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Academic Medicine:
Institutional Issues: Articles

Harvard v. Canada: The myc Mouse That Still Squeaks in the Maze of Biopatent Law

Deftos, Leonard John MD, JD, LLM

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Dr. Deftos is professor of medicine, University of California, San Diego, School of Medicine, and physician, San Diego VA Medical Center, La Jolla, California.

Correspondence and requests for reprints should be addressed to Dr. Deftos, SDVA Medical Center, 3350 La Jolla Village Drive, Room 3172, Mail Code 111C, San Diego, CA 92161; telephone: (858) 552-8585, ext 3715; fax: (858) 552-4314; e-mail: 〈ljdeftos@ucsd.edu〉.

The Biomedical Ethics Seminar Series of the University of California, San Diego, provided thoughtful discussions about biopatents.

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Abstract

The Canadian Supreme Court will soon make a decision about Harvard University's long-standing application for a Canadian patent on a mouse transgenic for the myc oncogene. That decision could reignite in North America the controversy that continues in Europe and elsewhere to surround the patenting of life forms. The tortuous steps in this 15-year patent maze are marked by the arguments about life patents that attended the U.S. Supreme Court's decision in Diamond v. Chakrabarty. This patent dispute about oil-digesting bacteria cracked open the door for animal patents in the United States and other countries, even though the legal arguments involved were based on patent applications for corn seeds and oysters, not mammals. The patent challenge to the Harvard mouse by the Canadian government now threatens to close this door in Canada.

The arguments against life patents are commonly based on moral and religious grounds that regard the sanctity of life and oppose its commodification. The most compelling arguments for such patents are based on the benefits they deliver through commercial exploitation of inventions. The debate about patenting animals has been more heated outside North America and cacaphonic in the Third World. However, the Canadian debate could be amplified by the U.S. Supreme Court's recent entry on the biopatent stage through the side door of a new corn seed patent dispute.

A narrow legal analysis by the Canadian Supreme Court would award the mouse patent to Harvard, while a policy analysis might support the government's challenge of the patent. Although the impact of the Harvard mouse patent process in Canada could be just a squeak, opponents of patenting life can mount the myc mouse to once again roar their opposition to animal patents. And the sound could resonate through the arguments about both biopatents and human cloning, with potentially important effects for academia, industry, and the public.

Among American physicians and scientists, the recent ethical discourse about biopatents has centered on gene patents rather than animal patents.1 This may be changed by the Canadian government's appeal in October 2000 to its Supreme Court, which again thwarted Harvard University's patent application for a transgenic mouse and sustained Canada's status as the only developed country that does not allow mammalian patents.2,3 This appeal can result in the recalescense in North America of the controversy that continues to surround the patenting of life forms in Europe and other counties.4–6 The Canadian government's appeal was a penultimate step in a 15-year process that began in June 1985, when Harvard applied for a Canadian patent on a mouse that was genetically engineered with the human myc oncogene to be cancer-prone.4–7 The tortuous steps in this prolonged patent process are marked by the arguments for and against the processing of life that have been invoked since the United States Supreme Court decision in Diamond v. Chakrabarty, which awarded a patent to General Electric on oil-digesting bacteria.8 The twisted course of the Harvard mouse through the maze of the patent process in Canada heightens many of the ethical and legal barriers to life patents put in place by the European and U.S. patent processes, especially the former.4–8 These obstacles have not been entirely hurdled, especially in Europe, and they are even higher in developing countries and are now raised in Canada.1–4 In this article, I review that twisted legal history of the mouse, discuss related issues of patenting life in the United States, Canada, and abroad; outline possible consequences of the Canadian Supreme Court's pending decision; and discuss implications for academia and industry.

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THE MYC MOUSE

The Mouse in Canada

The Canadian “transgenic animal” patent application for the Harvard Oncomouse, so named because of its susceptibility to cancer, was filed in June 1985.1–3 The invention had been assigned by its inventors, Drs. Phillip Leder and Timothy Stewart, to the president and Fellows of Harvard College.1 In March 1993, the Canadian patent examiner rejected the patent claim on the mouse itself, while accepting the claim for the genetic engineering process utilized to make the mouse.2–4 The mouse patent was denied on the grounds that the oncomouse was not a patentable invention because higher life forms were not identified as patentable subject matter by the Canadian Patent Act. In 1995, the commissioner of patents, upon review of the examiner's decision and a hearing before the patent appeal board, dismissed Harvard's appeal of the patent denial, further reasoning that, except for the oncogene, the Harvard mouse was made by nature, not by man, and thus not a patentable invention.3,4,7

In 1998, a Canadian federal trial court upheld the patent refusal.1,4 Extending the patent commissioner's arguments, the court further reasoned that the mouse did not conform to the requirement of Canadian patent policy that the mouse be “uniformly reproducible,” since, except for the introduced gene, nature, not Harvard, manufactured the mouse in the random manner of the reproductive process. Furthermore, the court agreed with the patent office that a higher life form such as a mouse is outside the definition of an “invention” under the Canadian Patent Act. The court emphasized that “the Commissioner of Patents has both a right and obligation to consider public interest in the granting of a patent.” Such policy statements are generally foreign to U.S. patent decisions.4,5

The Canadian Patent Act, modeled after U.S. patent law, allows patents in human genes, gene sequences, and cell lines, although this practice has yet to be reviewed by a senior court.4,9 But unlike the U.S. law, patents of higher, multicellular animals (and plants) are not awarded in Canada. In further contrast to the practice in the United States and most developed countries that patent plants and animals, the current Canadian patent office policy distinguishes between “higher life forms” and “lower life forms.”5 It currently views lower life forms such as fungi, yeasts, microorganisms, cells, transgenic cells, and cell lines as patentable subject matter, while higher life forms, such as mammals, are considered non-patentable subject matter. Unlike the case in European countries, neither Canadian nor U.S. patent law has a “morality clause” that expressly allows public policy considerations in granting patents. Nevertheless, as evidenced by the oncomouse controversy, policy issues are more likely to be found in patent decisions in Canada than in such decisions in the United States.4,9

In August 2000, a Canadian federal appeals court, in a 2-1 decision, characterized the patent commissioner's denial of the oncomouse patent as “clearly wrong” and awarded the mammalian patent to Harvard.5,10 The court rejected the commissioner's arguments, stating there was nothing in Canadian laws to prohibit a patent on the oncomouse. Writing for the majority, Justice Marshall Rothstein said that inventors can use the laws of nature in their inventions, “provided inventiveness and ingenuity are involved.” He did not find the “common understanding” invoked by the commissioner that Canadian patent law does not extend to living organisms. The court eschewed patent limitations on policy grounds and directed that a patent be issued for the oncomouse as a “composition of matter.” Like U.S. patent law, compositions of matter and manufactures, along with methods and machines, that are novel, useful, non-obvious, and sufficiently described are patentable under Canadian patent law. Writing for the dissent, Justice Julius Issac expressed views seldom articulated in Canadian patent law and rarely in U.S. patent law: “In morally divisive cases like this one, the court should defer to the commissioner's decision” and that “Parliament should debate the issue.”

But this latter view prevailed when in September 1999, the Canadian government formed the Canadian Biotechnical Advisory Committee (CBAC) to advise Parliament on biotechnology policies, such as animal and gene patents.3,11 In September 2000, the CBAC recommended two options to the government.11 A majority of the committee recommended the parliamentary consideration of an amendment to the Patent Act to forbid patenting of higher life forms and the addition of a “morality clause” to the Act that would allow policy issues to be part of the patent process. A committee minority recommended an appeal of the oncomouse patent to the Canadian Supreme Court. On October 2, 2000, on the last day that appeals were permitted, the Canadian government appealed the Harvard patent award to the Canadian Supreme Court and stated that a public dialog on the issue of animal patents was needed.1–3 A Supreme Court response is expected within a year of the date of the appeal. The “public dialog” requested by the Canadian government on this issue can reinvigorate the voices of opponents to life patents, recently muted in North America but remaining loud in Europe and cacophonic in the Third World.4,8

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THE MOUSE IN THE UNITED STATES

Controversy also surrounded the patenting of the Harvard mouse in the United States, but it has abated since its peak in the 1980s.3,5 The current debate about biopatents in the United States is instead about partial gene sequences and their conformity to the utility requirement for patents; this requirement evolved from the “any credible utility” criterion of 1995 to the now-proposed “specific, substantial, and credible utility” standard.3,6,9 While debate about this heightened utility standard overshadows debate about animal patents in the United States, opponents of the patenting of life in North America may use the developing debate about the Canadian oncomouse to once again voice their opposition to animal patents.5–7

Animal patents have been allowed in most developed countries for decades, even though opposition to them still exists, especially in Europe and more so in undeveloped countries that characterize the patent laws of developed countries as “biocolonialism.”3,5,6 The United States oncomouse patent was awarded in April 1988, years after Harvard's 1984 application for the “transgenic non-human mammal.”1,4 The seeds of this approval were planted by the 1980 decision of the U.S. Supreme Court in Diamond v. Chakrabarty and the subsequent protracted decisions of the U.S. Patent and Trademark Office (PTO) and federal courts.8 It is ironic that the Chakrabarty case about patenting bacteria and subsequent decisions by the PTO about patents for corn seeds and polypoid oysters opened the door to the patenting of mammals in the United States and can have implications for human cloning.9,12,14

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CHAKRABARTY—THE SEMINAL CASE

The Road to the Supreme Court

In 1972, Anand Chakrabarty, a microbiologist from General Electric, filed a patent application for oil-digesting bacteria to be used in the treatment of oil spills.8 Chakrabarty developed the Pseudomonas strain through bacterial conjugation by inserting oil-digesting plasmids from other bacteria that respectively metabolized four different types of oils.

The times were not inviting for life patents.5,9 Until 1930, patents on plants and animals were barred in the United States because they were considered “products of nature.” Although Congress passed legislation to assist plant breeders by allowing the patenting of asexually reproduced plants in 1930 and sexually produced plants in 1970, through the 1970s, the PTO rejected claims for genetically-engineered living organisms because “living organisms and cells were unpatentable products of nature.”4–6,9 Reflecting this view, the patent examiner denied Chakrabarty's claim to the bacteria themselves, while allowing the claims on the process of producing the bacteria and the composition of an inoculum containing the bacteria. The examiner reasoned that the bacteria were “products of nature” and as such were not patentable subject matter under patent law.

Upon appeal by Chakrabarty, the PTO Board disagreed that the bacteria were products of nature, but agreed that patent law was not intended to cover “living things.”5,9 The board based its decision on the 1930 Plant Patent Act, which allowed the patenting of plants but did not name bacteria as patentable, and the 1970 Plant Variety Protection Act, which excluded bacteria from its protection. Chakrabarty appealed to the Court of Customs and Patent Appeals (CCPA), the predecessor to the Court of Appeals for the Federal Circuit (CAFC), which was created by Congress in 1982 as the “Supreme Court” of patent law. The appeal was merged with another patent rejection, that of a purified strain of Streptomyces that produced lincomycin.9,12 The CCPA in a divided vote reversed the board on both, starkly stating that “the fact that microorganisms are alive is a distinction without legal significance and that they should be treated [by patent law] no differently from chemical compounds.”12

The Chakrabarty component of the CCPA decision was appealed by the patent and trademark commissioner, Sidney Diamond, to the Supreme Court.5,8 Because of commercial considerations, the Streptomyces patent was withdrawn by the applicant, Upjohn Pharmaceuticals, since it was deemed weaker as a patent based on the discovery of naturally-occurring bacteria and thus threatened the Chakrabarty patent based on the invention of genetically-altered bacteria.12 Upjohn's caution reflected the commonly-held view, often pronounced by patent opponents, that discoveries were patentable while inventions were not, even though this view has no legal basis in U.S. (or Canadian) patent law.

In a 5-4 decision, Chief Justice Warren Burger affirmed the CCPA and held that “a live, human-made microorganism is patentable subject matter … to a person who invents or discovers any new or useful manufacture or composition of matter….” The Court adopted the CCPA position in ruling that Chakrabarty's “discovery is not nature's handiwork, but his own.”8 The Court distinction was thus between “man-made” or not rather than “living” or not. The Court also supported their decision with a congressional committee report about the 1952 recodification of the Patent Act stating that patents can be issued for “anything under the sun that is made by man.”

The Supreme Court found that the passage of the Plant Variety Protection Act's exclusion of bacteria from its protection was not evidence for congressional exclusion of all living things from patent law, since it referred only to plants. The Court said that the dissents' policy arguments against patentability, echoed by some amicus briefs, should be addressed to the Congress, not the judiciary, and noted that only Congress can expressly regulate patentability on policy grounds, as it did by excluding atomic energy research from the ambit of patent law for national security reasons.

The dissent by liberal Justice William Brennan argued that both Plant Acts showed Congress's understanding that the U.S. Patent Act did not include living organisms. His policy position was the obverse of that of the majority: “It is the role of Congress, not this Court, to broaden or narrow the reach of the patent laws. This is especially true where, as here, the composition sought to be patented uniquely implicates matters of public concern.” The minority opinion noted that the amicus briefs filed by animal rights groups and scientists, among them Nobel laureates, argued that genetic research may pose a serious threat to the human race, that the dangers are far too substantial to permit such research to proceed apace at this time, that genetic research and related technologic developments may spread pollution and disease, that it may result in a loss of genetic diversity, and that its practice may tend to deprecate the value of human life. By contrast, the majority opinion relegated this type of argument to congressional, not judicial, consideration.

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After Chakrabarty

Subsequent to this ruling, numerous parties sought to patent other animals and previously unpatentable plants. The PTO and the Federal Circuit, considering the divided nature of the Chakrabarty decision and adverse public opinion, continued to generally deny such patent applications until the PTO's quasi-judicial decisions in Hibberd, in 1985, and Allen, in 1988.9,13,14 In Ex Parte Hibberd, the patent board relied on Chakrabarty in reversing the ruling of the patent examiner and allowing the seeds for a corn plant (maize) containing an increased level of the amino acid tryptophan to be patented.13 However, despite Chakrabarty and Hibberd, the commissioner continued to refuse patents on animal inventions until the Allen decision.5,9 In Ex Parte Allen, the patent examiner rejected a “product-by-process” patent for a radiation-induced variety of oysters, reasoning that the new variety of oysters was “controlled by the laws of nature and not manufactured by man.”14 Although the patent was eventually denied on other grounds (the invention was deemed “obvious” because of a prior publication), both the patent board and a federal court countered that the multicellular oysters could be patented as new “manufactures” or “compositions of matter,” reinforcing the proposition that newly created, genetically altered “living organisms” fall within the category of “patentable subject matter.”

On April 7, 1987, four days after the Allen decision was handed down, the patent commissioner issued a Rule stating that “the Patent and Trademark Office now considers non-naturally occurring, non-human, multi-cellular living organisms, including animals, to be patentable subject matter.”15 The PTO specifically excluded human beings from patentable subject matter. This exclusion was codified by Congress in 1988, although “human beings” have never been legally or genetically defined.6,9 Nevertheless, the PTO agreed on an eight-month moratorium on animal patents requested by Congressman Robert Kastenmeier.4,5 Then, on April 12, 1988, the PTO issued Patent Number 4,737,866 for the Harvard oncomouse. The patent described a myc oncogene-bear-ing mouse, but the claims covered all oncogenes and all mammals (including primates, excepting humans) and their progeny. This award notwithstanding and in contrast to the utility standards for gene patents, the PTO has yet to publish any standards of patent review for the “nonhuman, multicellular organisms” covered by the mouse patent and subsequent mammalian patents.

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ISSUES OF ANIMAL PATENTS

Attempts to Challenge Animal Patents

In several sessions of Congress in 1987 and 1988 after the PTO's Rule, Senator Mark Hatfield of Oregon introduced legislation to place a moratorium on animal patents.5,9 The legislation never passed, although the 1987 bill was passed by the House. Despite the absence of an official moratorium on patents of genetically engineered animals, the PTO, cognizant of the attendant controversy, did not issue any animal patents between 1988 and December 1992.

Public concern about the mouse patent was reflected in the 1998 Animal Legal Defense Fund (ALDF) challenge of the PTO's Rule in federal court.5,16 The ALDF challenge was based on both procedural and substantive grounds; it charged that the PTO was not empowered to make such a ruling with respect to patentability and that the PTO had issued the Rule in violation of the public notice and comment requirements. These charges were leveled because the Rule allowing animal patents was not published in the Federal Register, and the PTO did not invite public comments prior to its promulgation, both alleged violations of administrative law.4,9

The PTO filed a motion to dismiss, arguing that the Rule was not a new statute or regulation; was merely “interpretive” of precedent, namely Chakrabarty and Ex Parte Allen; and did not abridge or enlarge anyone's rights. The Northern District Court of California, the site of many patent trials, agreed with the PTO and granted the motion to dismiss, holding that the Rule was exempt from the notice and comment requirements of the Administrative Procedure Act and that the ADLF had no standing to sue.16 Following this logic, parties having such standing would be other genetic researchers (unlikely) and animals (unable). The court also expressed in dicta throughout the opinion that animals were patentable. This case has become the definitive judicial statement on the patentability of living organisms, even though the court never ruled on the substance of the protest to mouse patents. Although other groups opposing animal patents have tried, no challenge has proceeded as far, and no attempt has come close to challenging this federal court ruling.

On December 29, 1992, the PTO granted three additional patents for transgenic mice.4,9 The Harvard mouse was ultimately patented in Europe in 1992, after a four-year contest, and by Japan through administrative processes in 1994.9 Although European patents can be withheld for inventions contrary to the “ordre public” or morality, few applications have been ruled unpatentable on these grounds.6 Scores of biopatents have since been granted for transgenic animals in the United States, Europe, Japan, and most developed countries.9 Of the latter, only the Canadian government continues to argue the patentability of animals.1,4,9

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The Slippery Slope

Further to the many specific arguments against animal patents is the general argument that they start the slippery slide to patenting humans.9,17 Ironically, and in contrast to many developed countries, Canada has no express ban on patenting humans, although it could be argued that the Canadian Charter of Rights and Freedoms would offer such protection.5 Under U.S. law, humans cannot be patented, presumably because the 13th Amendment prohibits slavery, notwithstanding that a patent confers monopoly, not possessory, rights.4 The European Union confusingly prohibits patents on “the human body” but allows patents on “an isolated element of a human body.”6,17 In the United Kingdom, human cloning is unlawful, but patents do cover the cloning and growth of a human embryo to the level of the blastocyst, an early embryonic stage; by contrast, another Commonwealth country, Australia, has a version of a morality clause in its patent law and expressly prohibits the patenting of human beings as well as the processes for their generation.6,9,17

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PATENTING LIFE: INTERNATIONAL STATUS

Animal patent laws are far from settled, even in countries with robust patent systems.1–3 Although biopatents have been awarded in most developed countries for decades, there is still opposition to them, passionately proclaimed by the Green Party in Europe and by undeveloped countries, who characterize such patents as biopiracy.6,17,18 Some of these countries expressly prohibit the patenting of life.4,5,18 But there are many counterarguments to support the patenting of life forms.9,19

Many of the most compelling arguments for patents are based on the benefits that they deliver through the commercial exploitation of inventions.17–19 These arguments closely reflect the U.S. Constitutional basis for patents—“To Promote the Progress of … Useful Arts” and by federal courts, which view patents in commercial rather philosophical terms.5,20 That position has been supported by the U.S. patent process since the Chakrabarty decision in 1980.5,8 The arguments against life patents are often based on moral and religious grounds that regard the sanctity of life and oppose its commodification.21,22 Such arguments are supported by the letter of European patent law, which, unlike U.S. or Canadian patent law, provides for withholding of patents for inventions that are “contrary to the ‘ordre public’ or morality.”4–6 Many opposing arguments can be found on either side of all such arguments.23 However, the debate about patenting animals has been more heated outside North America, where the current patent debate is rather about DNA sequences.5,6,23

It is likely that months will pass before the oncomouse patent debate is adjudicated by the Canadian Supreme Court, and it is difficult to anticipate the decision5 — but whatever it is will likely have implications for international patent law. A narrow legal analysis would support the position of the Court of Appeals and award the mouse patent to Harvard. A policy analysis might support the Government challenge of the patent.24,25 While the impact of the Harvard mouse patent process in Canada could be just a squeak, opponents of patenting life can use the surrounding controversy to once again roar their opposition to all biopatents.23 Squeak or roar, the mighty myc mouse could gnarl international biotechnology patent law.

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POSSIBLE CONSEQUENCES OF THE CANADIAN DECISION

If the Court Hears the Case

The Canadian Supreme Court can take one of several actions in the case of the Harvard mouse, and each will have specific consequences. In the unlikely event that the Court decides not to hear the case, then the lower federal court decision would stand, and the Harvard mouse, with very little squeaking, would be awarded patent status in Canada. Such inaction would be regrettable, as it would recapitulate the tacit refusal of the U.S. Congress and the U.S. Patent Office to substantively address the concerns about the patentability of animals, especially mammals. Even the legal and ethical challenges to the transgenic mouse patent in the United States were denied on procedural grounds rather than substantive grounds.16

In the more likely even that the Canadian Supreme Court hears the case, a squeal would result from the hearing itself, as both sides would have the opportunity to express and disseminate their views in a respected forum. Such a consideration of the patentability of the Harvard mouse would represent the only substantial review of life patents by any country's high court since the U.S. Supreme Court's decision in Chakrabarty in 1980. Canada would become the only First World country with a recent judicial decision about the patenting of life that could lead to a corresponding legislative debate. Since the Chakrabarty decision is widely cited in the legal literature of both countries and remains central to the issue of patenting life in both countries, that case would be at the center of the legal argument in front of the Canadian Supreme Court about the Harvard mouse.8 Careful scrutiny of the decision in a country with enlightened social policies may reveal the weaknesses of the Chakrabarty decision, especially its legal basis and certainly its public policy implications.

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A House of Cards

Although Chakrabarty opened the door to biotechnology patents in the United States, the case was the first of a legal house of cards that led to the award of the Harvard mouse patent by the U.S. PTO. The Chakrabarty decision allowed the patentability of bacteria, not mammals, and by a mere 5-4 majority of the Supreme Court.8 The four dissenting justices had a cogent argument that Congress, not the courts, should broaden the reach of patents when matters of public concern are implicated. The next card, Hibberd, allowed a patent on corn seeds, not animals.13 The third card, Allen, addressed the patentability of a multicellular organism, an oyster; while both the patent board and a federal court agreed that the multicellular oyster could be patented, that particular patent was, in fact, eventually denied because the invention was deemed obvious.14 So from the fragile legal structure of these three submammalian decisions about bacteria, plants, and oysters, the U.S. Patent Office leaped to awarding a patent on a mammal. In so doing, that office did not distinguish between higher and lower life forms, as does Canada in allowing patents on only the latter. Specifically, the Canadian PTO currently considers only lower life forms, such as fungi, yeasts, and other microorganisms, to be patentable subject matter. The patentability of higher life forms, such as mammals, awaits the Court's ruling in the Harvard mouse case.11

The U.S. PTO offered little in the way of guidelines or definitions that could be applied to the wide variety of life forms that can now be patented in the United States as a result of the Chakrabarty decision. In fact, unlike other patent issues, the PTO does not have a published circular for the standards of patent review for animals. One consequence of this lack of guidelines is the backlog of patents for genetically-altered animals that resides in the PTO.9

It is likely that the discussion by the Canadian Supreme Court about the patentability of life would recapitulate the arguments that have been made by both sides about this issue in many arenas. While they fill volumes, these arguments generally fall into two ethical categories of Western moral philosophy, deontological and utilitarian.4 The former posit that certain acts are intrinsically wrong. Such arguments against life patents are generally based on moral and religious grounds that regard life as sacred. In contrast, the utilitarian arguments against patents posit that the harms outweigh the benefits. Respective counterarguments posit that humans have a duty to use God-given powers to improve their lot, and that the benefits that patents deliver to society through commercial exploitation of inventions outweigh their harms.

Among these arguments, the legalistic distinction between discovery and invention has been a philosophical favorite for drawing the line between patentable and unpatentable subject matter.4,5,6,7 According to this argument, inventions are patentable while discoveries are not. While philosophically attractive, this distinction between discovery and invention has no legal significance in Canadian or U.S. patent law. In fact, the Constitutional description and basis of patent law uses the word “discovery,” as does the Chakrabarty decision.8 And the concept of discovery in both Canadian and U.S. patent law is addressed by the nonobvious standard for patentability.24

If the Canadian Supreme Court awards the mouse patent, the squeak will not be very loud, since Canada would fall in line with essentially all First World countries. But the Harvard mouse would roar if the Canadian Supreme Court denies the patent on the Harvard transgenic oncomouse, a position consistent with Canadian patent law. Denial of the patent would most likely be followed by a parliamentary debate about life patents. Such a debate would provide the arena that many opponents of animal patents have been seeking, and the denial of the patent would be welcome by these opponents as a prudent course commensurate with Canada's civility and enlightened social policies.11

The Canadian Supreme Court decision, in any case, is unlikely to have any impact on animal patents in the United States. While the legal underpinnings of life patents in the United States could be considered a house of cards, the commercial exploitation of life patents is a steel-girded structure of patent practice. This is perhaps appropriate, because U.S. patent law represents the commercial exploitation of ideas, not a moral or ethical issue. As U.S. Supreme Court Justice Fortas stated in another rare patent decision of the Court, “a patent system must be related to the world of commerce rather than to the realm of philosophy.”20 And even though the U.S. Congress has not expressly approved of the patenting of life forms, the practice has gone on relentlessly since Chakrabarty and the Harvard mouse patent.

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Uneasy Alliance of Industry and Academia

The dispute about the Harvard mouse patent is an ironic example of the uneasy alliance between the biotechnology industry and academia that has flourished in the last decades. Although the academy and industry are often opposed, in this instance Harvard represents both camps. And while both members of this alliance can benefit from it, beneath the surface of this partnership there is a turmoil that often breaks the calm, as evidenced by the recent controversies about gene therapy.1 To put it bluntly, academia and industry usually have entirely different agendas and fundamentally mistrust each other's and each other. The aim of industry is to create money, the aim of academia is to create knowledge. Among the specific manifestations of these basic differences between industry and academia are conflicts of financial interest, conflicts of commitment, abuse of university personnel and facilities for outside activities, inhibition of the free flow of information, and exploitation of students as “cheap labor.”26

Reconciliation between these opposing positions of academia and industry has been possible because of the federal government's willingness to recognize and protect intellectual property rights in technologic advancements.28 Consequently, many academic institutions hold not only patents but equity positions in biotechnology companies. This aggressive intellectual property policy in the United States regarding biotechnology has created domestic and international controversy.26 The policy has been opposed vigorously by other countries and by groups within the United States as disparate as scientific and religious communities. American patent practice has created international uneasiness, especially about the propriety of “patenting life” and the competition rather than cooperation among countries for information that might save lives and cure and treat disease.28 Beyond Harvard v. Canada, the academic success of biotechnology and the financial promise of its discoveries and inventions have brought industry and academia together into this unprecedented but uneasy partnership.29

This academic—industrial alliance had a slow post—World-War-II start, but has grown dramatically during the last two decades. The inherent reluctance of industry and academia to work together, born of their disperate cultures, was dissolved by legal and legislative lubricants that promoted the partnership. The pivotal legal event was the Supreme Court's decision in Diamond v. Chakrabarty, which opened the door in the United States to the “patenting of life forms.” The pivotal legislative event was the Bayh—Dole Act, which provided incentives to both industry and academia that promoted cooperation.19 Key provisions of this Act were to allow universities to grant licenses—especially exclusive licenses—to companies for inventions developed at universities by taxpayer-funded grants and to enter into ownership agreements about the inventions of their faculties.27

The alliance between academia and industry has been considered a financial success by most, although critics express concern that the financial reward has been concentrated into the hands of a relatively small number of individuals and institutions.4,5,6 Academic and financial success notwithstanding, the road traveled by the partners in the uneasy alliance has been bumpy, and there have been many collisions, both major and minor, between them.21,23 At their core, many, if not all, of the collisions have been essentially about money.18 And the errant driver has often been an academician or entrepreneur who has tried to bypass institutional regulations, or the lack thereof, about the inherent conflicts of interest that arise in any industry—academic collaboration. Attempts to regulate such conflicts have been compromises that often satisfy neither party, with industry proponents considering them too restrictive, and academic advocates, too liberal.29 If the Canadian Supreme Court's decision weakens the legal basis for biopatents, it will remove a linchpin of the academic—industrial biotechnology alliance, and this road of commerce will become rockier.

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IMPLICATIONS OF THE CANADIAN DECISION

The best that biopatent opponents can expect from the Canadian consideration of the Harvard mouse patent is the implementation of policies that could lead to a more equitable distribution in both Canada and the United States of the fruits of scientific discoveries, especially those supported by taxpayers' money. For example, legislative bodies could attempt to obtain royalties from animal patents based on government-sponsored inventions. Legislators could also try to control prices on drugs developed with government-sponsored inventions. Granting agencies could make data sharing one of the criteria for grant evaluation and thus make information public and not novel; such agencies could also require patent-assignment approval. Academic institutions could eschew exclusive licensing arrangements, discourage agreements with onerous “reach through” provisions (such as proprietary demands on the offspring of patented animals crossbred with non-patented animals), encourage statutory registration of inventions that place them in the public domain and render them unpatentable, and protect their faculties in the experimental-use exception to patents.1,4 In fact, patents in the United States can be banned under exceptional circumstances; and in both counties, the law provides for compulsive licensing of inventions for public policy purposes. However, these steps might run the risk of inhibiting capital investment in biotechnology.

While the Canadian debate is about a mouse patent, the patenting of mammals has important implications for cloning technology, especially as it applies to humans.9 The slippery-slope argument posits that the patenting of mammals will ultimately lead to the patenting of cloned humans. Both countries contemplate a prohibition on cloning humans, while the United States prohibits such patents: Coincident with the award of the Harvard mouse patent, the U.S. PTO said that “a claim directed to or including within its scope a human being will not be considered to be patentable subject matter under the Patent Act. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution.”15 This prohibition presumably derives from the Constitutional prohibition against slavery of the 13th amendment and subsequent codification by the Animal Patent Bill of 1988. However, a “human being” has not been legally defined for the purposes of patent law. While this issue has not been raised by the small human myc gene component in the Harvard mouse, it was raised by a patent application for a human chimera (i.e., a “human” to be created partly with genetic material from non-humans).23 The application was denied by the U.S. PTO, but the decision did not address the question of how much genetic material constitutes a human. And even though human beings are not apparently patentable in Canada or the United States, the techniques for manipulating human cells through cloning technology are patentable, as are human cells themselves.25

The patent policies of both Canada and the United States, especially the latter, regarding the patenting of life, especially animals and particularly mammals, have been unexamined in recent years. Reviewing these policies through the Canadian Harvard mouse patent application in the light of recent legal and scientific developments, especially cloning and its potential application to humans, can only be beneficial for all involved and affected. Consequently, the juridical, and perhaps legislative, means to a decision about the mouse patent by the Canadian Supreme Court seems more important than its end.

The United States Supreme Court decision in Chakrabarty was fortified by the dictum that patents can be issued to “anything under the sun that is made by man.” And Jonas Salk, when questioned about patenting the polio vaccine, was reported to have asked, “Could you patent the sun?”

Recently, the U.S. Supreme Court took a surprising step that may provide its current view of Chakrabarty's and Salk's heliacal allusion to the patenting of life. The Court has agreed to hear a case about a corn-seed patent dispute that harkens back to the Court's 1980 debate in Chakrabarty.30 One seed company is defending itself against a patent infringement challenge to its sales of particular seeds by arguing that the contested seed patents should not have been awarded to the challenging company. The basis of the defense is the very argument invoked in Justice William Brennan's dissent to the majority decision in Chakrabarty—that U.S. patent law “does not include living organisms” because if it did, plants could have been patented without the Plant Acts. This argument had been narrowly rejected by the Supreme Court's 5-4 majority in Chakrabarty, and two federal appeals courts have also rejected the argument in the current case. So why has the U.S. Supreme Court agreed to hear this appeal of what is thought to be well-settled law? Is the Court signaling, as has Canada, that the time is ripe for a re-evaluation of Chakrabarty-based patent policies that allow biopatents in the United States?

Regardless of the U.S. Supreme Court's motive, the arguments on both sides of the biopatent issue raised by—and to be argued in—this case will echo the corresponding arguments in Chakrabarty.31 So, both the Canadian and the U.S. Supreme Courts will soon be addressing the patenting of life. Final decisions aside, the Courts' upcoming discourses will serve the important civic purpose of informing academia, industry, and the public about the issues surrounding the patenting of life, issues that take on even greater importance as the debate about human cloning proceeds.32 Causing both Courts to jump to such a discourse—final outcomes aside—will be the most important effect of the squeaking Harvard mouse.

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© 2001 Association of American Medical Colleges

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