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A Study of Issues Relating to the Patentability of Biotechnological Subject Matter: Footnotes

1. This is carried out by way of a vector (which is a DNA molecule that could be moved between cells and is functional in different cells - common types of vectors are plasmids (circular pieces of DNA often exchanged by bacteria - and viruses)). The recombinant gene, once in the cells of the host organism, if correctly transferred, conferred the gene's characteristic trait on the host organism. Indeed, Dr. Hebert Boyer, a research scientist at the University of California made critical contributions to this work and in 1976, with Robert Swanson founded a biotechnology company called Genentech. See R.W. Old and S.B. Primrose, "Principles of Gene Manipulation: An Introduction to Genetic Engineering " Fifth Ed. (Oxford: Blackwell Scientific Publications, 1994), Chapter 1.

2. National Biotechnology Advisory Committee, "National Biotechnology Business Strategy: Capturing Competitive Advantage for Canada, Fifth Report" (Ottawa: Industry, Science and Technology Canada, 1991) at 37-38; Science Council of Canada Summary of Report 38, Seeds of Renewal: Biotechnology and Canada's Resource Industries (Ottawa, 1985).

3. National Biotechnology Advisory Committee, Fifth Report: National Biotechnology Business Strategy: Capturing Competitive Advantage for Canada, (Ottawa: Supply and Services, Canada, November 1991) (Chairperson: W.A. Cochrane), at page 34-35. As an agricultural example from the U.S.:

The large research effort in respect of canola has recently yielded a variety with marked tolerance to commercial herbicides, see infra, note 14.

4. J.R. Rudolph, "Regulation of the Products of Biotechnology Under the Canadian Environmental Protection Act: Any Impetus for Innovation?" (1993) 10 C.I.P.R. 317 at 318. Following are illustrations of other definitions given to biotechnology:

The Organization for Economic Cooperation and Development (OECD) has indicated that biotechnology includes:

and the National Research Council of Canada has defined it as:

5. P. W. Grubb, "Patents in Biotechnology" Swiss Biotech v. 4: page 12 (1986) at 12.

6. R. Magnaval, "New Biotechnologies - A Financial Venture Without Industrial Strategy: Opinion" Industrial Biotechnology v. 8: page 34.

7. J. Cubert, "U.S. Patent Policy and Biotechnology: Growing Pains on the cutting Edge" (1995) JPTOS 77 at 174.

8. See supra, note 6.

9. See supra, note 7 at 158.

10. This situation is not unique to biotechnology insofar as all areas of technology advance such that what was unobvious early on in the development of the technology becomes obvious with time. The issue is whether this situation is uniquely detrimental to the biotechnology industry because so many of the products, or prospective products are, arguably, not novel, eg: Recombinant versions of naturally occurring proteins. However, as discussed infra, under Desideratum Inventions (See Chapter 4) there is still room for invention given that in biotechnology what may appear to be standard and straight forward is not necessarily.

11. A.S. Viksnins, "AmGen, Inc. v United States International Trade Commission: Designer Jeans Don't Fit" (1991) 76 Minnesota Law Review 161; L. Maher, "The Patent Environment: Domestic and European Community Frameworks for Biotechnology" (1992) 33 Jurimetrics Journal 67; and J. Cubert, "U.S. Patent Policy and Biotechnology: Growing Pains on the cutting Edge" (1995) JPTOS 77.

12. Paraphrased from a speech delivered in Toronto on June 14, 1995. Similar comments can be found in learned papers on the subject of patents and biotechnology. For example, an article entitled "Limited Protection for Proteins" by C. Collard published in the special edition of the Canadian Intellectual Property Review (C.P.I.R.) on Biotechnology , at volume 10 No.1, page 25 states at page 32:

13. J.D. Morrow, "Application of Patent Law to Biotechnology Subject Matter" 6 C.I.P.R. 34 (1989).

14. Id.

15. As discussed infra, this is currently the practice in Canada in respect of microorganisms, although it is about to change to official practice (See Chapter 4, infra, under non-obviousness.)

16. P.W. Grubb, "Patents in Biotechnology" Swiss Biotech v. 4: page 12 (1986) at 12. See also, supra, Chapter 1, Note 4.

17. L. Maher, "The Patent Environment: Domestic and European Community Frameworks for Biotechnology" (1992) 33 Jurimetrics Journal 67 E.C. Biotech, Patent Framework; GATT At 68 and 69.

18. This includes products in the form of starting materials and intermediates used in the method(s) and/or process(es).

19. Many biotech patents are directed to specific proteins and the DNA which codes for the protein, for example U.S. Patent No. 5,403,926 relates to an oncoprotein specific for hepatocellular carcinomas and a nucleotide sequence that codes for such a protein. The typical claiming language of such patents in respect of claims for the gene is "a pure [or substantially pure] nucleotide sequence comprising the nucleotide sequence substantially as shown in SEQ. ID NO.#". Given that the best way to identify a particular nucleotide sequence is to actually list it, a practice (which is an official requirement in many countries such as the U.S. - it will soon have official status here as well with the proclamation of Bill S-17. See Chapter 4 infra, Non-obviousness.) has arisen using sequence identification numbers ("SEQ. ID NO.). A variation on the "pure sequence" is "an isolated" sequence. This kind of language is used to deal with novelty objections. See Chapter 4, infra, "Products of Nature."

20. See generally: M. L. Gravelle "Biotechnology - An Overview", C.I.P.R., Volume 10, 1993, pages 1-10 or for a more technical approach see for example, K. Drlica, "Understanding DNA and Gene Cloning: A Guide for the Curious " (John Wiley & Sons, Inc.: Toronto, 1992).

21. One of the earliest cases in Canada which was concerned with a biotech product is the case of Continental Soya Co. Ltd. v. J.R. Short Milling Co. (Canada) Ltd. (1942) 2 C.P.R. (1) (S.C.C.) where it was held that claims to a specific enzyme found in soya bean flour were permissible.

22. It was Cohen and Boyer who obtained patents on the use of restriction enzymes to make recombinant DNA; and W.D. Noonan, "Patenting Medical and Surgical Procedures" Journal of the Patent and Trademark Office Society, vol 77 8: 651 at 657).

23. Biotechnology news items are typically concerned with this type of subject-matter. For example recent announcements of significance include the first cloning of the RNA component of telomerase, an enzyme which appears to play a role in stopping the molecular clock of aging by maintaining the length of telomeres (a component of genes) allowing cancer cells to proliferate indefinitely (Canadian Biotech News, Vol. 4, No. 36 at 3); the discovery of the "Bak" gene (Bcl-2-homologous antagonist/killer) which is believed to be a gene responsible for the control of the death of heart muscle cells during a heart attack (Canadian Biotech News, Vol. 4, No. 19 at 4); and the gene on Chromosome 1 which plays a key role in Alzheimer's disease (Canadian Biotech News, Vol. 4, No. 33 at 3), all of which are reported in learned scientific journals but which are also most likely the subject of patent applications.

24. Certain groups of naturally occurring microbes can produce valuable antibiotics. Such cells are typically found after directed prospecting of soil samples. For example, in Re: Bergy the antibiotic lincomycin and the pure culture of the microorganism Streptomyces vellosus which produced it were the subjects of the invention. The cells were "found" after laborious sifting through soil samples in a tropical location (In Re: Bergy, 201 U.S.P.Q. 352).

25. Arguably the most celebrated decision in the short history of patenting products of modern biotechnology, Diamond v. Chakrabarty, 206 U.S.P.Q. 193 (1980), related to microorganisms. The application asserted 36 claims related to Chakrabarty's bacterium containing two stable energy-generating plasmids, each of the plasmids was capable of providing a separate hydrocarbon degradative pathway. In essence, Chakrabarty had developed a genetically engineered bacterium which is capable of breaking down multiple components of crude oil. In the patent application Chakrabarty had three types of claims including process claims for the method of producing the bacteria, claims for an inoculum including the bacterium and claims to the bacterium themselves. The critical issue in the case was whether a claim to a bacteria was permissible under the Patent Act of the United States. The decision dramatically changed the direction of patent law in the United States by holding that such claims are permissible. Following on the heels of the Chakrabarty decision was a Canadian decision also in respect of a microorganism namely a microbial culture system composed of different forms of fungi (Application of Abitibi Company (1982) 62 C.P.R. (2d) 81 (PAB)). Indeed, in this case the Chakrabarty decision was of persuasive value in allowing the Patent Appeal Board to find that yeast culture is proper subject matter for patent protection in Canada. The decision extended to all new life forms which are produced en masse as chemical compounds are prepared, and are formed in such large numbers that any measurable quantity will possess uniform properties and characteristics (At page 89 of the decision). Subsequent to this decision another application came before the Patent Appeal Board, namely, Re: Application for Patent of Connaught Laboratories (1982) 82 C.P.R. (2d) 32 in which the Board allowed claims for bovine cells. Arguably this is the highest type of life form for which patent protection has been allowed in Canada.

26. Thomas D. Brock and Michael T. Madigan, "Biology of Microorganisms", 5th Edition (Prentice Hall: Toronto, 1988).

27. Patents for plants are not available in Canada, however, they are available in the United States, even though two Acts specifically for plants and plant varieties (the Plant Patent Act 35 USC 161 and the Plant Varieties Protection Act 7 USC 2321). The landmark decision on this point is Ex Parte Hibberd 227 U.S.P.Q. 443 (1985) where claims to a corn plant and its seeds were allowed.

28. Polyploid oysters are the subject of patent protection in the U.S. after the decision in Ex Parte Allen 2 U.S.P.Q. (2d) 1425 (1987) where it was held that the issue of whether subject matter is living matter is not controlling on the question of whether the claims to the polyploid oysters are drawn to patentable subject matter.

29. Diamond v. Chakrabarty, supra, at 197. In Pioneer Hi-Bred ltd. v. Commissioner of Patents(1989), 25 C.P.R. (3d) 257 (S.C.C.) at 264-265 the Court discusses the likelihood of patentability for such inventions, although the Court does not rule on this point.

30. In Canada, connected with the question of methods of making products of biotechnology is the issue of old Act versus new Act cases. Prior to November 19, 1987 ("Old Act" cases), in the case of inventions which related to naturally occurring substances as prepared or produced by or significantly derived from microbiological processes and which inventions were intended for food or medicine, arguably, it was possible to obtain a claim for the resulting food or medicine itself. It is arguable because prior to 1987, only foods or medicines prepared by chemical processes were unpatentable subject matter. Thus, is a microbiological process a "chemical" process? In any event, after November 19, 1987 ("New Act" cases), for a food or medicine that was prepared or produced or significantly derived from a microbiological process, it was only possible to obtain a claim for that food or medicine when it was prepared or produced or significantly derived from the microbiological process of manufacture, where that process could be particularly described or claimed. This was by virtue of the wording of subsection 39(1). This subsection was abolished in 1991 by virtue of subsection 39(1.1). Consequently, for the period from November 1 9, 1987 to November 19, 1991, there was a bar with respect to the ability to obtain patents in respect of this kind of subject matter. However, in respect of the method of manufacture itself, i.e., by chemical or microbiological process there was, and is no bar in respect of this type of subject matter, assuming the more significant questions in respect of the patentability, eg. novelty and obviousness., were satisfied.

31. For examples, the gene for naturally occurring BtCryIA(B) an insect toxin, has been successfully transferred to corn which enables the plants to produce an insecticidal protein which is similar to the naturally occurring version (Canadian Biotech News, Vol. 4, No. 33 at page 4); and two strains of canola which were treated with genes extracted from yeast culture demonstrate a marked tolerance to certain popular commercial herbicides (Canadian Biotech News , Vol. 4, No. 29 at page 6).

32. The report of the committee on Judiciary: Staff Report of the sub-committee on Courts, Civil Liberties and the Administration of Justice Accompanying the Transgenic Animal Patent Reform Act report 100-88 of the House of Representatives, 100th Congress 2nd session. Dated August 26, 1988 In: "Animal patents: The legal, economic and social issues " Ed. William Lesser (MacMillan Publishers Limited: New York, 1989) pages 185-265 at pp. 207-209. The quoted text provides in very broad brush important features of recombinant DNA techniques. Perhaps the most reported application of genetic engineering techniques were those used by Philip Leder and Timothy Stewart at Harvard University to produce a transgenic mouse which was the subject of the first U.S. Patent covering non-human mammals. The "Harvard Mouse," also known as the "Oncomouse" was "created" by viral transfection of a mouse embryo where the virus contained the foreign DNA which was inserted into the mouse cell genome (see U.S. Patent 4,736,866). The number of articles and books devoted to providing detail in respect of the techniques of genetic engineering is legion. A very few examples, which are in no way recommendations, are: M.D. Trevan et al. "Biotechnology: The Biological Principals " (Taylor and Francis: New York, 1987); K.E. Davies "Genome Analysis: A Practical Approach" (IRL Press: Washington, 1988); K. Drlica "Understanding DNA and Gene Cloning: A Guide for the Curious" (John Wiley & Sons, Inc.: New York, 1992); H.R. Bungay and G. Belfort "Advanced Biochemical Engineering" (John Wiley & Sons: New York, 1987); R.W. Old and S.B. Primrose, "Principles of Gene Manipulation: An Introduction to Genetic Engineering: 5th Ed. (Blackwell Scientific Publications: Oxford, 1994); and V. Moses and R.E. Cape "Biotechnology: The Science and The Business " (Harwood Academic Publishers: New York, 1991). Also, an excellent overview may be found in the English Court of Appeal decision Genentech Inc.'s Patent, at pages 159 to 169 of R.P.C.[1989].

33. For example, in U.S. Patent No. 5,411,732 which is entitled "Preparation of Fused Proteins, Antibodies and Processes Therefore", a process for preparing antibodies specific for an amino acid sequence is disclosed. The claims are directed to a process for preparing polyclonal antibodies and comprises the steps of immunizing a mammal with a fused protein comprising the particular amino acid sequence. Needless to say, the immune system of the mammal which is "immunized" is the element which produces the polyclonal antibody. A further step is the introduction of a cloned or synthetic DNA segment into a prokaryotic expression vector, however, this process also takes place by virtue of intrinsic properties of the DNA segment and the approach used to introduce the segment.

34. Tennessee Eastman v. The Commissioner of Patents, [1974] S.C.R. at 111. The patent laws of the European Patent Convention (EPC Article 52(4)); Japan and a number of other jurisdictions throughout the world refuse to allow patent protection for methods of medical treatment of the human body (W.D. Noonan, "Patenting Medical and Surgical Procedures" JPTOS, vol 77 no. 8 651 at 664 (1995)).

35. Manual of Patent Office Procedure ("MOPOP"). See also K.R. Britt, "Method of Use Claims in Biotechnology" (1993) 10 C.I.P.R. 101 as well as Shell Oil Co. v. Commissioner of Patents(1982), 67 C.P.R. (2d) 1 (S.C.C.) and Re Application for Patent of Wayne State University (1988), 22 C.P.R. (3d) 407 (PAB).

36. This portion of the report is not intended to be a rigorous philosophical analysis of invention rather, it is intended simply to explore the concept with a view to raising issues and questions which are arguably important considerations in assessing the patentability of the subject matter of biotechnology.

37. It has been suggested that part of the problem in the longstanding battle to understand this word "invention" has been related to the linguistic context in which the word is used:

These comments are equally applicable to the word and concept of "discovery" which, like "invention" also suffers in the English usage from being both a dynamic and a static: The scientist discovers a discovery.

38. Of course where the invention is a method or a use the "product" aspect of the invention is more readily captured in the concept of a "result" and consequently, when I use the word "product" it is my intent to include this understanding.

39. Crosley Radio v. G. 193 Ex. C.R.190 at 197.

40. Examples of other views are: One neuroscientist, when asked what invention meant to him responded:

A patent examiner explained that invention is:

While a medical doctor/research scientist said that invention is:

All of which points to a practicality or utility that does not exist in respect of discovery. Discovery becomes an invention when its utility becomes clear. An invention, on the other hand can never become a discovery, thus discovery always precedes invention.

41. Clearly this is not the case in respect of patentable invention as will be seen in the discussion, infra.

42. It is proposed that the facultative process is composed of elements which allow it to occur. These are elements which include the acquisition of basic, background knowledge which is combined with some recognition and/or integration along with understanding of the value of the subject matter.

Foundational knowledge is essential and it consists of the information about a particular discipline, and/or about all disciplines and areas of human endeavour. The broader the foundation, i.e., the more information from as many disciplines as possible, the more adept will the mind be at discovery, creation and/or invention. However, a computer can be provided with all knowledge known to humanity, but without the faculties of recognition and integration, the knowledge is me aningless. Recognition occurs at stages and to varying degrees. There is the mere understanding and recognition of the information itself. A next level is recognition of place, i.e., where the information belongs in relation to other information. A further level is recognition of relationships between information and integration as to the place where this belongs.

43. The process of bisociation, as it has been described by Arthur Koestler in his book "Insight and Outlook: An Inquiry into the Common Foundations of Science, Art and Social Ethics" (The MacMillan Company: New York, 1949), is fundamental to the processes of discovery and invention and helps to understand where this "ah ha" originates. At the end of the bisociation process, once the junctional nexus has been created, there is a conceptual invention or discovery as the case may be. As already suggested, there may be a number of such junctional nexus' along the path to a final invention, however, at each step, the process is similar.

The process of bisociation is the simultaneous connection of two association complexes which are suggested to be habitually incompatible. Koestler suggests that habitually incompatible does not mean logically incompatible, rather that the association of thought processes is regulated not by logic but by habits of thought acquired by past experience, i.e., the foundational knowledge. After a concept has become "bisociated" with two previously independent unassociated occurrences, these cease to be "independent". A given bisociate connection becomes, after a few repetitions, if not at once, transformed into an ordinary association and is incorporated into the realm of normal mental processes and concomitantly expands foundational knowledge.

The following provides an excellent illustration of bisociation in which the result is, in the realm of the individual chimpanzee whom is the subject of the observations, an invention:

As suggested by this example and in the comments of Koestler, it is the search for a solution to a problem which sparks and drives the process.

44. If the events which lead to the invention are reproducible then such invention may be patentable, however, it is the chance invention, which is not easily reproducible which is not likely to be patentable. This was one of the problems encountered by Pioneer Hi-bred in its application for a patent - see the reasons of Lamer, J (as he was then) at page 263 of the Hi-bred decision ((1989), 25 C.P.R. (3d) 257 (S.C.C.)).

45. Needless to say, serendipity is achieved with an understanding of what has gone on before, it just isn't as apparent. As will be seen below, without this knowledge of what has "gone on before" invention is not possible.

46. This is the same as the followers in the invention of new antibiotics as discussed in Faberwerke Hoecht A.G. V. Halocarbon (Ontario) Ltd. (1979), 42 C.P.R. (2d) 145, infra, Chapter 4.

47. See for examples: C. Joyce,"Prospectors for Tropical Medicines" (1991) New Scientist October 19, at 36-40; and M.J. Plotkin, "The Healing Forest" (1990) The Futurist January-February, at 9-14.

48. T.S. Harding "Exploitation of the Creators" at 386-387.

49. The word creation suffers the same type of linguistic difficulties that are encountered by invention. See footnote 37 for further discussion.

50. See Venn diagram at beginning of Chapter.

51. For products of biotechnology which are not living,eg., proteins, nucleic acids, fatty acids, etc. the concept of creation fits well in that they can be made from their substituent amino acids or even elemental parts. It is when the concept moves into the category of living matter that we encounter a situation where humans are unable to create. We can create a modified life form, but we cannot create that modified life form itself per se. We must depend upon the underlying biological processes in order to "create". As such, the creative element is removed from us. In all other aspects of invention, we can create. This, at first blush, is a fundamental difference between biotechnology and all other technologies of invention. In many respects this may be a fundamental distinction between products of biotechnology and all other types of products in that the living products are truly fundamental creations, which, as proposed here, are different from inventions.

52. This type of creation was well described by Bronowski (J. Bronowski, "The Experience of Creation " at 97-98):

53. See note 37, supra.

54. One research scientist suggested that all scientific discovery could be categorized as one or the other - from the Interviews of Research Scientists, 1995.

55. K. R. Popper, "The Logic of Scientific Discovery " (Basic Books, Inc.: New York, 1961) at 27.

56. K.R. Popper Ibid

57. K.R. Popper Ibid

58. A related issue with respect to discovery and invention is whether the isolation and purification of a micro-organism with unique features and properties is truly an invention under Canadian practice or is merely a discovery. The In Re: Bergy case ((1979), 201 U.S.P.Q. 352 (C.C.P.A.)) is a good example of this situation where the subject matter of the invention is really a discovery in that researchers devoted a considerable period of time searching through soil samples and methodically screened the various micro-organisms found in those cultures. It can be said that it was more a matter of discovery than that of invention which led to the researchers to obtain the Bergy patent, but the discovery of the micro-organisms was really only a part of the invention. The invention was in recognizing that the isolated and purified version of the microorganism was able to produce the desired antibiotic.

59. This is not to say that the subject of discovery needs to be new. As has been suggested, the discovery of a fossil is the discovery of something quite old in fact, and as such, on one level is not novel. However, since all of these terms are observer centred, the newness of the fossil comes in the fact that it was previously not known by humans. As such it is a discovery.

60. E. Daniell, "Polymerase Chain Reaction: Development of a Novel Technology in a Corporate Environment" In: Biotechnology: The Science and The Business , Ed V. Moses and R.E. Cape (Harwood Academic Publishers: New York, 1991) Chapter 11 at 147.

61. There are innumerable examples in biotechnology which can serve the purpose of asserting that all types of subject matter of biotechnology are susceptible to being considered invention as described here, Abitibi's yeast (see Chapter 4, Enumerated Categories of Statutory Invention), Chakrabarty's bacteria (see Chapter 4, Enumerated Categories of Statutory Invention) Mullis' Polymerase chain reaction, as well as Pioneer Hi-bred's soybean seeds (see Chapter 4, page 50 ff.).

62. Is there an economic element to invention? From a strictly definitional perspective, the answer is no. Invention can exist without any economic element. However, economics are intimately associated with invention, during the process and once it exists. This aspect is tied up with the concept of utility. It is, of course, from the element of utility that the economic consequences of invention flow. Put simply, no one is willing to invest money in a curiosity. However, something which has a practical benefit is a different matter. Furthermore, the degree of economic interest in an invention is directly proportional to the number of people who are directly impacted by the invention. It is for these kinds of reasons that "commercial success" has only ever been elevated to the level of a "secondary consideration" when the issue of invention has been judicially considered. However, this is not to say that economics is not a consideration in respect of invention and the inventive process:

M.S. Hart, "Getting Back to Basics: Reinventing Patent Law for Economic Efficiency" Intellectual Property Journal v. 8: 217 (1994) at 220-221.

63. United States Patent no. 4,736,866 "Transgenic Non-human mammals" April 12, 1988.

64. There are those who would argue that, but for the publishing of the Patent, the technique would not be known. In view of the sharing of information which occurs in the scientific community, and particularly given the objective in mind, i.e., of creating a transgenic mouse with an activated oncogene, the techniques would be known.

65. The opportunities to provide a reward to the inventor through licensing is beyond the discussion of the scope of this paper. The reader is referred to articles such as J.D. Morrow, "Biotechnology Licensing" (1993) 10/1 C.I.P.R. 277, for this kind of discussion.

66. The Patent Act , R.S.C. 1985 (3rd Supp. C. 33, s.42.) as amended.

67. This is based on the assumption that it will take approximately 3 years to marshall the application through the Patent Office, i.e., prosecution time is on average 3 years. In respect of complex biotechnological subject matter, this is often a longer period of time. Indeed in some cases it can take as long as 5 to 8 years.

68. Many inventions such as eyeglasses and the clock have taken effectively centuries to become completely crystallized into useful products. A.W. Deller, Deller's Walker on Patents, vol 1 2nd Ed. (New York: Baker, Voorhis, 1964) c. 1.

69. This sentiment was outlined by Maclean, J., ln Canadian Gypsum Co. v. Gypsum, Lime & Alabastine Can, Ltd. [1931] Ex.C.R.180:

70. T.I. Nguti, "Patent Law: Doctrinal Stab ility - A Research and Development Definition of Invention is Key " (1986) 20 Val. U.L. Rev. 59 (footnotes excluded).

71. "A patent is, after all, the grant of a powerful monopoly right provided by the state to the inventor". G.F. Henderson, "An Introduction to Patent Law" In: Patent Law of Canada, G.F. Henderson et al. eds. (Carswell: Toronto, 1994) at page 9.

72. In most countries, except for example the United States, the ability to examine occurs at least as early as 18 months after the first filing. At this time the application "laid open" for public inspection (section 10, Patent Act).

73. At this point one is led into a discussion concerning the free exchange of ideas which is claimed to exist in the scientific community, a place where there "is" free exchange of ideas. The notion of withholding knowledge and insight is rejected, in fact, scientists will argue that the patent system actually impedes progress because of the tendency to withhold information until the patent issues...or so the argument goes. The fact is, however, that it is rare to find a scientist who is willing to share their ideas unless they have already been published; but isn't publishing part of that free exchange? In a word, no. Publishing ideas in scientific journals provides the reward system of the scientific community. Without publication there are no financial rewards (grants), i.e., publish or perish. In effect, the system is entirely analogous to the patent system: If a scientific advance - invention is shared with the scientific community by publication, the analogy for patentable invention is it is share with the State, - the scientist has an increased probability of winning grant money to continue research, in the patent form the inventor has an increased the probability of making a profit and continuing a chosen discipline. In broad terms: not all scientific work is published, only that which is new and useful. Indeed, not all inventions are patented, only those which are new and useful. Counter-balanced with this view is the fact that today more research scientists are communicating their inventions to research technology transfer offices in their institutions wherein the invention is in theory quickly evaluated and a decision is made with respect to whether an application for a patent is to be filed. Of course, once the application is filed, the scientist is free to publish the invention at will. Because of the potential for economic rewards to academic institutions there is an increasing change in philosophy directing research scientists towards patenting the means to justify and maintain their position in the institution.

74. Indeed, it may be argued that the Patent Act is a tool by which undesirable social public policy is implemented, for example, the encouragement of scientists to unfairly take advantage of people in under-developed countries. The push for new inventions arising from the study of ethnobotany and the subsequent exploitation of indigenous peoples is arguably being fuelled by the patent system. For an example of such concern see an article entitled "Indigenous Person from Papua New Guinea claimed in U.S. Government Patent " published on the Internet by Fringeware Daily http://fringeware.com/HTML/ online.html#digest, on October 16, 1995, as forwarded by Mariman Batlivala (narib@sj.unisys.com) which concerns U.S. Patent No 5,397,696 "Papua New Guinea Human T-Lymphotrophic Virus". In accordance with this argument is the fact that not all types of invention can be patented and consequently, the Patent Act serves as a vehicle for promoting those "new and useful arts, processes, machines, manufactures or compositions of matter" which society deems appropriate. Indeed, some would argue that the Patent Act is a useful forum for shaping societal mores. In this respect the Patent Act has, since it inception in Canada, explicitly identified subject-matter which could not be patented. In particular a patent could not be obtained for an invention that had "an illicit object in view" or for any mere scientific principle or abstract theorem. Although the limitation with respect to inventions having an illicit object in view was removed in 1994 (Patent Act, R.S.C. 1985, c. P-4, s.27(3), as amended), as discussed below, caselaw makes it very clear that certain subject matter, beyond the mere scientific principle or abstract theorem, is not patentable subject matter. Consequently, notwithstanding the argument which has been put forward by some to suggest that a patent act is not the proper forum to put forward social ethical policy, there is considerable precedent for specifically excluding types of subject matter under the Patent Act. The real question is whether it is appropriate to do so, and where the line should be drawn with respect to what can be patented and what cannot. A more significant discussion of such ethical and moral issues is beyond the scope of this report, however, the reader is referred to the following papers as well as the bibliography for further reading: S.R. Avisar, "The Ethics of Biotechnology - The Argument in Favour of Patents" (1993) 10 Canadian Intellectual Property Review 209; J.F. Barshear, "Inoculum or Perilous Parasite? Encouraging Genetic Research through Patent Grants: A Call for Regulation and Debate" (1981) 18(2) San Diego Law Review 263; S. Chong, "The Relevancy of Ethical Concerns in the Patenting of Life Forms" (1993) 10 Canadian Intellectual Property Review 189.

75. However, as discussed infra, under "New, Useful and Unobvious - C. non-obviousness", the statute has been amended to include a non-obviousness analysis. The new section is yet to be proclaimed in force.

76. See discussion, infra, under "New, Useful and Unobvious", the heading of Non-obviousness.

77. By body parts what is meant is that genes, proteins or cells in their natural state in the human body are not patentable. Notwithstanding this when such elements are isolated from the human body they are in fact patentable and simply because of their human origin have not been held to be unpatentable in Canada.

78. The leading decision in Canada on this point is Tennessee Eastman v. The Commissioner of Patents, [1974] S.C.R. at 111. However, "methods of use" or "use" claims are now more commonly acceptable at the Canadian Patent Office if they are acceptably worded: Manual of Patent Office Procedure. See also K.R. Britt, "Method of Use Claims in Biotechnology" (1993) 10 C.I.P.R. 101 as well as Shell Oil Co. v. Commissioner of Patents (1982), 67 C.P.R. (2d) 1 (S.C.C.) and Re Application for Patent of Wayne State University (1988), 22 C.P.R. (3d) 407 (PAB).

79. D.S. Chisum, "Patenting Living Subject Matter, DNA sequences encoding proteins, Gene Therapy and Therapeutic Methods under United States Law " presented at Patenting Living Organisms Including Human Genes AIPPI, Montreal, June 27, 1995; and (W.D. Noonan, "Patenting Medical and Surgical Procedures" JPTOS, vol 77 no. 8 651 at 664 (1995)) While such claims are currently acceptable there is a movement underway to make such patents unavailable (BNA's Patent, Trademark & Copyright Journal, vol. 50, No. 1250, p. 737 (1995)).

80. "Examination Practice for Chemical and Biotechnological Inventions in Japan", Japanese Patent Office, December, 1994.

81. Article 52 of the EPC, paragraph 4 provides:

One commentator on the European provision stated the following:

[C. Gugerell, "Bio-technology patenting - the current practice of the European Patent Office" The Genetic Engineer and Bio-Technologist v. 14, p. 195 - 200 (1994) at 197.]

82. R. Moufang "Patenting of Human Genes, Cells and Parts of the Body? - The Ethical Dimensions of Patent Law" IIC v. 25: 487 (1994) at 489.

83. See United States Patent and Trade-marks Office Policy Statement dated 4\7\87 on the Patentability of Animals.

84. This is true also in other jurisdictions such as in Europe. (R. Moufang, "Patenting of Human Genes, Cells and Parts of the Body? - The Ethical Dimension of Patent Law" IIC v. 25: 487 (1994) at 509.) However, in his article R. Moufang suggests that certain inventions derived from human beings constitute questionable subject matter even though the subject matter is unicellular in nature:

85. This was the suggestion outlined in Farfan's article "Patentability of life forms" Canadian Computer Law Reporter v. 5: 138 (1988) at 138. Although Farfan does not appear to advocate or reject the argument, it is indeed an argument made by those who oppose the patenting of higher life forms. Although it is possible that patents may be sought for humans or human parts, this is most unlikely.

[Foote, R.H. "The Technology and Costs of Deposits" In: "Animal Patents: The Legal, Economic and Social Issues ", Ed. Lesser, W. H. (MacMillan Publishers Limited: New York, N.Y., 1989) pg. 48 at 48.]

86. The wording in the Australian Patent Act is as follows:

87. It is well settled in Canada that "art" is an act or series of acts which are carried out by some physical agent in respect of, or on some particular physical agent and producing in this object some change either of character or of condition and as such, can be considered as the means of achieving a particular result (Lawson v. Commissioner of Patents, (1970) 62 C.P.R. 101 at 109 (Ex.Ch.)).

88. An interpretation of the word "process" may be found in the words of Audette, J. in Grissinger v. Victor Talking Machine, even though there was no reference to it as such:

From this, it is clear that a process is a principle coupled with a mode of carrying this principle into effect..." but that a principle, per se, is not proper subject matter. This conclusion is buttressed by the words of Supreme Court Justice Martland, J. who stated at page 141 of the Ciba decision (Commissioner of Patents v. CIBA Ltd. (1959), 30 C.P.R. 135 (S.C.C.):

and by Maclean, J. who stated: "...there is that kind of invention which is to be found in some particular new method of applying a well known principle." (Canadian Radio Patents Ltd. v. Hobbs Hardware Co., [1929] Ex.C.R. 238) Certainly there are many methods and processes used in biotechnology which are consequently capable of fitting into this category of invention just as much as the processes of any other technology (See the discussion in Chapter 2 "Subject Matter of Biotechno logy" under the heading Methods and Processes of Making Products of Biotechnology for example, of the types of processes germane to Biotechnology.).

89. This is in line with the decision in Pioneer Hi-bred Ltd. v. Commissioner of Patents, (1989), 25 C.P.R. (3d) 257(S.C.C.). In the Hi-bred decision the Supreme Court of Canada distinguished between processes for producing plants which do and do not require significant technical intervention by man. The Court was concerned that traditional forms of cross-breeding of plants did not constitute sufficient intervention whereas new techniques of biotechnology, i.e., genetic engineering were potentially worthy of patent protection. The notion of "intervention by the hand of man" is also consistent with the broad notion to patentable subject matter taken in the U.S.

90. Manual of Patent Office Procedure (MOPOP) Ottawa-Hull, 1990.

91. The word "machine" is probably the most straight forward. This word is of such universal and common understanding that there has been little need to pursue the inquiry beyond the definition used in early English cases such as Morgan v. Seward:

From the perspective of biotechnology, this aspect of the definition has little relevance.

92. [1925] Ex.C.R. 93.

93. Concise Oxford Dictionary, (Clarendon Press: Oxford, 1985).

94. See H. Fox, "The Canadian Law and Practice relating to Letters Patent for Inventions", 4th ed. (Toronto: Carswell, 1969) at 19

95. For an example in Canadian case law see: Re Application of Pallos (1978), 1 C.P.R. (3d) 334 where the Patent Appeal Board states at 337:

Further, in England the Patent Act defines invention as meaning "any manner of new manufacture..." and this expression finds its origin in the Statute of Monopolies (1624). The English cases are not always consistent in their attempts to adopt this expression to the development to typical advances. In such cases it is considered that these words of the English statute express the same ideas as the categories found in Section 2(d) of the Canadian statute. The categories of subject matter in Section 2(d) find their origins in the early United States patent statutes, a difference being that process is an enumerated category in Canada while it is understood in the United States that process is included in the broad expression "process". Indeed it is a defined term which encompasses the word "art" (see 35 U.S.C. 100). Confusion will inevitably arise when one tries to equate "manner of new manufacture" in the English statute with the categories "art, process, manage machine, manufacture and composition of matter" as used in the Canadian Act. The English expression must include the concepts of utility and novelty as well as inventive step whereas the concepts appear to be outside the categories of the Canadian statute. On the basis of this distinction, it has been suggested that the rejection of claims for an application of professional skill has a different basis in England than in Canada and consequently such decision must be carefully considered. (Editorial note - Lawson v. Commissioner of Patents (1970), 62 C.P.R. 101 at 102-103.)

96. (1982), 62 C.P.R. (2d) 81 (PBA) at 87 which is an adoption of the definition offered by the United States Supreme Court in Diamond v. Chakrabarty (1980), 206 U.S.P.Q. 193.

97. A claim is the way in which a patentee, i.e., holder of patent rights, stakes out their territory with respect to what is covered under the patent and therefore the subject-matter of which only the patentee is allowed to practice or authorize practice versus what is not.

98. In Canada, one of the earliest cases concerning the p atentability of life forms per se was Re Application No. 086,556 (1975), C.P.R. (2d) 56 (PAB)(now Canadian patent no. 999,546 issued 76/11/09). In the decision claims for a human liver cell line per se were not allowed because the cells had been produced by random mutation which was held to be a non-repeatable fortuitous event. Method of use claims were allowed.

99. Diamond v. Chakrabarty, (1980) 206 U.S.P.Q. 193.

100. R.W. Marusyk "The Patentability of New Plant Life Forms in Canada" Can. Bus. L.J. v. 16: 333 (1990) at 337 and for the statement of Mr. Justice Marceau: Pioneer Hi-bred v. Commissioner of Patents (1987), 14 C.P.R. (3d) 491 at 496.

101. Electric Fireproofing Co. of Can. v. Electric Fireproofing Co. (1909), 43 S.C.R. 182.

102. [1932] Ex.C.R. 107 at 115.

103. Pioneer Hi-bred v. Commissioner of Patents (1987), 14 C.P.R. (3d) 491 at 495.

104. It is possible that His Lordship's remarks were confined to a plant variety produced by cross-breeding techniques. The issue of plant varieties and animal varieties is very much debated in the European Patent Office, and at the time of this decision, the draft Plant Breeders' Rights Act was receiving Parliamentary attention. His Lordship may have also found it objectionable to grant a patent in respect of a product of cross-breeding which, in the view of the Supreme Court lacked significant intervention by humans. It was more of a result obtained from "letting nature take its course" (even though it was being guided by humans).

105. R.W. Marusyk "The Patentability of New Plant Life Forms in Canada" Can. Bus. L.J. v. 16: 333 (1990) at 339.

106. Manual of Patent Office Procedure (MOPOP).

107. See discussion, supra, under "Methods of Medical Treatment".

108. MOPOP §8.05.01.

109. Paraphrased to "inventions" from H.G. Fox "The Canadian Law Practice relating to Letters Patent for Inventions" , 4th ed. (Toronto: Carswell, 1969) at 49.

110. W. Booth "Animals of Invention" Science v. 240: 718 (1988).

111. "Where the language of the specification, upon a reasonable view of it can be so read as to afford the inventor protection for that which he has actually in good faith invented, the Court, as a rule, will endeavour to give effect to that construction [of the claims]...The patent should be approached "with a judicial anxiety to support a really useful invention."

Consolboard Inc. v. MacMillan Bloedel (1981), 56 C.P.R.(2d) 145 at 156-157 (S.C.C.) quoting Western Electric Co. et al. v. Baldwin Int'l Radio of Canada Ltd.,[1934] S.C.R. 570 at 574.

112. An excellent discussion of these issues can be found in "The Art of Claiming and Reading a Claim" by William L. Hayhurst, Q.C. may be found at Chapter 8 of "Patent Law of Canada" G.F. Henderson et al. eds. (Toronto: Carswell, 1994) at page 177.

113. Beecham Canada Ltd. v. Procter & Gamble Co. (1982), 61 C.P.R. (2d) 1 at 11 (F.C.A.).

114. Metalliflex Ltd. v. Rodi & Wienenberger A.G. (1960), 35 C.P.R. 49 at 53 (S.C.C.).

115. Beecham Canada Ltd. v. Procter & Gamble Co. (1982), 61 C.P.R. (2d) 1 at 10 (F.C.A.).

116. W. L. Hayhurst, "The Art of Claiming and Reading a Claim" In: Henderson, G.F., et al., eds."Patent Law of Canada" (Toronto: Carswell, 1994) at 195.

117. T. Roberts "Broad Claims for Biotechnological Inventions : Opinion" EIPR v. 9: 371 (1994).

118. U.S. Patent No. 4,736,866.

119. See discussion, infra, "Product of Nature Doctrine".

120. R. Perry "What is a Patentable Biotechnological Invention?" Biotech 84: The proceedings of Biotech '84 Europe v. 1: 45 (1984) at 53.

121. If it is altered DNA which gives some new property then we are really back into the arena of a new compound as in the chemical arts, this would have the proper novelty, and a claim for the novel sequence, per se, should be possible. As already stated, this is the most powerful claim as it allows the holder of such a claim to prevent use in any setting.

122. MOPOP §8.05.02.

123. Patent Act, supra, s. 34(1)(a).

124. 35 U.S.C. 112.

125. In the United States this was the basis for an initial rejection of the application in Ex Parte Hibberd (1985), 227 U.S.P.Q. 443 wherein it was found that evidence demonstrating that the subject matter of the claims had been placed in a depository which was not a recognized depository in combination with evidence suggesting that the depository was not required to supply samples to anyone seeking such samples supported a rejection for insufficiency of disclosure under 35 U.S. 112.

126. Budapest Treaty on the International Recognition of the Deposit of Microorganisms (1977).

127. Indeed, it is an unofficial practice at the CIPO to deposit microorganisms in support of an applicant's disclosure. This practice will become official with the proclamation into force of bill S-17. See discussion at footnote next, infra.

128. Amendments to the Canadian Patent Act which were part of Bill S-17 have been enacted but as yet have not been proclaimed in force. This section of the Act is awaiting proclamation which will occur when new rules have been adopted which rules will govern patent procedure in connection with the making of deposits and filing applications in respect of DNA and protein sequences. Clause 41 of Bill S-17 provides the following new section for the Patent Act:

Subsection 27(3) is the section which provides the requirement for a detailed written disclosure of the invention. For further discussion of the topic of disclosure see the following: K.P. Kaminski, "Disclosure of Information in a Computer-Readable Form for Biotechnology Inventions" (1993) 10 C.I.P. Rev. 93; T. Orlhac, "Les Specificites de L'Invention Dans Le Domain de la Biotechnologie" (1993) 10 C.I.P.R. 57; J.C. Robinson, "Canadian Disclosure Requirements for Biotechnology Inventions" (1993) 10 C.I.P.R. 69; and B.G. Kingwell, "Functional Language and Finger Prints" (1993) 10 C.I.P. Rev. 87.

129. [1932] Ex.C.R.107 at 115.

130. Actually, Canadian Letters Patent 1,051,034 has claims known as "product-by-process" claims. Under Canadian practice at the time the patent issued, claims to the medicine itself were not permissible. See the discussion of the related problem in respect of products by microbiological processes as discussed in Chapter 2 at footnote 15. Today however, claims to the product itself now are permissible.

131. Monsanto Co. v. Commissioner of Patents (1979), 42 C.P.R. (2d) 161 (S.C.C.).

132. Notwithstanding this, even in respect of proteins, Patent agents will make the argument that the effect of changes to the basic structure of a protein, even as minor as changing one amino acid, are not predictable. Indeed, while most molecular biologists can simply and easily state what would appear to be an elegant solution to a particular problem in biotechnology, the same people would also agree that reducing that "obvious" solution to practise is often extraordinarily difficult, being fraught with unexpected problems along the way (M. Paver, "A Tale of Two Rodents, or a Rodent with Two Tails: Europe Grapples with Patenting Animals" Patent World, June (1993) 29 at 31.). Such arguments are also often made in respect of inventions which are the subject of obviousness rejections. See discussion below under the heading "Desideratum Inventions".

133. In Europe, however, the Board of Appeals found that the invention was sufficiently disclosed to support claims to mammals in general (see Onco-mouse/Harvard (1990) T 19/90 (Decision of Technical Board of Appeal 3.3.2 at 3.0-3.9 ). Although it may turn out that this is problematic for the Leder patent. In a recent decision of the U.S. District Court for the Southern District of Indiana (Regents of the University of California v. Eli Lilly and Co. DC SInd, No. MDL 912, 12/11/95) the court found that the isolation and characterization of proinsulin cDNA from one member of a genus is not sufficient to support claims to the insulin cDNA of thousands of other species from that genus. The patent at issue only described rat insulin cDNA, while the claims were drawn to the genera of vertebrates and mammals to the human species. See "Human Insulin Patent is Invalid for Inadequate Written Description" in BNA's Patent, Trademark & Copyright Journal V. 51 No. 1260 (1996).

134. In addition, the similarity in experience with the subject matter of chemistry is striking. Indeed, in an extreme view the subject matter of biotechnology and chemistry is identical - or in time will be understood as identical. This view is premised on the perception that biological systems are really nothing more than extremely complex mixtures of chemicals, and when viewed on the molecular level, this is correct. Indeed the "activity" of biological systems in certain respects is driven by chemical functionality. As such, it will only be a matter of time before prevision will be more of a reality in all aspects of biotechnology.

135. Arguably, the Leder patent didn't even have to refer to ancestors. The mere statement "A non-human mammal with the activated sequence..." includes within its scope all generations containing this trait.

136. J.H. Barton "Patenting Life" Scientific American, v. 264: 40 (1991) at 43. Such exemption, although not explicit, does exist under the Plant Breeders' Rights Act of Canada.

137. "On the Complex Economics of Patent Scope" Columbia Law Review v. 9E: 839 (1990).

138. Y. Ko "An Economic Analysis of Biotechnology Patent Protection" The Yale Law Journal, v. 102: 777 (1992) at 782-783.

139. S.A. Bent "Issues and Prospects in the U.S.A." In "Animal Patents: The Legal, Economic and Social Issues", Ed. Lesser, W.H. (MacMillan Publishers Limited: New York, N.Y., 1989) pg 5 at pg 13.

140. Id.

141. J.H. Barton "Patenting Life" Scientific American , v. 264: 40 (1991) at 43. Although, in Europe there was such concern about this issue, Article 13 of the EPC was amended to provide that farmers may use for purposes of multiplication or propagation on their own farm the seeds obtained from crops cultivated on their own farms using seeds protected by patents. In the same manner, livestock which are the subject of patent protection can be used for multiplication/propagation by farmers so long as it is on their own farms in order to renew stock. The "own farm" wording is intended to avoid abuse by co-operatives (J. Thurston, "Recent EC Developments in Biotechnology" [1993] 6 EIPR 187 at 188.)

142. Y. Ko "An Economic A nalysis of Biotechnology Patent Protection" The Yale Law Journal, v. 102: 777 (1992) at 780-781.

143. The key difference being that the English Court found the patent invalid for lack of invention.

144. Unipak Cartons Ltd. v. Crown Zellerbach Canada Ltd. (1960, 20 Fox Pat C. 1 (Ex. Ct) at 34; and Rubbermaid (Canada) Ltd. v. Tucker Plastic Products Ltd. (1972), 8 C.P.R. (2d) 6 (F.C.T.D.).

145. (1981), 56 C.P.R. (2d) 145 (S.C.C.) at 160.

146. The so-called Venter Patent Application which is continuation-in-part June 20, 1991 of NIH as cited in (1992), 11 Biotech . L.R. 1324; and the rejection of the claims in the application as provided in Office action dated August 20, 1992 of the USPTO to the representatives of the NIH - see E. McMahon, Nucleic Acid Sequences and other Naturally Occurring Products: Are they Patentable in Canada? (1993) 10 C.I.P.R. 11. A technique had been developed or isolating and identifying portions of the human genome. The result of this technology was pieces of DNA from the Hayman genome whose function was not understood at the date of filing the patent applications

147. Under U.S. practise in respect of biotechnology subject matter the standard of utility has been extremely high. In fact so much debate was engendered by the practise of the U.S.P.T.O. Public Hearings on Patent Protection for Biotechnological Inventions were held on October 17, 1994 in San Diego, California. With the Supreme Court's ruling in Diamond v. Chakrabarty the patent system was faced with enormous challenges.

["Biotech Industry Blasts PTO at San Diego Hearing", BNA's Patent, Trademark & Copyright Journal , Volume 48: 677 (1994) at 677.]

Indeed, with respect to many biotechnology-based inventions which were to be used in the treatment of human beings, they were held not to be "inventions" for the purposes of patenting because the applicant had not demonstrated that the subject matter actually worked, and were therefore not useful. The biotechnology examiners were requiring Phase III clinical trial data before they were "convinced" that utility existed. Phase III means that significant preliminary testing in clinical trials had taken place to get to Phase III. Phase III itself is a thorough experimental\clinical investigation of the value of a drug substance. The basis for this position arose from an interpretation of case law which interpreted the utility requirements of 35 U.S.C. 101 to require that an invention be operative to possess utility. See, e.g., Raytheon Co. v. Roper Corp., 220 U.S.P.Q. 592 (Fed. Cir. 1983). ...; Stiftung v. Renishaw PLC ... 20 U.S.P.Q. 2d 1094 (Fed. Cir. 1991); In Re Gazave... 154 U.S.P.Q. 92 (C.C.P.A. 1967); In Re Chilowsky... 108 U.S.P.Q. 321 (C.C.P.A. 1956). Second, because 35 U.S.C. 112, requires that an inventor provide a disclosure of the invention that will enable a person of skill in the art to make and use the claimed invention, the examiners interpreted this as requiring a disclosure proving operability, otherwise they would reject the invention as being insufficiently disclosed as to be enabling. Following the hearings, the USPTO recognized there was a problem and has amended its policy on utility in respect of inventions in biotechnology. See the discussion in Stinson, S., "New rules ease bio-tech patent requirements". Chem. & Eng. News, January 1995, p. 7-8 (Utility) (1995) where it is stated: "The new guidelines shift PTO's policy for compliance with this "utility" requirement from an approach that doubts whether an invention works, to one that assumes the invention works, at most there are sound reasons to suspect otherwise."

148. For a good discussion of the novelty requirements see H.G. Fox, The Canadian Law and Practice Relating to Letters Patent for Inventions, 4th ed. (Toronto: Carswell, 1969) c. 4 and for anticipation see page 128ff of the test; also R.E. Dimock "Patent Anticipation or What's New, Patent Act" In: Patent Law of Canada Eds. G.F. Henderson et al. (Carswell: Toronto, 1994) at 101.

This is the current state of the legislation at the date of writing. As mentioned above, Bill S-17 introduced a number of amendments one of which included amending this novelty provision. This section 27 will be repealed when the amendments come into force and replaced with a new section 27 which is concerned with content of the specification. New section 28 will be concerned with novelty, and as discussed supra, non-obviousness. The section as presently enacted, but which is not yet in force is as follows:

28.2 - Subject-matter of Claim Must not be Previously Disclosed

The main effect of the amendments is to better define the time at which applications are made. Under the old sections there was some confusion between the filing date of an application in another country and which was being relied upon as a priority date, and the date of filing the application in Canada. The introduction of the "claim date" is intended to clarify this situation. In addition, as the Canadian statute is presently framed, the novelty inquiry is in respect of the "invention". The new section purportedly modifies this to "the subject-matter defined by a claim in an application". Whether this modification will impact significantly on the nature of the novelty inquiry will remain to be seen.

149. Canadian jurisprudence established the test (or standard) for novelty in the Reeves Brothers case ((1978), 43 C.P.R.(2nd) 145 at 157 (Fed. T.D.)) which held that the following criteria were required in order to find anticipation, or lack of novelty, in a published document:

1. Give an exact prior description;
2. Give directions which will inevitably result in something within the claims;
3. Give clear and unmistakeable directions;
4. Give information which for the purpose of practical utility is equal to that given by the subject patent;
5. Convey information so that a person grappling with the same problem must be able to say "that gives what I wish";
6. Give information to a person of ordinary knowledge so that he must at once perceive the invention;
7. In the absence of explicit directions, teach an "inevitable" result which "can only be proved by experiments"; and
8. Satisfy all of these tests in a single document without making a mosaic.

This would apply in respect of all published literature which, of course, includes patents and patent applications. The test was interpreted as requiring that all of the above 8 aspects be met before anticipation existed in the prior art. In essence, the invention had to exist or the invention had to have been precisely described. Consequently from 1978 until the Court of Appeal in the Tye-Sil case modified this approach, it could be said that the standard of novelty was low, i.e., very little had to be "new", and the standard for anticipation, which is the opposite view of novelty, was very high. Notwithstanding the comments on the Reeves Brothers standard in the Tye-Sil ((1991), 35 C.P.R. (3rd) 350 at 361 (Fed. C.A.)) decision, which arguably softened the requirements under Reeves Brothers, from a practical perspective for one to find an anticipation, a prior publication still must details something which is be the same as the invention. this is not surprising considering the words of the statute which state: "the invention was...disclosed...". This too means that any prior art reference which is not a printed document, but is a physical embodiment, must be the same as the invention. Indeed, at the CPO, the Reeves Brother's test, as modified by Tye-sil, has been distilled into a simple question of "Is it the same?" which is asked when evaluating the prior art in respect of applications in biotechnology.

150. In almost every other country worldwide which has a patent system, except for Mexico, the United States and Japan, absolute novelty is required, where any showing or disclosure prior to filing is sufficient to negate any possibility of obtaining a patent. In the United States the "world" is a somewhat smaller place than it is under Canadian practise. There, as in Canada, publication of the invention anywhere in the world will render the invention not novel. However, public use or sale is restricted to the United States, i.e., so long as the invention has not been disclosed anywhere in the United States it may be considered new, notwithstanding that it may have been publically available in another country. 35 U.S.C. 102 states:

Prior to 1989 the Canadian statute was similarly limited with respect to novelty to disclosures in public in Canada. However, with the amendments to the Canadian Patent Act which came into effect in 1989 disclosure anywhere in the world was sufficient to destroy the novelty or newness of an invention which was the subject of a patent application.

151. Xerox of Canada Ltd. v. IBM Canada Ltd. (1977), 33 C.P.R. (2d) 24 (F.C.T.D.) at 85.

152. (1979), 201 U.S.P.Q. 352 (C.C.P.A.).

153. Jackson, "Patenting of Genes: Ground Rules in ASM, Forum on Patentability of Micro-organisms 17 (1981) at 25 In: Cooper, I.P., "Biotechnology in the Law - 1995 Revision" v. 1 (Clark, Bordman, Callaghan: New York, N.Y., 1995) at page 3-12.

154. (1902), 20 R.P.C. 123 (Ch. D.). In that case the patentee had claims only for an article made of commonly available materials. The invention involved a strip of canvas with a piece of india rubber attached to it, to be used for wrapping around damaged tires in order to make a repair.

155. (1943), 2 C.P.R. 1 (S.C.C.).

156. Continental Soya Co. Ltd. v. J.R. Short Milling Co. Ltd. [1940] 4 D.L.R. 579 at 597-598.

157. This is as discussed in Chapter 3 where invention is defined as something which is new and has some element of useful or utility. Continental Soya Co. Ltd. case the isolated enzyme was interesting and of value as a discovery, however, it was the fact that enzyme could be used to bleach flour that constituted the invention.

158. (1948), 65 R.P.C. 255

159. (1959), 30 C.P.R. 135 at p. 383.

160. Shell Oil v. Commissioner of Patents (1982), 67 C.P.R. (2d) 1 (S.C.C.) at 11.

161. (1989), 25 C.P.R. (3d) 257 (S.C.C.).

162. The information in this section is drawn from the MOPOP and from an interview with Examiners at the Canadian Patent Office.

163. See Appendix "A" which is a form setting out the classification scheme used at the CIPO in connection with biotechnology cases.

164. Rule 40 of the Patent Rules SOR 78-673 as amended, allows an examiner to require of the applicant any information which the applicant has in the way of prior art, and related documents, cited against corresponding applications in other countries, in any proceedings which relate to those applications such as interferences in the United States.

165. The examiners indicated that currently, the patent databases known as "Orbit" and "STA" are routinely searched.

166. Prior art references are considered as "not available" for citation of they are not available to the public, for example, if not available from a library or other publically accessible reference location. The standard suggested in the MOPOP is whether the reference is "readily available" (see paragraph 11.06).

167. Although the MOPOP discusses novelty together with utility (see for example part 11.01) it is clear form the interview with the examiners that novelty is a separate inquiry. With respect to the standard for novelty, the MOPOP paraphrases the test from Reeves Brothers and indicates that anticipation can only be found in one reference (see paragraph 11.02.01.01).

168. The situation is very analogous the situation faced by Hoffman-La Roche in the case of F. Hoffman-La Roche & Co. Ltd. v. Commissioner of Patents (1955), 23 C.P.R. 1 (S.C.C.). In that case, a novel method of making an aldehyde had been invented. The applicant tried to claim the aldehyde when made by the novel process. The Supreme Court of Canada would only allow claims to the inventive process, it would not allow the product-by-process claims. The aldehyde, it reasoned, was a well known compound and could not be made an invention merely by association with the inventive process. Indeed, this was the basis of the decision of the English Court of Appeal in its invalidation of all of the claims of the Genetech patent in Genentech's Patent notwithstanding the considerable time, money and effort which went into producing the Genetech t-PA. Although this decision was in respect of a European patent it was from an English perspective and consequently will be influential in any Canadian decisions concerning the same subject matter. This is of course the complicating factor in biotechnology: in many cases most of the techniques for producing synthetic versions of products of nature are standard, well known techniques that allow anyone with a specific object in mind (product of nature) to achieve the result. At least these products appear to be straight forward to produce. See the discussion infra, under desideratum inventions. The problem is that to undertake this kind of work requires considerable financial resources.

169. A decision in the United States by the Court of Customs and Patent Appeals In Re Bergy was among the first which wrestled with the question of whether a product found in nature could be considered new for the purposes of patenting. The case related to an antibiotic known as lincomycin as well as to the micro-organisms which produced the antibiotic. The claims were worded in a manner which did not refer to the micro-organisms as they were originally found rather the claims recited a "biologically pure culture" of the specific micro-organism. Evidence provided to the Court indicated that a biologically pure culture (such as the one at issue) is a well defined product of a microbiologist which is capable of producing a particular antibiotic under controlled fermentation conditions. There was also evidence that the soil source in which the micro-organism was discovered is a complex microbial environment which could not be used to produce a desired product under any known fermentation conditions. The Court held that because a biologically pure culture does not exist in nature, this constituted sufficient novelty for the purposes of a patent. This was the result, notwithstanding the fact that the micro-organisms which are the subject of Bergy's patent were found in soil samples, and, the only thing which distinguishes those micro-organisms from Bergy's micro-organisms was the fact that Bergy's micro-organisms had been purified and maintained in a laboratory culture setting.

170. While there is no caselaw on the point, some Patent Agent practitioners who prosecute applications for biotechnological subject matter before the Canadian Patent Office have indicated some difficulty in obtaining such claims. However, where the chosen vector, such as bacterium, provides a recombinant version of the native form of protein which is different, eg. unglycosylated, claims to the purified recombinant, unglycosylated form may be allowed.

171. Austin, H."Bio-Technology Patent Law: A European Perspective" The Genetic Engineer and Bio-Technologist v. 10, p. 15 (1990).

172. As cited in "Biological Inventions" In: "European Patents Handbook" (2nd) Edn Rel 20 1995 at 18/11.

173. Austin, H."Bio-Technology Patent Law: A European Perspective" The Genetic Engineer and Bio-Technologist v. 10, p. 15 (1990).

174. To date, Canada does not have any legislative language concerning the concept of non-obviousness. This is about to change with the introduction into the Patent Act of section 28.3 which is, at the time of this writing, enacted but not yet proclaimed in force. The section states:

28.3 - Invention must not be Obvious

The subject-matter defined by a claim in an application for a patent in Canada must be subject-matter that would not have been obvious on the claim date to a person skilled in the art or science to which it pertains, having regard to:

1. information disclosed more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant in such a manner that the information became available to the public in Canada or elsewhere; and
2. information disclosed before the claim date by a person not mentioned in paragraph (a) in such a manner that the information became available to the public in Canada or elsewhere.

These amendments were part of an omnibus intellectual property improvement bill known as Bill S-17. These amendments are now found at S.C. 1993, c. 15. The coming into force of this section and other sections of this Improvement Act is dependent upon the completion of a significant overhaul of the Patent Rules. It was the consensus of those Patent agents and Examiners interviewed and asked for their opinion on this section that it is unlikely that section 28.3 will have much of an impact on the general interpretation and application of the concept in the analysis of invention.

175. For an excellent discussions of the "Inventive Step" see J. Bochnovic,"Invention/Inventive Step/Obviousness" In: "Patent Law of Canada" G.F. Henderson et al. eds. (Carswell: Toronto, 1994) at p.41; and J. Bochnovic, "The Inventive Step" IIC Studies Volume 5 (IIC Publications: Basel, 1982).

176. (1986) 8 C.P.R. (3d) 289

177. This test has been formulated in many ways over the years, the most famous formulation being that of Sir Stafford Cripps as counsel in Sharpe & Dohme Inc. v. Boots Pure Drug Coy Ld. (1928), 45 R.P.C. 153 at 163:

This formulation of the test, and others were quoted with approval by Mr. Justice Pigeon speaking for the majority of the Supreme court of Canada in Faberwerke Hoecht A/G v. Halocarbon (Ontario) Ltd. (1979), 42 C.P.R. (2d) 145 at 156 (S.C.C.). In addition to the formulation of Mr. Justice Hugessen set out in the text, the test has also been well formulated by Mr. justice Urie in Beecham Canada Ltd. v. Procter & Gamble Co.(1982), 61 C.P.R. (2d) 1 at 27 (F.C.A.) and by Mr. Justice Stone in Reading & Bates Construction Co. v. Baker Resources Corp.(1987), 18 C.P.R. (3d) 181 at 188 (F.C.A.). See generally "Hughes and Woodley on Patents" by R.T. Hughes and J.H. Woodley issue 1995,(Markham: Butterworths, 1984-1995) at §11; bochnovic, J. "Invention/Inventive Step/Obviousness" In: "Patent Law of Canada" Henderson G.F. et al. eds. (Toronto: Carswell, 1994) at 41; and Fox, H.G. "The Canadian Law and Practice relating to Letters Patent for Inventions", 4th ed., (Toronto: Carswell, 1969) at 69.

178. This concept is intended to capture that person who has sufficient grasp of the information, "knowledge" of an art so as to be able to appreciate the nature of the invention which they are considering.

from Fox at page 184.

179. The common general knowledge is to be distinguished from the "public knowledge" as a broader level of inquiry. The distinction between public knowledge and common knowledge is that the former is any information which is available to the public, regardless of who has seen it:

from Fox at page 103-104.

The latter is that information which is a part of the knowledge generally well known by those skilled in an art, and has been held to include that information which such a skilled person would be able to find in a reasonable diligent search (Procter & Gamble v. Kimberly-Clark Ltd., (1991) 40 C.P.R. (3d) 1 (F.C.T.D.) at 45-48 per Teitelbaum J.).

180. After S-17 is proclaimed, this enquiry will be as of the "claim date". S-17 is the Omnibus Intellectual Property Improvement Bill referred to above with respect to the footnote concerning Section 28.3 and non-obviousness.

181. Though easy to state, this concept is difficult in application. In essence, the skilled technician, charged with the common general knowledge, must be able to perceive the invention, which must be plain and obvious. It is said to be a very low standard. The "worth a try" doctrine has been suggested as an element of this analysis, however as discussed below, that doctrine has been held to put the standard too high.

182. As discussed supra, predictability is directed to whether a claim in a patent is too broad. In other words, based on the prior art, and from the perspective of the person skilled in the art, would the disputed subject matter which is the subject of a claim have been predictably included in the scope of the claim? It has been held by the Supreme Court of Canada in Monsanto c. v. Commissioner of Patents (1979), 42 C.P.R. (2d) 161 at 174, that so long as it is possible for the patentee to make a sound prediction and to frame a claim which does not go beyond the limits within which the prediction remains sound, then he is entitled to do so.

183. Johns-Manville Corporation's Patent [1967] R.P.C. 479 cited with approval by the English Court of Appeal in Genentech Inc's Patent [1989] R.P.C. 147 (C.A.) as quoted in M. Paver "A Tale of Two Rodents, or a Rodent with two tails: Europe grapples with patenting animals." Patent World June 1993, p. 29 at page 31.

184. Olin Mathieson Chemical Corporation v. Biorex Laboratories [1970] R.P.C. 157 cited with approval by the English Court of Appeal in Genentech, supra, as cited in M. Paver, "A Tale of Two Rodents, or a Rodent with two tails: Europe grapples with patenting animals." Patent World June 1993, p. 29 at 31.

185. Amgen Inc. v. Chugai Pharmaceutical Co. Ltd 927 F.2d 1200 (Fed. Cir.) at 1209 (1991).

186. 6 U.S.P.Q. (2d) 1959 (1988) (C.C.P.A.).

187. K.R. Adamo, "The Power of Suggestion (Teaching, Reason or Motivation) and Combined-Reference Obviousness: Part I" Patent World , July/August 1993, page 29 at 37-38.

188. However, even though the standard may appear to be similar, significantly different results can arise out of similar facts. The case to consider in this respect is Genentech, Inc. v. Welcome Foundation, Ltd., 14 U.S.P.Q. 2d 1363 (P.N.A.). The critical issue was determining the scope of Genentech's patents [one patent described a method to isolate and purify tissue-type plasminogen activator (t-PA) from cultured human melanoma cells and included a claim to the resulting purified t-PA and the second patent described the use of genetic engineering techniques to produce a recombinant t-PA]. The Genentech products were two-fold: one with a single amino acid substitution at position 245 and a second which was short two domains found in the naturally occurring protein.

The court construed the term "human plasminogen activator" restrictively and concluded that the term could only refer to human t-PA or naturally occurring variance of human t-PA. Consequently neither protein produced by Welcome Foundation literally infringed. The court then looked at the question of substantial infringement under the doctrine of equivalents. The Delaware Federal District Court decided in respect of this issue that a critical question was whether the patented t-PA and the accused's variance produced the cleavage of plasminogen to plasmin in the same way. The issue was decided by a jury which returned a verdict against Welcome.

In the United Kingdom with the same facts, it was held that the Welcome variant which contained a single amino acid substitution was an infringing version however the further modified form of t-PA was held not to infringe. This is because the entire patent of Genentech's was held to be invalid on the basis of being obvious and not having an inventive step in that the product was well known and it would have been worth a try to produce t-PA.

189. Given the state of technology, arguably the entire gene would be obvious or at least "worth a try" to produce because routine procedures should allow an investigator to design probes based on the published amino acid sequence to extract the relevant gene sequence from a DNA library.

Traditionally, in the United States, a gene has been considered a new chemical compound and the test to decide whether a new compound is obvious is based on: a. The structure of the new compound in comparison with similar compounds previously uncovered; and b. A review of the prior art which is searched for suggestions or any hint or direction of how to create the new compound. In other words, if literature in the prior art made it "worth a try." In chemistry cases where both of these elements are found the Patent Office would find found the compound under consideration to be obvious. It was purportedly on this basis that the USPTO denied claims to DNA sequences in two U.S. decisions, In Re Bell(90991 F. 2d 781 (Fed.Cir. 1993)) and Ex Parte Deuel(This decision went from the Patent Appeals Board to the Federal Circuit and those decisions are reported at 33 U.S.P.Q. 2d 1445 and 34 U.S.P.Q. 2d 1210, respectively).

When the case came before the Court In re Bell it was held that, in respect of biotechnological inventions, the Patent Board had taken a view quite different from the traditional chemical test. It was the Court's view that the Board had incorrectly compared the DNA sequence and the amino acid sequence and imposed techniques for using one sequence to obtain the other as the link between the compounds. The Court stated that DNA and proteins are different chemical compounds which cannot be compared. The Court ultimately found in favour of Bell.

In Re Deuel followed In Re Bell. Notwithstanding the Federal Circuit's decision In re Bell, the Board again found obviousness in a DNA sequence based on previously available amino acid sequence information, and a "method of cloning" reference which suggested a way to isolate from a DNA library the gene which was the subject of the case. The Federal Circuit rejected the USPTO's views and stated that the proper test is the traditional structural test for new compounds. The Court found that in light of the redundancy of the genetic code one could not have conceived of the natural DNA sequences from published protein sequences. It stated that no particular one of [the enormous number of possible] DNAs can be obvious unless there is something in prior art to lead to the particular DNA.

190. (1979), 42 C.P.R. (2d) 145 at 155 (S.C.C.).

191. Id.

192. It is noteworthy that at the Trial level on the reference back from the Supreme Court, the trial Judge (Mr. Justice Collier) found obviousness on the basis of the invention having been "worth a try". See Hoecht v. Halocarbon (1983), 74 C.P.R. (2d) 95 at 99 (F.C.T.D.). Although, it is arguable that the context of use of the "worth a try" doctrine by the trial Judge was as no more than a restatement of "was it obvious or very plain". Indeed, in the "first' trial decision Collier, J. was well aware of the importance of not elevating the "worth a try" approach - he stated at p. 125 of the decision:

193. Y. Ko "An Economic Analysis of Biot echnology Patent Protection" The Yale Law Journal, v. 102: 777 (1992) at 784.

194. M. Paver, "A Tale of Two Rodents, or a Rodent with two tails: Europe grapples with patenting animals." Patent World June 1993, p. 29 at 31. Indeed, as discussed in M. Vicente, "Introduction: A Simple Expression? Complexities of Genetic Regulation in Micro-organisms", World Journal of Microbiology and Biotechnoloy Volume 9 401 (1993) extreme complexity is involved in "gene expression". Vicente argues that the complexity creates endless opportunities for invention. His view is that as knowledge increases about how cells and bio matter works the opportunities for invention increase with them. This fits with the general impression that as information about a subject becomes known the questions and problems and solutions to those problems become possible. In the end invention in biotechnology is not really any different than it is with any other area of scientific endeavour where there is great complexity in the subject matter.

195. 927 F.2d 1200 (Fed. Cir.) 112 S.Ct. (1991), as cited in B. C. Cannon, "Toward a Clear Standard of Obviousness For Biotechnology Patents" [1994] Cornell L. Rev. 735 at 755.

196. Consequently, is a scientific discovery which is made according to this type of research program truly an invention worthy of patent protection? The answer is probably yes. This is because in biotechnology as in any other field of endeavour, inventors work with the known to create the new and unobvious:

E. Corcoran "Charlotte's Patent: Spider Webs and Other Proteins Inspire Engineers" Scientific American, April 1992: 138 at 140.

197. [1995] R.P.C. 25 (C.A.).

198. It was also held by the Court of Appeal that the main claims to the product had been drafted in terms wide enough to cover both core and surface antigens and in any host whether bacterial or non-bacterial. This relates back to the discussion, supra, concerning the scope of claims and "sound prediction," In biotechnology, it is difficult to extrapolate results in on host or species to other varieties of hosts or species. The underlying science is simply not well enough understood yet. The Court of Appeal applied the same standard as required in all fields of technology, namely that the disclosure had to be wide enough to enable the man skilled in the art to perform the claimed invention across its full width, and not, in the instant case, just by reference to one type of antigen or one type of host. The plaintiff was unable to make that disclosure and that showed it was seeking to claim an invention to which it was not entitled. The question of sufficiency of the specification was to be assessed by reference to the state of the art at the date of filing of the application. Consequently, if there was insufficient prior art to allow for such prediction, the claims would fail for insufficiency of disclosure and inherently, unsound prediction.

199. Interestingly, and illustrative of the fact that this is universally never a clear cut issue, the same facts in the European system also resulted in an issued European patent. Also like the British Court of Appeal, in opposition before the Opposition division, the patent was revoked. However, on appeal to the Technical Board of Appeal, the decision of the Opposition division was set aside and the Patent allowed to stand (EPO T 296/93 Biogen Inc.). It will be interesting to see if the House of Lords agrees with the Technical Board of Appeal.

200. Beloit Canada Ltd. v. Valmet OY (1986), 8 C.P.R. (3d) 289 at 294 (F.C.A.).

201. According to Fox at 185-186, it may be necessary to call in more than one person to make up this "skilled technician." In support of this he cited Orsam lamp Works Ltd. v. Popes Electric Lamp Co. Ltd.:

202. J. Culbert, "U.S. Patent Policy and Biotechnology: Growing Pains on the Cutting Edge" (1995) 77 (2) J.P.T.O.S. 151, at 154-155. This comment is from the perspective of the United States however it is universally recognized (although not necessarily commented upon universally) as can be seen in the following comment by P.W. Grubb speaking from the European perspective:

P.W. Grubb "Patents in Biotechnology" Swiss Biotech Vol. 4: pg 12 at pg 15 (1986).

203. Prior to the implementation of section 103 in the United States in 1952, the standard for patentability of an invention was whether there was "invention"(Witherspoon, J.F., ed.,"Nonobviousness - The ultimate Condition of Patentability" (Washington: The Bureau of National Affairs Inc., 1978)). Section 103, which states:

35 U.S.C.103 - Conditions for patentability; nonobvious subject matter

was interpreted by the Supreme Court of the U.S. in what has been considered the leading decision on the question of obviousness in the United States Graham v. John Deere 383 U.S. 1 (1966) (U.S.S.C.). There was considerable grumbling in the United States over the application of the standard of non-obviousness as set forth in that decision in the USPTO by examiners in biotechnology. On July 20, 1994 a public hearing on the standard of non-obviousness was held.

"Biotech Industry Blasts PTO at San Diego Hearing", BNA's Patent, Trademark & Copyright Journal , Volume 48: 677 (1994) at 678. The transcript is available through the United State Patents and Trade-mark Office and is entitled "In the Matter of: Public Hearing on the Standard of Non-obviousness" held Wednesday, July 20, 1994.

204. The same cannot be said in the United States where the law has taken a turn for the worse. In particular the In Re Durden case stood in the way of inventors in biotechnology from claiming known processes when used to prepare new, non-obvious products. The case stands for the proposition that the existence of a patentable starting matter or end-product does not make an obvious process non-obvious, and therefore patentable. In the case, the Federal Circuit rejected Durden's process claims as obvious because another inventor had already described the process in a patent, even though Durden used a different starting material and created a different end-product ( for further discussion see Viksnins, A.S. "Amgen, Inc. v. United States International Trade Commission: Designer Genes Don't Fit" Minnesota Law Review of v. 76: at 161).

Illustrative of this is the Amgen case where the company Amg en owned a patent which was a product patent covering certain DNA sequences, vectors and wholesales used to make recombinant erythropoietin (EPO). Amgen sued a company named Chugai under United States patent law for infringement of this patent based on Chugai's importation of EPO product which was manufactured off shore. The court held that importation of a non-patented product notwithstanding the fact that the intermediates were patented would not constitute infringement. Furthermore, because the process involved could not be patented notwithstanding the fact that it was used to produce new intermediates which themselves were patentable it was not possible to sue on the basis of importation of a product which was produced by a patented process.

These two decisions posed considerable problems for the biotechnology industry wherein the end products are typically not novel notwithstanding the fact that intermediate products may be. It was proposed that Section 103 of Title 35 be amended to expand the definition of non-obviousness, and this is exactly what happened. Bill S 1111 was passed prohibiting obviousness rejections of process patent applications for biotechnological processes "using or resulting in a composition of matter" that is novel and non-obvious if: (1) the product and process are in the same application and have the same filing date; and (2) the product and process claims were owned by the same person when they were invented. ("Senate Passes Biotech Process Patent Bill" BNA's Patent, Trademark & Copyright Journal, (1995) vol. 50 at 633.) President Clinton has signed this bill into law.

This kind of problem has not occurred in Canada and is unlikely to do so. In Canada, claims for a process which is limited to the production of a new, useful and non-obvious product are allowable (MOPOP 10.02.01.) Judicial support for this can be found in the Shell Oil decision where it was held that claims to an old compound are allowable if limited to a new, useful and non-obvious use.

205. Group 180 examiners are those who consider patent applications wherein the subject matter is classified as biotechnology.

206. For further discussion see Chapter 4, and the footnotes associated with the section concerning Utility.

207. A.S. Viksnins, "Amgen, Inc. v. United States International Trade Commission: Designer Genes Don't Fit" Minnesota Law Review of v. 76: 161 at 182-183.

208. (1982), 62 C.P.R. (2d) 81 (PBA).

209. Concerning the ability of a person reading a disclosure to such an invention to be able to replicate the invention, techniques in biotechnology have advanced to the point where it should possible, in the same way that Abitibi was able to produce its microorganism en masse, to faithfully reproduce whole organisms and, as such, this should not be a bar to patentability today.

210. (1989), 25 C.P.R. (3d) 257 (S.C.C.).

211. (1987), 14 C.P.R. (3d) 491 (F.C.A.).

212. At page 495 of the decision.

213. North American Free Trade Agreement, Article 1709(1)

214. Although arguably the Canadian Charter of Rights and Freedoms is available to ensure such is not a possibility. In particular, section 7 of the Charter provides:

Support for the argument that section 7 could prevent the possibility of a patent issuing in respect of a human, or human body part may be found in the decision of R v. Morgentaler (No. 2) [1988] 1 S.C.R. 30 where Wilson J., one of the 5 majority judges, found, amongst other deprivations, a deprivation of liberty in the loss of a woman's control over the termination of her pregnancy. In examining the concept of liberty Wilson J. said at p. 164:

In order find that a section 7 Charter right had been contravened arguably there would have to be evidence that the grant of a patent had in some way diminished the freedom of the individual. Where such evidence exists, the grant of such a patent would have been contrary to section 7.

215. First proposed in Doc. COM (88) 196. See (1989) 20 IIC 55 for the Directive and see the next note for further references concerning the fate of the Directive.

216. As indicated supra, in the Report, the European Directive was rejected by a co-decision procedure of the European Parliament on March 1, 1995. For further discussion see Rothley, "Why Parliament Must Think Again About Biotechnological Protection" (1995) 26 IIC 668; R. Stephen Crespi, "The European Biotechnology Patent Directive is Dead", Trends in Biotechnology Volume 13 No. 5 at 162, 1995; S. Hassler, "European Patent Legislation: A Missed Opportunity" (1995) 13(4) Bio/Technology 305; and J. Straus, "Patenting Human Genes in Europe - Past Developments and Prospects for the Future (1995) 26 IIC 920.

217. Recently, fresh wording has been suggested for a new Directive and in respect of the patentability of human beings the wording is as follows:

Article 3

1. The human body and its elements in their natural state shall not be considered patentable inventions.
2. Notwithstanding paragraph 1, the subject-matter of an invention capable of industrial application which relates to an element isolated from the human body or otherwise produced by means of a technical process shall be patentable, even if the structure of that element is identical to that of a natural element.

Article 9

1. Inventions shall be considered unpatentable where exploitation would be contrary to public policy or morality, provided that exploitation is not deemed to be so contrary merely because it is prohibited by law or regulation.
2. On the basis of paragraph 1, the following shall be considered unpatentable:
   1. methods of human treatment involving germ line therapy;
   2. processes for modifying the genetic identity of animals which are likely to cause them suffering or physical handicaps without any substantial benefit to man or animal, and animals resulting from such processes, insofar as the suffering or physical handicaps inflicted on the animals concerned are out of proportion to the objective pursued.

218. Although this wording is, in many respects, similar to the wording of its predecessor, the wording of the new Directive is somewhat more restrictive, the intention being to avoid the possibility for allowing patents on isolated human genes, and in particular, human gene therapy (see J. Straus, "Patenting Human Genes in Europe - Past Developments and Prospects for the Future (1995) 26 IIC 920).

219. See the section supra, in Chapter 4, concerning "Methods of Medical Treatment."

220. North American Free Trade Agreement, Article 1709(2).

221. Co-operatives consist of a number of farms banded together wherein the produce of one marketer may be exchanged for those of another.

222. For the purposes of the following discussion, products of nature can be classified as "known" and "new." Known products of nature are those which have been isolated and ch aracterized. New products of nature are those just isolated, and not previously known. Once a new product of nature is published, including in patent art, it becomes known. Further, products of nature isolated from nature are referred to herein as "natural" products of nature. Products of nature produced through significant human intervention, eg., by recombinant DNA techniques, are referred to herein as "synthetic" products of nature. As such there will be situations where a synthetic version may exist in respect of known products of nature, and there may be synthetic versions of new products of nature.

223. The expression "second generation compound" is intended to mean those naturally occurring substances which have been modified in order to confer some property, feature or characteristic which distinguishes it from the natural or "first generation" of the substance.

224. As discussed, supra, in Canada, it is even possible to obtain claims to a "product of nature" produced by recombinant means where the only difference between the recombinant version and the natural version is the presence of a glycan. As such, Canada is a very favourable jurisdiction in which to obtain patent protection for such products. Whether such patents would withstand the scrutiny of the Courts (in view of decisions like Genentech's Patent) remains to be seen.

The question of the patentability of second use, or second generation proteins is always subject to the following caveat, notwithstanding the newness:

225. "There are a number of roadblocks to achieving this end including the difficulty of isolating the target protein; the search for the gene which expresses the desired protein - this involves searching DNA libraries with a probe which may be a DNA fragment from other animal species or a synthetic construct from the amino acid sequence of the naturally-derived protein; once the gene is isolated the researcher may explore ways to modify the sequence to produce a protein with one or more variations in its amino acid structure. These new proteins are known as "second generation" proteins and the variations may enhance potency, resistance to degradation or other desirable qualities. Because the relationship between structure and function in proteins is still not completely understood this relationship remains unpredictable and consequently the creation of an improved "second generation" protein may be as daunting a task as producing the first generation protein."

Y. Ko, "An Economic Analysis of Biotechnology Patent Protection" The Yale Law Journal, v. 102: 777 (1992) at 784-785.

The inference from this author is that because so much work is involved in generating a recombinant "second generation" protein some rights should flow to the creator. However as mentioned supra, it is important to distinguish between true second generation proteins and proteins which have been synthesized to replicate the protein found in nature. The true second generation protein will have some new and desirable feature which makes it better than the native or sy nthetically modeled protein which copies the natural protein. As such, according to the traditional rules of patent law, such proteins would not likely be obvious and should be accorded patent protection.

226. Where an inventor is able to recognize the utility of a previously unknown, or "new" product of nature, and that inventor also finds a way of synthesizing the "new" product of nature, unrestricted product claims would probably be available, as opposed to being fettered with the "purified isolated" limitations. However, according to the analysis presented infra, claims would be limited in scope to that which is truly invented, i.e., the natural product of nature and the synthetic product of nature when produced by a described process.

227. Otherwise, the manufacturer of the Recombinant version is likely to be sued:

Ko, Y."An Economic Analysis of Biotechnology Patent Protection" The Yale Law Journal , v. 102: 777 (1992) at 788.

228. Such avenues to patentability for so-called "products of nature" include claims to products isolated and purified from a soil sample, etc.

229. Section 39(1) and its forerunners, including when it was better known as section 41(1), related to substances intended for food or medicine and in effect allowed patents for new substances which were, or were intended for food or medicine only when claimed by the processes of their manufacture. For a brief discussion of the history of these provisions see: Jennifer Morton, "Pharmaceutical Patents and Bill C-91: The Historical Perspective" C.I.P.R. 10(1) 145 (1993).

230. Hoffman-LaRoche v. Commissioner of Patents (1955), 23 C.P.R. 1 (S.C.C.) at 4 and 5. This was a case where the applicant Hoffman-LaRoche had developed a new and useful process to manufacture an old, well-known compound, aldehyde. The applicant sought to obtain claims to the product produced by the patentable process, even though the product was old.

231. Michael S. Greenfield, "Recombinant DNA Technology: A Science Struggling with the Patent Law" Stanford Law Review 44:1052 (1992). Greenfield ultimately recommends limiting the scope of all patent protection for "products of nature" to process patents only. It is arguable that such an approach is overly restrictive in that the true pioneer who sets the stage for subsequent recombinant production of a given "product of nature" is denied the benefit that would be awarded to the counterpart in other fields of technology. This raises potential problems with respect to compliance with obligations under NAFTA. It is likely that Greenfield was not considering NAFTA at the time of writing his article given the timing of NAFTA implementation in the U.S.

232. An argument may be made, however, that patentee's with claims to the original isolated purified product of nature are disadvantaged by PBA legislation in so far as they would not be fully able to prevent others from manufacturing their claimed product, at least where the others are using a new, non-obvious, useful process. This would arguably be contrary to Article 1709(5)(a). In response, it may be said that Article 1709(6) provides support for any such derogation of rights in that the PBA represents a limited exception to the exclusive rights conferred by the patent and that this exception does not unreasonably conflict with the normal exploitation of the patent, nor would it unreasonably prejudice the legitimate interests of the patent owner, taking into account the legitimate interests of the PBA rights holder.

233. Article 1702 of NAFTA states:

234. As suggested by Teitelbaum, J. in Procter & Gamble v. Kimberly-Clark Ltd. (1991) 40 C.P.R. (3d) 1 (F.C.T.D.) at 45-48.

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