Patent-Busting: The Public Patent Foundation, Gene Patents and the Seed Wars
In the United States, there has been much concern about the operation of the patent system – with concerns raised about the quality of the patents granted by the United States Patent and Trademark Office (USPTO), and the enforcement of patents in the courts.1 There has been a particular concern about the rise of ‘patent trolls’ – strategic non-practising entities which use patents to threaten others with the Hobbesian choice of paying licensing fees or facing patent infringement proceedings.
In reaction to the perceived malaise of the patent system, there has been an emergence of ‘patent-busters’, which seek to challenge the validity of patents of dubious novelty, inventiveness and utility. The Public Patent Foundation (PUBPAT for short) is a not-for-profit legal services organization based at the Benjamin N. Cardozo School of Law that ‘represents the public’s interests against the harms caused by the patent system, particularly the harms caused by undeserved patents and unsound patent policy’.2 The organization has observed: ‘Undeserved patents injure the public because they can be used by private actors to preclude activity that would otherwise be permissible, if not desirable.’3 The Foundation has sought to represent the larger public interest in patent law through legal representation, public education and advocacy.
The director of the Public Patent Foundation is Daniel Ravicher. He has been labelled a modern day ‘Robin Hood’ by Science magazine.4 His interest in patent law was piqued by classes at the University of Virginia by Randall Rader, a chief judge of the Federal Circuit Court of Appeals. In an interview with Groklaw, Ravicher explains the reasons for establishing the foundation:
The patent system is being abused by private actors to the detriment of the mostly unaware public. Our health, our freedom, and our economic prosperity are all under assault from bogus rights meted out to the few with the power and expertise to game a system originally established hundreds of years ago to promote progress within society as a whole. The government, through primarily a captured patent office utterly failing to achieve its mission and skewed policies implement into patent law by Congress and the courts, is not just failing to defend the public interest from abuse of the patent system, but is complicit in and supportive of such efforts. In information technology industries, abuse of the patent system means illicit restraint of civil liberties and unjustified disproportionate burdening of small businesses. In life science industries, abuse of the patent system has even more devastating results, including the exacerbation of pain and suffering by those who cannot afford medical technologies covered by undeserved patents. This situation is abhorrent and the Public Patent Foundation is beginning a campaign against such abuses.5
The influential magazine Managing Intellectual Property rated Ravicher one of the 50 Most Influential People in Intellectual Property in 2012.6
The Public Patent Foundation’s Daniel Ravicher envisaged:
PubPat’s four core activities are (1) challenging patents that threaten the public’s health, freedom, or other interests, (2) helping small businesses defend themselves from patents being asserted against them, (3) establishing patent commons within markets crippled by patent thickets, and (4) educating the public regarding these issues and advocating for reform of the patent system.7
Ravicher explains that the most difficult part of his job is encouraging the legal profession to have an open mind about his work:
People like to say: Oh, that guy he hates all patents. It could not be further from the truth. That’s like saying the guy from The Innocence Project hates criminal law… I felt nobody was representing the public interest. There was nobody standing up saying that sometimes the Patent Office goes too far or patent holders go too far.8
The Public Patent Foundation has earned a certain amount of ire from the patent profession and related industries. Susan Hansen notes: ‘For a guy who gave up a high-paying corporate law job to try to improve the patent system, Daniel Ravicher doesn’t always get a lot of thanks’.9
The Public Patent Foundation carefully selects the patents that it is challenging. According to Science, Ravicher ‘supervises a handful of volunteer scientists, occasional grad students, and legal interns as they search for potential flaws in big-name patents’.10 He particularly targets the patents that he believes ‘are causing the most harm’.11 In a profile, Crispin Littlehales notes that Ravicher uses ‘sources willing to give him tips – usually disgruntled scientists – to help identify his challenges’.12 Moreover, he observes that Ravicher ‘relies on the wisdom of a like-minded board of directors and several advisors who believe in what PUBPAT does but do not want to be publicly affiliated with it for political and other reasons’.13 The board of directors for the Public Patent Foundation currently include Professor Margo Bagley, Professor Michael Herz, Brian Kahin, Professor Eben Moglen, the General Counsel for the Free Software Foundation and Associate Professor Joshua Sarnoff.
The group has had some success in filing requests for re-examination of patents at the USPTO. The Public Patent Foundation has been active in the area of information technology patents. In 2004, the Foundation presented prior art which invalidated Microsoft Corporation’s patent on the FAT File System, which was promoted as ‘the ubiquitous format used for interchange of media between computers, and, since the advent of inexpensive, removable flash memory, also between digital devices’.14 In 2008, the Public Patent Foundation sought a review of a patent on photomosaics, which are pictures made through the use of many small pictures.15 There had been concern that the patentee, Robert Silvers, had been threatening to assert the patent against individuals, small businesses and even open source developers. In 2010, the patent examiner issued a final rejection of the majority of the patent’s claims.
In 2004, the Public Patent Foundation filed a request for re-examination in relation to a ‘co-transformation’ patent – this is a process for inserting foreign DNA into a host cell to produce certain produce certain proteins, which are the basis for a wide range of pharmaceutical products.16 The underlying technology was relevant for Epogen for anaemia, Activase for heart attacks strokes, Avonex for multiple sclerosis and recombinant for Haemophilia. The USPTO and Columbia University waived any right to assert the patent in December 2004. The Public Patent Foundation has also had a keen interest in patent law and biotechnology. In 2006, the Foundation filed formal requests with the Patent Office on behalf of the Foundation for Taxpayer and Consumer Rights to revoke three patents owned by the Wisconsin Alumni Research Foundation in respect of stem research. The Patent office rejected all claims of each of the patents on March 30, 2007.17
The Public Patent Foundation has also been active in the field of patent law, pharmaceutical drugs and access to essential medicines.18 In 2004, the Public Patent Foundation submitted prior art, challenging the validity of Pfizer’s patent on Lipitor, a treatment for lowering cholesterol.19 As a result, the USPTO rejected the patent in June 2005, and Pfizer conceded its original broad claims. In 2007 and 2008, the Public Patent Foundation challenged key HIV/AIDS pharmaceutical drug patents held by Gilead Sciences.20 The USPTO rejected all of the claims of each of the patents. In 2010, the Public Patent Foundation challenged eight patents held by Abbott Laboratories for the key HIV/AIDS drug ritonavir (which has been marketed under the trade name, Norvir).21 This challenge is under consideration by the USPTO. In the 2011 matter of Public Patent Foundation Inc. v. GlaxoSmithKline Consumer Healthcare LP, the Public Patent Foundation filed a complaint against GlaxoSmithKline Consumer Healthcare LP, alleging that the company had violated the False Marking Statute, since January 2005, ‘by marking certain of its products with the patent numbers of expired patents’.22 The district court judge held that the licensee had no knowledge that patents marking products had expired, and, even assuming the licensee’s knowledge, the products were not marked with expired patents to deceive the public.
This chapter considers the Public Patent Foundation as a novel institution in the patent framework. It contends that such a model can play a productive role in challenging the validity of high-profile patents; working as amicus curiae in significant court cases; and also promoting patent law reform. However, there are limits to the ‘patent-busting’ of the Foundation. The not-for-profit legal services organization has only had the time and resources to challenge a number of noteworthy patents. Other jurisdictions – such as Australia – lack such public-spirited ‘patent-busting’ entities. This chapter considers a number of key disputes involving the Public Patent Foundation. Part I examines the role of the Public Patent Foundation in the landmark dispute in the United States over Myriad Genetics’ patents in respect of breast cancer and ovarian cancer.23 Part II considers the role of the Public Patent Foundation in litigation between organic farmers and Monsanto in the United States.24 Part III examines the role of the Public Patent Foundation in larger debates about patent law reform in the United States – particularly looking at the Leahy-Smith America Invents Act 2011 (US).25 The conclusion contends that the patent-busting model of the Public Patent Foundation should be emulated in respect of other technological fields, and other jurisdictions – such as Australia. The initiative could also be productively applied to other forms of intellectual property – such as trade mark law, designs law, plant breeders’ rights and access to genetic resources.
I. Gene Patents
There has been longstanding controversy over Myriad Genetics and its patents in respect of genetic testing for breast cancer and ovarian cancer.26 The Public Patent Foundation collaborated with the American Civil Liberties Union in mounting a challenge in the United States courts against Myriad Genetics’ patents in respect of BRCA1 and BRCA2, which are related to breast cancer and ovarian cancer. In May 2009, the two groups filed a lawsuit ‘charging that patents on two human genes associated with breast and ovarian cancer stifle research that could lead to cures and limit women’s options regarding their medical care’.27 Discussing the legal action, Daniel Ravicher of the Public Patent Foundation emphasized: ‘Patenting human genes is counter to common sense, patent law and the Constitution. Genes are identified, not invented, and patenting genetic sequences is like patenting blood, air or e=mc2.’
The legal action was filed on behalf of women patients, cancer survivors, scientific researchers, health groups and scientific associations, representing pathologists, scientists and researchers. The plaintiffs provided powerful testimony about the impact of the patents upon patient health, scientific research and the health-care system.28 The legal action was filed against the USPTO, as well as Myriad Genetics and the University of Utah Research Foundation. The epic litigation has progressed from a District Court of the United States; to the Court of Appeals for the Federal Circuit; and has been appealed to the Supreme Court of the United States.
The United States District Court for the Southern District of New York
At first instance, Sweet J of the United States District Court for the Southern District of New York was sympathetic to the arguments of the Public Patent Foundation and the American Civil Liberties Union.29 The judge observed of the conflict:
Plaintiffs’ challenge to the validity of these claims, and the arguments presented by the parties and amici, have presented a unique and challenging question: Are isolated human genes and the comparison of their sequences patentable? Two complicated areas of science and law are involved: molecular biology and patent law. The task is to seek the governing principles in each and to determine the essential elements of the claimed biological compositions and processes and their relationship to the laws of nature. The resolution of the issues presented to this Court deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their investors, and those seeking to advance public health.30
The judge commented: ‘The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature.’31 Sweet J ‘concluded that DNA’s existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes’.32 The judge ruled that ‘the patents at issue directed to “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101’.33 The judge also ruled that, ‘because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter under § 101’.34
In the course of the judgment in his discussion of law and genetics, Sweet J refers back to debates over agriculture as a touchstone. The judge provides a portrait of Mendelian genetics:
The field of genetics – the science of heredity and variation in living organisms – and the concept of units of heredity that could be transmitted from one generation to another originated in the 19th century from experiments with pea plants conducted by Gregor Mendel. Mendel showed that certain traits are passed on from parent to offspring as discrete entities and do not appear blended in the offspring. He hypothesized that it was the plant’s genotype, or assortment of hereditary factors, that determined the plant’s phenotype, or appearance. In 1909, this unit of inheritance was termed a ‘gene’. Yet the gene remained an abstract concept until 1915, when it was shown that genes corresponded to physical spans of chromosomal material.35
While the Supreme Court in J.E.M. Ag Supply36 noted the USPTO’s practice of issuing patents on sexually reproducing plants in concluding that such plants represented patentable subject matter under § 101, that passing observation was neither dispositive nor central to the Court’s holding and does not establish a rule of judicial deference to the USPTO’s practices.37
Lauding the decision by Sweet J, Daniel Ravicher wrote about the potential implications of the ruling on gene patents in The Huffington Post.38 He maintained: ‘To say that the Honorable Robert Sweet of the Southern District of New York saved the lives of millions of Americans on Monday with the stroke of a pen is not a hyperbole.’39 Ravicher expressed the hope that the decision would have a positive impact upon the burgeoning field of personalized medicine:
Our victory this week will enable a transformative change in medicine to the benefit of patients, society and, yes, even industry. In the not too distant future, when you go to the doctor, she will screen your entire DNA to determine which medicines would work best for you and which would be harmful. This will become as common as taking your temperature and running other blood work. The now realizable prospect of leaving behind the one-size-fits-all world of medical treatment for custom-tailored diagnosis and treatment should make all Americans breath a deep sigh of relief. And it would not be possible if gene patents were upheld, because then the cost of a full genetic screening would be prohibitively high due to the hold up incentives placed on patent holders, who are driven to maximize profit, not public good.40
In his 2012 book on the future of intellectual property and health-care, Identity and Invention, Shubha Ghosh explores the culture and ethics of patent law and personalized medicine.41 He notes in his conclusion that ‘Medical information is as much a part of the information age as the Internet, software, and social networking.’42 There is certainly a larger interest in the impact of the litigation upon intellectual property and a variety of fields of biotechnology – cutting across the agriculture, health-care, medicine, the environment, and climate mitigation and adaptation.
The United States Court of Appeals for the Federal Circuit
The United States Court of Appeals for the Federal Circuit reviewed the decision of Sweet J.43 Lourie J for the majority summarized the complex ruling of the court:
On the threshold issue of jurisdiction, we affirm the district court’s decision to exercise declaratory judgment jurisdiction because we conclude that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad’s patents. On the merits, we reverse the district court’s decision that Myriad’s composition claims to ‘isolated’ DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature. We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle. We, however, affirm the court’s decision that Myriad’s method claims directed to ‘comparing’ or ‘analyzing’ DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent ineligible abstract, mental steps.44
The judge emphasized: ‘If the law is to be changed, and DNA inventions excluded from the broad scope of § 101 contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress.’45
In a separate judgment, Moore J was reluctant to disrupt and unsettle established practice in respect of patent law and biotechnology:
This case typifies an observation by the late Chief Judge Markey, our first Chief Judge, that ‘[o]nly God works from nothing. Men must work with old elements.’ Human DNA is, for better or worse, one of the old elements bequeathed to men to use in their work. The patents in this case revealed a new molecular understanding about ourselves; ‘the inventions most benefiting mankind are those that “push back the frontiers of chemistry, physics, and the like”.’ We cannot, after decades of patents and judicial precedent, now call human DNA fruit from the poisonous tree, and punish those inquisitive enough to investigate, isolate, and patent it. ‘Our task … is the narrow one of determining what Congress meant by the words it used in the statute; once that is done our powers are exhausted.’ This inquiry does not have moral, ethical, or theological components. Cf. id. (‘[W]e are without competence to entertain’ arguments about ‘the grave risks’ generated by genetic research.). The patents in this case might well deserve to be excluded from the patent system, but that is a debate for Congress to resolve.46
The judge declined ‘to extend the “laws of nature” exception to include isolated DNA sequences’.47
In dissent, Bryson J maintained that Myriad Genetics should be able to obtain patent protection in relation to genes:
In its simplest form, the question in this case is whether an individual can obtain patent rights to a human gene. From a common-sense point of view, most observers would answer, ‘Of course not. Patents are for inventions. A human gene is not an invention.’ The essence of Myriad’s argument in this case is to say that it has not patented a human gene, but something quite different – an isolated human gene, which differs from a native gene because the process of extracting it results in changes in its molecular structure (although not in its genetic code). We are therefore required to decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic material a patentable invention. The court concludes that it does; I conclude that it does not.48
The judge emphasized that, while ‘it may be very difficult to extract the newly found mineral or to find, extract, and propagate the newly discovered plant’, ‘that does not make those naturally occurring items the products of invention’.49 Bryson J observed: ‘The same is true for human genes.’50 The judge emphasized: ‘In each case, merely isolating the products of nature by extracting them from their natural location and making those alterations attendant to their extraction does not give the extractor the right to patent the products themselves.’51
Considering the outcome, Daniel Ravicher stressed for the Public Patent Foundation: ‘As all the judges today agreed that our clients had standing to bring this case and that analyzing gene sequences for alterations is not patentable.’52 He expressed his preference for the dissent of Bryson J: ‘The judges disagreed with each other on whether pieces of the human genome are patentable, and we agree with Judge Bryson who explained they are not because no one “invents” genes.’53 Ravicher reiterated his case: ‘Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves.’54
The Supreme Court of the United States and the Prometheus Decision
In December 2011, the American Civil Liberties Union and the Public Patent Foundation requested that the Supreme Court of the United States consider an appeal against the ruling of the Court of the Appeals for the Federal Circuit.55
In the interim, the Supreme Court of the United States ruled upon the nature of patentable subject matter in the Prometheus matter.
In the 2012 case of Mayo Collaborative Services v. Prometheus Laboratories Inc., the Supreme Court of the United States rejected a patent application in respect of medical information on the grounds that it claimed the underlying laws of nature.56 This decision marked an important shift from an earlier consideration of the matter.57 In his lead judgment for the Supreme Court of the United States, Breyer J re-articulates the law with respect to patentable subject matter: ‘If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.’58 Focusing on ‘laws of nature’, Breyer J comments: ‘The Court has repeatedly emphasized … a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature’.59 His Honour noted: ‘These statements reflect the fact that, even though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are “the basic tools of scientific and technological work”.’60 Breyer J was concerned about the danger ‘that the grant of patents that tie up their use will inhibit future innovation’ – particularly where ‘patented process amounts to no more than an instruction to “apply the natural law”’.61 In his reasoning, Breyer J was, in particular, influenced by the work of Professors Mark Lemley and Rebecca Eisenberg on patentable subject matter.62
Summing up, Breyer J considered the competing policy arguments by the parties and the amici curiae in the case. His Honour counterpointed the views. On side, ‘Prometheus, supported by several amici, argues that a principle of law denying patent coverage here will interfere significantly with the ability of medical researchers to make valuable discoveries, particularly in the area of diagnostic research.’63 On the other side,
the American Medical Association, the American College of Medical Genetics, the American Hospital Association, the American Society of Human Genetics, the Association of American Medical Colleges, the Association for Molecular Pathology, and other medical organizations tell us that if ‘claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care’.64
Considering the various policy arguments about the impact of patent law, Breyer J commented:
‘In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another.’65 He concluded ‘that the patent claims at issue here effectively claim the underlying laws of nature themselves’, and ‘the claims are consequently invalid’.66
As a result of this decision, the Supreme Court of the United States remanded the Myriad Genetics’ gene patent case to the United States Court of Appeals for the Federal Circuit for further consideration in light of the ruling in the Prometheus case.67
The United States Court of Appeals for the Federal Circuit’s Reconsideration
In the decision in Association for Molecular Pathology v. USPTO and Myriad Genetics Inc., the United States Court of Appeals for the Federal Circuit reconsidered its ruling in light of the new Prometheus precedent.68 The three judges became even more entrenched in their respective positions.
For the majority, Lourie J summarized the new decision:
On the threshold issue of jurisdiction, we affirm the district court’s decision to exercise declaratory judgment jurisdiction because we conclude that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad’s patents. On the merits, we reverse the district court’s decision that Myriad’s composition claims to ‘isolated’ DNA molecules cover patent-ineligible products of nature under §101 because each of the claimed molecules represents a nonnaturally occurring composition of matter. We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle. We affirm the court’s decision, however, that Myriad’s method claims directed to ‘comparing’ or ‘analyzing’ DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.69
In the judgment, Lourie J emphasized that the isolated DNA molecules were not ‘products of nature’:
The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules.70
Considering the composition claims, Lourie J noted: ‘The remand of this case for reconsideration in light of Mayo might suggest, as Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature.’71
Lourie responded: ‘Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature.’72 Lourie J concluded that, while ‘Everything and everyone comes from nature’, ‘the compositions here are not natural products’.73 Lourie J held that the inventions ‘are the products of man, albeit following, as all materials do, laws of nature’.74
The judge emphasized that such a position was supported by past precedent, including rulings in respect of patent law and agriculture: ‘The Supreme Court has repeatedly stated that changes to longstanding practice should come from Congress, not the courts.’75 The judge noted:
In J.E.M. Ag Supply, Inc. v. Pioneer Hi–Bred International, Inc.,76 the Court rejected the argument that plants did not fall within the scope of § 101, relying in part on the fact that ‘the PTO has assigned utility patents for plants for at least 16 years and there has been no indication from either Congress or agencies with expertise that such coverage is inconsistent with [federal law].’77
Concurring, in part, Moore J considered the doctrine of products of nature under patent law. The judge observed: ‘The analysis is relatively simple if the invention previously existed in nature exactly as claimed.’78 Interestingly, the judge discusses in this context the example of bioprospecting, mentioning that the discovery of a wild plant would be considered to be a product of nature and not subject to patent protection: ‘For example, naturally existing minerals, a plant found in the wild, and physical laws such as gravity or E=mc2 are not patentable subject matter, even if they were “discovered” by an enterprising inventor.’79
Moore J comments: ‘Even if the invention was based on nature, and resulted in a living organism, it may fall within the scope of section 101.’80 Referring to plant breeding, the judge notes ‘For example, “the work of the plant breeder ‘in aid of nature’ was patentable invention” because “a plant discovery resulting from cultivation is unique, isolated, and is not repeated by nature, nor can it be reproduced by nature unaided by man”.’81 Moore J comments more broadly that there should be judicial deference shown towards the role of the United States Congress:
The judiciary cannot engage in an ad hoc innovation-based analysis, which is why the exceptions to patentability apply only to the clearest cases: a new mineral discovered in the earth, or a new plant found in the wild, or E=mc2, or the law of gravity. It is Congress, with ‘the constitutional authority and the institutional ability to accommodate fully the varied permutations of competing interests that are inevitably implicated by such new technology,’ Sony Corp. of America v. Universal City Studios, Inc., 464 U.S. 417, 431, 104 S.Ct. 774, 78 L.Ed.2d 574 (1984), who must decide whether it is necessary to change the scope of section 101 to exclude the kind of isolated DNA claims at issue here. It is not clear to me that Chakrabarty, Funk Brothers, or Prometheus leads inexorably to the conclusion that isolated DNA molecules are not patentable subject matter. I decline the invitation to broaden the law of nature exception. Given the complicated technology and conflicting incentives at issue here, any change must come from Congress.82
The judge was concerned about disrupting established business expectations: ‘The settled expectations of the biotechnology industry – not to mention the thousands of issued patents –cannot be taken lightly and deserve deference.’83 The judge observed: ‘I believe leaving intact the settled expectations of property owners is particularly important in light of the large number of property rights involved, both to isolated DNA and to purified natural products generally.’84 Moore J insisted: ‘Given the complicated technology and conflicting incentives at issue here, any change must come from Congress.’85
Bryson J dissented from ‘the court’s holding that Myriad’s BRCA gene claims and its claims to gene fragments are patent-eligible’.86 The judge held:
Although my colleagues believe our analysis of the legal question in this case should be influenced by purported expectations of the inventing community based on the PTO’s past practice of issuing patents on human genes, that is in effect to give the PTO lawmaking authority that Congress has not accorded it. There is no collective right of adverse possession to intellectual property and we should not create one. Our role is to interpret the law that Congress has written in accordance with the governing precedents.87
Citing the Prometheus case as instructive, the judge noted: ‘Just as a patent involving a law of nature must have an “inventive concept” that does “significantly more than simply describe … natural relations,” Mayo, a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product.’88
The Supreme Court of the United States
Dissatisfied with this ruling, the Public Patent Foundation and the American Civil Liberties Union are appealing, once more, to the Supreme Court of the United States.89 Daniel Ravicher, executive director of PUBPAT and co-counsel in the lawsuit, observed:
Our genes were given to us by our creator, and not inventions created by Myriad. The patenting of human genes, even in isolated form, has the effect of giving ownership over human genes to corporations, allowing them to decide who is allowed to know what they have inside their own body.90
Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project, commented: ‘In our view, the court of appeals did not fully consider or correctly apply the Supreme Court’s most recent and relevant patent law decisions.’91 The lawyer argued: ‘DNA occurs naturally in the human body and cannot be patented by a single company that can then use its patents to limit scientific research and the free exchange of ideas.’92
The Supreme Court of the United States granted the petition to hear the appeal on 30 November 2012 – although it limited the appeal to the first question presented by the petition.93 On 24 January 2013, the American Civil Liberties Union and the Public Patent Foundation filed the brief for the petitioners.94 The brief argued:
Human genes are, of course, products of nature. Genetic variants, including mutations, are also products of nature. How genes work and whether variants are harmful or not are laws of nature. Respondents Myriad Genetics et al. did not invent any genes or variants or cause their significance, but they did obtain patent claims on two naturally-occurring human genes known as BRCA1 and BRCA2 (so named because one of the diseases to which the genes are linked is breast cancer). The claims are not limited to any form, variation, or structure of the BRCA1 or BRCA2 genes, and they cover the BRCA genes of every person in the United States, even genes that Myriad has never seen.95
The brief urged the Supreme Court of the United States: ‘This Court should apply long-standing doctrine without regard to PTO deference and industry reliance and find the challenged claims unpatentable.’96
The Supreme Court of the United States ruling in the matter of Association for Molecular Pathology v Myriad Genetics Inc. promises to be a landmark decision in respect of patent law and biotechnology.
II. The Seed Wars
The late Professor Keith Aoki97 observed in his book Seed Wars: ‘Contemporary debate over the legal treatment of plant genetic resources has been described as the “Seed Wars”.’98 He noted that ‘the phrase “Seed Wars” as it is used here comes from a Wall Street Journal report that refers to the conflict implicating “access to, control over, and preservation of plant genetic resources”’.99
There have been a number of significant skirmishes, conflicts and flash-points in the ‘Seed Wars’. The Supreme Court of the United States considered whether plants were patentable subject matter in the case of JEM Ag Supply v. Pioneer Hibred International.100 In the matter of in re Fisher, the United States Court of Appeals for the Federal Circuit considered the application of the utility standards to patent applications in respect of express sequence tags for maize.101 The Supreme Court of the United States is also hearing an appeal in Bowman v. Monsanto on matters of patent exhaustion.102 There has been disquiet over Monsanto’s patent applications in relation to the enhancement of meat, including Omega-3 fatty acids.103 The Supreme Court of Canada considered questions of patentable subject matter, patent infringement, farmers’ rights and innocent bystanders, and remedies in the epic case of Monsanto v Schmeiser.104 The European Court of Justice in Monsanto v Cefetra considered complex questions in the export of genetically modified seed to Argentina.105 The High Court of Australia heard a constitutional challenge to the plant breeders’ rights regime in Grain Pool of Western Australia v. the Commonwealth, and lower Australian courts have considered conflicts over plant breeders’ rights and Franklin Barley.106 There have also been larger concerns about the relationship between intellectual property, climate change, agriculture and food security.107
The Public Patent Foundation has joined the ‘Seed Wars’. In March 2011, the Public Patent Foundation filed a lawsuit on behalf of 60 farmers, seeds businesses and organic agricultural organizations, challenging the validity of Monsanto’s patents in respect of genetically modified seeds.108 In the press release about the case, Daniel Ravicher discussed the significance of the litigation:
This case asks whether Monsanto has the right to sue organic farmers for patent infringement if Monsanto’s transgenic seed should land on their property. It seems quite perverse that an organic farmer contaminated by transgenic seed could be accused of patent infringement, but Monsanto has made such accusations before and is notorious for having sued hundreds of farmers for patent infringement, so we had to act to protect the interests of our clients.109
The Public Patent Foundation sought a declaration that, if organic farmers are ever contaminated by Monsanto’s genetically modified seed, they need not fear legal action for patent infringement.
Much like they did in the lawsuit against Myriad Genetics, the Public Patent Foundation relied upon testimonials from the plaintiffs affected by the patents in respect of genetically modified seed. Jim Gerritsen, a family farmer in Maine who raises organic seed, and President of lead plaintiff Organic Seed Growers and Trade Association, said: ‘Today is Independence Day for America’.110 He commented that ‘Americans have the right to choice in the marketplace – to decide what kind of food they will feed their families – and we are taking this action on their behalf to protect that right to choose.’111 Gerritsen stressed that: ‘Organic farmers have the right to raise our organic crops for our families and our customers on our farms without the threat of invasion by Monsanto’s genetic contamination and without harassment by a reckless polluter.’112 Rose Marie Burroughs of plaintiff California Cloverleaf Farms said, ‘We must protect the environment, farmers’ livelihood, public health and people’s right to non GMO food contamination.’113
The Public Patent Foundation Complaint
Sabrina Hassan, a legal attorney with the Public Patent Foundation, comments: ‘While the Myriad Genetics matter is about patenting the laws and products of nature, the Monsanto matter is about patenting products that destroy nature, biodiversity, and the environment’.114
In the complaint on behalf of the Organic Seed Growers and Trade Association, the Public Patent Foundation articulates the nature of the conflict in dramatic terms:
Society stands on the precipice of forever being bound to transgenic agriculture and transgenic food. Coexistence between transgenic seed and organic seed is impossible because transgenic seed contaminates and eventually overcomes organic seed. History has already shown this, as soon after transgenic seed for canola was introduced, organic canola became virtually extinct as a result of transgenic seed contamination. Organic corn, soybean, cotton, sugar beet and alfalfa now face the same fate, as transgenic seed has been released for each of those crops, too. And transgenic seed is being developed for many other crops, thus putting the future of all food, and indeed all agriculture, at stake.115
The complaint notes that the ‘Plaintiffs are largely organic farmers and organic seed businesses, but also include non-organic farmers who nonetheless wish to farm without transgenic seed.’116
The Public Patent Foundation stresses that ‘Monsanto is a chemical company that was previously responsible for introducing to the world Agent Orange, DDT, PCB’s and other toxins.’117 Monsanto is now the world’s leading proponent of transgenic seed and holds many patents relating thereto that it has aggressively asserted against literally hundreds of farmers, including those farmers who became contaminated by Monsanto’s transgenic seed through no fault of their own.’118
The Public Patent Foundation contends that Monsanto’s patents are invalid, because among other things, they fail to satisfy the constitutional requirement that inventions promote ‘the Progress of Science’ and the threshold patent demand of ‘utility’:
The principal one of which is that patents on transgenic seed fail to satisfy the requirement of both the Constitution and the Patent Act that only technology with a beneficial societal use may be patented. U. S. Const., Art. I, §8, cl. 8 (‘To promote the Progress of Science and useful Arts’) (emphasis added); 35 U.S.C. §101 (‘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’) (emphasis added). As Justice Story wrote in 1817, to be patentable, an invention must not be ‘injurious to the wellbeing, good policy, or sound morals of society,’ and ‘a new invention to poison people … is not a patentable invention’. Because transgenic seed, and in particular Monsanto’s transgenic seed, is ‘injurious to the wellbeing, good policy, or sound morals of society’ and threatens to ‘poison people,’ Monsanto’s transgenic seed patents are all invalid.119
This complaint has echoes of other case law. In the area of copyright law, there were constitutional challenges to the copyright term extension – some emphasizing that such a lengthening of term did not promote ‘the Progress of Science and the Useful Arts’.120 In the area of patent law, Monsanto faced a challenge in respect of the utility of its express sequence tags. The notion of utility and morality has been explored in contemporary times in the context of some of the test cases involving animal-human chimera.121
The Public Patent Foundation122 draws upon the 1817 authority of Justice Story in Lowell v. Lewis, in which the judge held that inventions that are ‘injurious to the well-being, good policy, or sound morals of society’ are unpatentable.123 The Foundation seizes upon his examples of unpatentable inventions, including ‘a new invention to poison people, or to promote debauchery, or to facilitate private assassination’.
Furthermore, the Public Patent Foundation contend that ‘Monsanto’s patents are additionally invalid for other failures to meet the requirements of patent law, including that each violates the prohibition against double patenting, each is anticipated or rendered obvious by prior art, and each fails to satisfy the requirements of written description, enablement and best mode.’124 The Foundation elaborates:
Monsanto began applying for patents on glyphosate tolerance in the mid 1980s. Its first patents on the trait were granted in 1990 and are now expired. After pursuing its earliest patents on glyphosate resistance, Monsanto continued to seek and receive patents on Roundup Ready technology for over two decades. Although the United States patent system allows improvements on existing inventions, it does not permit a party to extend its monopoly over a field of invention by receiving a patent that expires later than and is not patentably distinct from a patent it already owns. In acquiring the transgenic seed patents, Monsanto unjustly extended its period of patent exclusivity by duplicating its ownership of a field of invention already covered by other Monsanto patents. Monsanto’s transgenic seed patents are thus invalid for violating the prohibition against double patenting. Monsanto’s patents are invalid because prior art exists that anticipates or renders obvious each of their claims. Monsanto’s patents are invalid for failure to meet the written description, enablement and best mode requirements.125
The Foundation is contending that Monsanto has been engaging in the practice of ‘evergreening’ – seeking to obtain a longer period of protection that warranted under patent law through strategic means.
The Public Patent Foundation also argues that
Monsanto’s patents would also not be infringed by Plaintiffs because, amongst other things, Plaintiffs do not intend to use Monsanto’s transgenic seed, any seed possessed by Plaintiffs that may be contaminated by Monsanto’s transgenic seed is not covered by any valid and properly construed claim of any patent in suit, and Monsanto’s patents rights in transgenic seed exhaust upon the authorized distribution by Monsanto to its customers.126
The Foundation maintains that ‘Transgenic seed that may come to contaminate Plaintiffs cannot infringe any of Monsanto’s transgenic seed patents.’127 The Foundation argues that the ‘Plaintiffs cannot be held to have infringed any Monsanto transgenic seed patent if Plaintiffs become contaminated by Monsanto’s transgenic seed through no intentional act of their own.’128 The Foundation contends: ‘Because Monsanto sells, licenses and distributes its transgenic seed in a manner such that contamination of Plaintiffs is reasonably foreseeable, any patent rights Monsanto may have in transgenic seed are exhausted when it or its distributors make authorized sales to customers.’129 In this context, it will be interesting to see whether the United States courts take any notice of the Supreme Court of Canada ruling on Percy Schmeiser and patent infringement in respect of Monsanto’s patents on genetically modified canola.
Furthermore, the Public Patent Foundation submitted that ‘Monsanto’s patents are also unenforceable because, among other things, Monsanto has committed misuse, Monsanto is equitably estopped from enforcing them, and Monsanto commits trespass when its transgenic seed contaminates another.’130
The Public Patent Foundation also maintained that, in any case,
Monsanto would not be entitled to any remedy under law or equity even if its patents were held to be valid, infringed and enforceable against Plaintiffs, as no economic injury happens to Monsanto and the public interest would not support granting Monsanto an injunction when its patented seed contaminates another.131
The Farm and Ranch Freedom Alliance
There was an amicus curiae brief filed in support of organic farms by a collection of groups including the Farm and Ranch Freedom Alliance, Slow Food USA, Virginia Independent Consumers and Farmers Association, and others.132 The organizations included ‘members who feed grain to livestock and poultry, who certify organic production of crops, who use grains or cotton as raw ingredients for other products, and who consume or use products made from these crops’.133 A number of the ‘amici are in privity with the affected farmers, either by buying their crops or otherwise conducting business with them such as through organic certification of the crops’.134 In its statement of interests, the amici curiae emphasized that the case had larger implications for a wide range of farmers, food producers, and retailers:
While the Plaintiffs are at the most immediate risk of suit for patent infringement by Monsanto, the legal principles involved in this Court’s decision will have even broader ramifications. For example, livestock and poultry farmers who feed grain to their animals face issues of GM-contaminated feed. Organic certifiers must make decisions about whether or not, and under what conditions, to require testing for GM contamination as part of the certification process. Food processors, whether they operate on a large-scale or simply bake a few loaves of bread for a local farmers market, use ingredients that may be contaminated with Monsanto’s patented products. And, ultimately, almost every American consumer somehow makes use products made from corn, soybeans, canola, sugar beets, or cotton, all of which may implicate the scope and enforceability of Monsanto’s patents. The entire food chain is impacted by the spread of Monsanto’s patented crops.135
The amici curiae stressed that they had an ‘interest in having the scope and enforceability of Monsanto’s patents determined by this Court, both because of the direct issue of their own liability and because of the indirect impact the decision will have on the availability of these crops’.136 The amici curiae emphasized that the outcome of this case ‘will have repercussions for almost every American’.137