Earlier this week, I had the opportunity to speak again with Colin O’Keefe of LXBN regarding last week’s oral arguments in Association for Molecular Pathology v. Myriad Genetics. In the interview, I share some quick observations on the oral arguments and offer my thoughts why I believe the Justices will “split the baby” with their ruling.
Petitioners (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or ”Petitioner” or “ACLU”) filed their brief with the U.S. Supreme Court yesterday urging the Court to reverse the Federal Circuit’s decision and the USPTO’s decades long practice of granting patents on isolated DNA. Similar to their arguments in all prior briefings, the Petitioners argue that the patents issued to Respondent Myriad Genetics, Inc. et al. (“Myriad”) were erroneously issued because they claims products of nature. Petitioner also applied the Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)(“Mayo”). A copy of the brief is attached [MyriadPetitionersMeritsBrief].Continue reading this entry
As reported in my November 30th, 2012 post, the U.S. Supreme Court granted certiorari to review the issue “are human genes patentable?” The issue arises from the long-running dispute among a consortium of plaintiffs, led by the American Civil Liberties Union (collectively “ACLU”) who sued Myriad Genetics, Inc. and the Directors of the University of of Utah Research Foundation (collectively “Myriad”) challenging the patentability of composition and method claims related to human genetics. The Supreme Court’s opinion has the potential to overrule over 30 years USPTO practice that supported the growth of the U.S. biotechnology industry. Continue reading this entry
On October 31, 2012, Myriad Genetics, Inc. et al. (“Respondent” or “Myriad”) filed its brief in opposition to Petitioners’ (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or “ACLU”) quest for U.S. Supreme Court review in the ongoing legal battle over whether isolated DNA is patent-eligible subject matter. Myriad argued that U.S. Supreme Court review is not warranted, and that if it is, the question for the Supreme Court is not whether human genes are patentable, but whether isolated DNA molecules that were identified and defined by human inventors are patent-eligible subject matter in the United States. Continue reading this entry
The ACLU and PUBPAT issued a press release today announcing that they are petitioning the U.S. Supreme Court to review the U.S. Federal Circuit’s decision upholding the patent-eligibility of isolated DNA . The release announces in part:
“The American Civil Liberties Union and the Public Patent Foundation today asked the U.S. Supreme Court to invalidate patents for two genes associated with hereditary breast and ovarian cancer that allow a Utah company to control access to crucial genetic tests that could lead to life-saving treatment.”
A copy of the petition is attached [Cert. Petition].
The biotechnology industry, including those investing in personalized medicine, have been waiting for the Federal Circuit’s decision that answers the questions whether isolated DNA and use of the isolated material are patent-eligible under 35 U.S.C. § 101. As reported in our August 16th post, the same three judges (Lourie, Bryson and Moore) held that isolated DNA and cells transformed with the DNA are patent-eligible. Claims that broadly claim detecting alterations in a gene, in this case the BRCA1 gene, were held to be patent-ineligible. The Ass’n for Molecular Pathology et al. v. USPTO, et al., No. 2010-1406 (Fed. Cir. 2012). In addition, the court determined that the plaintiffs had standing to maintain the action. This decision validates that the tools (DNA and isolated naturally occurring materials) underlying personalized medicine are still patent-eligible. Moreover, the court’s evaluation of the claimed methods are informative to those seeking to patent medical diagnostic tests because the court compared and contrasted a patent-ineligible claimed method to a patent eligible one.Continue reading this entry
Today, in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406 (Fed. Cir. 2012), the Federal Circuit held that non-naturally occurring DNA is patent eligible as well as the use of a transformed, non-naturally occurring cell for screening drug candidates. Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences were held to be patent-ineligible. A copy of the Federal Circuit’s decision is attached Federal Circuit Myriad Decision. A detailed analysis by Foley & Lardner, LLP and this blog post will follow.
On July 20th, 2012, the parties in the Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 10-1406 (Fed. Cir. 2011)(also known as the “ACLU gene patenting” case) argued (again) before the Federal Circuit. Recall, the U.S. Supreme Court had asked the court to reconsider its prior ruling as to the patent-eligibility of claims to isolated DNA, in light of its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012) (“Mayo”). In Mayo, the U.S. Supreme Court held that that certain diagnostic inventions cannot be patented under 35 USC Secion 101 because they effectively claim a law of nature.Continue reading this entry
June 15th, 2012 was the deadline for the parties and interested parties to file briefs in the controversial ACLU gene patenting case (see our post of March 26th, 2012), remanded to the Federal Circuit after the U.S. Supreme Court’s recent Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. __, 132 S.Ct. 1289 (2012) (“Prometheus”) decision which held that certain claims to medical methods are not patent-eligible for failing to satisfy 35 U.S.C. § 101. On June 12th, Eli Lilly and Company (“Lilly”) filed an amicus brief that urged the Federal Circuit to review the U.S. Supreme Court’s holding in Prometheus as it applies to multi-step process claims. Lilly’s amicus brief, filed in support of neither party, argued that new test is required to simplify the line between patent-eligible and ineligible subject matter, as [i]t is as best intellectually challenging to meaningfully apply the tripartite exclusions from patenting for laws of nature, natural phenomena and abstract ideas.” The issue of whether or not the DNA claims are patent-eligible, the most contentious issue in this proceeding, was not briefed by Lilly. Rather, in footnote 1 of the brief, Lilly stated that only the appealed process claim is addressed because Prometheus “appears to be irrelevant to the manifest patent-eligibility of man-made materials that are nowhere to be found as such in nature.”Continue reading this entry
The increasing importance of genetic markers and diagnostic tests in the drug approval process and the delivery of health care requires consideration of who will underwrite the necessary research and development, Michael Hopkins and Stuart Hogarth argue in the recent issue of Nature Biotechnology. “Biomarker patents for diagnostics: problem or solution?” Nature Biotechnology, Vol. 30(6): 498-500. Consistent with the biomedical model, many innovators have relied on patents and the temporary monopoly patents provide to recoup the cost of innovation, but the appropriateness of this model is being challenged. Whether are not patents covering diagnostic medical tests support or spurn innovation was considered in the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus, Inc., decision, (see our March 20th post) and is currently under review by the U.S. Patent and Trademark Office (see our January 25th post). The issue also is central to the ACLU’s challenge to the patenting of isolated DNA now before the Federal Circuit in the Association for Molecular Pathology v. Myriad Genetics et al. or the ”gene patenting case” recently sent back to the Federal Circuit for reconsideration in light of the U.S. Supreme Court’s Mayo decision (see our March 26th post.) Patents for this technology are argued to be unnecessary as the cost of providing the tests are low and could prevent clinical scientists in hospital laboratories from developing and offering their services.
A Missed Opportunity
The co-authors suggest that whatever judgments are made against gene patents, the debate thus far has missed an opportunity to consider the wider issue of diagnostic patents and their role in innovation. The conclusions drawn by the co-authors were informed by a seminar convened in London in 2010 by the Human Genetics Commission, whose membership included hospital staff, diagnostic and pharmaceutical firms, research funders, lawyers and ethicists. The co-authors also note that the context of the debate differs between Europe and the United States. However, several important points are raised by the co-authors that are relevant to the ongoing debate in the United States.
For too long, the co-authors note, the gene-patenting debate has been framed by an innovation model that assumes low regulatory barriers to market entry and an easy path to market and clinical adoption. Recent evidence suggests that low-cost and therefore easy market entry is no longer the norm. Test developers are now being asked to provide more evidence, not less, and more quickly, and conventional business models do not support large-scale trials of the utility of new biomarkers. In addition, as noted in our January 24th post, the U.S. Food and Drug Administration will begin regulating laboratory developed tests offered as companion diagnostics.
The SACGHS Report
The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) for the U.S. Department of Health and Human Services has often been cited by those who oppose the patenting of this technology. The SACGHS committee concluded that the exclusivity provided by patents or licenses had not been necessary to ensure that tests were developed and made available to patients. What is lost in the discussion but noted by Hopkins and Hogarth is that the evidence informing the SACGHS report and conclusion was mainly limited to tests for the diagnosis of rare genetic disorders. Tests related to, for example, infectious agents and drug metabolism were neglected in the SACGHS analysis. The co-authors report that the approach SACGHS took on framing the issues and evidence split their committee, with dissenters writing that the burden of regulatory compliance and the need for clinical utility were pushing up R & D costs for test development. IP was therefore required to incentivize companies to invest in this technology.
Who Will Pay for Personalized Medicine?
The co-authors also argue that extensive evidence is necessary for a biomarker’s acceptance by drug regulators and health care providers. Such evidence includes, for example, that the biomarker accurately and reliably identifies the target population. If the biomarker is tied to a drug under development by a pharmaceutical company, the drug company has the economic incentive to fund the necessary research. IP can serve additional strategic roles – stakeholders such as diagnostic developers, pharmaceutical companies and regulators are increasingly eager to control who provides diagnostic tests in the future, because safe, speedy and effective prescription of drugs will depend on reliable diagnostics. However, if the test is not tied to the company’s drug, incentives to fund the development of the diagnostic are less obvious. Hopkins and Hogarth cite the case of Roche’s AmpliChip CYP450 as an example of a test that has been approved by the FDA but not widely adopted because follow-up studies to establish its clinical utility were not completed. Although Roche shepherded the test through the FDA, it did not invest in the necessary clinical studies demanded for wide-spread adoption of the technology. The co-authors note that Roche holds no patents or exclusive licenses on the genes encoding CYP450 and that therefore any investment it makes in building the clinical evidence would also benefit rival companies who have entered the CYP450 market or are preparing to do so.
No Easy Answers
Hopkins and Hogarth provide no simple solution to the question of what should be done to ensure that well-validated diagnostics are made available to patients. They encourage continued public debate by all stakeholders to address the contentious issues that surround funding of research and development to generate evidence on the safe and effective use of diagnostics with clinical utility. In concluding this informative report, the co-authors argue that one point is clear: supporting innovation in the diagnostics sector while ensuring patient access to valuable new tests will require different strategies for different circumstances. Even previously controversial options, such at patented diagnostics and exclusive licenses that restrict market entrants, may have a part to play.
The other day I had the opportunity to speak with Colin O’Keefe of LXBN TV on the subject of Mayo Collaborative Services v. Prometheus Laboratories, Inc. In the short interview, I explain the background of the case, offer my thoughts on why Prometheus’ patent wouldn’t have a detrimental impact on medical research and give my thoughts on what this means for the Myriad “gene patenting” case.
For those of you closely following Assn. Molec. Path. et al. v. USPTO et al., otherwise known as the Myriad “gene patenting” case, you already know that both sides petitioned the Federal Circuit for a rehearing by the three-judge panel (not en banc), albeit for different reasons. Specifically, on August 25, 2011, on behalf of Plaintiffs/Appellees, the ACLU filed a Petition for Panel Rehearing on the merits, while Myriad/Appellant filed its own Petition for Panel Rehearing on the standing issue four days later. Both parties filed petitions in response to the precedential decision by the Federal Circuit on July 29, 2011. The latest update is that yesterday, September 13, 2011, the Federal Circuit denied ACLU’s petition, although we still await word on Myriad’s petition.
On August 25, 2011, on behalf of Plaintiffs, the ACLU filed a Petition for Panel Rehearing with the Federal Circuit in Assn. Molec. Path. et al. v. USPTO et al., known as the Myriad “gene patenting” case. Four days later, on August 29, 2011, Myriad likewise filed its own Petition for Panel Rehearing. Both parties filed their Petitions in response to a precedential decision by the Federal Circuit a month earlier. In that decision, a three-judge panel held, among other things, that all “isolated DNA” claims at issue are patent-eligible, contrary to Plaintiffs’ position. All three judges wrote detailed opinions, with Judge Lourie writing the majority opinion, Judge Moore concurring-in-part, and Judge Bryson concurring-in-part but dissenting-in-part regarding claims encompassing isolated genomic DNA. For background details of the case, see August 9 post, July 31 post and July 29 post. (Many thanks to Kevin Noonan at Patent Docs for first providing the Petitions.)
ACLU/Plaintiffs Petition for Panel Rehearing
In their recent petition, Plaintiffs ask the same three judges rehear the case again. Notably, they do not ask for a rehearing en banc, which would entail reconsideration by all active Federal Circuit judges.
Subject Matter Patent-Eligibility of Isolated DNA and Diagnostic Methods Addressed Head-on
On Friday, July 29, 2011, in one of the most controversial and publicized biotech patent cases in recent years, the Federal Circuit decided the “ACLU/Myriad” gene patenting case, formally known as Assn. Molec. Path. et al. v. USPTO et al. In a majority opinion by Judge Lourie, the court addressed the case on the merits, after finding that at least one plaintiff had standing to sue. The court held all “isolated DNA” claims at issue patent-eligible, but held as patent-ineligible diagnostic method claims that in effect recited only “comparing” or “analyzing” DNA sequences. While this ruling could ultimately be subject to en banc review before all judges at the Federal Circuit and/or find its way to the Supreme Court, this decision now and its impact will undoubtedly be of great interest to everyone working in the biotechnology and diagnostic medicine fields.