Morality: An Important Consideration at the Patent Office
Recent developments in biotechnology have opened new avenues not only for research but also for patenting. However, recent United States Supreme Court decisions such as Association for Molecular Pathology v. Myriad Genetics demonstrate the interpretive difficulties these new technologies raise in patent law. Many scholars, for example, have argued that rather than using the “product of nature” doctrine and focusing on the line between human and natural constructs, the Court in Myriad should have ruled based on the doctrine’s policy goal: protecting the basic tools of scientific and technological work. Not doing so has led to doctrinal confusion, decreased patent protection, and increased uncertainty in industry.
In addition, recent biotechnological developments also raise increased ethical concerns. These concerns should lead us to reconsider the relationship between patent law and ethics. After reviewing the history of intellectual property protection for biotechnology inventions, this Note considers the policy rationale of promoting “useful” inventions and proposes implementation of a new procedure for ethical review at the United States Patent and Trademark Office.
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Introduction
In June 2018, an international assembly of researchers published a study examining patents on marine genetic resources.
BASF’s interest in marine life is not surprising. Many of these animals have unique characteristics that make them commercially valuable. A New York Times exposé on the animals behind these patents highlighted that many are “extremophiles,” or organisms capable of surviving in harsh environments. One such animal, for instance, is the Alvinella pompejana, a type of deep sea worm that can thrive at extreme temperatures.
Blasiak’s publication demonstrates a recent example of the tension between public and private for-profit ideals in patenting. It resurrects concerns flagged at the turn of the century around the completion of the Human Genome Project—concerns that have a pre-history in discussions around the commodification of the animal bodies more generally.
The second approach was adopted by the US in 2013 with Association for Molecular Pathology v. Myriad Genetics (Myriad).
A third approach—and the topic of this Note—is for the patent office to consider the morality of inventions. Several patent systems, including the European system, already evaluate the morality of patent applications, and allow examiners or judges to reject patents on this basis.
Whether considering the morality of inventions at the United States Patent and Trademark Office (USPTO) makes sense depends on how one conceptualizes the purpose of the patent system. As the US Constitution states, the US patent system was created to “promote the Progress of Science and useful Arts.”
Patents fit into a larger intellectual property regime whose existence is often questioned. As one commentator writes, “Scholarly justification for the propertization of ideas has tended to resemble martyrdom—an act of faith.”
Most theoretical writing justifying intellectual property falls into one of four approaches: the utilitarian approach, the Lockean approach, personality theory, and social planning theory. The utilitarian approach is the dominant approach in the US.
Some utilitarian scholars argue that patents indeed “promote the progress of science and useful arts” by providing the foundation of the “market for inventions.”
Others argue, however, that the US patent system does not promote innovation and productivity.
Regardless of which side of the debate ultimately proves correct, the utilitarian aim of the patent system remains to encourage progress in the field in which a patent is granted. With the promise of patent protection, BASF, for example, invests billions of dollars into uncertain commercialization endeavors yearly.
Our patent system was “[d]esigned more than 100 years ago to meet the simpler needs of an industrial era, [and uses] an undifferentiated, one-size-fits-all approach.”
The judicially created “moral utility doctrine” served as a gatekeeper of patent subject matter eligibility, allowing the USPTO and the courts to deny patents on morally controversial subject matter under the premise that such inventions were not “useful.”
However, the tension that gave rise to the moral utility doctrine—that a system that rewards individuals can harm communities—is not dead. It was apparent in the first recorded reference to patents in Aristotle’s Politics
This Note explores the debate around when exclusion from patentability is the best social mechanism for addressing “morally offensive” technologies, including defining “morally offensive” technology to begin with. It will argue that, as with European and international patent law, the legislature should restrict subject matter eligibility by explicitly promulgating a process for challenging patents on moral grounds. This would avoid repeating the lower courts’ misuse of the moral utility doctrine by which judges base their decisions on subjective moral harms. After all, what constitutes an invention in the US is not clearly delineated, in large part due to the sparseness of legislative guidance on the matter.
This Note begins with a history of the moral utility doctrine. It then explores the rise of the biotechnology industry, its union with intellectual property, and the role of academia in that union. It continues with an analysis of how courts have approached biotechnology patenting in the US and Europe. It ends by considering why the morality of inventions should be addressed by the USPTO and with several proposals for implementing ethical review at the USPTO.
I. History of the Moral Utility Doctrine
“There is a common presumption that, until its encounter with biotechnology, patent law was hermetically sealed from external considerations.”
The first English patent law, the 1623 Statute of Monopolies, arguably includes moral standards. It expressed prohibitions on patents that were “contrary to law,” “mischievous to the state,” and “generally inconvenient.” Scholars have interpreted the last of these policy phrases in particular to have served as a “broad public benefit test.”
Justice Joseph Story is generally credited with introducing the moral utility doctrine in Lowell v. Lewis. He asserted: “all that the law requires is, that the invention should not be frivolous or injurious to the well-being, good policy, or sound morals of society.”
Justice Story’s formulation was later used by lower courts to invalidate two main types of patents:
In the second line of cases, courts applied the moral utility doctrine to deceptive devices. For example, in 1901 the Eight Circuit invalidated a patent for a medical device called the “Oxydonor” because the patent claim was “at best an imaginary hypothesis” put forth merely to obtain a patent.
Eventually, the Federal Circuit dealt a fatal blow to the moral utility doctrine in Juicy Whip, Inc. v. Orange Bang, Inc.
Juicy Whip is emblematic of the transition in US patent jurisprudence to a purely utilitarian approach. A more recent example is the Federal Circuit’s decision in In re Fisher.
Some commentators have blamed the moral utility doctrine’s demise on judicial misinterpretation of Justice Story’s articulation requirement.
Today, the USPTO’s Manual of Patent Examining Procedure does not mention morality or ethics anywhere in its section on utility. Instead, the manual cites Juicy Whip and expressly states, “A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy.”
II. The Rise of the Biotechnology Industry
To understand why US courts became interested in the patentability of biotechnology during the 1970s and 1980s, it is important to understand the role intellectual property played in biotechnology’s commercial exploitation. This section considers the origins of biotechnology, segues into addressing the union of biotechnology with intellectual property and the role academia played in that merger, and closes by presenting the Human Genome Project as an example that demonstrates the importance of this union.
A. Origins of Biotechnology
The early 20th century saw the union of Darwin’s theory of evolution with Mendelian genetics, and, soon after, the biological sciences’ union and reliance upon computer science.
While biotechnology generally brings to mind genetic engineering or editing, it can be conceived of broadly as any use of biological organisms or processes in industrial, medical, agricultural, and environmental engineering.
Molecular geneticists, however, credit a “little book” as having launched their discipline.
As demonstrated by Schrödinger, a quantum physicist, biotechnology is an interdisciplinary affair. His book presented the problem of life as a puzzle posed to no single discipline.
B. Union of Intellectual Property with Biotechnology
The 1960s and ’70s ushered biotechnology into the modern age.
The income from these patents surpassed $200 million for both Stanford and UCSF, and this initial success rapidly intensified research and commercial development of the new recombinant DNA technology.
Boyer and Rathman symbolize the creation of a new figure, what historian Steven Shapin calls the “entrepreneurial scientist.”
As part of the US government’s efforts to spur the research of American firms, Congress passed the 1980 Tax Reform Act, giving tax credits to corporations funding academic research and development.
C. Academia and Intellectual Property
Patents have not functioned uniformly across science and engineering disciplines. In fact, a boundary has existed between academic science and the commercial sphere.
The case of the oncomouse is an early example. Mouse geneticists studying cancer were among the first to recognize the potential of molecular biology.
The pair then licensed their research to DuPont, a chemicals giant that had made significant investment in the research.
At that time, academics widely assumed that they were not subject to the rules of the commercial economy.
Some scientists responded by operating in the shadows of the commercial credit cycle, while others ignored the law and boycotted the company by breeding their own oncomice.
The oncomouse patent paved the way for future patenting opportunities. Many scientists upset with DuPont for imposing a commercial economy on academics took advantage of the precedent set by the oncomouse patent and started patenting their own mice—albeit for non-commercial purposes.
With this new focus on application rather than research, patents formed an important tool based on exercising control over assets. This transition helped shift the balance in research away from cooperation and towards competition, as is seen in current disputes over such technologies as CRISPR.
D. The Human Genome Project: A Case Study
The controversy around public access to genomic information is an important case study. The Human Genome Project (HGP) originated in the US in 1988.
Great hope for scientific and social advances accompanied the accomplishment of mapping the human genome. President Bill Clinton hailed the human genome sequence, the “blueprint of life,” as able to guide humans into a peaceful and prosperous new millennium.
Yet, fears and questions of morality accompanied the research. As sociologist Jenny Reardon documents in her poignant book, The Postgenomic Condition, with the completion of the HGP in 2003, many people were asking, “now that we have the ‘human genome’ sequence, what does it mean?”
Many HGP participants have argued that “the story that the Human Genome Project sought to liberate the genome for all was an appealing and powerful one, but it ignored on-the-ground realties.”
It made it materially more difficult for minor contributors to the [H]uman Genome Project to meet the Bermuda rules. The Sanger Institute had a one-hundred-person IT [] staff, and it wasn’t really a problem for them to funnel their data right into GenBank. It was a serious problem for me, and I resented being told that I should divert other modest resources from what I thought was the best management of our endeavor.
The Bermuda Principle of openness also raised questions about how to achieve the quality of data needed to create genomic knowledge. Many scientists worried about the epistemic value of their research.
“This meeting of the private property regimes of technological innovation with the Mertonian norm of scientific openness created a formative tension that powerfully shaped genomics from its start.”
Whether these sequences could be patented, however, was another matter. This question will be further addressed below in light of the decision in Myriad,
The USPTO rejected the NIH applications, which sought patent protection for inventions associated with the identification of partial complementary DNA (cDNA)
As this analysis demonstrates, the general concern for the utility requirement lies with premature filing. Eisenberg and Merges observed that “[s]cientists quoted in the popular and scientific press repeatedly expressed an intuition that NIH was claiming too much in light of the very preliminary information that they had disclosed.”
This analysis demonstrates the concern with the utility requirement at the turn of the 20th century, but, as will be discussed below, the Court later broadened the ability to challenge patents on sequences of DNA in Myriad.
III. Biotechnology and the Courts
More than many other fields, biology has special salience in patent law.
A. The US Approach
The application of patent law to biology “appears to have given rise to more doctrinal exceptions, statutory carve-outs, and sui generis laws in the US than its sister fields.”
The doctrine’s prohibition on patenting “products of nature” appears directed mainly toward biological inventions. But for a long time, courts recognized a broad exception for “isolated” or “purified” natural products, an exception stemming from one of the foundational cases in the gene patenting debate, Parke-Davis & Co. v. H. K. Mulford Co.
At the turn of the 20th century, researchers observed that extracts from the adrenal gland possessed pharmaceutical properties.
Surprisingly, Judge Learned Hand upheld the patent, finding that the adrenaline claimed in the patent was isolated and purified from its natural surroundings and, thus, it was not a product of nature.
The Supreme Court decided the next watershed case Diamond v. Chakrabarty in 1980. In 1972, Ananda Chakrabarty at General Electric applied for a patent on Pseudomonas putida, a bacterium that he had transformed to digest hydrocarbon.
The USPTO reiterated Chakrabarty’s conclusion that animals were patentable subject matter seven years later in a policy statement.
Although it is rare for USPTO decisions to draw scrutiny, Allen entered the mainstream to great furor. United States Senator Mark Hatfield even proposed a moratorium on animal patents and various stakeholders, including farmers and animal rights groups, sued the Patent Office for its policy decision.
A year after the USPTO’s policy announcement, it issued the oncomouse patent which raised the stakes even higher, and took on international prominence as the world’s first patent for a “higher form of life.”
And what about patents on humans? In 1987, the USPTO clarified the subject matter doctrine with a moral caveat, explaining, “[A] claim directed to or including within its scope a human being will not be considered to be patentable subject matter.”
Activist Jeremy Rifkin led the march to address the moral quandary around patenting human material. Rifkin had been a vocal opponent of genetic engineering, authoring several amicus briefs on previously mentioned cases through his organization, the New American Movement (later called Peoples Business Commission and Foundation on Economic Trends).
The most recent Supreme Court case in the field was decided in 2013, Association for Molecular Pathology v. Myriad Genetics. In 1990, Mary-Claire King, a researcher at the University of California, Berkeley, discovered that a single gene, BRCA1, was responsible for a large number of early-onset breast cancers.
Unlike King and Stratton, Skolnick was particularly aggressive about seeking patent protection for his discoveries, which were licensed to Myriad Genetics, a Utah-based diagnostics company that Skolnick and a colleague had founded in 1991.
The Supreme Court tackled the issue head-on: “Are human genes patentable?”
Many applauded the Court for its decision, which goes to the heart of patent law: balancing incentive with access. The Court wrote, “Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes.”
The Court’s distinction between genomic DNA that was extracted from human cells and cDNA that was synthesized in the laboratory is incoherent. As Dan L. Burk observes, “We should begin by recognizing the simple and obvious proposition that genes don’t exist in nature. . . . Dividing those networks into conceptual bits such as genes is a practice that is useful to humans, but not one that is somehow mandated by the structure of the universe.”
These misconceptions allow not only for clever claim drafting workarounds but also for unclear doctrine. Because of the lack of clear guidance regarding how to apply the Supreme Court’s ruling,
Other scholars have noted that the Myriad decision may have been unnecessary given that the empirical evidence that gene patents were tying up basic tools of scientific research and inhibiting innovation was arguable, at best.
In conclusion, the US has dealt with biotechnology patents through evolving caselaw.
B. The European Approach
Although Europe is often painted as having stricter patentability standards than the US, as a consequence of the Myriad decision, this is no longer the case, at least when it comes to gene-related technologies.
Unlike the US, Europe has dealt with policy issues relating to biotechnology at the legislative level. Much of Europe’s substantive law on patentability comes from the Strasbourg Convention of 1963, which was the first serious attempt to harmonize the patent laws of the various European countries.
After attempting to harmonize the treatment of biotechnology in the 1980s, the EU passed the Biotech Directive in 1998. The original attempt in 1988 emphasized the economic importance of biotech and the concern that differences between European countries could serve as a barrier to the growth of the European biotech industry.
Together, the Biotech Directive and the EPC regulate whether and how inventions can be patented. An EU directive such as the Biotech Directive does not itself have direct legal effect as far as its provisions are concerned. Rather, a directive serves as an instruction to member states of the EU to adapt their law by appropriate legislative means to achieve the results specified in the directive.
Unlike the US patent statute, the EPC does not attempt to define what constitutes patentable subject matter. Instead, it clarifies for member states what are not to be regarded as inventions. Article 52 of the EPC defines patentable inventions in a negative sense:
- European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.
- The following in particular shall not be regarded as inventions within the meaning of paragraph (1):
- discoveries, scientific theories and mathematical methods;
- aesthetic creations;
- schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;
- presentations of information.
- Paragraph (2) shall exclude the patentability of the subject-matter or activities referred to therein only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such.
Regarding the life sciences, the most relevant exclusion is new discoveries. Finding a new property of a product is considered to be a mere discovery, but if that property can be put to use in some way, then it is considered to be an invention.
One of the purposes of the Directive was to introduce greater certainty into the “ordre public” or morality
- inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
- plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;
- methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.
The EPC Implementing Regulations clarify that the ordre public/morality clause excludes from patentability “processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.”
The previously discussed oncomouse case clarifies this clause and is useful for contrasting with the US approach. In the US, the court approached the oncomouse patent by addressing its effect on upstream research. By contrast, following opposition, the EPO Board also considered the morality of the patent. In doing so, it decided to allow claims to transgenic mice but not to rodents generally, arguing that the need of humankind to treat disease had to be balanced with avoiding suffering to animals and protecting against uncontrolled dissemination of unwanted genes.
As will be argued below, that Europe has included ethical concerns legislatively is a better approach than the US’s wavering judicial approach.
IV. Why Morality Should be Addressed by the USPTO
Scholars have noted an inherent tension between patent legislation and public interest concerns, such as the protection of human health and dignity, as well as the environment. As a matter of fact, the patent system aims to encourage research and development activities by offering inventors monopolistic rights. But who should be tasked with assessing the morality of those inventions? Should questions of morality be addressed at the patent office? While there is not uniform agreement on the answer to this question, this Note argues that patent offices should be entrusted with the task. But first, we look at arguments against that approach.
A. Why Commentators Disagree
Many commentators argue that patent law is morally neutral and that the grant of a patent is a non-ethical event. The patent system, they argue, does not represent a positive right to work and commercially exploit the invention, but merely provides a legal means by which the patent holder can prohibit another from using the invention. The argument that the patent is “only a negative right” is extended to imply that any restriction upon exploitation of the invention should be dealt with by other regulatory bodies and not through the cumbersome and indirect means of patents laws.
Professor Robert Merges, for example, takes a historical approach to argue that moral worth is a difficult test of patentability.
Analyzing the success of the moral utility doctrine and the EU’s morality clause lend credence to Merges’s argument that determining the morality of an invention is difficult. Just as the moral utility doctrine saw inconsistent application, some scholars argue that the EPO applies inconsistent legal tests for determining whether an invention is contrary to ordre public or morality.
Merges also argues that potential social consequences should be dealt with by other bodies. For example, he cites the creation of the Food and Drug Administration (FDA) as a regulatory body.
Arguing that the provision is superfluous, those in favor of broad patent protection for biotech inventions made a similar argument when debating the EU’s Article 6 morality provision. The grant of a patent does not authorize the patent holder to implement her invention, they argued, it only prohibits third parties from exploiting it.
Thomas Magnani is another opponent to regulating biotechnology at the patent office.
B. Why Commentators Agree
In opposition to the scholars referenced above, others have argued that patent law should not be considered isolated, “untouchable,” and neutral to moral and ordre public issues. The patent system, they argue, is naturally subject to such overriding principles.
Enrico Bonadio, for example, argues that “patent law is not neutral but is subject to moral principles.”
Bonadio’s arguments echo those of Justice Story regarding the moral utility doctrine in Lowell v. Lewis. While the market decides how “useful” an invention is, the patent system should decide which inventions to incentivize.
Bonadio also responds to Magnani’s argument that eliminating patent protection for controversial technologies might actually result in more people practicing the controversial technology.
Professor Sivaramjani Thambisetty responds to Merges by arguing that regulatory bodies are not undermined by patent decisions taking into consideration morality.
As deconstructed above, the European Union has taken this approach by excluding from patentability on morality grounds through Articles 53(a) of the EPC—“inventions the commercial exploitation of which would be contrary to ‘ordre public’ or morality” are not patentable—and 6(a) of the EU Biotech Directive—“inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality.”
Sigrid Sterckx and Julian Cockbain demonstrate the EPO’s decisions’ evolution regarding its approach to “morality” from a procedural approach to morality to a consequentialist approach to a deontological approach.
Bonadio further demonstrates how these decisions can make a real impact. In Oliver Brüstle v. Greenpeace eV, the CJEU interpreted Article 6(2)(c) of the EU Biotech Directive’s prohibition of patents on “uses of human embryos for industrial or commercial purposes[.]”
C. Considering Morals at the Patent Office
The European approach demonstrates that considering morals at the patent office is not only workable but also desirable. Through such an integrated process, the patent office has the power to grant a stamp of approval and to incentivize invention. A morality provision similar to that in Europe would help create a systematic approach currently lacking in the US and avoid the problems of the moral utility doctrine that saw disorganized application. The European approach, however, only illustrates a first step. As scholars have demonstrated, its approach to applying a morality clause is still maturing.
V. Proposal
Since the early 1990s, the USPTO has maneuvered to occupy a more central position in making patent law and policy.
So why should technically trained patent examiners who have no expertise in social values make ethical judgments? As argued above, the USPTO, as “first port of call” is the most logical place for these judgments to be made.
A. Two Approaches for Ethical Review
Among the different approaches Congress and the USPTO could take to begin implementing an ethical review of patent applications, two are immediately clear. The first is that, Congress does not, in fact, need to act. The USPTO could assert that it has plenary rule making power and that section 101 of the Patent Act includes an ethical dimension. Because of “Chevron Deference,” courts could defer to this USPTO action.
For the second approach, Congress could amend the Patent Act to include language similar to Article 53(a) of the EPC—“inventions the commercial exploitation of which would be contrary to ‘ordre public’ or morality” are not patentable—and Article 6(a) of the EU Biotech Directive— “inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality.” Congress has, in fact, already begun this process by including in the AIA a provision that expressly excludes patents on specific subject matter categories, namely tax strategies and human organisms.
Under either of these approaches, the USPTO could incorporate ethics committees similar to those provided for under the European Commission’s European Group on Ethics in Science and New Technologies. Just as patent examiners are assigned to a particular technology, each technology group would include its own ethics committee. This group could offer expert guidance in a particular field, updating its guidance as inventors propose new inventions. Through the guidance of the ethics committees, patent examiners and PTAB judges would be capable of assessing the merits of these claims. As with current successful prosecution (i.e., issuance of the patent), these inventions would be entitled to a statutory presumption of ethical validity.
Along with including ethics review at the examination stage, another viable approach as an initial step for implementation is to allow morality challenges during post-grant review (PGR), a post-grant proceeding enacted by the AIA. Considered “the first window” for challenging patent validity, PGR may be sought within the first nine months after a patent is issued by any person who is not the patent owner.
B. Issues with Implementation
At a general level, some may argue that it is risky and counterproductive to place ethical decision-making powers in the hands of patent examiners, PTAB judges, and federal judges. Some may argue that these individuals, while admittedly knowledgeable about the technical and administrative aspects of the patent process, are ill-suited for making ethical decisions. Admittedly, this would represent a significant change to the existing system. Finding the right balance between ethical standard and guidance provided by Congress and USPTO independence will undoubtedly require a lengthy process of stakeholder vetting. Fortunately, the EU system provides a rough but well-documented roadmap. In addition, this proposal is similar to the one that already exists in hospitals, whereby bioethicists help close the gap between high-level theory and application to the real-world challenges health professionals face in providing patient care. For example, bioethics consults occur in hospitals when a treating physician and patient or a patient and the patient’s family disagree on the goals of care or course of treatment.
In addition, given that this will be a new avenue for rejecting and challenging issued patents, a variety of other considerations, such as standing requirements will also have to be considered to minimize unintended consequences, including potential abuse of this new process.
The US patent system was created to “promote the progress of science and useful arts.” However, with technological innovation accelerating at an unprecedented pace and unclear guidance regarding patentable subject matter—in particular for biotech inventions—it is time to broaden the range of the USPTO to also factor in moral considerations when making determinations on patent applications. It is clear that recent US Supreme Court and Congressional statutes lean in this direction. The scale of patenting in areas like marine biodiversity also suggest the need to spark a more nuanced and global conversation around the ramifications of gene patenting.
DOI: https://doi.org/10.15779/Z38222R644.
Copyright © 2020 Julien Crockett, J.D. Candidate, University of California, Berkeley, School of Law, 2020. The author thanks Professor Robert Merges for his encouragement and guidance.
- Robert Blasiak et al., Corporate Control and Global Governance of Marine Genetic Resources, 4 Sci. Advances 1 (2018). ↑
- Id. at 2. ↑
- *Heather Murphy, What 13,000 Patents Involving the DNA of Sea Life Tell Us About the Future*, N.Y. Times (Sept. 17, 2018), https://www.nytimes.com/2018/09/17/science/patents-marine-dna.html [https://perma.cc/6JB9-8U99]. ↑
- See Ryan P. Smith, Nearly Half the Patents on Marine Genes Belong to Just One Company, Smithsonian.com (June 13, 2018), https://www.smithsonianmag.com/science-nature/nearly-half-all-patents-marine-genes-belong-just-one-company-180969325 [https://perma.cc/P22V-ZTMQ] (“And it seems the company is using these marine patents in order to open up avenues of research—potentially lucrative ones. For example, Blasiak notes that BASF has been harnessing the genes of some tiny aquatic lifeforms in an effort to produce designer health foods: ‘They’ve been splicing genes from different microorganisms into grapeseed and canola, then taking the seeds and seeing if they can produce oils that contain omega-3 fatty acids,’ he says.”). ↑
- While naturally-occurring genetic sequences are patent-eligible in the European Union, following Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), which is discussed below, they are not patent eligible in the United States. While this may appear to simplify eligibility concerns in the US, it has, in fact, sown judicial uncertainty. See Paul Cole, Patentability of Genes: A European Union Perspective, Cold Spring Harbor Persp. Med. 2–5 (2015). ↑
- See Timothy Caulfield et al., Patenting Human Genetic Material: Refocusing the Debate, Nat. Rev. Genet. 227–31 (2000) (identifying both moral concerns such as gene patents infringing human dignity or leading to the commoditization of the human experience, and practical concerns such as patents deterring innovation). ↑
- For example, US patent requirements—namely regarding subject matter, utility, novelty, non-obviousness, and disclosure—see 35 U.S.C. §§ 101, 102, 103, 112 (2012). ↑
- G.A. Res. 72/429 (Jan. 19, 2018) (deciding to convene the first intergovernmental conference to write an international legally binding instrument on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction in September 2018). ↑
- The Nagoya Protocol already protects countries from exploitative bioprospecting. See About the Nagoya Protocol, Convention on Biological Diversity, https://www.cbd.int/abs/about [https://perma.cc/6DJF-3K9S]; see also, Eli Kintisch, U.N. Talks to Tackle Tough Question: Who Should Benefit from DNA Collected from the High Seas?, Science (Sept. 3, 2018) (“Under another U.N. pact, the 2010 Nagoya Protocol, 105 countries have agreed to rules to prevent so-called biopiracy: the removal of biological resources—such as plant or animal DNA—from a nation’s habitats without proper permission or compensation. Those rules don’t apply in international waters, which begin 200 nautical miles from shore and are attracting growing interest from researchers and companies searching for valuable genes.”). ↑
- About the Nagoya Protocol, supra note 9. ↑
- Kintisch, supra 9. ↑
- 569 U.S. 576 (2013). ↑
- Id. at 580. ↑
- See Glob. Innovation Policy Ctr., Create: U.S. Chamber International IP Index 35 (6th ed. 2018), http://www.theglobalipcenter.com/wp-content/uploads/2018/02/GIPC_IP_Index_2018.pdf [https://perma.cc/F4F3-FEQT] (“[T]he patentability of basic biotech inventions was compromised by the Supreme Court decisions in the 2013 Molecular Pathology v. Myriad Genetics and 2012 Prometheus Laboratories, Inc v. Mayo Collaborative Services cases. . . . In 2017, interpretation of the recent Supreme Court decisions in Myriad, Mayo, and Alice Corp vs. CLS Bank International by lower courts and guidance from the USPTO remained inconsistent and difficult to apply.”); see also Gregory D. Graff et al., Not Quite a Myriad of Gene Patents, Nature Biotechnology 31, 404-10 (2013) (arguing that gene patents were declining before the decision); Michele Wales & Eddie Cartier, The Impact of Myriad on the Future Development and Commercialization of DNA-Based Therapies and Diagnostics, Cold Spring Harbor Persp. Med. (2015) (arguing that given the Human Genome Project’s publishing the human genome and the 20-year patent term, “it was not necessary to make dramatic and sweeping changes in rights” to solve a problem that was close to being a “nonissue”). ↑
- See Press Release, Sen. Thom Tillis, Sens. Tillis and Coons and Reps. Collins, Johnson, and Stivers Release Draft Bill Text to Reform Section 101 of the Patent Act (May 22, 2019), https://www.tillis.senate.gov/2019/5/sens-tillis-and-coons-and-reps-collins-johnson-and-stivers-release-draft-bill-text-to-reform-section-101-of-the-patent-act [https://perma.cc/KG55-PVWH]. ↑
- Unlike in the US, the patent laws of the European Union and many European countries contain specific provisions that exclude immoral inventions from patentability. See Enrico Bonadio, Patents and Morality in Europe, in Diversity in Intellectual Property 149 (Irene Calboli & Srividhya Ragavan, eds., 2015). Further, Article 27.2 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement permits member states to exclude inventions from patentability in the name of “morality.” Agreement on Trade-Related Aspects of Intellectual Property Rights, pt. II, art. 27, Jan 1, 1995 [hereinafter TRIPS Agreement] in Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Apr. 15, 1994, 1867 U.N.T.S. 154. As will be discussed, European patent law allows for the patenting of genetic sequences with important caveats. See Jessica C. Lai, Myriad Genetics and the BRCA Patents in Europe: The Implications of the U.S. Supreme Court Decision, 5 UC Irvine L. Rev. 1041, 1044–57 (2015) (explaining the restrictions on the patentability of genetic sequences laid out in the Biotech Directive and the European Patent Convention). ↑
- U.S. Const. art. 1 § 8, cl. 8. ↑
- 35 U.S.C. § 154 (a)(1) (2012). ↑
- Ikechi MgBeoji, Book Review: Justifying Intellectual Property, by Robert P. Merges, 50 Osgoode Hall L. J. 291, 292 (2012) (book review). ↑
- See generally, Giulio Mandich, Venetian Patents (1450–1550), 30 J. Pat. Off. Soc’y 166 (1948) (examining protections accorded to inventors under Venetian law). Patents have been increasingly relevant, from helping launch life science and software companies in the late 20th century to being at the center of the current US-China trade war. See e.g., Nat’l Bureau of Asian Research, Update to the IP Commission Report: The Theft of American Intellectual Property (2017); Charlene L. Fu & Curtis S. Chin, China is Stealing American Intellectual Property. Trump’s Tariffs are a Chance to Stop It, L.A. Times (Sept. 17, 2018), https://www.latimes.com/opinion/op-ed/la-oe-fu-chin-the-upside-of-trumps-china-trade-war-20180917-story.html [perma.cc/933Y-L4TR]. ↑
- Blasiak, supra note 1, at 3. ↑
- U.S. Pat. & Trademark Off., U.S. Patent Statistics Chart Calendar Years 1963–2015 (2016), https://www.uspto.gov/web/offices/ac/ido/oeip/taf/us_stat.htm [perma.cc/25DX-8K3N] (demonstrating that the number of patents issued doubled from 157,772 in 2008 to 320,003 in 2017); 2017 Patent Trends and Insights, IFI Claims Pat. Servs., https://www.ificlaims.com/rankings-trends-2017.htm [perma.cc/EUE4-DF5X]. ↑
- William Fisher, Theories of Intellectual Property, in New Essays in the Legal and Politic Theory of Property 168, 173–74 (Stephen Munzer ed., 2001). ↑
- See id. at 176–83. ↑
- Daniel F. Spulber, How Patents Provide the Foundation of the Market for Inventions, 11 J. Competition L. & Econ. 271, 272 (2015). ↑
- Id. ↑
- Id. ↑
- See, e.g., Michele Boldrin & David K. Levine, The Case Against Patents, 27 J. Econ. Persp. 3, 18 (2013) (arguing that there is no empirical evidence that patents serve to increase innovation and productivity); Jeffrey Funk, Beyond Patents, 34 Issues Sci. & Tech. 48 (2018) (arguing that patent analysis is a smoke screen that prevents us from measuring innovation). ↑
- See, e.g., Berger v. New York, 388 U.S. 41, 49 (1967) (“The law, though jealous of individual privacy, has not kept pace with these advances in scientific knowledge.”); Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996) (“[T]he courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.”); J. Benjamin Hurlbut, Experiments in Democracy: Human Embryo Research and the politics of Bioethics 141–46 (2017) (“The law lag narrative is common in American discourse about science and technology.”). ↑
- Boldrin & Levine, supra note 2828, at 4. ↑
- Pub. L. No. 112-29, 125 Stat. 284 (2011) (codified as amended at 35 U.S.C. §§ 1–375 (2012)). ↑
- See 157 Cong. Rec. S1361, S1380 (daily ed. Mar. 8, 2011) (statement of Sen. Leahy). ↑
- See Russell Slifer, Five Years After the AIA Created the PTAB, IPWatchdog, http://www.ipwatchdog.com/2017/09/16/five-years-after-the-aia-created-the-ptab/id=87994 [https://perma.cc/RW55-6QZD] (arguing that post-grant proceedings have substituted defendant abuse in district court litigation with patent owner abuse in the Patent Trial and Appeal Board); see also Restoring America’s Leadership in Innovation Act of 2018, H.R. 6264, 115th Cong. (2018) (proposing to abolish the PTAB and eliminate both IPRs and PGRs because they “have harmed the progress of science and the useful arts by subjecting inventors to serial challenges to patents”). ↑
- Slifer, supra note 33. ↑
- Blasiak, supra note 1, at 3 (“Its annual corporate and financial reports underscore a strategic focus on patents and innovation, which suggests continuity and long-term planning, with 2006 research and development investments already being tied to expectations of two- to fourfold returns in annual sales starting in 2015. Since 2004, BASF has continuously expanded its investments in research and development, reaching a new record of € 1.9 billion in 2017.”). ↑
- In the United States Chamber of Commerce’s International IP Index for 2018, the US patent system, which was the top-rated country as recently as 2016 for patent protection, ranked behind eleven other national systems. Global Innovation Policy Ctr., supra note 14, at 35. The Index attributed the ratings decline to the ease of challenging patents through post-grant proceedings at the Patent Trial and Appeal Board (PTAB), Supreme Court decisions on patent eligibility, and interpretations of those cases and guidance from the United States Patent and Trademark Office (USPTO). Id. at 157. The USPTO released revised guidance for subject matter eligibility in January 2019, which has been favorably received by commentators. See Gene Quinn, Revised Patent Eligibility Guidance Effectively Defines What is an Abstract Idea, IPWatchdog, (Jan. 4, 2019), https://www.ipwatchdog.com/2019/01/04/patent-eligibility-guidance-abstract-idea/id=104754 [perma.cc/BV8G-Q5L8]; Press Release, U.S. Pat. & Trademark Off., U.S. Patent and Trademark Office Announces Revised Guidance for Determining Subject Matter Eligibility (Jan. 4, 2019), https://www.uspto.gov/about-us/news-updates/us-patent-and-trademark-office-announces-revised-guidance-determining-subject [perma.cc/8SZJ-LSPD]. ↑
- Global Innovation Policy Ctr., supra note 14, at 8. ↑
- Dan L. Burk & Mark A. Lemley, Is Patent Law Technology-Specific?, 17 Berkeley Tech. L.J. 1155, 1156 (2002). ↑
- Sivaramjani Thambisetty, The Learning Needs of the Patent System: Implications from Institutionalism for Emerging Technologies Like Synthetic Biology 4 (London Sch. Econ. Law, Working Paper No. 18, 2018) (“Dominant critiques based on normative or foundational views of how patent protection does or does not serve public interest are unable to conclusively justify or determine patentability standards going forward.”). Another such variance in patent standards is attributable to the use of a legal construct known as the “person having ordinary skill in the art,” to determine obviousness and enablement. Burk & Lemley, supra note 38, at 1156. ↑
- Margo A. Bagley, Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law, 45 Wm. & Mary L. Rev. 469, 476 (2003). ↑
- See, e.g., Laura A. Keay, Morality’s Move Within U.S. Patent Law: From Moral Utility to Subject Matter, 40 AIPLA Q. J. 409, 410 (2012). ↑
- Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). ↑
- Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1366–67 (Fed. Cir. 1999), aff’d, 292 F.3d 728 (Fed. Cir. 2002). ↑
- Robert Patrick Merges & John Fitzgerald Duffy, Patent Law and Policy: Cases and Materials 3–4 (7th ed. 2017) (describing Aristotle’s concerns with Hippodamus’s proposal for a system that rewards those who discover things useful to the state). ↑
- See Leahy-Smith America Invents Act, Pub. L. 112-29 §§ 14, 33, 125 Stat. 284 (2011) (codified as amended at 35 U.S.C. §§ 101–02 (2012)). Congress has also withdrawn patent protection from inventions relating to atomic weapons. See 42 U.S.C. § 2181(a) (2012) (“No patent shall hereafter be granted for any invention or discovery which is useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon.”). ↑
- Patent FAQs, U.S. Pat. & Trademark Off., https://www.uspto.gov/help/patent-help#1902 [perma.cc/HT2D-RYYK]. ↑
- See Keay, supra note 41, at 411. ↑
- Utility is only one of many requirements for obtaining a patent, and thus only one of many avenues for challenging a patent. There are other substantive requirements—subject matter eligibility, novelty, and non-obviousness—and procedural requirements. ↑
- Jessica C. Lai, Myriad Genetics and the BRCA Patents in Europe: The Implications of the U.S. Supreme Court Decision, 5 UC Irvine L. Rev. 1041, 1074 (2015). ↑
- Blasiak, supra note 1, at 5. ↑
- Sivaramjani Thambisetty, Understanding Morality as a Ground for Exclusion from Patentability under European Law, 12 Eubios J. Asian & Int’l Bioethics 48, 48 (2002). ↑
- See Chris Dent, “Generally Inconvenient”: The 1624 Statute of Monopolies as Political Compromise, 33 Melb. U. L. Rev. 415, 444-45 (2009); Peter Drahos, Biotechnology Patents, Markets and Morality, 21 Eur. Intell. Prop. Rev. 441, 441 (1999). ↑
- U.S. Const. art. I, § 8, cl. 8. ↑
- Graham v. John Deere Co., 383 U.S. 1, 5-6 (1966). ↑
- Id. at 5-6. ↑
- Lowell v. Lewis, 15 F. Cas. 1018, 1019 (C.C.D. Mass. 1817) (No. 8,568) (Story, J.); see Peter Menell et al., Intellectual Property in the New Technological Age: 2018: Volume 1: Perspectives, Trade Secrets and Patents 243-44 (2018). ↑
- Lowell, 15 F. Cas. at 1019. ↑
- Bedford v. Hunt, 3 F. Cas. 37, 37 (C.C.D. Mass. 1817) (No. 1,216) (Story, J.). ↑
- Other types of patents excluded based on morality included artificially spotted tobacco leaves, Rickard v. Du Bon, 103 F. 868 (2d Cir. 1900), and faux-seamed women’s hosiery, Scott & Williams, Inc. v. Aristo Hosiery Co., 7 F.2d 1003 (2d Cir. 1925). ↑
- Keay, supra note 41, at 412 (internal citations omitted). ↑
- Nat’l Automatic Device Co. v. Lloyd, 40 F. 89, 90 (C.C.N.D. Ill. 1889). ↑
- Id. ↑
- Reliance Novelty Co. v. Dworzek, 80 F. 902, 904 (C.C.N.D. Cal. 1897). ↑
- Schultze v. Holtz, 82 F. 448, 449 (C.C.N.D. Cal. 1897). ↑
- Brewer v. Lichtenstein, 278 F. 512, 514 (7th Cir. 1922). ↑
- This is not to say that all inventions used at gambling establishments were held unpatentable. For example, in Chicago Patent Corp. v. Genco, the defendant argued that a pinball machine was inherently a “gambling machine without utility and, therefore, beyond protection by the patent laws.” 124 F.2d 725, 727 (7th Cir. 1941). But by measuring the ratio of skill to luck, the Seventh Circuit upheld a patent for the pinball machine because the skill in “operating the device [was] not wholly absent.” Id. at 728. ↑
- Mahler v. Animarium Co., 111 F. 530, 536-37 (8th Cir. 1901). ↑
- Id. at 534. ↑
- Id. at 535–36. ↑
- 185 F.3d 1364 (Fed. Cir. 1999). ↑
- Id. at 1365. ↑
- Id. at 1365–66. ↑
- Id. at 1366. ↑
- Id. at 1367. ↑
- Id. at 1368. ↑
- Id. ↑
- 421 F.3d 1365 (Fed. Cir. 2005). ↑
- Expressed sequence tags are short subsequences of complementary DNA (cDNA), or synthetically created DNA often used for expressing a protein in a cell that doesn’t normally express that protein. ↑
- In re Fisher, 421 F.3d at 1369. ↑
- 383 U.S. 519, 532–33 (1966) (upholding the patent office’s determination that an allegedly novel chemical process failed to meet the utility requirement). ↑
- In re Fisher, 421 F.3d at 1371. ↑
- See, e.g., Nathan Machin, Prospective Utility: A New Interpretation of the Utility Requirement of Section 101 of the Patent Act, 87 Calif. L. Rev. 421, 436, 448 (1999). ↑
- “If [the invention] be not extensively useful, it will silently sink into contempt and disregard.” Lowell v. Lewis, 15 F. Cas. 1018, 1019 (C.C.N.D. Mass. 1817) (No. 8,568). ↑
- Brennar, 383 U.S. at 534. ↑
- U.S. Pat. & Trademark Off., Manual of Patent Examining Procedure, 706 Rejection of Claims [R-07.2015], https://www.uspto.gov/web/offices/pac/mpep/s706.html [perma.cc/QGW8-HUVY] (emphasis in original) (citing Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1367–68 (Fed. Cir. 1999)). ↑
- Patent FAQs, supra note 46; see Benjamin D. Enerson, Protecting Society from Patently Offensive Inventions: The Risk of Reviving the Moral Utility Doctrine, 89 Cornell L. Rev. 685 (2004) (arguing that the USPTO’s history for denying patents appears to be devoid of ethical considerations). ↑
- John C. Avise, The Best and the Worst of Times for Evolutionary Biology, 53 BioScience 247, 247–49 (2003). ↑
- Jennifer Doudna & Siddhartha Mukherjee, In Conversation on The Future of Humans: Gene Editing and the Unthinkable Power to Control, at the Innovative Genomics Institute, University of California, Berkeley (Jan. 18, 2018) (video available at https://www.youtube.com/watch?v=4fjwj92UNn4 [perma.cc/BC7S-LDZM]). ↑
- Biotechnology, Nature, https://www.nature.com/subjects/biotechnology [perma.cc/GWR7-GZV8]. ↑
- Id. at 321–23 (discussing Gregor Mendel’s experiments with pea plants, the basis of his “Laws of Inheritance,” and Charles Darwin’s Theory of Evolution in relation to biotechnology). ↑
- Letter from Charles Darwin to Asa Gray (July 20, 1857), http://www.darwinproject.ac.uk/letter/?docId=letters/DCP-LETT-2125.xml;query=all%20my%20notion%20about%20how%20species%20change%20are%20derived%20from%20long%20continued;brand=default [perma.cc/U62J-RYXA]. ↑
- Ashish Swarup Verma et al., Biotechnology in the Realm of History, 3 J. Pharm. & BioAllied Sci. 321, 321–23 (2011) (Wilhelm Johannsen, for example, coined the term “gene” and T.H. Morgan demonstrated the role of chromosomes in inheritance). ↑
- Jessica Riskin, The Restless Clock 369 (2016). ↑
- Erwin Shrödinger, What is Life? The Physical Aspect of the Living Cell (1944). ↑
- Id. ↑
- Sheila Jasanoff, Can Science Make Sense of Life? 2 (2019) (“But the moral implications of Schrödinger’s essay lay elsewhere, in his conviction that the complex and abundant phenomenon we know as life could and would yield to material analysis at molecular levels.”). ↑
- Watson and Crick relied on x-ray crystallography work by English researchers Rosalind Franklin and Maurice Wilkins. See Leslie Pray, Discovery of DNA Structure and Function: Watson and Crick, 1 Nature Educ. 100 (2008). ↑
- What is Life? The Lectures of Physicist Erwin Schrodinger Helped to Change Attitudes in Biology, 561 Nature (Sept. 3, 2018), https://www.nature.com/articles/d41586-018-06166-x [perma.cc/2PN2-DKVL]. ↑
- Id. ↑
- See Jacob Sherkow & Henry Greely, The History of Patenting Genetic Material, 49 Ann. Rev. Genetics 161, 162 (2015) (“The history of applied molecular biology, therefore, is the history of law applied to biology. One of the most important of these areas of law has been patent law.”). ↑
- See Baruch Brody, Intellectual Property and Biotechnology: The U.S. Internal Experience—Part I, 16 Kennedy Inst. Ethics J. 1, 3 (2006). ↑
- Id. at 3. ↑
- Id. ↑
- Because Stanford was seeking a patent before the Supreme Court’s 1980 decision in Diamond v. Chakrabarty, Stanford felt it was necessary to seek a process patent. 447 U.S. 303, 309 (1980). In Chakrabarty, while considering a recombinant bacterium that could break down crude oil, the Court found that “anything under the sun that is made by man” is eligible for patent protection—living or otherwise. Id. ↑
- Brody, supra note 101, at 6. By the end of 2000, American universities received more than $1 billion in annual revenue for licenses and patents, mostly in the area of biotechnology. Id. ↑
- Id. ↑
- Id. 7–8. ↑
- Id. 7–9. ↑
- Steven Shapin, The Scientific Life: A Moral History of Late Modern Vocation 209 (2008). ↑
- Id. ↑
- Id. at 213. ↑
- Id. at 214–215. ↑
- Id. ↑
- Wendy H. Schacht, Cong. Research Serv., The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology 1 (2012). ↑
- Id. ↑
- Id. ↑
- Shapin, supra note 109, at 214. ↑
- See, e.g., Robert K. Merton, A Note on Science and Democracy, 1 J. Legal & Pol. Soc. 115, 122 (1942) (explaining that science is a communal good and its results should reside in “the public domain”). ↑
- Stephen Hilgartner, Selective Flows of Knowledge in Technoscientific Interaction: Information Control in Genome Research, 45 Brit. J. Hist. Sci. 267, 268 (2012). ↑
- Fiona Murray, Patenting Life: How the Oncomouse Patent Changed the Lives of Mice and Men, in Making and Unmaking Intellectual Property: Creative Produce in Legal and Cultural Perspective 399, 400 (Mario Biagioli, et al. eds., 2011). ↑
- Id. ↑
- Id. ↑
- Id. at 401 n.4. ↑
- Id. at 403. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Id. at 403–04. ↑
- Id. at 405. ↑
- Id. ↑
- Id. at 406. ↑
- Id. ↑
- Id. ↑
- Id. at 407. ↑
- Id. ↑
- Along with a very public battle over the traditional banners of recognition—the so-called “patent-paper pair” and scientific awards—the CRISPR inventors have also commercialized the gene-editing tool. Feng Zhang, the first to use CRISPR in mammalian cells, is cofounder of several CRISPR-based companies. Emmanuelle Charpentier, cofounder of CRISPR Therapeutics, was the first to publish, along with Jennifer Doudna, the invention of the CRISPR gene editor in June 2012. Jennifer Doudna co-founded a CRISPR-based diagnostics company called Mammoth Biosciences. Virginijus Siksnys cofounded the start-up CasZyme. See e.g., Ryan Cross, CRISPR Researchers Receive Kavli Prize in Nanoscience, C&EN (June 1, 2018), https://cen.acs.org/biological-chemistry/biotechnology/CRISPR-researchers-receive-Kavli-Prize/96/web/2018/06 [perma.cc/9GB2-JEUR]; Heidi Ledford, Pivotal CRISPR Patent Battle Won by Broad Institute, Nature (Sept. 10, 2018), https://www.nature.com/articles/d41586-018-06656-y [perma.cc/SC8J-K9RC]. ↑
- What is the Human Genome Project?, Nat’l Hum. Genome Res. Inst., https://www.genome.gov/12011239/a-brief-history-of-the-human-genome-project [https://perma.cc/BRC3-G5KE]. ↑
- Jenny Reardon, The Postgenomic Condition 25 (2017). ↑
- Robert Mullen Cook-Deegan, Alta Summit, December 1984, 5 Genomics 661–63 (1989). ↑
- Reardon, supra note 138, at 26. ↑
- Id. ↑
- Id. at 33. ↑
- Id. at 34. ↑
- The Bermuda Principles, Duke U. Libr., https://dukespace.lib.duke.edu/dspace/handle/10161/7407 [perma.cc/G29N-7DV9]. ↑
- President Bill Clinton, State of the Union Address (Jan. 27, 2000) (noting that researchers would soon “complete the first draft of the entire human genome, the very blueprint of life”). ↑
- Reardon, supra note 138, at 2. ↑
- Id. ↑
- Id. at 5. ↑
- Id. ↑
- Id. at 33. ↑
- Id. at 33–34. ↑
- Id. at 34. ↑
- Id. ↑
- Id. at 38. ↑
- Id. at 30–31. ↑
- Id. at 32. ↑
- Id. ↑
- Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). ↑
- Rebecca S. Eisenberg & Robert P. Merges, Opinion Letter as to the Patentability of Certain Inventions Associated with the Identification of Partial cDNA Sequences, 23 AIPLA Q. J. 1 (1995). ↑
- See id. at 3 (“Perhaps the issue that has drawn the most attention in public discussions of the patentability of the NIH cDNA sequences is whether these sequences have patentable utility.”). ↑
- See infra notes 70–86 and accompanying text (discussing Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364 (Fed. Cir. 1999) and In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005)). ↑
- Eisenberg & Merges, supra note 159, at 15. ↑
- cDNA is synthetically created DNA through a process called revere transcription and is often used for expressing a protein in a cell that doesn’t normally express that protein. ↑
- See Eisenberg & Merges, supra note 159, at 18. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Id. at 19. ↑
- Sherkow & Greely, supra note 100, at 164. ↑
- Id. ↑
- Clarisa Long, The PTO and the Market for Influence, 157 U. Penn. L. Rev. 1965, 1968 (2009). ↑
- 35 U.S.C. §§ 101, 102, 103, & 112 (2018). ↑
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71 (2012). ↑
- Parke-Davis & Co. v. H. K. Mulford Co., 189 F. 95, 99, 102 (S.D.N.Y. 1911). ↑
- Sherkow & Greely, supra note 100, at 164. ↑
- Id. ↑
- Id. ↑
- Parke-Davis, 189 F. at 103. ↑
- Id. ↑
- Sherkow & Greely, supra note 100, at 165. ↑
- Id. ↑
- Id. ↑
- Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980). ↑
- Sherkow & Greely, supra note 100, at 165. ↑
- Chakrabarty, 447 U.S. at 306. ↑
- Id. at 305, 309. ↑
- Id. ↑
- U.S. Pat. & Trademark Off., Animals – Patentability, 1077 Official Gazette 24 (Apr. 21, 1987) (commissioner notice) (“The Patent and Trademark Office now considers nonnaturally occurring, non-human multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 USC 101.”); see also Elizabeth Joy Hecht, Beyond Animal Legal Defense Fund v. Quigg: The Controversy Over Transgenic Animal Patents Continues, 41 Am. U. L. Rev. 1023 (1992) (exploring whether the USPTO’s rule constitutes valid law and whether transgenic animals should be patentable); Danielle K. Miller, A Patent on the Conscious: A Theoretical Perspective of the Law on Patentable Life, 2 Stan. J. Animal L. & Pol’y 144 (2009) (exploring legal developments leading to and following the USPTO’s announcement of the policy). ↑
- 2 U.S.P.Q.2d 1425 (1987). ↑
- Id. ↑
- Id. ↑
- U.S. Pat. & Trademark Off., Manual of Patent Examining Procedure, 2105 Patent Eligible Subject Matter — Living Subject Matter [R-08.2017], https://www.uspto.gov/web/offices/pac/mpep/s2105.html [perma.cc/H2MA-Y35Q]. ↑
- Animal Legal Def. Fund v. Quigg, 932 F.2d 920 (Fed. Cir. 1991) (never reaching the substantive issue whether the 1987 rule constituted valid law and holding that plaintiffs lack standing). ↑
- See supra notes 120–136 and accompanying text (discussing the oncomouse case in more depth). ↑
- Animal Legal Def. Fund, 932 F.2d at 922. ↑
- Id. at 924. ↑
- In re Quigg, 710 F. Supp. 728, 732 (N.D. Cal. 1989). ↑
- Animal Legal Def. Fund, 932 F.2d at 939. ↑
- Id. ↑
- Sander Rabin, The Human Use of Humanoid Beings: Chimeras and Patent Law, 24 Nature Biotechnology 517, 517 (2006). ↑
- Keay, supra note 41, at 425. ↑
- Id. at 429. ↑
- Id. ↑
- Id. at 432. ↑
- Sherkow & Greely, supra note 100, at 172. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013); Sherkow & Greely, supra note 100, at 172–73. ↑
- Sherkow & Greely, supra note 100, at 172–73. ↑
- Myriad, 569 U.S. at 580. ↑
- Id. at 577. ↑
- Id. at 585. ↑
- Some scholars have argued that the Supreme Court’s distinction between DNA and cDNA was an attempt at giving something to both the plaintiffs and defendants (i.e., the biotechnology industry that had come to expect patent protection for genetic sequences). See Dan L. Burk, The Curious Incident of the Supreme Court in Myriad Genetics, 90 Notre Dame L. Rev. 505, 510 (2014). ↑
- Dan L. Burk, Edifying Thoughts of a Patent Watcher: The Nature of DNA, 60 UCLA L. Rev. Discourse 92, 95 (2013) [hereinafter Burk, Edifying Thoughts]. ↑
- See, e.g., id.; Robert M. Schwartz & Timo Minssen, Life After Myriad: The Uncertain Future of Patenting Biomedical Innovation and Personalized Medicine in an International Context, 2015 intell. Prop. Q. 189 (2015). ↑
- Burk, Edifying Thoughts, supra note 219, at 508. ↑
- The court left open questions such as what counts as a natural product or how much modification is required to render a molecule sufficiently distinct from “naturally” occurring counterparts. ↑
- Global Innovation Policy Ctr., supra note 14, at 8; see also Jeffrey A. Lefstin et al., Final Report of the Berkeley Center for Law & Technology Section 101 Workshop: Addressing Patent Eligibility Challenges, 33 Berkeley Tech. L. J. 551, 561 (2018) (“The uncertainty and confusion resulting from the Court’s recent jurisprudence create significant problems for many companies and investors contemplating research and development projects, as well as for patent prosecutors, patent examiners, and patent jurists. In the decade prior to the Mayo decision, the USPTO rarely rejected patents on subject matter grounds, and one could count on one hand the number of judicial § 101 invalidity decisions in any year. Since Mayo, the number of § 101 invalidity rulings has skyrocketed, with more than one hundred invalidity determinations per year during the past two years. Courts now routinely confront § 101 invalidity motions at the very outset of, and throughout, many patent cases. The USPTO has issued numerous guidance documents cataloging this rapidly evolving terrain.”). ↑
- Global Innovation Policy Ctr., supra note 14, at 8. As noted earlier, the USPTO has released revised guidance for subject matter eligibility in January 2019. See Press Release (Jan. 4, 2019), supra note 36. ↑
- 566 U.S. 66, 72, 73 (2012) (holding that such processes “disproportionately [tie up] the use of the underlying natural laws, inhibiting their use in the making of further discoveries”). ↑
- Rochelle C. Dreyfuss et al., Patenting Nature—A Comparative Perspective, J. L. & Biosciences, 550 (2018). ↑
- Id. ↑
- See e.g., Johnathon Liddicoat et al., Continental Drift? Do European Clinical Genetic Testing Laboratories Have a Patent Problem?, Eur. J. Hum. Genetics (2019) (collecting studies demonstrating both that patents have adversely impacted genetic testing services and that patents rarely hamper and in fact promote academic and commercial research). ↑
- See e.g., Samantak Ghosh, Are All Genes Equal?, 20 Bos. U. J. Sci. Tech. L. 1, 10–14 (2014) (italics omitted). ↑
- Id. at 2. ↑
- However, as previously noted, this may change. There is bipartisan interest in Congress to amend the patent statute and overrule Myriad. See Press Release, Tillis, supra note 15. ↑
- Lai, supra note 49, at 1043. ↑
- Id. at 1044. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Comm’n of the European Comms., Proposal for a Council Directive on the Legal Protection of Biotechnological Inventions (1988). ↑
- The backlash against biotechnology was particularly strong in Germany because of the history of genetic engineering by the Nazis in World War II and militant environmentalists, including the politically powerful Green movement during the 1990s. See Nathaniel C. Nash, Germany Shuns Biotechnology, N.Y. Times (Dec. 21 1994), https://www.nytimes.com/1994/12/21/business/germany-shuns-biotechnology.html [perma.cc/EUP7-W2CN]; see also Andreas Schrell et al., Biotechnology Patenting Policy in the European Union – as Exemplified by the Development in Germany, 107 Advances Biochemical Engineering/Biotechnology 13 (2007) (reviewing the principal requirements for biotechnology patents in the signatory states of the European Patent Convention (EPC) and the historical development of biotech-patent legislation in Europe). ↑
- Donna M. Gitter, Led Astray by the Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law, 19 Berkeley J. Int’l L. 1, 13 (2001). ↑
- Convention on the Grant of European Patents (European Patent Convention), art. 52, Oct. 5, 1973, 1065 U.N.T.S. 16208 [hereinafter European Patent Convention].
- Lai, supra note 49, at 1042. ↑
- Directive 98/44/EC, of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, 1998 O.J. (L 213/13) pmbl. ¶¶ 20–21 [hereinafter Biotech Directive] (“Whereas, therefore, it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment; [] Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself[.]”). ↑
- Ordre public and morality are vague yet distinguishable terms in European patent law. The EPO defined both terms in Plant Genetic Systems. It first defined ordre public: “the concept of ‘ordre public’ covers the protection of public security and the physical integrity of individuals as part of society. This concept encompasses also the protection of the environment. Accordingly, under Article 53(a) EPC, inventions the exploitation of which is likely to breach public peace or social order . . . or to seriously prejudice the environment are to be excluded from patentability as being contrary to ‘ordre public.’” Plant Genetic Systems N.V. v. Greenpeace Ltd. (Plant Cells/PLANT GENETIC SYSTEMS), Case T-356/93 - 3.3.4, Eur. Pat. Off. Tech. Bd. App. 5 (Feb. 21, 1995). It then described morality: “[t]he concept of morality is related to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deeply rooted in a particular culture. For the purposes of the EPC, the culture in question is the culture inherent in European society and civilisation. Accordingly, under Article 53(a) EPC, inventions the exploitation of which is not in conformity with the conventionally-accepted standards of conduct pertaining to this culture are to be excluded from patentability as being contrary to morality.” Id. at 6. ↑
- Bonadio, supra note 16, at 149. ↑
- European Patent Convention, supra note 240, art. 53.
- Id. at Rule 28 Exceptions to Patentability (clarifying art. 53). ↑
- See Ellen-Marie Forsberg & Nico Groenendijk, RRI and Patenting: A Study of European Patent Governance, 13 NanoEthics 83 (2019) (summarizing various tests the EPO has used to determine whether to deny a patent as contrary to ordre public or morality). ↑
- Harvard Coll. v. British Union for the Abolition of Vivisection (Transgenic Animals/HARVARD), Case T-0315/03 – 3.3.08, Eur. Pat. Off. Tech. Bd. App. (July 6, 2004). ↑
- Id. ↑
- Robert P. Merges, Intellectual Property in Higher Life Forms: The Patent System and Controversial Technologies, 47 Md. L. Rev. 1051 (1987). ↑
- Id. at 1064–65 (quoting R. Choate, Cases And Materials On Patent Law 76 (3d ed. 1987)). ↑
- Id. at 1065. ↑
- Gitter, supra note 239, at 4 (illustrating confusion on whether the EPO applies the “public abhorrence” or “unacceptability” standard). ↑
- Merges, supra note 250, at 1064. ↑
- Id. ↑
- Carter-Wallace, Inc. v. Riverton Laboratories, Inc., 433 F.2d 1034, 1039 n.7 (2d Cir. 1970). ↑
- Gitter, supra note 239, at 36 n.272. ↑
- See Thomas A. Magnani, The Patentability of Human-Animal Chimeras, 14 Berkeley Tech. L. J. 443 (1999). ↑
- Id. at 459. ↑
- Id. ↑
- Bonadio, supra note 16, at 152. ↑
- Id. ↑
- Id. at 167; see supra notes 56–58 and accompanying text (describing Justice Story’s framework). ↑
- Bonadio, supra note 16, at 153. ↑
- See generally James Summers, Principles of Healthcare Ethics, in Health Care Ethics: Critical Issues for the 21st Century 41 (Eileen E. Morrison & Elizabeth Furlong eds., 4th ed. 2019) (discussing theories of ethics that provide a practical basis for making practice decisions and proposing a model to assist with making ethics-based decisions). ↑
- Bonadio, supra note 16, at 153. ↑
- Id. ↑
- See Thambisetty, supra note 51, at 48. ↑
- Id. ↑
- Id. ↑
- Id. ↑
- Drahos, supra note 52, at 447. ↑
- See supra Part III.B. ↑
- Sigrid Sterckx & Julian Cockbain, Exclusions from Patentability: How Far Has the European Patent Office Eroded Boundaries? 295 (2012). ↑
- Plant Genetic Systems N.V. v. Greenpeace Ltd. (Plant Cells/PLANT GENETIC SYSTEMS), Case T-356/93 - 3.3.4, Eur. Pat. Off. Tech. Bd. App. 15 (Feb. 21, 1995). ↑
- See Gitter, supra note 239, at 21. ↑
- Sterckx & Cockbain, supra note 274, at 295. ↑
- See Gitter, supra note 239, at 21. ↑
- Stem Cells/WARF, Case T-1374/04 (I) – 3.3.08, Eur. Pat. Off. Tech. Bd. App. 15 (Nov. 18, 2005). ↑
- Sterckx & Cockbain, supra note 274, at 297. ↑
- Case C-34/10, Brüstle v. Greenpeace eV, 2011 E.C.R. I-0981; Biotech Directive, supra note 242, art. 6(2)(c) (establishing “uses of human embryos for industrial or commercial purposes” are not patentable). ↑
- Brüstle, 2011 E.C.R. at I-9864; Bonadio, supra note 16, at 154. ↑
- Bonadio, supra note 16, at 154. ↑
- Brüstle, 2011 E.C.R. at I-9876. ↑
- Bonadio, supra note 16, at 167. ↑
- Long, supra note 172, at 1991. ↑
- Id. ↑
- U.S. Pat. & Trademark Off., General Requirements Bulletin for Admission to the Examination for Registration to Practice in Patent Cases before the United States Patent and Trademark Office 4 (2018), https://www.uspto.gov/sites/default/files/documents/OED_GRB.pdf [perma.cc/C3QB-LZK4]. ↑
- See Thambisetty, supra note 268, at 48–53. ↑
- As discussed above, along with being hailed as a path of enlightenment, genomics and molecular biology during the 20th century was also steeped in complex social and cultural contexts, which included partnering with state power in the name of Nazi experimentation, eugenic sterilization, and racially motivated immigration laws. CRISPR is the most recent milestone in the molecular biology revolution. Its use has instigated calls for a more global dialogue, reminiscent of the 1975 International Conference on Recombinant DNA Molecules held at the Asilomar Conference Center in California, which brought together research scientists, lawyers, and ethicists. In a TED talk, a workshop, and in her book A Crack in Creation: The Uunthinkable Power to Control Evolution, biochemist and CRISPR co-discoverer Jennifer Doudna has warned that the public discussion of the technology is falling behind its emerging applications. Doudna’s concerns were validated by the November 2018 announcement that He Jiankui, a DNA-sequencing expert at the Southern University of Science and Technology in Shenzhen, had orchestrated the birth of the world’s first gene-edited babies—allegedly conferring immunity to infection by HIV in one of them. See e.g., Next Time, Ask First: The Affair of the Gene-Edited Babies Rumbles On, Economist (Dec. 15, 2018), https://www.economist.com/science-and-technology/2018/12/15/the-affair-of-the-gene-edited-babies-rumbles-on [https://perma.cc/QPK9-UNK4]. As many have noted, unless the value of the applications of the technology are exposed to public review and inclusively debated, well-intentioned research could move humanity closer to a future it has not assented to and might not want. See e.g., Sheila Jasanoff & J. Benjamin Hurlbut, A Global Observatory for Gene Editing, Nature (Mar. 22, 2018), https://www.nature.com/articles/d41586-018-03270-w [https://perma.cc/C4ZK-LPAK]. Important efforts include the International Summit on Human Gene Editing, held in Washington DC in December 2015, and the Global Observatory for Gene Editing, a project to be launched in Cambridge, Massachusetts in spring 2019. These efforts demonstrate a societal recognition that more ports of ethical review are needed for emerging technology. ↑
- Some scholars have argued, however, that the USPTO should not be accorded Chevron deference when it interprets the Patent Act. See, e.g., Robert P. Merges, The Hamiltonian Origins of the US Patent System, and Why They Matter Today, 104 Iowa L. Rev 2559, 2561 (2019) (“In practical terms, I am arguing in support of two propositions. First, we should not push for Chevron deference to Patent Office interpretations of the Patent Act.”). ↑
- See Leahy-Smith America Invents Act, Pub. L. 112-29 §§ 14, 33, 125 Stat. 284 (2018) (codified as amended at 35 U.S.C. §§ 101–02 (2012)). ↑
- See 35 U.S.C. § 282. ↑
- 35 U.S.C. § 321. ↑
- See Rochelle Cooper Dreyfuss, Giving the Federal Circuit a Run for Its Money: Challenging Patents in the PTAB, 91 Notre Dame L. Rev. 235, 292 (2015) (“[B]ecause standing in court largely limits the class of potential challenges to entities within the same industrial sector as the patent holder, no one raises questions that call the entire industry’s holdings into question.”); Sapna Kumar, Standing Against Bad Patents, 32 Berkeley Tech. L. J. 87, 92–104 (2018) (arguing that impediments that prevent direct competitors from challenging bad patents include “the high cost of bringing challenges and the risk to the direct competitor’s own patents”). ↑
- 35 U.S.C. § 321(b). ↑
- See Jennie Thomas, Bioethics Consultations and Resources, 11 Ochsner J. 357, 357 (2011). ↑
- See id. ↑
- See Summers, supra note 265, at 56. ↑
- Justice Brennan observed that it has become “a catchall for an unarticulated discretion.” Simon v. E. Ky. Welfare Rights Org., 426 U.S. 26, 66 (1976) (Brennan, J., dissenting). ↑
- See Kumar, supra note 295, at 119–30. ↑
- 35 U.S.C. § 311 (2012). ↑
- See Blasiak, supra note 1, at 1. ↑