BRCA gene case: James D. Watson, co-founder of double helix structure, rejects patentability of DNA and other amici filings
On Friday, July 20, 2012, the Court of Appeals for the Federal Circuit will re-hear the case Association for Molecular Pathology, et. al. v. United States Patent and Trademark Office, et. al. This case, involving the patent eligibility of DNA--specifically claims directed at two human genes, BRCA1 and BRCA2, associated with an individual's susceptibility to breast cancer--has been litigated for three years now and has resulted in fractured rulings and widely varying reasoning.
The case was first heard by the District Court for the Southern District of New York where Judge Sweet ruled that the claims-at-issue were directed at products of nature and therefore not patent eligible. Subsequently, the defendants appealed to the Federal Circuit where a three-judge panel overturned the lower court's ruling in a 2-1 decision with each judge writing his or her own opinion. Notably, each opinion differed in reasoning from Judge Sweet's decision, essentially leaving a four-way split in reasoning.
On petition for writ of certiorari to the Supreme Court of the United States, the Court granted the petition, vacated the Federal Circuit ruling, and remanded the case back to the Federal Circuit to be heard in light of the Supreme Court's unanimous ruling in Mayo v. Prometheus (decided shortly before the Court's grant-vacate-remand) which held that Prometheus' patents were not eligible for patent protection because the claims-at-issue were directed at mere applications of laws of nature. The Prometheus case covered issues (including in dicta) relevant to the Myriad case, including the application of well-understood research tools, field preemption and impacts of patents on future innovation.
Because the Federal Circuit has already heard the case on its merits once before and issued a ruling, the central issue at its current stage is the applicability of the Mayo v. Prometheus ruling to the present case. Interestingly, the Federal Circuit had previously been asked to re-hear the Mayo v. Prometheus case after the Supreme Court's ruling in Bilski; when it did, the Federal Circuit affirmed its previous ruling and the Supreme Court again granted writ, ultimately reversing the Federal Circuit in a 9-0 decision.
In addition to the applicability of Mayo v. Prometheus, significant attention may be given to standing. The Federal Circuit previously found standing in the present case on the basis of Dr. Harry Ostrer. However, just two days prior to the Federal Circuit's release of its decision in AMP v. USPTO, the Defendants-Appellants filed notice further challenging Dr. Ostrer's standing because of his change of employment from NYU Langone to the Department of Genetics at Albert Einstein College. Plaintiffs-Appellees have maintained that the change in employment does not alter Dr. Ostrer's standing and further argues that the Federal Circuit erroneously found that other named plaintiffs did not have standing.
Throughout the long litigation process, numerous amici have filed briefs. At the current stage of the case (re-hearing by the Federal Circuit), the following amici have filed briefs, though it is important to keep in mind that this list does not include all amici as some that previously filed elected not to file a new brief at this stage:
In Support of Neither Party (note that most briefs do advocate for a particular side)
- United States
- James D. Watson
- Eli Lilly and Company
- Protein Sciences Corporation
- Gilead Sciences, Inc., et. al.
- American Bar Association
- American Intellectual Property Law Association
- Croplife International
- Law Professor Christopher M. Holman
- Mark J. Gatschet and Richard W. Knight
- New York Intellectual Property Law Association
- Federal Circuit Bar Association
In Support of Plaintiffs (ACLU/PUBPAT)
- American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American Osteopathic Association, American College of Legal Medicine, American College of Embryology, and the Medical Society of the State of New York
- AARP, Canavan Foundation, Claire Altman Heine Foundation, Facing Our Risk of Cancer Empowered, March of Dimes Foundation, National Association of Pseudoxanthoma Elasticism, and Ovarian Cancer National Alliance
- Professor Eileen Kane
- National Women's Health Network, Reproductive Health Technologies Project, Forward Together, The Center for Genetics and Society, The Pro-Choice Alliance for Responsible Research, Alliance for Human Biotechnology, G. Michael Roybal, MD, MPH, and Anne L. Peters, MD
- Information Society Project at Yale Law School Scholars
- Knowledge Ecology International and Universities Allied for Essential Medicines
In Support of Defendants (Myriad)
- Pharmaceutical Research and Manufacturers of America
- Biotechnology Industry Organization, The Association of University Technology Managers, and the Coalition for 21st Century Medicine
- Intellectual Property Owners Association
- Advanced Biological Laboratories, SA
- Immatics Biotechnologies, GMBH
Out of the 23 briefs, 12 were filed in support of neither party. However, the majority of the briefs do argue for a specific outcome--either affirmance or reversal of the previous Federal Circuit ruling. Although I have not read all 23 briefs filed at this stage, two were of particular interest to me: the one filed by the United States and the one filed by James D. Watson.
The US position is significant in part because it undercuts the argument that the claims-at-issue should be upheld because of the USPTO's long history of granting such patents and that courts should defer to USPTO's determinations in these matters. By filing a brief arguing against patent eligibility of isolated DNA, the US DOJ makes clear that the Executive Branch is split on the issue, a fact which Judge Bryson noted in his original dissent in the case last summer. The other significant filing at the current stage was that of a new amicus curiae to the case, James D. Watson, Nobel Prize winner and co-discoverer of the double helix. These two briefs are detailed below.
Amicus Brief of the United States
The United States previously filed a brief in support of neither party when the case was heard by the Federal Circuit last year. There, the US argued that isolated DNA was not eligible for patent protection, citing "common sense" and the "products of nature" doctrine. The US did, however, take the opposite viewpoint with respect to cDNA. Neal Katyal, then acting-Solicitor General, argued at oral arguments against the patentability of isolated DNA using part of the time reserved for the plaintiffs-appellees.
In its current brief, the US again argues that isolated-DNA--as products of nature--should not receive patent protection and that this position is supported by the Supreme Court's decision in Mayo v. Prometheus. The US quotes the Supreme Court opinion extensively noting that prior precedent "warn[s] against upholding patents that 'too broadly preempt the use of a natural law.'" The US brief reminds, "Patent protection is not available to those who simply discover existing aspects of nature, even if the discovery requires arduous work, represents keen scientific insight, and is of great value to society."
Applying the decision in Mayo to the present case, the US notes:
In analyzing the claimed methods in Mayo, the Supreme Court repeatedly emphasized the need to ensure that claims not "tie up" laws of nature by preventing the public from exploring and exploiting those laws. See, e.g., 132 S.Ct. at 1294 (warning "against upholding patents that claim processes that too broadly preempt the use of a natural law"); id. at 1301 ("The Court has repeatedly emphasized . . . that patent law not inhibit further discovery by improperly tying up the future uses of laws of nature."); ibid. (warning against the "danger that the grant of patents that tie up [natural laws'] use will inhibit future innovation premised upon them"). To avoid that outcome the Court held that a "process reciting of law of nature" is not patent-eligible "unless that process has additional feature that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Id. at 1297. With respect to the method claims in Mayo, the Court concluded that "the steps add nothing of significance to the natural laws themselves" and "amount to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.' Id. at 1298, 1302. For that reason, upholding such claims 'would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries." Id. at 1294; see also id. at 1302 (discussing "basic underling concern that these patents tie up too much future use of laws of nature").
The concerns implicated by patent claims that "t[ie] up the use of the underlying natural laws," and thereby 'inhibit their use in the making of further discoveries," may also be present when a patent contains a composition claim that relates to a product of nature. Products of nature, like laws of nature, are "manifestations of * * * nature" that are "free to all men and reserved exclusively to none.' Chakrabarty, 447 U.S. at 309 (internal quotation marks omitted). A composition claim that effectively prevents the public from studying and making use o fa product of nature is just as objectionable, and for the same underlying reason, as a method claim that effectively prevents the public from studying and exploiting a law of nature.
Using preemption as evidence that the claim improperly ties up laws of nature, the brief goes on to argue that
Issuance of a patent should leave others free to study and exploit the natural substance and to devise other alternations to it. If it does not, that is a strong indication that the differences between the claimed composition and the product of nature are insufficient to render the composition patent-eligible.
In addition to arguing that the claims-at-issue are not patent-eligible because they are directed at laws of nature and permitting these patents would preempt nearly all other uses, the US adds that the need for financial incentives in a particular field does not alter analysis of 35 USC 101:
In this case, Myriad has argued that the extension of patent protection to isolated DNA is necessary in order to preserve financial incentives for making DNA discoveries. See, e.g., Myriad Opening Br. at 3-4. Mayo strongly suggests that the judicial inquiry should not focus on industry-specific incentive arguments of this sort, pro or con, and instead should focus on "established general legal rules." See U.S. Amicus Br. at 34-36 (arguing that appellants' assertions regarding financial incentives do not distinguish isolated genes from other, clearly unpatentable products of nature). The potential incentive effects of allowing private parties to monetize discoveries about a particular naturally occurring product do not alter the boundaries the Supreme Court has set--and in Mayo reinforced--between unpatentable products of nature and patentable creations of man.
The US argues that the asserted need for patent protection to induce financial investment does not alter the characteristic of the claims-at-issue, that is the very fact that the claimed substances are products of nature or directed at laws of nature renders them ineligible for patent protection. I note that in our amici brief, we resolve this issue by noting the wide range of incentive mechanisms that exist outside of the patent system and suggesting that such alternatives can and should be used where patents are burdensome or inappropriate rewards.
Amicus Brief of James D. Watson
While the majority of amici filing at the current stage also previously filed a brief at some previous stage, James D. Watson filed as amici for the first time. He, along with Francis Crick, discovered the double helix structure of DNA and were awarded the Nobel Prize in Physiology or Medicine in 1962. Dr. Watson has also played a significant role in the Human Genome Project. In his brief, Dr. Watson focuses on the importance of DNA to research and the progress of science. He also suggests that, in the alternative, if patents are granted on DNA, that compulsory licenses be granted to ensure access and promote progress of science, particularly with respect to life-saving medicines and medical technologies.
Dr. Watson's brief begins by asserting that DNA:
is a chemical entity, but DNA's importance flows from its ability to encode and transmit the instructions for creating humans. Life's instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts.
Dr. Watson then discusses the discovery of the structure of DNA and its significance as information. He notes the importance of continued research on DNA, stating that
To this day, we continue to learn how human genes function. We estimate that humans have approximately 22,000 genes. We have yet to fully understand the functions of all human genes, but this lack of understanding is further reason that scientists should be permitted to experiment on human genes free from any threat of patent infringement.
In years to come, with the right advances in genetic engineering, we may well be able to treat or rectify mental disabilities and physical diseases which today are deemed incurable. Such hope is all the more reason that scientific research on human genes should not be impeded by the existence of unnecessary patents. More importantly, we would not want one individual or company to monopolize the legal right to the beneficial information of a human gene--information that should be used for the betterment of the human race as a whole.
Dr. Watson details the history of the Human Genome Project which "was started not to increase the profits of select companies but to expand [...] our understanding of the human genome and make this information available to all scientists" and his involvement in the project. He notes that
Even at the early stages of the project, we were concerned about the issue of patenting human genes. Most, although not all, eminent scientists recognized that human genes should not be monopolized by patents. I believe at the time--and continue to believe--that the issue of patenting human genes went to the very crux of whether the information encoded by human DNA should be freely available to the scientific community, Some twenty years ago, I explained that patenting human genes was lunacy, and I was not a lone voice.
Sadly, and to the detriment of scientific research, my view did not control the policy decisions of NIH, which had filed for numerous patents covering human genes. Even more egregious were the types of patents being filed on human genes. Many of NIH's patents described only small portions of a gene.
He points out that many patents were filed for sequences despite the applicants "having no clue about the function of those sequences." Ultimately, Dr. Watson resigned from the NIH, believing that patenting of human genes was unnecessary. Additionally, the brief notes that the Human Genome PRoject was largely funded by taxpayer money:
The Human Genome Project was a multi-agency, international effort. It was funded in large part by taxpayer money, and the primary expectation was that the information derived from the sequenced human genes would be available for all scientists to use. Unfortunately, a decade later, private companies are still trying to unnecessarily restrict access to human genes and the information encoded in those genes. This situation burdens all of society. Other scientists involved in the Human Genome Project continue to warn about the harms caused by patenting human genes. For instance, John Sulston, who received the 2002 Nobel Prize in Physiology or Medicine, headed the British effort of the Human Genome Project. He has explained that "many human genes have patent rights on them and this is going to get in the way of treatment unless you have a lot of money."
In the final portion of his argument, Dr. Watson argues that if patents are granted on DNA, compulsory licenses should be required to ensure fair access. He notes that new diagnostic tools often rely on multiple genes and
If each of the human genes used in a new multi-gene assay are subject to patents, I fear that useful tests requiring multiple human genes will be unnecessarily delayed, become prohibitively expensive, or, worse yet, never be made available to patients at all. For a new assay using hundreds of human genes, the sea of patents and patent applications would crate hundreds, if not thousands, of individual obstacles to developing and commercializing the assay. The best way, in my view, to resolve this problem is to eliminate the unnecessary patenting of human genes.
If, for some reason, patents on human genes are deemed necessary, the next best, albeit imperfect, solution is to require those patent holders to license the patents to other researchers so that scientific progress is not obstructed. This is often called a "compulsory license." In my view, a compulsory license can establish reasonable access to human genes and genetic information--which is what scientists in general want, had the lawyers and courts not complicated matters. Reasonable access facilitates scientific and social progress.
Compulsory licensing ensures that scientists and researchers will have reasonable access to human genes and genetic information. Compulsory licensing will attenuate the negative consequences of the genetic monopolies created by patents. Implementing a compulsory license protocol will also reduce the risk that a patient is denied access to life-saving medicines and technologies using human genes and the information encoded in the genes.
The KEI/UAEM brief does not discuss compulsory licensing of patents on DNA. However, KEI did propose a liability rule when we submitted comments to USPTO regarding genetic diagnostic testing. The rule proposed by KEI to USPTO for patents relating to genetic diagnostic testing would permit anyone to "use any patented invention to make and sell a medical diagnostic test or service, if the manufacturer of the diagnostic test or the provider of the patented testing service pays a royalty" to be distributed by USPTO or its designee to patent owners.