely aloof from this current of change. Whether this was proper without legislative amendment may be arguable…”

27. Life Forms & Repeatability • “Now the creation of a new micro-organism by mutation, or by other means, is fraught with considerable difficulty, and it is by no means certain that the inventor, others following his directions, will be able to produce it again using the original method of manufacture.” • However, the PAB, following American Cyanamid, unilaterally validated deposit of life forms in lieu of written description. • Note the SC decision in Pioneer Hi-Bred.

28. Low and High Life Forms • “if an inventor creates a new and unobvious insect which did not exist before and can recreate it uniformly at will, and it is useful, for example to destroy the spruce bud worm, then it is every bit as much a new tool of man as a micro-organism ….we do not see why it (hypothetical new insect) should be treated differently from a micro-organism.”

29. Hybrids &Transgenic Inventions • 5 years after the Patent Board’s decision in Abitibi, the Federal Court had the opportunity to wade into the controversy of patents on life forms. In the Pioneer Hi-Bred case, the applicant sought to patent a new variety of soybean derived from artificial cross-breeding, but cultivated naturally. The new product did not previously exist in nature since soybean reproductive organs are contained in the same flower and are ordinarily protected against external intrusion. Hence, artificial human intervention was necessary to create a hybrid.

30. Hybrids & Transgenic Inventions • The patent Office Examiner rejected the application on the basis that new plant varieties do not come within meaning of “invention” as defined in s. 2 of the Act. On appeal, the decision was upheld on the additional ground that it was impossible for such “inventions” to comply with s. 27(3) on the requirement for full, detailed and complete disclosure.

31. Marceau, J. in Hi-Bred • In the opinion of Marceau, J. the new plant variety was not an invention because Parliament seemed to have excluded plants from patentability by creating a specific legislation for it. Thus, there was implied exclusion of plants from patentability. (See the fuller reasoning of Marceau J and the minority view of the court in Diamond v. Chakrabarty)

32. Pratte, J. in Hi-Bred • On his part, Pratte, J. concurred with Marceau but reasoned that he would reject the patentability of the new soybean variety on the grounds that the alleged invention could not be described as required by s. 27 (3) of the Act. In the absence of a statutory basis for depositing cultures, he was unable to accept that such practice is coeval with the written disclosure as required under s. 27 (3). • The PAB in Abitibi held that deposit of microbial cultures was a substitute for written disclosure.

33. Hi-Bred at the Supreme Ct • At the Supreme Court, Lamer, C.J, per curiam, distinguished hybridization from transgenic intervention but anchored his decision on the incompatibility of the alleged invention with s. 27 (3) on disclosure. Arguing that the Court lacked the “right to stretch the scope of patent protection beyond the limits of existing legislation” on deposits in lieu of disclosures, the court unanimously dismissed the appeal.

34. Oncomouse & Multicellular Life • Following the decision in Diamond v. Chakrabarty, there was some initial confusion in both the USPTO and court as to the patentability of transgenic multi-cellular life forms. This confusion was cleared by a Guideline dated April 7, 1987 by USPTO announcing that it considered “non-naturally occurring non-human multi-cellular living organisms, including animals to be patentable subject-matter within the scope of 35 U.S.C. 101.

35. The Oncomouse • The invention involved obtaining the oncogene, incorporating it into a plasmid and injecting the plasmid into ferlized mouse eggs, preferably while they are at the one-cell stage. The eggs are then implanted into a female host mouse and permitted to develop to term. After the offspring are delivered, they are tested for the presence of the oncogene. Those that positive are mated with mice that have not been genetically altered. 50 per cent of the offspring will naturally have the oncogene making them suitable for carcinogenic studies.

36. Oncomouse • The patent application contained claims to the process by which the oncomouse was produced, the founder mouse, and the offspring mouse. • The Process and product claims also extended to all non-human mammals. • In Canada, the Harvard claims were rejected by the Patent Office, the Appeal Board, and Federal Court, in respect of the oncomouse but the process patents were issued.

37. Oncomouse in Canada • On appeal to the Federal Court (Appeals), Rothstein and Linden, JJ.A. reasoned (along the lines of the majority in Chakrabarty) that the oncomouse is unobvious, new and useful composition of matter and hence, an invention. Having reasoned thus, the question of whether the oncomouse was a manufacture became moot. The only question left was whether it fit the category of patentable subject matter.

38. Oncomouse in Canada (Appeals) • In its metaphorical construction of the genetic constituents of the oncomouse, the court came to the conclusion that DNA is a “physical substance and is therefore matter.” A fortiori, the oncomouse was a bundle of DNA and hence patentable subject matter.

39. Oncomouse in Europe • Article 52 of EPC provides that: “European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.” • The following in particular shall not be regarded as inventions: discoveries; scientific theories and mathematical methods; esthetic creations; schemes; rules and methods for performing mental acts, playing games or doing business; and programs for computers; Presentations of information.

40. Oncomouse in EPC • “Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of para. 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.”

41. Oncomouse in EPC • Article 53, “European patents shall not be granted in respect of (a) inventions the publication or exploitation of which would be contrary to ‘ordre public’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; • (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes of the products thereof.

42. Oncomouse in EPC • The application was filed on 24/6/85. • On 12/04/1988, the USPTO granted the corresponding US patent. • On 14/07/89, the Examining Division rejected the application after ex parte oral hearings on the grounds of Art. 53. • On 07/09/89, the applicant appealed against the decision of the Examining Division. • On 22/10/90 in decision T19/90, the Boards of Appeal decided that the application satisfied the provisions of Article 83.

43. Oncomouse in EPC Law • In the view of the Board, there was no serious doubt that the invention could not be carried out over the whole claimed scope. • The Board disagreed with the interpretation of the Examining Division that Article 53 (b) EPC should be interpreted as excluding not only certain groups of animals but, in fact, animals as such. • It remitted the case back to the Examining Division for prosecution on the issue of whether or not the subject matter of the application is an “animal variety” as per Art 53

44. Oncomouse in EPC • The Examining Division was also asked to consider whether Art. 53 (a) constitutes a bar to patenting the oncomouse. This issue depended mainly on a careful weighing up of the suffering of the animals and possible risks to the environment on the one hand and the invention’s usefulness to mankind on the other.

45. Oncomouse in EPC Law • On 13/05/92, the Examining Division granted the patent and, in view of the extraordinary public attention the case generated, it published a statement explaining the reasons for the grant. • On 18/12/92, the “British Union for the Abolition of Vivisection” filed an opposition on the grounds of Article 53 (a) EPC. • Sixteen further notes of opposition followed on the grounds of Arts. 83, 52 (2), 54, 56, 57 of EPC.

46. Oncomouse in EPC Law • On 21-24/11/95, oral proceedings were held. The opposition Division found that the opponents did not convincingly prove that the patent in suit failed to meet the requirements of Art. 83, 52 (2), 54, 56 of EPC. No conclusion was reached at the oral proceedings on the allowability under Arts. 57, 53 (a), 54 and 56. • The proceedings could not be concluded within the three days scheduled.

47. Oncomouse in EPC Law • The Examining Division gave extra time for filing of further submissions. Between 1996-99, observations were made. • In 1997, the Technical Board of the EPO gave a negative opinion on a plant-patent from Novartis. • In June 1999, the Administrative Council of the EPO, launched its “coup de main” by issuing a Directive to the effect that transgenic animals and plants, and also human cells and genes shall, effective September 1, 1999 be patentable under the EPC.

48. Oncomouse in EPC Law • What is really significant is that the Revision of the “Implementing Regulations” by the Administrative Council was a fundamental re-writing of a treaty text without the participation of the Contracting States. • Such a change can only be done by a Diplomatic Conference of all member states in an unanimous vote. • This would have meant a democratic and constitutionally transparent process, lacking in the intervention by the Administrative Council.

49. Oncomouse in EPC Law • The Administrative Council rested its argument on the controversial EU Patent Directive 98/44/EC, which was adopted by the European Parliament in 1998. • However, the EU-Patent Directive 98/44/EC is being opposed at the European Court of Justice by 3 states, Netherlands, Italy and Norway. Their main argument is that the EU Patent Directive contradicts the EPC.

50. Oncomouse in EPC Law • On 01/09/99 new Rules 23b-23e entered into force, implementing the requirements of the EU Directive 98/44/EC on the legal protection of biotechnological inventions into European patent law. • Rule 23c (b) provides for the patentability of inventions which concern animals if the technical feasibility of the invention is not confined to a particular animal variety.