Dialogue Across the 49 th Parallel

1. Dialogue Across the 49th Parallel Does US Jurisprudence Influence Canadian Patent Law?

2. Pushing the Envelope • The scope of patentable subject-matter is inherently plastic and expansionist. • While patent law seeks to offer clues and hints on the parameters for determining patentable subject-matter, the visionary and futuristic nature of inventions compels the need to avoid finite definitions of what is patentable subject-matter. • Until 1980, the prevalent legal opinion was that transgenic life forms were not juridical inventions.

3. The US and Canada • 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. • The interaction between both cases illustrates the often awkward dialogue between US and Canadian jurisprudence on patentability subject-matter.

4. 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.

5. 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.”

6. The Claims • Anand’s patent claims may be classified into three categories, viz; • Process claims for the method of producing the bacteria, • Claims for an inoculum comprised of a carrier material floating on water, such as straw, and the new bacteria, • Claims to the new bacteria itself.

7. The Decision of the USPTO • 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, including Canada.

8. Appeal to the Board • 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.

9. Appeal, Contd., • 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:

10. Majority Decision • 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.” • 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.”

11. Majority Decision • 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.

12. The Courts or Legislature? • “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.

13. The Minority Decision • 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.’ • “…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.”

14. The Minority, contd., • “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.”

15. Minority Decision, contd., • “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.” • “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”

16. 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. • 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.

17. Chakrabarty in Canada • 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. • 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.

18. Chakrabarty 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. • Interestingly, the fuller reasoning of Marceau J reads like the minority view of the US Supreme Court in Diamond v. Chakrabarty. • 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).

19. Hi-Bred at the SC • 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.

20. Chakrabarty Comes of Age • 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. • A year later, Harvard College was granted a patent for a genetically-engineered animal valuable in cancer research. The claim actually encompasses all non-human mammals altered in the same manner. • The patent elicited frenzied opposition from animal rights advocates, and other people ostensibly troubled by the “ethical” consequences of transgenic research and extension of property rights over animals and “complex” life forms.

21. The Mouse Comes to Canada • Since 1992, more than 2000 patent applications in respect of genetically-altered animals have been filed in the US and more than 300 such patents have been issued. • 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.

22. The Mouse 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.

23. déjà vu? • At the Supreme Court, a plurality of the court (L’Heurex-Dube, Gonthier, Gonthier, Iaccobucci, Bastarache, and LeBel), agreeing with the reasoning of the minority in Chakrabarty held that a higher life form is neither a manufacture nor a composition of matter. • For a fuller detail of the reasoning of the court, see Justices Iacobucci and Binnie, respectively. Perhaps, the most striking thing about the majority decision is that in many respects, it reads like a verbatim reproduction of the reasoning of the minority in the US case of Diamond v. Chaktrabarty

24. The Awkward Dialogue • The short point here is that the apex courts of industrialized states often “talk to one another” in patent law. • Whether this can be construed as a form of informative and constructive dialogue is a question that often elicits elusive answers. • How this dialogue will play out in the aftermath of the Bilski case is a subject of interest to patent lawyers and Canadian inventors.