BRCA Patent Lawsuit

Supreme Oral Arguments took place on April 15, 2013

The Supreme Court heard oral arguments on April 15, 2013. View the transcript here.

Supreme Court grants certiorari on November 30, 2012

The Supreme Court granted certiorari on November 30, 2012, indicating that they will take AMP v. Myriad Genetics, Inc., et al. To read more about the case and follow its progress, see the case page on ScotusBlog.

ACLU and Public Patent Foundation Appeal to Supreme Court on September 25, 2012

The American Civil Liberties Union and Public Patent Foundation filed a petition for a Writ of Certioriari on September 25, 2012.  The petition asks the Supreme Court to reconsider the CAFC's ruling on specific issues, and, once again, broadly questions a fundamental inquiry of this case: are human genes are, in fact, patentable substances? As can be seen on the certpool.com entry, the case will be distributed for conference on November 30, 2012. The petition can be read in full on our BRCA Resources page.

Court of Appeals for Federal Circuit Rules on Myriad Case on August 16, 2012

After the oral arguments on July 20, the United States Court of Appeals for the Federal Circuit issued a ruling on August 16, 2012.This ruling upheld the patentability of isolated genes, but called into question Myriad’s method claims directed at the comparison or analysis of gene sequences. The full decision can be viewed on our BRCA Resources page.

Court of Appeals for Federal Circuit Orders Oral Arguments on July 20, 2012

As a result of the Supreme Court's decision to remand the case, the CAFC ordered for amicus briefs to be submitted by June 15, and oral arguments to take place on July 20, 2012. The court received many supplemental briefs, all of which can be viewed on professor of law Christopher Holman's Biotech IP blog and on Patent Docs. To view select amicus briefs and the CAFC order for oral arguments, please see our BRCA Resources page.

Supreme Court Remands Case on March 26, 2012

The long-awaited result of the February 17 Supreme Court Conference was a referral of the decision to the CAFC for further review. The Supreme Court requested that the CAFC reconsider the case in light of their recent decision in Prometheus v. Mayo.  In this ruling, justices unanimously invalidated the method patent obtained by Prometheus laboratories (for the opinion, written by Justice Breyer, and other information about the case, visit the ScotusBlog website).

Supreme Court of the United States Conference on February 17, 2012

On February 17, 2012, the Supreme Court will confer on whether or not to hear the BRCA case (Association for Molecular Pathology v. US Patent and Trademark Office, or AMP v USPTO).  Their decision may be announced as early as Tuesday, February 21.  The petition for a Writ of Certiorari was submitted on December 7, 2011.  The main issues of the case are 1) whether isolated DNA corresponding to sequences of human genes is patentable, and 2) whether the petitioners have standing to sue.  Numerous amicus curiae briefs were written on behalf of the petitioners.  All of the amicus briefs filed for this case can be seen on our BRCA Resources page (with other background documents).

Congressional Briefing, 15 Sept 2011: The Myriad Genetics/ Breast Cancer Gene Case: What Just Happened? What Happens Next? What are the Implications for Congress?

On July 29, 2011 the U.S Court of Appeals for the Federal Circuit (CAFC) handed down its long-awaited ruling about the patent lawsuit brought against Myriad Genetics and the US Patent and Trademark Office by a group of more than 20 plaintiffs, led by the American Civil Liberties Union and Public Patent Foundation.  This case has attracted worldwide attention, because it speaks to women's access to information about their own susceptibility to breast cancer. 

In a 2-1 split vote, the CAFC ruled that “isolated” human genes can be patented, overturning a March 2010 federal district court decision.  At the same time, the appeals court affirmed the lower court’s judgment that broad claims on the process of analyzing genes were invalid (although on much narrower grounds than the district court). This closely watched decision stirred up the long-standing debate about the patentability of genes. 

The Congressional briefing aimed to educate policymakers, advocacy groups, stakeholders, and other interested parties about the Myriad case. The goals were to offer attendees an unbiased overview of the CAFC decision and its implications, and to outline potential next steps, including Congress' role. 

Among the topics discussed:

• The history of the Myriad case and explanation of the CAFC ruling.
• Implications of the CAFC decision for breast cancer and other genetic diseases: How will existing and future gene patents be affected?
• Why should Congress be engaged in this debate?

Speakers included:

• Robert Cook-Deegan, Director of Duke University’s Center for Genome Ethics, Law & Policy
• Arti Rai, Elvin R. Latty Professor of Law at Duke Law School
• Kevin Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff; and author on the Patent Docs blog

Video of the briefing below. (Link provided for those having trouble viewing the video in their mobile browser.)

For more materials from the Congressional briefing, see our BRCA Resources page.

Plaintiffs and Defendants Both Petition for Panel Rehearing of CAFC Ruling

In late August, nearly a month after the U.S. Court of Appeals for the Federal Circuit (CAFC) handed down the ruling summarized below, both plaintiffs and defendants petitioned for a panel rehearing of the case in the CAFC. Plaintiffs submitted their petition on August 25th and defendants quickly followed suit on August 29th. The appeal will be heard only if the court accepts it, and may be followed by an appeal to the Supreme Court. If heard, this appeal could set a precedent for whether naturally occurring DNA sequences can be patented. Discussions of the petitions for rehearing can be found on blog sites such as the Genomics Law Report and Patent Docs.

The US Court of Appeals for the Federal Circuit Hands Down Ruling on Association of Molecular Pathology, et al. v. US Patent and Trademark Office, et al. (the "Myriad Case" or "BRCA case")

On July 29, 2011 the US Court of Appeals for the Federal Circuit (CAFC) handed down its long-awaited ruling about the patent lawsuit brought against Myriad Genetics and the US Patent and Trademark Office by a group of more than 20 plaintiffs. The lawsuit has been coordinated and argued by the American Civil Liberties Union and the Public Patent Foundation. Briefly, the Court held that only one plaintiff actually had standing to sue, but that is all that is needed to bring the case.

On the merits of the arguments, the three judges agreed that:

1. Some kinds of DNA can be patented, such as cDNA molecules that are not found in nature and other clearly "engineered" DNA constructs;

2. Five of the broadest method claims in Myriad's patents are invalid because they claimed any way of comparing sequences to look for differences, a mental act that cannot be patented; and

3. The claim for an assay on cancer therapeutics is valid because it entailed several "transformative" steps (it is not entirely clear why this claim was in the case at all, and it received very little attention in the briefings or oral arguments).

Myriad Genetics is in a much stronger patent position than it was after Judge Robert Sweet's District Court ruling of March 29, 2010, which invalidated 15 claims in 7 patents. However, Myriad is also in a weaker position than before the case began. CAFC has sent a mixed message: yes to gene patents, but no to some broad method claims. Some claims that have been granted are invalid, and some are vulnerable to challenge in subsequent cases. What will happen now? There is likely to be at least one more level of appeal that could set precedent on whether naturally occurring DNA sequences can be patented.

Courtenay Brinckerhoff of Foley & Lardner has prepared a concise summary of the ruling. Dan Vorhaus and John Conley have a saucy summary at Genomics Law Report, and Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff has prepared a judge-by-judge analysis at Patent Docs. Finally, Robert Cook-Deegan has prepared an invited editorial, describing the implications and background of this landmark CAFC ruling, for the August 5, 2011 edition of The Cancer Letter. This letter, as well as other supplementary documents, can be viewed on the BRCA Resources page.

Background on the case is explained below.

Background on Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al.

The lawsuit against Myriad Genetics filed May 12, 2009, in Federal District Court (Southern District of New York, Judge Robert Sweet, presiding) is a landmark case. Myriad Genetics holds patents on genes that affect women's (and more rarely, men's) inherited susceptibility to develop breast and ovarian cancers. The company made headlines when it raced to find the genes now called BRCA1 and BRCA2 and, later, when it used its intellectual property to dominate the American genetic testing market for those genes. One of the best accounts of this intense race to find the BRCA genes is in Kevin Davies' book, Breakthrough (Wiley, John & Sons, Inc., 1995). The company and its patent-based business model have attracted both praise and criticism in the United States and beyond.

In 2006, Caulfield et al., explored in Nature Biotechnology the dominant policy concerns sparked by the issue of human gene patenting more broadly. More specifically, in 2007, Caulfield and Bubela detailed in Genetics in Medicine the English language media coverage of the controversial BRCA case.

The lawsuit against Myriad, the United States Patent and Trademark Office (USPTO), and Directors of the University of Utah Research Foundation was filed by a group of plaintiffs that included patients, professional medical organizations, and patient advocacy groups. The plaintiffs argued that the court should invalidate several claims in patents assigned to Myriad Genetics, which they believed were in violation of both 35 U.S. Code Section 101 and Article I, Section 8, Clause 8 of the United States Constitution. 35 U.S.C. 101 describes subject matter that patents can claim: "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title." Similarly, Article 1, Section 8, Clause 8, also known as the Patent and Copyright Clause, delineates the right to Congress "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries". In other words, this clause authorizes the U.S. patent system.

The plaintiffs in the Myriad case assert that the claims in dispute give Myriad an illegal monopoly over “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.” Following the judge's decision to deny the defendants' motion to dismiss (669 F. Supp. 2d 365 [S.D.N.Y. 2009]), both sides asked the judge to rule based on the documents already submitted to the court. On March 29, 2010, Judge Robert Sweet ruled that, “[b]ecause the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter...” Furthermore, in other sections of his ruling, he determined that the claimed methods for analyzing genetic samples were also invalid, ruled that an additional claim on a specific use of testing was invalid, and indicated that he did not have to address the constitutional questions raised against the US Patent and Trademark Office.

Myriad appealed the decision to the Court of Appeals for the Federal Circuit (CAFC), which was formed by federal statute in 1982 and hears appeals of patent cases from all U.S. District courts. Oral arguments were held on April 4, 2011. The Solicitor General of the United States presented the US government's position; this was the first time that the Solicitor General had appeared before the C.A.F.C. (the task of the Office of the Solicitor General is to supervise and conduct litigation in the United States Supreme Court). Many other amicus curiae briefs were also filed in the case, including one by Christopher Holman (University of Missouri-Kansas City School of Law) and Robert Cook-Deegan (Duke), and have been made publically available by PatentDocs (see BRCA Resources page for link).

The highly anticipated CAFC ruling in this landmark case was handed down on July 29, 2011. Details and commentary on the ruling, including initial complaint, subsequent motions and rulings, and challenged claims are provided on the BRCA Resources page that is linked above. Also available on this page are short summaries of the case and media coverage.

Plaintiffs and Defendants

Plaintiffs

Public Patent Foundation (counsel for plaintiffs)

American Civil Liberties Union (counsel for plaintiffs)

Association for Molecular Pathology

American College of Medical Genetics

American Society for Clinical Pathology

College of American Pathologists

Breast Cancer Action

Boston Women's Health Book Collective

Defendants

United States Patent and Trademark Office

Myriad Genetics

University of Utah Research Foundation (defendants include individuals sued in their official capacity as Directors of the University of Utah Research Foundation)

Case studies of Myriad Genetics

Researchers at Duke University prepared a case study that compared patient access to genetic tests for breast and ovarian cancers with patient access to genetic tests for colorectal cancers. In addition to providing some basic medical background, this study compares prices of the various tests on a per amplicon basis, which allows for a more meaningful comparison than a simple comparison of total prices. E. Richard Gold and Julia Carbone of McGill University and Duke University, respectively, prepared a case study on Myriad Genetics’ business strategy and its communication difficulties, especially outside of the United States." The Danger of Diagnostic Monopolies," is a two-page summary of the Duke University researchers' empirical study of gene patents and licensing of ten clinical conditions, including breast and ovarian cancers. The article does not require a technical background. A six-page article, based on an April 2009 workshop on patenting and licensing in DNA diagnostics, appeared in Nature Biotechnology in 2010.

Introductions to gene patents

Duke's Center for Public Genomics has prepared two summaries of gene patents of short and full length, for somewhat different audiences.

Robert Cook-Deegan prepared a very brief introduction to gene patents in 2008, written for policy-makers and those without a formal legal or scientific background. (Cite as: Robert Cook-Deegan, "Gene Patents," in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns. Pp. 69-72. Ed. Mary Crowley. Garrison, NY: The Hastings Center, 2008.)

Robert Cook-Deegan and Christopher Heaney prepared a longer, general introduction on gene patents intended for scientists interested in an overview and review of the material. It appeared in the 2010 Annual Review of Genomics and Human Genetics.

Myriad Case in Australia

On February 15, 2013, the Federal Court of Australia affirmed the patent eligibility of of isolated DNA molecules under Australian law. The decision has been posted on our BRCA Resources page.

***

This webpage developed by Lane Baldwin, Kathryn Maxson, Christopher Heaney, and Robert Cook-Deegan for the Duke University IGSP Center for Genome Ethics, Law, and Policy and the Duke/Georgetown Center for Public Genomics, funded by the U.S. National Human Genome Research Institute (P50 HG 003391).