Center for Advanced Study & Research on Intellectual Property

 

Patentable Subject Matter in Biotechnology:

Transgencic Animals and Higher Life Forms

A. Patricia Campbell, Ph.D.1

Table of Contents

I. Genetic Engineering, Transgenic Animals and Biotechnological Inventions

  • A. Recombinant DNA Technology, Genetic Engineering, and Transgenic Animals
  • B. The Role of Patent Law in Protecting Biotechnological Inventions

II. Patentability of Transgenic Animals in the United States

  • A. 35 U.S.C. §101: Patentable Inventions
  • B. Diamond v. Chakrabarty
  • C. U.S. Patent and Trademark Office: Patents for Multicellular Organisms
  • D. The Harvard Oncomouse Patent

III. Patentability of Transgenic Animals in Canada

  • A. The Harvard Oncomouse Patent in Canada
  • B. President and Fellows of Harvard College v. Canada (Commissioner of Patents)
    • 1. The Federal Court of Appeal Decision
    • 2. Supreme Court of Canada Decision
  • C. Analysis of the Canadian Supreme Court Decision

IV. Patentability of Transgenic Animals in Europe and Japan

  • A. European Union
    • 1. Statutory Definition of Patentable Subject Matter
      • a. Material Articles of the EPC
      • b. EPC Article 53(a): Ordre Public and Morality
      • c. EPC Article 53(b): Plant or Animal Varieties
    • 2. EPO Decision T19/90 on the Harvard Oncomouse
    • 3. Directive 98/44
  • B. Japan
    • 1. Statutory Definition of Patentable Subject Matter
    • 2. The Harvard Oncomouse Patent in Japan

V. Comparative Law Analysis

  • A. Summary of Differences between U.S., Canada, Europe and Japan Regarding Patentability of Transgenic Animals
  • B. Differing Applications to Moral Considerations
    • 1. Moral Utility Doctrine in the U.S.
    • 2. Ordre Public or Morality Doctrine in the E.U.
  • C. Harmonization: Is it Practicable?

VI. Economic Considerations and Conclusions



In December 2002, the Supreme Court of Canada rendered one of the most significant decisions in the area of biotech patent law anywhere in the world. In Harvard College v. Canada (Commissioner of Patents),2 the Supreme Court of Canada became the first top-level appellate court to consider directly whether a genetically engineered animal was patentable subject matter. In a 5-4 split decision, the majority ruled that a genetically altered mouse (the “oncomouse”) was not patentable subject matter. The decision brought to an end a case that had been running since 1995 between the president and fellows of Harvard College and the Canadian Commissioner of Patents. The majority decision, written by Justice Bastarache, held that “a higher life form is not patentable because it is not a ‘manufacture’ or ‘composition of matter’ within the meaning of the Canadian Patent Act.”3 Canada is now one of the few jurisdictions that have refused to provide patent protection to the oncomouse. Patent protection has been extended to the oncomouse in Australia, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, the United Kingdom, and the United States. Similar patents have been provided in Japan and New Zealand. Thus, the 5-4 decision sent Canadian law moving in a direction at odds with Canada’s major trading partners.

This paper addresses the legal development of animal patenting around the world and the ethical and economic challenges facing this controversial area of law. Particular emphasis is placed on the Canadian Supreme Court decision and its impact on the likelihood of global harmonization for this subject matter. Part I presents an overview of biotechnologies surrounding genetic engineering and transgenic animals. Part II examines the patentability of transgenic animals in the U.S., starting with the landmark 1980 Supreme Court case, Diamond v. Chakrabarty,4 and ending with the granting by the U.S. Patent and Trademark Office of the Harvard oncomouse patent in 1988. Part III examines the patentability of transgenic animals in Canada and analyzes in detail the Supreme Court of Canada’s decision in Harvard College v. Canada. Part IV examines the patentability of transgenic animals in Europe and Japan, with particular emphasis on EPO decision T 19/90, Harvard/Oncomouse, which gave rise in part to the drafting of the Biotechnology Directive governing the patentability of biotechnological inventions in the European Union. Part V undertakes a comparative law analysis and questions whether harmonization is practicable given the different standards for patentability and the different moral considerations used in the U.S. versus the E.U. Finally, Part VI examines economic considerations in light of the traditional justifications ascribed to the U.S. patent system and concludes with a look at the ramifications of the Harvard decision to the biotechnology industry in Canada.

I. Genetic Engineering, Transgenic Animals and Biotechnological Inventions

A. Recombinant DNA Technology, Genetic Engineering, and Transgenic Animals

Recombinant DNA technology creates new DNA sequences by joining pieces of DNA from different organisms.5 The use of recombinant DNA technologies permits genetic engineering of organisms. An organism in which foreign material from an organism of a different species is introduced is called “transgenic.”

Methods used for the transfer and recombination of foreign DNA fragments, either in vivo or in vitro, include: the use of restriction enzymes (enzymes that cut DNA at particular base sequences to allow splicing); electroporation (using high-voltage current to make cell membranes permeable to foreign DNA); micro-injection (a fine microcapillary pipet is used to inject foreign DNA into the cell nucleus); nucleus transplantation (replacing the nucleus of a zygote with a foreign nucleus); DNA gun bombardment (bombarding cells with small gold or tungsten particles coated with foreign DNA); and viral transformation (packaging foreign DNA into a virus, which delivers the genetic material to target host cells).6 These methods may be applied in combination with other technologies, such as cloning (the production of multiple, exact copies of a single gene or other segment of DNA, or of a genetically identical copy of a cell or an organism), mutagenesis (the production of either random or specific mutations in a piece of cloned DNA through chemical or radioactive treatment), artificial insemination, embryo transplantation, and embryo fusion.7 These techniques may also be applied to animals, for example, the Harvard oncomouse discussed in Part II of this paper, which was micro-injected with foreign DNA.

B. The Role of Patent Law in Protecting Biotechnological Inventions

Transgenic animals have commercial value in agriculture, biomedical research, medicine, and the pharmaceutical industry.8 The social impact of these forms of biotechnology is potentially enormous. In addition to providing accurate and cost-effective models for the study of human disease, transgenic animals are capable of improving food sources and disease resistance in animals.9

Despite the great commercial and social rewards associated with patenting biotechnological inventions, they require significant investment.10 Without patent protection, anyone could profit from the invention and free-ride on the inventor’s investment. Patents reward innovation and promote the disclosure of inventions to the public by allowing the patent holder the right, for a limited time period, to prevent others from making, using, selling, offering to sell or importing the patented invention, thereby affording protection from exploitation by free-riding competitors. This time-limited monopoly allows the inventor to recover a profit through licensing of the invention, providing an incentive to investors to assume the financial risks of supporting research and development of new products and processes to advance the invention. Consequently, there exists a fairly tight nexus between patent protection for a biotechnological invention, and the investment capital required to support research and development of the invention.

II. Patentability of Transgenic Animals in the United States

A. 35 U.S.C. §101: Patentable Inventions

The Constitution gives Congress legislative authority to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”11 Pursuant to this power, Congress established the United States Patent and Trademark Office (“USPTO”).12 The statutory subject matter upon which a patent may be issued is defined in 35 U.S.C. §101:

101. Inventions Patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.13

Section 100 of the Act defines “process” as “process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.”14 A process may be patented, even if the resulting product cannot.15 A manufacture is the production of articles from raw or non-raw materials by giving them new forms, characteristics, qualities, or combining them in a new fashion, regardless of whether it is done by hand or by machine.16 A composition of matter includes all compositions “of two or more substances and ... all composite articles, whether they be the result of chemical union, or mechanical mixture, or whether they be gases, fluids, powders, or solids.”17 Even though the scope of patentable subject matter is broad, there are exclusions.18 Laws of nature, principles, physical phenomena, abstract ideas, and products of nature are not patentable.19 Also, human beings are not patentable.20

No patent will issue if the subject matter does not meet the criterion of patentability under §101. Thus, determining whether the subject matter requirement of §101 has been met is key to an overall determination of whether an animal invention is patentable.

B. Diamond v. Chakrabarty

The development of recombinant DNA technology in the 1970s forced courts to interpret the broad language of the Patent Act to determine whether new and improved life forms could be patented.21 The issue was presented to the Supreme Court in 1980 in Diamond v. Chakrabarty.22 Chakrabarty involved an application for a patent on a genetically engineered bacterium capable of breaking down crude oil, which Chakrabarty proposed to use in treating oil spills. The patent application claimed a method of producing the genetically engineered bacteria, an inoculum comprising a carrier material containing the bacteria, and the bacterial organism itself. The patent examiner allowed the claims falling into the first two categories, but rejected claims for the bacterial organism.23 His decision rested on two grounds: that micro-organisms are “products of nature;” and that micro-organisms as living things are not patentable subject matter under 35 U.S.C. §101.24 Several appeals were brought, and the Supreme Court finally heard the case.

At issue was whether the human-made, genetically engineered, oil-eating bacterium constituted a manufacture or composition of matter within the meaning of the statute.25 In a 5-4 decision, the Court ruled in favor of Chakrabarty, holding that: “A live, human-made micro-organism is patentable subject matter under 101. Respondent’s micro-organism constitutes a ‘manufacture’ or ‘composition of matter’ within that statute.”26

The Court relied on the legislative history and statutory construction of §101 to conclude that Congress intended the statutory definition of patentable subject matter to be broadly interpreted to include organisms that were made with human intervention, whether living or not.27 In so construing §101, the Court stated that Congress, in enacting the 1952 patent statute, had intended statutory subject matter to “include anything under the sun that is made by man.”28 The Court also stressed the non-natural character of the new bacterium, stating that the bacterium was a product of human ingenuity, with markedly different characteristics from any found in nature and one having the potential for significant utility.29 The discovery was the inventor’s, not nature’s handiwork.30

The Court further rejected the contention that the 1930 Plant Patent Act (“PPA”),31 which afforded protection to certain asexually reproduced plants, and the 1970 Plant Variety Protection Act (“PVPA”),32 which afforded patent-like protection for sexually reproduced plants but excluded bacteria from such protection, intended to limit the scope of patentable subject matter under §101.33 The Court stated that, according to the legislative intent underlying those statutes, they were enacted not because the plants covered by them were not patentable subject matter under §101, but because inventions involving plants faced other obstacles to qualifying for patent protection under the existing statutes.34

Amicus briefs were filed with the Court warning of the potentially hazardous effects of genetically engineered organisms on the environment (spread of pollution and disease, loss of genetic diversity, etc.) and the risks of depreciating the value of human life, but the Court declined to weigh these risks in its analysis.35 The Court opined that the grant or denial of patents on microorganisms would have little impact on genetic research or its attendant risks.36 Furthermore, the court argued that it was without competence to entertain such arguments and that other political branches should address the issue.

C. U.S. Patent and Trademark Office: Patents for Multicellular Organisms

Seven years after the Chakrabarty decision, the USPTO announced that it “now considers non-naturally occurring non-human multi-cellular living organisms, including animals, to be patentable subject matter.”37 The catalyst for the announcement was a decision of the Patent Office’s Board of Patent Appeals and Interferences, Ex parte Allen.38 In Allen, the Board followed a previous case, Ex parte Hibberd,39 and ruled that oysters, which had been artificially treated to alter the number of their chromosomes, were properly patentable subject matter under §101 of the patent statute. Following Chakrabarty, Hibberd held that higher plants are patentable subject matter.

D. The Harvard Oncomouse Patent

In 1984, Harvard University filed a U.S. patent application for a transgenic mouse that was genetically altered to increase its susceptibility to cancer by incorporating a cancer-promoting “oncogene”40 into each of its cells.41 The resultant oncomouse was a research tool for carcinogenic studies. To create this research tool, the fertilized mouse eggs were injected with the oncogene, and then implanted into a female host mouse and permitted to develop to term.42 The first generation offspring that contained the oncogene were then mated with mice that had not been genetically altered.43 Fifty percent of the resultant second generation offspring carried the oncogene and were suitable for animal carcinogenic research.44 The patent application sought to protect both the process by which the oncomice are produced and the end product of the process, the oncomouse itself.

The relevant claims read:45

1. A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.
11. The mammal of claim 1, said mammal being a rodent.
12. The mammal of claim 11, said rodent being a mouse.

Claims 1 to 12 of the application were directed to a transgenic non-human mammal. Claims 2 to 12 were dependent on claim 1. Claim 1 was very broad and pertained to a “mammal,” however, the preferred embodiment in claim 11 read to a “mouse.” Claims 2 to 10 of the patent application were directed to a transgenic non-human mammal containing chromosomes with certain specific features, such as enhancers or promoters, which control expression of the gene.46 The remaining claims in the application related to aspects of the invention other than the transgenic mammal itself.47

The Harvard oncomouse patent, U.S. Patent No. 4,736,866, issued in 1988, almost four years after its filing date, with broad claims to a transgenic nonhuman mammal. The patents give Harvard exclusive rights to create the mice and charge licensing fees for their use. The “invention” is licensed to DuPont, which sells the mice to research labs.48

The oncomouse application was also filed in Australia, Japan, Europe and Canada.49 The application was initially rejected in Europe.50 The rejection was overturned on appeal, and the European Patent Office (“EPO”) granted the patent in 1992 with claims to transgenic mice. The EPO decision will be explored in detail in Part IV of this paper.

The oncomouse has been patented in numerous jurisdictions, including Australia, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, the United Kingdom, and the United States.51 Similar patents have been granted in Japan and New Zealand.52 However, on December 5, 2002, the Supreme Court of Canada decided that the definition of “invention” under the Canadian Patent Act excluded the patenting of higher organisms.53 The Canadian Supreme Court decision, discussed in detail in Part III of this paper, makes Canada the only industrialized country to prohibit patents on higher life forms.

Since the Harvard oncomouse patent, the USPTO has granted numerous patents for other transgenic animals.54 The scope of most of these patents is restricted to the animals that were used by the inventor, and thus belonging to one race. Other patents have a broader scope, encompassing not only the genetically modified animals, but also the animals’ offspring and/or animals of different races and/or higher taxonomical units, such as species.55 Most of the patents granted after 1988, however, have a more limited scope than the patent granted for the Harvard oncomouse in that they only claim transgenic animals for a defined species, for example, mice or rodents. In contrast, claim 1 of the Harvard mouse patent, which reads “A transgenic non-human animal…,” extends to all mammals having the particular genetic feature, excepting human beings.

III. Patentability of Transgenic Animals in Canada

A. The Harvard Oncomouse Patent in Canada

Canada did not follow the U.S. lead in granting the oncomouse patent, despite the fact that claims 1 through 12 of the U.S. and Canadian patent applications were identical.56 Harvard filed its Canadian patent application for “Transgenic Animals” on June 21, 1985.57 Following a lengthy prosecution battle,58 the patent examiner issued a Final Action on March 24, 1993, rejecting product claims 1 through 12.59 The examiner did, however, allow claims 13 through 26, which claimed the process of making a transgenic mammal.60

The examiner rejected claims 1 through 12 because they did not fall within the definition of “invention” under Section 2 of the Canadian Patent Act.61 The Canadian Patent Act defines “invention” as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.”62 The examiner noted that, had Parliament intended to include animals as patentable subject matter, it would have expressly included animals in the definition of “invention.”63 Further, the examiner relied on the Manual of Patent Office Practice’s (“MOPOP”) express exclusion of animals as statutory subject matter.64

Following review and a hearing before the Patent Appeal Board, the Commissioner of Patents confirmed the examiner’s decision on August 4, 1995.65 In his decision, the Commissioner noted that the oncomouse had been patented in the United States,66 but found that this decision did not carry much weight in Canada.67 In particular, the Commissioner decided that, for an invention to be eligible for a patent in Canada, it must be made under the inventor’s control and the resulting product must be consistently reproducible.68

In evaluating control and reproducibility of the rejected claims, the Commissioner separated the claims into two distinct categories: (1) the preparation of the genetically modified embryo, and (2) the development of the embryo in the host mother’s uterus.69 The first category did fall within the statutory definition of “invention,” as a “manufacture” or “composition of matter;” but the second category was controlled by the laws of nature, not by the inventor.70 In making his conclusion,71 the Commissioner was strongly influenced by the Federal Court of Appeal’s decision in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents).72 Lacking “full control over all the characteristics of the resulting mouse,”73 the inventor’s influence only extended to the preparation of the genetically modified embryo, not to the development of the embryo in the host mother’s uterus.74

Harvard appealed the Commissioner’s decision to the Federal Court of Canada Trial Division (“Trial Division”).75 The Trial Division judge, Judge Nadon, recognized the Chakrabarty decision, but favored the dissenting view,76 refusing to grant patent rights to claims 1 through 12 and dismissing the appeal.77

Judge Nadon then listed four distinct reasons for his refusal to grant patent rights.78 First, Judge Nadon found that the inventor did not exercise sufficient control to warrant patentability,79 stating that “the ultimate end product which will result from the process is completely unknown and unknowable.”80 Second, he distinguished between human intervention and the laws of nature81 : although the product might exhibit a single genetic characteristic resulting from human intervention, the remainder of the product resulted from complex laws of nature.82 Third, he stated that the inventors’ inability to predict the chromosomal location of the oncogene, and the degree of oncogene expression indicated a lack of reproducibility.83 Consequently, the transgenic mammal was not sufficiently reproducible to be a “composition of matter” or an “Article of manufacture” under the Patent Act. Fourth, Judge Nadon noted that “a complex life form does not fit within the current parameters of the Patent Act.”84

B. President and Fellows of Harvard College v. Canada (Commissioner of Patents)

1. The Federal Court of Appeal Decision

In 2000, the Federal Court of Appeal (“Appeal Division”) overturned Judge Nadon and concluded that both the process and the mouse could be patented.85 Ruling 2-1 in favor of the full patent, the court held that nothing in Canada’s Patent Act outlawed patenting animals, although it also asserted that the Act should not be extended to allow patenting of human beings.86

At the outset of its opinion, the Appeal Division noted that “significant policy questions are at stake.”87 In particular, the court noted the health and environmental concerns weighing against patents on higher organisms,88 but declared its intention not to deal with these and other policy issues. Instead, the court confined its analysis solely to “whether claims 1 to 12 amounted to an ‘invention’ within the meaning of that term in section 2 of the Patent Act.”89 The court also noted that the oncomouse had been granted patents in both the United States and Europe, and that Canada should follow suit in the interest of patent law harmonization.90

The Appeal Division then held for patentability, finding that claims 1 to 12 did amount to an invention within the meaning of Section 2 of the Patent Act.91 Borrowing the definition of “composition of matter” from Chakrabarty – “all compositions of two or more substances and all composite articles, whether they be results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders, or solids”92 – the court concluded that the invention fell within the meaning of a “composition of matter.”93

In holding for patentability, the Appeal Division pointed out the errors in the Trial Division’s reasoning. In particular, the court focused on Judge Nadon’s unwillingness to rely on the U.S. Supreme Court decision in Chakrabarty, and on his erroneous assessments with regard to the issues of control, reproducibility, and distinction between higher and lower life forms.94

The Appeal Division found that Judge Nadon’s reliance on the dissenting view in Chakrabarty was in error.95 The decision in Chakrabarty was relevant because Canada had modeled its own Patent Act on U.S. patent law.96 While the decisions of U.S. courts do not constitute binding authority, they can be persuasive in cases where particular statutory similarities existed, as was the case here with the definition of “invention.”97 Finding the majority in Chakrabarty more persuasive, the Appeal Division “placed significant reliance on it in concluding that the definition of ‘invention’ [did] not exclude from patentability, higher life forms such as the oncomouse.”98

As for the issue of control, the court held that the control test applies only to process claims, not product claims.99 With regard to reproducibility, the court determined that the specification sufficiently disclosed a process by which a person skilled in the art could compound the same composition of matter.100

Finally, the Appeal Division held that the distinction between lower and higher life forms was inappropriate.101 The court again relied upon the Chakrabarty decision, noting that no such limitation was found in the similar U.S. patent statute.102 Moreover, the court agreed with the majority’s conclusion in Chakrabarty that the issue of patentability for higher life forms was a matter of policy better resolved by the legislative branch.103

2. The Supreme Court of Canada Decision

In a 5-4 decision, the Supreme Court of Canada (“Supreme Court”) reversed the Appeal Division’s decision, declaring that higher life forms such as the transgenic Harvard oncomouse are not patentable in Canada.104 The core legal issue considered by the Supreme Court was whether the Harvard oncomouse was an “invention” as that term is defined in Section 2 of the Canadian Patent Act. The Court ruled that the mouse was not a “manufacture,” as the Court found “that the word would commonly be understood to denote a non-living mechanistic product or process.”105 The Court also ruled that the mouse was not a “composition,” as defined by the Oxford English Dictionary, because it did not consist of ingredients or substances that had been mixed together by a person.106 Moreover, the word “matter” as “composition of matter,” is only captured in one aspect of a higher life form.107 “Higher life forms are generally regarded as possessing qualities and characteristics that transcend the particular genetic material of which they are composed,” wrote Justice Bastarache for the majority.108 Thus, the Supreme Court concluded that “composition of matter,” and hence patenting, can apply to lesser life forms, but not to higher life forms.109

The majority acknowledged that the Patent Office had accepted lower life forms as patentable since 1982, but that while the Patent Act does not explicitly differentiate between lower and higher life forms, making such a distinction “is nonetheless defensible on the basis of common sense differences between the two.”110 In invoking such an arbitrary “common sense” standard, the majority provided limited guidance as to where to place the dividing line between patentable lower life forms and unpatentable higher life forms.

The majority also decided that Parliament never intended that higher life forms be covered, as indicated by the fact that the Patent Act is simply inadequate to deal appropriately with higher life forms as patentable subject matter.111 The majority argued (echoing the opinion in Chakrabarty) that the Court does not possess the institutional competence to deal with ethical and legal issues of this complexity.112 Rather than extending patent laws to higher life forms, as had been done by other nations’ courts, the Court reasoned that Parliament must give an express legislative directive to authorize the patenting of higher life forms.

In his forceful dissent, Justice Binnie disagreed with the distinction the majority drew between the “composition of matter” of higher and lower life forms:

‘Matter’ is a most chameleon-like word. The expression ‘grey matter’ refers in everyday use to ‘intelligence’ - which is about as incorporeal as ‘spirit’ or ‘mind’... If the oncomouse is not composed of matter, what, one might ask, are such things as oncomouse ‘minds’ composed of? The Court’s mandate is to approach this issue as a matter (that slippery word in yet another context!) of law, not murine metaphysics. In the absence of any evidence or expert assistance, the Commissioner now asks the Court to take judicial notice of the oncomouse, if I may use Arthur Koestler’s phrase, as a ‘ghost in the machine’ but this pushes the scope of judicial notice too far. With respect, this sort of literary metaphor (or its dictionary equivalent) is an inadequate basis on which to narrow the scope of the Patent Act, and thus to narrow the patentability of scientific invention at the dawn of the third Millennium.113

Taking an international perspective, Justice Binnie then contended that Canada was out of step with comparable jurisdictions with similar intellectual property legislation: “The truth is that our legislation is not unique. The Canadian definition of what constitutes an invention, initially adopted in pre-Confederation statutes, was essentially taken from the United States Patent Act of 1793, a definition generally attributed to Thomas Jefferson.”114

Justice Binnie also dismissed the prospect that allowing the patent on the Harvard oncomouse would open the door to patenting humans, saying that the Canadian Charter of Rights would prohibit ownership of human beings for commercial purposes.115 He called it ludicrous that Canada should be the sole jurisdiction to refuse patent protection to the oncomouse,116 and concluded that the patent office’s approach in refusing the patent application for the genetically modified oncomouse sounded a highly discordant note, because “the massive investment of the private sector in biotechnical research is exactly the sort of research and innovation that the Patent Act was intended to promote.”117

Certain interveners in the Harvard case118 argued that the patentability of higher life forms ought to be precluded on moral, ethical, and environmental grounds. Regardless, the Supreme Court unanimously held that the Commissioner has no discretion to refuse a patent on the basis of public policy considerations independent of any express provision in the Patent Act.119 Considerations of public order or morality do not arise in the Canadian Patent Act. This situation is in contrast with EPC Article 53(a), which specifically provides that European patents shall not be granted in respect of “inventions the publication or exploitation of which would be contrary to ordre public or morality . . ..”120 Interestingly, in Europe, where the Harvard oncomouse claims were specifically examined with regard to the morality of the claimed subject matter, they were held to be patentable.121

C. Analysis of the Canadian Supreme Court Decision

In Harvard College v. Canada, the Supreme Court of Canada found that a genetically engineered animal (a mouse) was not patentable subject matter. In Chakrabarty, heavily referenced in the Harvard decision, the U.S. Supreme Court found exactly the opposite – that a genetically engineered animal (a bacterium) was patentable subject matter. Notwithstanding their very different outcomes, these Supreme Court decisions exhibit two important similarities.

First, both courts refused to consider the moral implications of allowing a patent on a living organism. In fact, the Canadian Supreme Court found that it did not possess the institutional competence to entertain such issues.122 The Canadian Supreme Court thus paralleled the U.S. Supreme Court’s position in Chakrabarty that the courts were “without competence to entertain [such] arguments.”123 Instead of entertaining the complicated issues of morality and public policy, both courts decided to adhere to their roles as interpreters of the patent statute. In choosing not to consider morality and public policy, however, both courts recognized the importance of such factors, leaving these considerations to their respective country’s legislatures.124

Second, the U.S. and Canadian Supreme Court decisions relied on similar statutory language defining patentable subject matter. As indicated in Justice Binnie’s dissent, the Canadian Parliament borrowed heavily from the U.S. patent laws in constructing its own statutory regime. In so doing, Canada adopted a similar definition of statutory subject matter. Accordingly, both the Appeal Division and the Canadian Supreme Court found it appropriate to consider U.S. decisions interpreting statutory subject matter, and in particular Chakrabarty.

How, then, did the U.S. and Canadian Supreme Courts come to such different conclusions? The reason advanced in the Harvard majority opinion is that the patented inventions differed significantly in the complexity of the life form claimed. In Chakrabarty, the patent covered a bacterium, a lower life form. In Harvard, the patent covered a mouse, a higher life form, and higher life forms are not included within the term “invention” in Section 2 of the Canadian Patent Act.

A more subtle reason that potentially underlies the differing outcomes of the U.S. versus Canadian Supreme Courts may be found in the composition of the Canadian Supreme Court bench. Intriguingly, the majority in Harvard consisted entirely of judges trained in the civil law tradition: Justices Bastarache, Gonthier, Iacobucci, L’ Heureux-Dube, and Le Bel. In contrast, the dissenting minority consisted entirely of judges with a background in the British common law: Chief Justice McLachlin, and Justices Binnie, Major, and Arbour. Thus, the 5-4 split between the French Canadian versus the English Canadian side of the Supreme Court bench may have reflected the French Canadian justices’ sympathy toward an European concept of morality, as comprehended by the “ordre public” provision of the European Patent Convention (“EPC”), and not an adherence to the neutral principles of statutory interpretation. Discomfited by the morality of animal patents, but unable to point to any morality provision in their laws, the majority may have turned to a narrow statutory interpretation of “invention,” producing the same result as if the patent had been invalidated on moral grounds.

IV. Patentability of Transgenic Animals in Europe and Japan

A. European Union

1. Statutory Definition of Patentable Subject Matter

a. Material Articles of the EPC

Before issuing as a patent, an application submitted to the European Patent Office (“EPO”) must first satisfy the standards for patentability under EPC Article 52(1): “inventions which are susceptible of industrial application, which are new and which involve an inventive step.”125 The “inventive step” requirement is generally assessed by applying the “problem/solution” approach, which consists of three main stages: first, determining the “closest prior art;” second, establishing the “objective technical problem to be solved;” and third, considering whether the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to a person skilled in the art.126

The EPC contains specific classes excluded from patentability. Article 52(2) excludes discoveries, scientific and mathematical theories, aesthetic designs, business methods, computer programs, and presentations of data. Article 53 excludes inventions contrary to public morality and certain plant and animal varieties, providing as follows:

European patents shall not be granted in respect of:

(a) inventions the publication or exploitation of which would be contrary to “ordre public” or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.127

b. EPC Article 53(a): Ordre Public and Morality

EPC Article 53(a) strictly excludes patentability of inventions that are contrary to “ordre public” or morality.128 The EPC does not define the meaning of ordre public and morality, nor does it define what subject matter is contrary to public morality.129 However, in decision T 356/93, Plant Genetic Systems/Glutamine Synthetase Inhibitors, the EPO Technical Board of Appeal (“TBA”) extensively analyzed the ordre public exclusion.130 The TBA interpreted ordre public as covering “the protection of public security and the physical integrity of individuals as part of society.”131 Hence, inventions must be excluded from patentability as contrary to ordre public if their exploitation is “likely to breach public peace or social order (for example, through acts of terrorism) or seriously to prejudice the environment.”132 If the exploitation of an invention is contrary to ordre public or morality, then the invention will not be patented.133 The EPC provides an opportunity for any concerned public citizen (no commercial or other interest need be shown) to challenge a pending or previously issued European patent if the citizen believes that the patent is contrary to ordre public.134

c. EPC Article 53(b): Plant or Animal Varieties

The first clause of EPC Article 53(b), excluding plant and animal varieties, is derived from Article 2 of the Strasbourg Patent Convention,135 which allowed member states to ban patents on plant and animal varieties. At the time of the Strasbourg Convention, “essentially biological processes” referred only to the normal, or traditional, breeding activities of plants and animals.136 It had been recognized that traditional, natural processes were either not worthy of patent protection, or could not meet the enablement requirement of EPC Article 83 (i.e., it was hard to repeat the result of a natural process, and a natural process lacks technical character).137 Recombinant DNA technology changed this situation. Now, distinguishing an “essentially biological” process is more difficult because humans are able to alter the genetic material of plants and animals by manipulating the natural, or essentially biological, processes.138

In view of the advances in recombinant DNA technology, the EPO had to reassess what processes are “essentially biological.” It did so in decision T 320/87, Lubrizol/Hybrid plants,139 where the TBA held that a determination of whether a nonmicrobiological process is essentially biological depends on the extent of human intervention, the result achieved thereby, and the essence of the invention.140 Human intervention is not enough per se; such intervention has to be more than trivial.141

The second clause of EPC Article 53(b), which indicates that microbiological processes and their direct products are distinguishable from essentially biological products,142 also derives from Article 2 of the Strasbourg Patent Convention.143 At the time, macrobiological processes and products were not considered to be technological, and thus were not within the ambit of patent law.144 Meanwhile, microbiological processes, and their direct products, had been granted patents since the nineteenth century.145

In decision T 320/87, the TBA determined that the term “microorganism” also encompasses multicellular material, such as plants, animals, plasmids, and viruses.146 Also, products that are created or manipulated with the help of microorganisms, by a process that is entirely microbiological, are the products that “derive directly therefrom.”147 Hence, these products are patentable under EPC Article 53(b).

2. EPO Decision T19/90 on the Harvard Oncomouse

In 1985, around the time that the EPO was examining the Lubrizol patent, Harvard University filed an application for its oncomouse with the EPO.148 The initial application contained the following claims:

1. A method for producing a transgenic non-human mammalian animal having an increased probability of developing neo-plasmas, said method comprising introducing an activated oncogene sequence into a non-human mammalian animal at a stage no later than the 8-cell stage ... .
17. A transgenic non-human mammalian animal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said animal, or an ancestor of said animal, at a stage no later than the 8-cell stage.
18. An animal as claimed in claim 17, which is a rodent.

The Examining Division rejected the application by interpreting the term “animal varieties” in EPC Article 53(b) as excluding animals per se from patentability.149 Thus, Claims 1, 17, and 18 included unacceptable subject matter in the form of a method of producing both the genetically modified animal itself, and also its descendents through sexual reproduction.

Harvard University appealed the decision of the Division to the TBA. On October 3, 1990, the TBA issued decision T 19/90 setting aside the Division’s decision and remanding the application back for further prosecution.150 The TBA interpreted “animal varieties” based on its decision T 320/87, Lubrizol/Hybrid plants, which held that exceptions to patentability should be strictly construed.151 The TBA then identified a discrepancy in the terminology used between the English, French and German texts of EPC Article 53(b): the French term “races animals” and the German term “Tierarten” translate in English as animal breeds and animal species respectively, and as such the German term covers a higher taxonomic order (species) than both the English and French terms (races).152 The TBA also noted that the legislators could not have intended to exclude animal varieties and animals as such from patentable subject matter, and therefore rejected the Division’s interpretation of EPC Article 53(b).153 The TBA consequently remanded the case back to the Division with the order to determine whether the application’s subject matter qualified as an “animal variety” within a clarified meaning of EPC Article 53(b).154

Next, the TBA confirmed the Division’s interpretation of “essentially biological processes” as meaning the opposite of man-made transformations.155 Claim 1 recited a man-made transformation; a method for producing a transgenic non-human mammalian animal by injecting the oncogene into a vector plasmid and transfecting a cell at an early embryonic stage, or a fertilized oocyte no later than the 8-cell stage.156 Hence, if “animal variety” was found to be patentable on remand, the Division should hold Claim 1 as patentable.

Finally, the TBA rejected the Division’s disposition of the “microbiological processes” exclusion to patentability.157 The Division justified avoiding an examination of whether the invention included a microbiological process by stating that the second clause of EPC Article 53(b) (“this provision does not apply to microbiological processes or the products thereof”) failed to apply if the product was excluded from patentability under the first clause of the same Article (exclusion for “plant or animal varieties or essentially biological processes for the production of plants or animals”).158 The Board concluded that the second clause of EPC Article 53(b) must be read as an exception to the first clause, thus reestablishing the patentability of microbiological processes and the products thereof under EPC Article 52(1).159

On remand, the Examining Division concluded that the meaning of EPC Article 53(b) was unclear in light of the different terms its translations contain (Tierarten, animal varieties, and races animaux).160 The Examining Division subsequently defined “animal variety” or “race animale” as a sub-unit of species and therefore of lower ranking than a species. Accordingly, the subject matter of the claims to animals per se was considered not to be covered by the terms of EPC Article 53(b).161 Hence, with respect to the animals, the application was not rejected under EPC Article 53(b).162

Furthermore, the Examining Division held that genetic engineering inventions did not necessarily violate ordre public or morality, and, therefore, did not need to be excluded per se from patentability under EPC Article 53(a).163 Specifically, the Division determined that the following interests should be balanced when determining patentability:164

(i) A patent does not give the patentee a right to exploitation, but the right to exclude others from exploiting the invention for a certain period of time;
(ii) the principle is patentability; exclusions therefrom need to be interpreted restrictively;
(iii) new technologies always bring new risks; the risks need to be reviewed in view of the benefits from those technologies; after such review the determination about patentability can be made;
(iv) if inventions concern higher forms of life, the possible sufferance of these forms because of the invention needs to be considered in aforementioned review; [and]
(v) this review needs to be made with respect to every invention, on a case-by-case basis.

The Examining Division then balanced these enumerated interests and concluded that the invention at hand did not violate the ordre public or morality.

The following reasons were provided:165

(i) The invention is beneficial to human beings; cancer is a disease that has numerous victims, and every new means in the battle against this disease should be welcomed;
(ii) animal suffering will decrease because of this invention; a smaller number of animal models will be needed than in conventional research;
(iii) there are no alternatives to animal models for cancer research;
(iv) in view of the need for environmental protection, the purpose and use of the invention needs to be considered; the animal models that are produced by the invention are to be used in laboratories by skilled personnel; the chance that the animals may end up in free nature is small, and would only increase by a mistake - and the risk of a mistake cannot in itself support denial of the application at hand; [and]
(v) the fact that a certain technology may create risks does not render it a violation of ordre public or morality; the exploitation of such technologies must be regulated by governmental bodies other than the EPO.

Following this reasoning, the Division finally granted the claims in dispute on May 13, 1992.166

The grant of the application as EP 0169672 did not end the dispute, however. Religious groups, animal rights organizations, legal and political entities, environmental protection agencies, and private individuals all filed notices of opposition with the EPO.167 The EPO Opposition Division held oral proceedings related to these oppositions on November 21, 1995.168 These proceedings yielded no definite resolution, ending in confusion three days later.169 The case languished for six years, until the EPO resumed hearings on November 6, 2001.170 At the close of the second day of hearings, the Opposition Division ruled that Harvard University’s oncomouse patent was maintained in amended form and that both the method (Claim 1) and the animal (Claim 17) “must be limited to transgenic rodents containing an additional cancer gene.”171

3. Directive 98/44/EC

Around the time that Harvard University sought its patent on the oncomouse in the EPO, Plant Genetic Systems (“PGS”) sought a patent for a transgenic plant, which the EPO granted as European Patent No. 0242236 on October 10, 1990.172 Greenpeace then filed a notice of opposition declaring the subject matter of the invention unpatentable under EPC Article 53(b)’s “plant varieties” exclusion.173 On re-examination, the EPO found nothing immoral in the patenting of the plant under 53(a), but rejected the application under 53(b) because it interpreted the PGS plant as an unpatentable “plant variety.”174 Thus, within the span of two years, the EPO granted a patent for a transgenic animal, but denied a patent for a transgenic plant.

EPO’s contradictory rulings in the area of animal and plant transgenics created enough uncertainty that inventors and their investors were wary of launching their commercially viable intellectual properties.175 Discontent finally fueled the drafting of new legislation known as Directive 98/44/EC, or the E.U. Biotechnology Directive (“Biotech Directive”). The Biotech Directive, approved in its final form in 1998, recognized the need for harmonization of patent laws among the member states to secure research and development funds,176 to improve the functioning of the common market,177 and to clarify uncertainties in European patent law.178 Introduced to the EPC in June 1999, the provisions set forth in this Directive have become binding on the examination process at the EPO.

These provisions can be summarized in two major rules. First, with regard to patenting life forms, inventions relating to plants and animals per se shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. Second, with regard to patenting the human body, elements of the human body such as an embryo and gene sequences may be patentable if they are isolated from the human body by means of a technical process, even if the structure of the element is identical to that of a natural element.

Article 2 defines the terms “biological material” and “microbiological process.” Article 2(1)(a) states that “biological material” means any material containing genetic information capable of reproducing itself or being reproduced in a biological system. This definition clearly encompasses animals. Article 3(1) determines that inventions that fulfill the general requirements of patent law are patentable, even if they concern biological material. Article 3(2) states that biological material, which is isolated from its natural environment or produced through a technical process, can be the subject of an invention, even if it occurred previously in nature. This provision allows the patenting of genes that are isolated from the genome, and also of plasmids, viruses, and entire animals – provided the latter can be produced through a technical process.179

Article 4(1) excludes from patentability (a) plant and animal varieties, and (b) essentially biological processes for the production of plants or animals. Article 4(2) provides that “plants or animals, shall be patentable if the technical feasibility of invention is not confined to a particular plant or animal variety.” Thus, Article 4(1)(a) and (b) follow EPC Article 53(b) and pre-existing case law.180 Article 4(2) also follows the case law of the EPO, but makes clear that plant and animal varieties as such are excluded from patentability.181 The terms in the effective text of the Directive are “Tierrassen,” “races animals,” and “animal varieties.”182

Finally, Article 6 excludes from patentability a number of inventions as being contrary to ordre public or morality. These inventions include: processes for cloning human beings, processes for modifying the germ line identity of human beings, uses of human embryos for industrial or commercial purposes, and processes for modifying the genetic identity of animals that are “likely to cause them suffering without any substantial medical benefit to man or animal.” Article 6(1) is narrower than EPC Article 53(a); only commercial exploitation can be contrary to ordre public or morality.183 Article 6(2)(d) is in line with the balancing test outlined in Harvard/Oncomouse.184

B. Japan

1. Statutory Definition of Patentable Subject Matter

Japanese Patent Office (“JPO”) requirements for patenting living matter are similar to the requirements of both the USPTO and the EPO.185 In Japan, a biotechnological invention must be non-naturally occurring matter.186 However, the JPO maintains that “processes in the fields of medicine, diagnosis, therapy, and pharmacology in which the human body is an indispensable element” fall outside the scope of patentable living matter.187

There are no statements about possible exclusions of biological inventions in Japanese Patent Law other than the morality provision in Art. 32 JPL:

Art. 32. Unpatentable Inventions. The inventions liable to contravene public order, morality or public health shall not be patented, notwithstanding Section 29.

This means that all kinds of biotechnological inventions can be protected by patents if they are in conformity with general patent law.

2. The Harvard Oncomouse Patent in Japan

Despite the morality provision in Art. 32 JPL, there was no judicial or public debate over the morality of patenting the oncomouse in Japan.188 Therefore, in 1994, just two years after EP 0169672 was granted, the oncomouse patent was granted in Japan as JP 61081743.189 The first claim of the Japanese patent refers to a “non-human animal.”190 The other claims resemble those in the U.S. patent; they are very broad in their wording and do not cover only mice, as in Europe.191 However, in the U.S., only the animals themselves are claimed, whereas in Europe and Japan, both the animal and a method to produce it are claimed.192

V. Comparative Law Analysis

Parts II, III and IV of this paper have examined the patentability of transgenic animals in the U.S., Canada, Europe and Japan using the Harvard oncomouse case as the centerpiece for discussion. Part V now undertakes a comparative law analysis of these four jurisdictions and questions whether harmonization is practicable given the different standards for patentability and the different approaches to the morality of the claimed subject matter used by the various jurisdictions.

A. Summary of Differences between U.S., Canada, Europe and Japan Regarding Patentability of Transgenic Animals

The USPTO “considers non-naturally occurring non-human multi-cellular living organisms, including animals, to be patentable subject matter.”193 The only requirements are that the plant or animal invention be a non-naturally occurring substance,194 have a substantial amount of human intervention,195 and the invention must have some useful industrial applicability.196 The U.S. threshold for patentability of living matter is low.197 The courts have generally applied the Chakrabarty policy behind the U.S. patent system of patenting “anything under the sun that is made by man.”198 As a result, biotechnological companies have been able to patent almost all inventions, including transgenic animals, provided the claimed invention meets the other requirements of patentability.199

The Canadian Intellectual Property Office (“CIPO”) provides guidelines for patentability in Chapter 12 of MOPOP, titled “Utility and Subject Matter.” Paragraph 12.04 of Chapter 12 provides that “uni-cellular life forms which are new, useful and inventive are patentable.”200 Uni-cellular life forms provided by way of example include microscopic algae, moulds and yeasts, bacteria, viruses, cells in culture, transformed cell lines, and hybridomas.201 Paragraph 12.04 of Chapter 12 further provides that “[i]n general, a process to produce, or which utilizes these organisms is patentable.”202 However, Chapter 12 excludes from patentability higher life forms, with the exception that “a process for producing a higher life form may be patentable provided the process requires significant technical intervention by man and is not essentially a natural biological process which occurs according to the laws of nature.”203 Higher life forms provided by way of example include animals, plants, seeds, and mushrooms.204 Thus, the two main prohibitions to patentability are “products of nature” and “higher life forms.” There are no morality provisions in the Canadian Patent Act.

Consistent with those statements of principle, CIPO will not patent genetically modified plant, animal, or human organs, even if they are new and useful.205 Organs are considered to be analogous to such subject matter as seeds.206 CIPO will grant patents to tissues of undifferentiated cells, but not to organs that are differentiated.207 The distinction appears to be based on complexity, a criterion that does not exist in any other category of invention under the Canadian Patent Act.

The JPO requires that the invention be a non-natural occurring substance; that the invention has substantial human intervention; that the claim language is limited to claims and; that the human body is not an essential element.208 The Japanese patent system limits the scope of patentable subject matter to exclude processes in the field of medicine, diagnosis, therapy, and pharmacology.209 As a result, an inventor cannot receive Japanese patent protection for biotechnology inventions of products falling within these areas where the human body is an essential element. Further, the Japanese patent statute contains a morality provision. Article 32 excludes the patentability of inventions that are “liable to contravene public order, morality or public health.”210

The EPO requires that: the invention be a non-naturally occurring substance;211 the invention have industrial applicability;212 the invention not include a medical method;213 the claims be limited to processes and not biological products;214 and the claims not include “plant varieties” and “essential biological processes for the production of plants or animals.”215 However, inventions, which concern plants or animals, shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.216 The scope of patentable subject matter in Europe is therefore narrower than both the U.S. and Japanese patent systems. Unlike the U.S. patent system, an inventor is only allowed patent protection of product claims relating to the biological invention.217 In addition, EPC Article 53(a) strictly excludes patentability of inventions that are contrary to “ordre public” or morality.

This comparative analysis shows that conflicts between patentable subject matter exist between the U.S., Canadian, European and Japanese patent systems. For example, Japan will not patent processes in the field of medicine, diagnosis, therapy and pharmacology; Europe will not patent medical methods, plant varieties, or essential biological processes; and Canada will not patent organisms higher than a uni-cellular life form. However, while these subject matter conflicts may appear to be significant, the single greatest conflict that stands in the way of global harmonization arises from differing approaches to the morality of the claimed subject matter: Jurisdictions descended from a French civil law tradition consider public morality in determining patentability (Europe and Japan); Jurisdictions descended from an English common law tradition do not (U.S. and Canada).

With regard to Canada, the lone jurisdiction that still refuses to allow patents on higher organisms, the Canadian Supreme Court decision in Harvard College v. Canada may have had less to do with statutory interpretation and more to do with the morality of the claimed subject matter. The 5-4 bipartisan split between the French versus the English justices suggests that the majority opinion was influenced by French civil law notions of morality.218

B. Differing Approaches to the Morality of the Claimed Subject Matter

1. Moral Utility Doctrine in the U.S

Since differing approaches to the morality of the claimed subject matter seem to underpin all of the recent decisions on the patentability of transgenic animals, it is appropriate to spend some time examining these approaches in greater detail. United States patent law is largely neutral on the question of morality. In a 1977 study, Ronald Schapira found that most patent attorneys in the U.S. believe that the “American view” is that “morality should . . . have nothing to do with patents.”219 But this view was not always the consensus. In Lowell v. Lewis, for example, Justice Story stated that for an invention to be “useful,” it cannot conflict with the “sound morals of society.”220 This requirement is referred to as the moral utility doctrine. Recently, however, courts have not broadly applied the moral utility doctrine in the U.S. to reject patent applications or to invalidate existing patents. Indeed, the USPTO’s Revised Interim Utility Guidelines Training Materials require that the application must show specific, substantial, and credible utility.221 The Guidelines are silent as to whether an invention must have moral utility.

The moral utility doctrine is not completely dead, however. The court in Geneva Pharmaceuticals, Inc. v. Glaxosmithkline PLC noted that a patent possesses utility “if it will operate to perform the functions and secure the results intended, and its use is not contrary to law, moral principles, or public policy.”222 Further, Professor Donald Chisum has argued that, although narrow, moral utility as a public policy doctrine requires that “[a] patent will be withheld only if the invention cannot be used for any honest and moral purpose.”223

In 1998 the narrow reach of the moral utility doctrine was tested when Stuart Newman, a cellular biologist, sought to patent a technique for producing a half-human, half-animal species.224 Paradoxically, rather than seeking to create such a “minotaur,” Newman applied to the USPTO to “reignite debate about the ethics of genetic engineering and the patenting of life forms.”225 The USPTO denied Newman’s application because it “embrace[d]” a human being, and thus did not constitute patentable subject matter.226 The Newman application resulted in the issuance of a media advisory in which the USPTO claimed to continue to rely on Justice Story’s formulation of moral utility. Regardless, the USPTO’s revised 2001 examiner guidelines concerning utility make no mention of morality or public policy issues.227

2. Ordre Public or Morality Doctrine in the E.U.

In contrast to the judicially created moral utility doctrine and its diminishing role in the U.S., the European community codified such a requirement into EPC Article 53(a).228 The TBA defined the concept of “morality” in decision T 356/93, Plant Genetic Systems/Glutamine Synthetase Inhibitors,229 as:

… related to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deeply rooted in a particular culture. For the purposes of the EPC, the culture in question is the culture inherent in European society and civilisation.230

The ordre public or morality requirement was largely unused until 1985, when Harvard University sought to patent the oncomouse. Since T 19/90, Harvard/Oncomouse,231 more and more cases have arisen in the European patent system involving whether the patent office should invalidate a patent because it is contrary to public morality.232

C. Harmonization: Is it Practicable?

Any attempt at harmonization must take into account the differing approaches to the morality of patentable subject matter used by common law versus civil law jurisdictions. The discrepancies between these two systems concern important issues; e.g., whether countries should enhance technological developments neutrally without paying attention to their moral and social consequences; or whether it should be recognized that patent law does not function in a social vacuum, but can be one of the instruments used to govern and direct the technical and ethical character of a society.

The U.S. and Canada, both common law jurisdictions, purport to adopt a neutral standard when considering the morality of claimed subject matter. In the U.S., “everything under the sun made by man”233 is patentable. Japan and the E.U., both civil law jurisdictions, consider the morality of the claimed subject matter when determining patentability, although only the E.U. has a record of enforcement of the morality requirement when considering the patentability of transgenic animals. Thus, if global harmonization is to occur, either the U.S. and Canada must adopt a moral standard for patentability, or the E.U. and Japan must adopt a neutral standard for patentability. The latter is highly unlikely, as a finely tuned morality provision was codified in Article 6 in the Biotech Directive just eight years ago, following fierce debate over harmonization of patent laws and proper incentivization of the European biotechnology industry. Consequently, if harmonization is to occur, U.S. and Canada must be the jurisdictions to respond.

If the U.S. were to respond to a call for harmonization, either the USPTO would have to revive the common law moral utility doctrine, or Congress would have to meet Chief Justice Burger’s majority opinion challenge in Chakrabarty “to amend §101 so as to exclude from patent protection organisms produced by engineering” if Congress wished to exclude “living things” from patent protection.234 Similarly, if Canada were to respond, Canadian Parliament would have to pay heed to Justice Bastarche’s call in Harvard for “clear and unequivocal direction.”

U.S. Congress has made brave attempts in this arena. Immediately after the April 1987 USPTO ruling that “nonnaturally occurring non-human multicellular organisms, including animals, [are] patentable subject matter within the scope of 35 U.S.C. 101,”235 Representative Robert W. Kastenmeier (D. Wisc.) encouraged the USPTO to impose an eight-month moratorium on issuing such patents.236 The USPTO agreed, however, it issued the patent for the Harvard Mouse shortly after the moratorium expired.237 Representative Kastenmeier then ushered the Transgenic Animal Patent Reform Act (H.R. 4970) through the House of Representatives. The bill never became law.238

Since Rep. Kastenmeier’s bill, many others have been introduced. A sample of the bills introduced in Congress as a result of the transgenic animal patent boom include the “Transgenic Animal Patent Reform Act,”239 the “Transgenic Animal Regulatory Reform Act,”240 the “Transgenic Animal Patent Improvement Act,”241 and the “Life Patenting Moratorium Act of 1993.”242 The number of bills to regulate the patenting of transgenic animals has declined in recent years, perhaps because the “gruesome parade of horribles” dismissed in Chakrabarty has failed to materialize.

Canadian Parliament has also responded by convening a “Standing Committee on Agriculture and Agrifood”243 and a “Canadian Biotechnology Advisory Committee.”244 Both committees are working to draft legislative and regulatory schemes that would consider the environmental implications of patenting genetically modified organisms, while meeting the objectives of the Canadian patent system of providing economic incentives to the growing Canadian biotechnology industry.

VI. Economic Considerations and Conclusions

The traditional “incentive to innovate” argument presented by proponents of strong patent rights provides that inventors are the primary benefactors of patent protection and that they deserve some reward for their hard work and innovative ideas.245 Closer to the truth is that investors, not inventors, are the primary financial benefactors of monopoly protection granted through the patent scheme.246 Regardless of whether it is the incentive to innovate or the incentive to invest in research and development, empirical evidence suggests that a fairly tight nexus exists between patent protection for a biotechnological invention, and the investment capital required to support research and development of the invention.247 The Chakrabarty decision, bolstered by federal policy relating to technology transfer of federally-funded research,248 has arguably promoted increased patenting in all technology areas, ultimately providing the incentives that were necessary to finance the growth of the U.S. biotechnology industry.249

It is this strong empirical link between Chakrabarty and the subsequent growth of the biotechnology industry in the U.S. that led Harvard University to denounce the Harvard College v. Canada decision, stating, “Canadian scientists are at risk of being left behind their colleagues around the world,”250 and urging Parliament to change Canadian law to enable patenting of the mouse (and in general non-human higher life forms).251 Canada’s national association of biotechnology research companies agreed. Janet Lambert, president of BIOTECanada, said “This decision stops dead in its tracks our pursuit of knowledge and innovation, … [the inability to receive life form patents] could create a chilling effect on scientists doing research here.”252

However, it is not a priori evident that a broadening of patentable subject matter is essential for the viability of Canada’s biotechnology industry. First, Canadian Supreme Court decisions that restrict patentability have had no impact on Canadians’ patent applications in the powerful economies of the U.S., Japan and the U.K., which collectively represent 80 percent of the global market.253 Second, there is no evidence that the Harvard College v. Canada decision has led to a “race to the bottom,” with Canadian biotechnology industry migrating to the U.S. to take advantage of its more expansive and accommodating patent laws. Indeed, despite its “weak” intellectual property regimes, Canada continues to have one of the fastest growing and most dynamic biotechnology industry in the world.254 Of the 24 biopharmaceuticals approved for sale on the world market in 2004, three came from Canadian firms: 3TC by BioChem Pharma Inc. for the treatment of HIV/AIDS; Photofrin by QLT PhotoTherapeutics Inc. for the treatment of various cancers; and, Truquant BR by Biomira Diagnostics Inc. for the detection of breast cancer.255

Regardless of the merits of these economic arguments, Canadian Parliament has been given a mandate by the Canadian Supreme Court to review its patent laws. If Parliament chooses to accept this mandate, it should first erase the arbitrary bright line drawn by the Canadian Supreme Court between higher and lower life forms. Assuming it were even possible to separate higher from lower life forms in a way that is scientifically sound, the test might lead to rigid prohibitions on patenting certain life forms.256 In any case, legal tests that set bright line rules are unworkable in a biotechnology industry that continues to grow and evolve in unpredictable ways.

Instead, Parliament could take a middle road between a neutral and a moral standard for patentability, one that seeks to balance competing social interests through intricate statutory legislative drafting, while still providing a predictable and reliable legal structure. Such a middle-of-the-road approach acknowledges that patent law does not function in a social vacuum, but also recognizes the importance of encouraging continued investment in the Canadian biotechnology industry so that its inventions can benefit society for years to come. Such a middle-of-the-road approach might also lead to a reconciliation between the opposite positions taken by the U.S. and Canadian patent offices with regard to patentability of transgenic animals, and thus, might contribute ultimately toward a global harmonization of patent laws in the field of biotechnology.

Footnotes

  1. A. Patricia Campbell is a J.D. student at the University of Washington School of Law. She wrote this research article for Professor Toshiko Takenaka's Advanced Patent Law Seminar. Campbell has a Ph.D. in Biochemistry from the University of Alberta (1992), and is Affiliate Professor in the Department of Medicinal Chemistry, University of Washington.
  2. Commissioner of Patents v. President and Fellows of Harvard College, [2002] SCC 76.
  3. Id. at 159.
  4. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
  5. For a good guide to recombinant DNA technologies, see Molecular Biotechnology: Principles and Applications of Recombinant DNA (3rd edition), Bernard J Glick and Jack J Pasternak (University of Waterloo), 2003.
  6. See id.
  7. See id.
  8. See Terri A. Jones, Note, Patenting Transgenic Animals: When the Cat’s Away, the Mice Will Play, 17 Vt. L. Rev. 875, 880-81 (1993).
  9. Thomas Traian Moga, Transgenic Animals as Intellectual Property (or The Patented Mouse That Roared), 76 J. Pat. [& Trademark] Off. Soc’y 511, 527 (1994).
  10. Amy E. Carroll, A Review of Recent Decisions of the United States Court of Appeals for the Federal Circuit: Comment: Not Always the Best Medicine: Biotechnology and the Global Impact of U.S. Patent Law, 44 Am. U. L. Rev. 2433, 2476-77 (acknowledging that it takes a quarter of a billion dollars and four to seven years to bring a biotechnology-based pharmaceutical product to market).
  11. U.S. Const. art. I, §8, cl. 8.
  12. Pub. L. No. 593, 66 Stat. 792 (codified as amended at 35 U.S.C. 1-376 (2006)).
  13. 35 U.S.C. §101 (2006).
  14. 35 U.S.C. §100 (2006).
  15. Jerzy Koopman, The Patentability of Transgenic Animals in the United States of America and the European Union: A Proposal for Harmonization, 13 Fordham Intell. Prop. Media & Ent. L.J. 103, 120, n.69 (2002) (referring to Eileen Morin, Of Mice and Men: The Ethics of Patenting Animals, 5 Health L.J. 147, 153 (1997)).
  16. Id. at 121, n.71, referring to Am. Fruit Growers v. Brogdex Co., 283 U.S. 1, 11 (1931).
  17. Id. at 121, n.72, referring to Shell Development Co. v. Watson, 149 F. Supp. 279, 280-81 (D.D.C. 1957), aff’d, 252 F.2d 861 (D.C. Cir. 1958).
  18. Chakrabarty, supra note 3 at 309 (“Congress plainly contemplated that the patent laws would be given wide scope ... [but t]his is not to suggest that 101 has no limits or that it embraces every discovery.”).
  19. See, e.g., id. at 310 (finding that laws of nature, phenomena and abstract ideas held not patentable); Gottschalk v. Benson, 409 U.S. 63, 67-68 (1972) (deciding that mathematical algorithm is akin to mental process and unpatentable).
  20. Pat. & Trademark Off. Notice: Animals-Patentability (Patent and Trademark Office Notice), reprinted in 1077 Official Gazette Pat. & Trademark Off. 24 (Apr. 21, 1987). See also Patents and the Constitution: Transgenic Animals: Hearings Before the House Subcomm. on Courts, Civil Liberties and the Administration of Justice, 100th Cong. 22 (1987) (statement of Donald Quigg, Commissioner, U.S. Pat. & Trademark Off.).
  21. See Susan J. Friedman, Patenting Life: Issues and Controversies, available at http://www.speckmanlaw.com/IP%20Materials/Patenting%20Life.pdf.
  22. Chakrabarty, supra note 3.
  23. Id.
  24. Id.
  25. Id. at 307.
  26. Id. at 309.
  27. Michael E. Sellers, Patenting Nonnaturally Occurring, Man-Made Life: A Practical Look at the Economic, Environmental, and Ethical Challenges Facing Animal Patents, 47 Ark. L. Rev. 269, 274 (1994).
  28. Chakrabarty, supra note 3 (quoting S. Rep. No. 1979, 82d Cong., 2d Sess. 5).
  29. Sellers, supra note 26 at 275.
  30. Chakrabarty, supra note 3 at 310.
  31. Plant Patent Act of 1930, Pub. L. No. 71-245, 46 Stat. 376 (1930) (codified as amended at 35 U.S.C. 161 (2006)). This Act provides in relevant part: “Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor….”
  32. Plant Variety Protection Act of 1970, Pub. L. No. 91-577, 84 Stat. 1542 (1970) (codified as amended at 7 U.S.C. 2402 (2006)). This Act provides in relevant part: The breeder of any novel variety of sexually reproduced plant (other than fungi, bacteria, or first generation hybrids) who has so reproduced the variety, or his successor in interest, shall be entitled to plant variety protection therefor ...
  33. Chakrabarty, supra note 3 at 310-314.
  34. Id.
  35. Friedman, supra note 20.
  36. Chakrabarty, supra note 3 at 317. The Court stated: “The large amount of research that has already occurred when no researcher had sure knowledge that patent protection would be available suggests that legislative or judicial fiat as to patentability will not deter the scientific mind from probing into the unknown any more than Canute could command the tides. Whether respondent’s claims are patentable may determine whether research efforts are accelerated by the hope of reward or slowed by want of incentives, but that is all.”
  37. 1077 Off. Gaz. Pat. Office 24 (Apr. 21, 1987).
  38. Ex parte Allen, 2 U.S.P.Q. 2d 1425 (Bd. Pat. App. & Interferences 1987).
  39. Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. & Interferences 1985).
  40. An oncogene is a gene that contributes to the production of a cancer. Oncogenes are generally mutated forms of normal cellular genes (proto-oncogenes). The so-called c-myc oncogene, which was incorporated into the Harvard oncomouse, codes for a mammalian transcription factor which plays a very important role in regulating cell growth, apoptosis, differentiation and stem cell self-renewal. C-myc is a very strong proto-oncogene and it is very often found to be upregulated in many types of cancers.
  41. Friedman, supra note 20.
  42. Anwar N. Khan, Canadian Researchers and Patenting Higher Life, 33 J.L. & Educ. 63, 65 (2004).
  43. Id.
  44. Id.
  45. U.S. Patent No. 4,736,866 (issued Apr. 12, 1988).
  46. David Morrow & Colin B. Ingram, Case Comment, Transgenic Mice And Roundup Ready Canola: The Decisions Of The Supreme Court Of Canada In Harvard College v. Canada And Monsanto v. Schmeiser, 38 U.B.C. L. Rev. 189, 191 (2005).
  47. Id.
  48. Lim Li Ching, Canada Rejects Patents on Higher Life Forms (Canada Rejects Patents), Institute of Science in Society, available at http://www.i-sis.org.uk/crpohlf.php
  49. Friedman, supra note 20.
  50. EPC Article 53(b) excludes plant or animal varieties or biological processes for the production of plants or animals, except for microbiological processes or their products. In addition, the Examiner believed that the application lacked support for claims to transgenic mammals other than mice.
  51. Harvard, supra note 1 at 2.
  52. Id.
  53. Harvard, supra note 1.
  54. Koopman, supra note 14 at 129.
  55. Broad patents were, among others, have been granted for: 1. transgenic mouse offspring produced by the mating of a first transgenic mouse carrying a transresponder transgene whose expression is regulated by a viral gene product of Hbv-1 and a second transgenic mouse carrying a transactivator transgene; U.S. Patent No. 5,221,778 (issued June 22, 1993); 2. [a t]ransgenic mouse or the progeny thereof whose somatic and germline cells contain a stably integrated DNA sequence selected from the ... rat AGP gene which is expressed in the mouse to produce rat alpha-1-acid glycoprotein; U.S. Patent No. 5,648,597 (issued July 15, 1997); 3. [a] transgenic non-human mammal whose genome comprises DNA construct comprising...a rabbit WAP promoter ... said mammal expresses said DNA sequence such that a recoverable amount of ... protein is produced in the milk of said mammal; U.S. Patent No. 5,965,788 (issued Oct. 12, 1999); 4. a non-human mammal, a mouse in particular ... wherein the ... Kir6.2 gene ... essential for insulin secretion ...is lost ... ; U.S. Patent No. 6,194,634 (issued Feb. 27, 2001) [and]; 5. a transgenic rodent, comprising amyloid plaques in its brain tissue ... said rodent has at least 50% increase in the number of amyloid plaques compared to ... a control rodent ... ; U.S. Patent No. 6,172,277 (issued Jan. 9, 2001).
  56. Commissioner of Patents v. President and Fellows of Harvard College, [2000] 4 F.C. 528.
  57. Id. at 564.
  58. Id. at 538-45 (Isaac, J.A. dissenting) (describing prosecution history).
  59. Id. at 560-61.
  60. Id. at 562.
  61. Id.
  62. Patent Act, R.S.C., ch. P-4, 2 (1985) (Can.).
  63. Harvard, supra note 55 at 540 (Isaac, J.A. dissenting).
  64. To assess patentability, the Canadian Patent Office divides living matter into “higher life forms,” defined as multi-cellular differentiated organisms (e.g. plants, seeds, and animals), and “lower life forms,” defined as essentially unicellular organisms in composition (e.g. bacteria, many fungi, cells in culture, transformed cell lines, and hybridomas). Manual of Patent Office Practice 12.03(a) (Can.) (as amended January 1990) (“Plants and animals are not patentable subject matter.”). Since 1982, the Patent Office has allowed patents that claim lower life forms that otherwise meet the criteria for patentability in Canada (the most important criterion being that the invention claimed is new, useful, and not obvious). See Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81 (Patent Appeal Board). However, the Patent Office has maintained the position that “higher life forms” are not patentable. This was the distinction challenged in Harvard.
  65. Harvard, supra note 55 at 562 (Isaac, J.A. dissenting).
  66. Id. at 564-65.
  67. Id.
  68. Id.
  69. Id. at 563.
  70. Id.
  71. Id. at 564.
  72. Pioneer Hi Bred Ltd. v. Canada, [1987] 3 F.C. 8, aff'd, [1989] S.C.R. 1623.
  73. Harvard, supra note 55 at 564.
  74. Id.
  75. Id. at 510.
  76. Id. at 522.
  77. Id. at 533.
  78. Matthias Kamber, Note, Coming Out Of The Maze: Canada Grants The Harvard Mouse Patent, 35 Geo. Wash. Int’l L. Rev. 761, 767 (2003).
  79. Harvard, supra note 55 at 526.
  80. Id.
  81. Id. at 527.
  82. Id. at 529.
  83. Id. at 531.
  84. Id. at 532.
  85. Id. at 606.
  86. Id.
  87. Id. at 570.
  88. Id.
  89. Id. at 571.
  90. Id.
  91. Id. at 606.
  92. Id. at 582 (quoting Chakrabarty, supra note 3 at 308).
  93. Id.
  94. Kamber, supra note 77 at 769.
  95. Harvard, supra note 55 at 580.
  96. Id.
  97. Id. at 582 (citing H.G. Fox, The Canadian Law and Practice Relating to Letters Patent for Invention (4th ed. 1969)).
  98. Id. at 585.
  99. Id. at 586-87.
  100. Id. at 591.
  101. Id. at 593.
  102. Id.
  103. Id.
  104. Harvard, supra note 1.
  105. Id. at 159.
  106. Id. at 38.
  107. Id.
  108. Id. at 148-150.
  109. Id.
  110. Id. at 45.
  111. Canada Rejects Patents, supra note 47.
  112. Harvard, supra note 1 at 129.
  113. Id. at 45.
  114. Id. at 3.
  115. Canada Rejects Patents, supra note 47.
  116. Id.
  117. Harvard, supra note 1 at 18.
  118. A number of submissions were made to the Supreme Court of Canada from friends of the court. The amicus curiae included religious groups such as the Canadian Council of Churches and the Evangelical Fellowship of Canada, environment organizations like Greenpeace Canada and the Canadian Institute for Environmental Law and Policy, and animals’ rights activists such as the Animal Alliance of Canada, the International Fund for Animal Welfare, and Zoocheck Canada.
  119. Harvard, supra note 1 at 116-121 per Bastarache J., and at 89-102 per Binnie J.
  120. European Patent Convention (EPC), Oct. 5, 1973, Art. 53(a), 13 I.L.M. 268 (as amended Dec. 21, 1978).
  121. The European patent was unsuccessfully opposed in a post-grant procedure, although its scope was limited to transgenic rodents based on the ordre public provisions of the European patent statute: “Decision of the opposition division dated 7 November 2001” (2003) 26 O.J.E.P.O. 473.
  122. Harvard, supra note 1 at 129.
  123. Chakrabarty, supra note 3 at 317.
  124. Harvard, supra note 1 at 129.
  125. EPC, supra note 119, Art. 52.
  126. Karen A. Spindler, Comment, Current Patent Protection Granted for Genetically Modified Organisms under the European Patent Convention and the Scandal of EP 0695351, 18 Santa Clara Computer & High Tech. L.J. 95, 98, n.23 (2001), referring to Akim F. Czmus, M.D., Comment, Biotechnology Protection in Japan, the European Community, and the United States, 8 Temp. Int’l & Comp. L.J. 435, 438 (1994).
  127. EPC, supra note 119, Art. 53.
  128. Case T 320/87, Lubrizol/Hybrid plants, 1990 O.J. 71 (TBA 1988).
  129. Lydia Nenow, Comment, To Patent or not to Patent: The European Union’s new Biotech Directive, 23 Hous. J. Int’l L. 569, 587 (2001).
  130. Case T 356/93, Plant Genetic Systems/Glutamine Synthetase Inhibitors, 1995 E.O.P.R. 357 (TBA 1995) (discussing genetically transformed plant cells and plants).
  131. Id. at 366.
  132. Id.
  133. Nenow, supra note 128 at 585.
  134. EPC, supra note 119, Arts. 52, 99-100.
  135. Convention on the Unification of Certain Points of Substantive Law on Patents for Inventions (Convention), Nov. 27, 1963, Europ. T.S. No. 47.
  136. Koopman, supra note 14 at 152, n.222, referring to Van de Graaf, Patent Law and Modern Biotechnology: A Comparative Study About the Requirements and the Scope of Protection 28, 103 (1997); and Ulrich Schatz, Patentability of Genetic Engineering Inventions in EPO Practise, 1 Int'l Rev. Indus. Prop. & Copyright L. 4, 7 (1998).
  137. Id. at 152, n. 223, referring to Schatz, supra note 135 at 7.
  138. Id. at 152, n. 224, referring to Van de Graaf, supra note 135 at 103.
  139. Case T 320/87, supra note 127.
  140. Koopman, supra note 14 at 152, n. 225, referring to Case T 320/87, supra note 127.
  141. Id. at 152, n. 227, referring to Case T 320/87, supra note 127, para. V(6).
  142. EPC, supra note 119, Art. 53(b).
  143. See Convention, supra note 134.
  144. Koopman, supra note 14 at 153.
  145. Id. at 153, n. 235, referring to Schatz, supra note 135 at 5.
  146. Id. at 154, n. 239, referring to Case T 320/87, supra note 127.
  147. Id. at 154.
  148. See EP 0169672 (issued May 13, 1992).
  149. See Harvard/Oncomouse: Application 85 304 490.7, 5 Eur. Pat. Off. Rep. 4, 7 (1990).
  150. Case T 19/90, Harvard/Oncomouse, 5 Eur. Pat. Off. Rep. 501, 513 (1990).
  151. Spindler, supra note 125 at 101, n.50, referring to Case T 19/90, supra note 149 at 502.
  152. Id. at 102, n.51, referring to Case T 19/90, supra note 149, 4.2, at 510.
  153. Case T 19/90, supra note 149, 4.4, at 510.
  154. Case T 19/90, supra note 149, 4.8 at 511.
  155. Spindler, supra note 125 at 103, n.59, referring to Case T 19/90, supra note 149, 4.9.1 at 511.
  156. EP 0169672, supra note 147.
  157. Spindler, supra note 125 at 104.
  158. Case T 19/90, supra note 149, 4.10, at 512.
  159. Id.
  160. Case V 6/92, Oncomouse/Harvard, 1992 O.J. E.P.O. 589 para. 2 (Examining Div. 1992).
  161. Thus, the claims do not focus on Tierarten, “animal varieties,” and races animaux. In fact, the Examining Division conducted a zoological classification.
  162. Case V 6/92, supra note 159, para. 4(v).
  163. Koopman, supra note 14 at 161, n.302, referring to Case V 6/92, supra note 159.
  164. Case V 6/92, supra note 159, para. 3.
  165. Id. paras. 4(i)-(v).
  166. Id. para. 4(v).
  167. Spindler, supra note 125, referring to the European Patent Register, at http://www.epoline.org/register.html (search for publication number EP0169672).
  168. Id.
  169. Tom Wilkie, “Oncomouse” Spreads Confusion in Patent Office, The Independent, Nov. 25, 1995, at 8, LEXIS, Nexis World Library, Allwld File.
  170. Id.
  171. Press Release, European Patent Office, European Patent Office limits Harvard’s “oncomouse” patent (Nov. 7, 2001), available at http://www.european-patent-office.org/news/pressrel/2001_11_07_e.htm.
  172. Case T 356/93, supra note 129 at 360.
  173. Id. at 357.
  174. Id.
  175. See generally Hans-Rainer Jaenichen, Dr., Is It Possible to Patent Transgenic Animals and Transgenic Plants in the European Patent Office After the Technical Board’s Decision T 356/93, “Plant Cells/PLANT GENETIC SYSTEMS”?, 14 Biotech. L. Rep. 545 (1995).
  176. Council Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (Biotech Directive), 1998 O.J. (L 213) 13, paras. 2-3.
  177. Id. para. 5.
  178. Id. paras. 4, 8-9.
  179. Koopman, supra note 14 at 166.
  180. Id. at 166, n.343, referring to Case G 1/98, Transgenic plant/Novartis, 2000 O.J. E.P.O. 111, paras. 48-50 (Enlarged Bd. of App. 1999); Case T 356/93, supra note 129 at 545; Case T 19/90, supra note 149 at 476.
  181. See id.
  182. Id. at 166, n.345, referring to Eckehart Von Pechmann, Is the Exclusion from Patentability of Animal Products and Animal Therapeutic Methods Justified? 36 GRUR Int’l 347 (1987).
  183. Id. at 169.
  184. Id.
  185. See Dr. Miyako Okada-Tskagi, Intellectual Property in Biotechnology, 16 Med. & L. 9, 11-13 (1997) (discussing attempts by the Japanese to promote the development of biotechnological research).
  186. Id. at 12.
  187. Id. at 11.
  188. The Board of Appeal of the EPO however was the first court to host a detailed debate on a morality provision in relation to animals.
  189. Corina Schütt, Patents for Biotechnological Inventions: Current Legal Situation and Case Law in Europe, the U.S. and Japan, Swiss Federal Institute in Technology, Oct 2004, p. 2, available at http://e-collection.ethbib.ethz.ch/show?type=dipl&nr=204&part=text.
  190. Id. at 25.
  191. Id.
  192. Id.
  193. 1077 Off. Gaz. Pat. Office 24 (Apr. 21, 1987).
  194. Chakrabarty, supra note 3 at 309.
  195. See id.
  196. See id.
  197. Michael North, Note, The U.S. Expansion Of Patentable Subject Matter: Creating A Competitive Advantage For Foreign Multinational Companies? 18 B.U. Int’l L.J. 111, 129 (2000).
  198. Chakrabarty, supra note 3 at 309 (citing S. Rep. No. 82-1979).
  199. North, supra note 196 at 129.
  200. Manual of Patent Office Practice (MOPOP), paragraph 12.04.01.
  201. Id.
  202. Id.
  203. Id.
  204. Id.
  205. Eileen McMahon and Jessica Lumiere, Canada Lags Behind on Patenting Higher Life Forms, IPL Newsletter, Volume 22, No.3, Spring 2004.
  206. Id.
  207. Id.
  208. Under Japanese Patent Law, human biological materials are patentable subject matter unless they are mere discoveries of products of nature. If biological materials have been artificially isolated from their surroundings, then they are “creations” and are considered statutory patentable subject matter. JPO Guidelines, Part II, Chapter 1, 1.1. Also see Okada-Tskagi, supra note 184 at 12.
  209. Medical related activities are not explicitly excluded from patentable subject matter under the Japanese Patent Law (JPL). However, methods for treating the human body by surgery or therapy and diagnostic methods have been excluded from patentability as they are inventions which are not industrially applicable. This non-patentability applies only when the claims are directed to a method. If an invention relating to a medical method is claimed as a medical device (i.e., product) to be used for the medical method, it may be patented. See Japanese Patent Office’s (JPO) “Revised Examination Guidelines for Inventions Available for Industrial Use,” released on June 21, 2006 (English translation not yet available). Also see Matsuo Nonaka, Recent Debate over Patent Protection for Medical Related Activities in Japan, CASRIP Newsletter, Autumn 2004; and Okada-Tskagi, supra note 184, at 11.
  210. JPL, Article 32.
  211. EPC, supra note 119, Art. 52.
  212. See id.
  213. Medical related activities are explicitly excluded from patentable subject matter under the EPC, which stipulates that medical methods are unpatentable. EPC, supra note 119, Art. 52(4). The provision regarding patentability of medical methods was moved from Art. 52(4) (not industrial applicable) to Article 54(5) (exception to patentability) when the EPC was revised in 2000, but the revised convention has not yet become effective. See Nonaka, supra note 208, n.7. Further, we note the recent December 2005 ruling on Case G 1/04, Diagnostic Methods, by the EPO Enlarged Board of Appeal, that held that the exclusion of patentability of diagnostic methods practiced on the human or animal body should be construed narrowly. In particular, the exclusion should only apply to diagnostic methods which include all steps required for a diagnosis, from the initial examination through to the final diagnosis, and then only when all the steps of technical character involve some interaction with the human or animal body. A nice discussion of the case is provided by Claire Baldock, European Patent Office Enlarged Board of Appeal Ruling on the Patentability of Diagnostic Methods in Europe, March 2006, available at http://www.boult.com/information/BulletinPrint.cfm?BulletinID=109.
  214. EPC, supra note 119, Art. 53(b).
  215. Id.
  216. Biotech Directive, supra note 175, Article 4(2).
  217. See id.
  218. Justices Bastarache, Gonthier, Iacobucci, L’Heureux-Dube, and Le Bel were justices of the Quebec Supreme Court prior to being called to the Canadian Supreme Court. Quebec follows French civil law.
  219. Ronald Schapira, Biotechnology Patents in the United States, in Biotechnology, Patents and Morality, at 171, 172 (Sigrid Sterckx ed., 1997).
  220. Lowell v. Lewis, 15 F. Cas. 1018, 1019 (C.C. Mass. 1817) Justice Story states: “All that the law requires is, that the invention should not be frivolous or injurious to the well-being, good policy, or sound morals of society. The word ‘useful,’ therefore, is incorporated into the act in contradistinction to mischievous or immoral. For instance, a new invention to poison people, or to promote debauchery, or to facilitate private assassination, is not a patentable invention.”
  221. See U.S. Patent & Trademark Office, Revised Interim Utility Guidelines Training Materials 3, at http://www.uspto.gov/web/menu/utility.pdf.
  222. Geneva Pharms., Inc. v. Glaxosmithkline PLC, 213 F. Supp. 2d 597, 610 (E.D. Va. 2002) (quoting Callison v. Dean, 70 F.2d 55, 58 (10th Cir. 1934) (emphasis added)).
  223. Donald S. Chisum, 1 Patents: A Treatise on the Law of Patentability, Validity and Infringement § 4.03 (1995).
  224. See Group Faults PTO for Issuing Patent on Method of Producing Cloned Mammal (Group Faults), 64 Pat. Trademark & Copyright J. 81 (2002).
  225. Id.
  226. See Patent Application Is Disallowed As “Embracing” Human Being, 58 Pat. Trademark & Copyright J. 203 (1999).
  227. See Group Faults, supra note 223 at 81.
  228. EPC, supra note 119, Art. 53(a).
  229. Case T 356/93, supra note 129 (discussing genetically transformed plant cells and plants).
  230. Id.
  231. Case T 19/90, supra note 149 at 513.
  232. Gerald Paterson, The European Patent System: The Law and Practice of the European Patent Convention § 7-44 at 434-36 (2d ed. 2001).
  233. Chakrabarty, supra note 3 at 309 (quoting S. Rep. No. 1979, 82d Cong., 2d Sess. 5). We note that the “everything under the sun” approach to patentability has come under recent criticism, most notably by Justice Breyer of the U.S. Supreme Court, who argued that some inventions should be excluded from the scope of patentability in his dissenting opinion to the June 22, 2006 dismissal of writ of certiori for LabCorp. v. Metabolite (No. 04-607) decision that some inventions should be excluded from the scope of patentability.
  234. Id. at 318.
  235. Patent and Trademark Office Notice, supra note 19.
  236. See Edmund J. Sease, From Microbe to Corn Seeds, to Oysters, to Mice: Patentability of New Life Forms, 38 Drake L. Rev. 551, 565 n.85 (1988-1989).
  237. Id.
  238. Id.
  239. H.R. 1556, 101st Cong. (1989).
  240. H.R. 1556, 101st Cong. (1989).
  241. H.R. 5598, 101st Cong. (1990).
  242. S. 387, 103rd Cong. (1993).
  243. See http://www.parl.gc.ca/InfocomDoc/36/1/agri/Meetings/Evidence/AGRIEV38-E.HTM
  244. See http://www.cbac-cccb.ca/epic/internet/incbac-cccb.nsf/en/ah00440e.html.
  245. See F.M. Scherer, Industrial Market Structure and Economic Performance 441 (2d ed. 1980).
  246. See John M. Golden, Biotechnology, Technology Policy, and Patentability: Natural Products and Invention in the American System, 50 Emory L.J. 101 (2001).
  247. Id.
  248. Bayh-Dole Act, 35 U.S.C. §§200-212, allows for the transfer of exclusive control over many government funded inventions to universities and businesses operating with federal contracts for the purpose of further development and commercialization.
  249. According to statistics compiled by BIO, the Biotechnology Industry Organization, more than 370 biotech drug products and vaccines targeting more than 200 diseases are in clinical trials. As of 2001, there were 1457 biotechnology companies in the U.S. These companies spent in the aggregate more than 15.7 billion dollars per year, had sales amounting to 20.7 billion dollars, and revenues of 28.5 billion dollars. The number of U.S. patents granted annually for biotechnology inventions grew from approximately 1000 in 1983 to almost 8000 in 2003, and these numbers do not include patents that were granted by other countries.
  250. Canada Rejects Patents, supra note 47.
  251. Id.
  252. Id.
  253. Market Report – Global Pharmaceutical Market Forecasts, available at http://www.ims-global.com/insight/report/global/report.htm
  254. Canada’s Biopharmaceutical Industry: Open for Global Business, available at http://www.pharmabiz.com/Article/detnews.asp?Articleid=11304§ionid=46
  255. Id.
  256. Ryan J. Atkinson, Mixed Messages: Canada’s Stance on Patentable Subject Matter in Biotechnology, 19 Intell. Prop. J. 1, 26 (2005).
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