In 2019, 1.7 million people in the United States will be diagnosed with cancer. More than a third of these patients will succumb to the disease. Committed diagnosticians, researchers, and pharmaceutical companies all are fighting to win the war on cancer and save lives, but research into new diagnostics and development of potential cures are hampered by recent U.S. Supreme Court decisions with respect to patent eligibility.
Meredith Addy, co-founder and partner at AddyHart P.C., and Sherry Knowles, founder of Knowles Intellectual Property Strategies, today filed an amici curiae brief for Freenome Holdings, Inc. (Freenome) and New Cures for Cancer (NCFC) in support of a petition for certiorari to the Supreme Court of the United States filed by Wilmer Cutler’s Seth Waxman on behalf of petitioner Athena Diagnostics in Athena Diagnostics v. Mayo Collaborative Services.
Amici Freenome and NCFC ask the Supreme Court to consider the effect of its recent rulings on patent eligibility that inhibit innovative companies, researchers and other organizations from exploring promising new cures for cancer and seeking to bring those cures to people.
“Recent decisions by the Supreme Court have made the path to commercialize new treatments more difficult, increasing risk and disincentivizing companies, organizations, and other committed individuals from pursuing much needed cures,” notes Addy. “Freenome and NCFC encourages the Court to take up Athena Diagnostics v. Mayo Collaborative Services, to consider if current law determining what subject matter is eligible for a patent is inconsistent as a result of the Court’s own recent decisions.”
In Athena v. Mayo, the question presented by the petitioner is “Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.” Freenome and NCFC’s brief argues that the rubric offered in the Supreme Court’s 2011 decision in Mayo Collaborative Services v. Prometheus Laboratories then developed its 2014 decision in Alice Corp. v. CLS Bank is inconsistent with the wording of U.S.C. 35 Section 101.
Freenome and NCFC argue inter alia that the Court’s application of Section 101 is inconsistent with the intent of the patent statute and its legislative history and that the Court’s application of statutory construction principles to patent-eligibility law is inconsistent with its application of statutory construction principles to other federal laws.
The petition for certiorari concerns Athena Diagnostics, Inc., et al. v. Mayo Collaborative Services, LLC, dba Mayo Medical Laboratories, et al. (19-430) on appeal from the Federal Circuit after a petition for rehearing en banc filed by plaintiffs-appellants Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V. was denied in July 2019.
Notably, the Federal Circuit’s Order per curiam to deny the petitioners’ request for rehearing was accompanied by eight opinions—four concurring in denial and four dissenting. Seven members of the Court authored opinions concurring with or joining in the denial; five members of the Court authored or joined opinions dissenting from it.
Freenome and NCFC are joined by nine other amici in support of petitioners Athena et al. Amicus curiae briefs were filed by the New York Intellectual Property Law Association; the Intellectual Property Law Association of Chicago; the Chartered Institute of Patent Attorneys; the Biotechnology Innovation Organization; the Intellectual Property Owners Association; Pharmaceutical Research and Manufacturers of America; The Hon. Paul R. Michel, former Chief Judge of the U.S. Court of Appeals for the Federal Circuit, and others.
Meredith Addy is an intellectual property litigator who has handled more than 40 cases before trial courts and argued more than 60 appeals to the Federal Circuit. She has held leadership positions at several AmLaw100 firms, and is a recipient of many awards and honors; she also consults to executive teams on the most efficient strategies for realizing their IP goals. Addy has testified before Congress to address issues relating to the Federal Circuit and the state of patent law. She has been a member of the Federal Circuit’s Advisory Council and a member of the board of directors of the Federal Circuit Bar Association. Addy is also a co-founder of the Richard Linn American Inn of Court, which is directed to intellectual property, and served as its first president. Law360 recently named Addy one of the Most Influential Women in IP Law.
Sherry Knowles is an intellectual property attorney with 30 years’ experience in global corporate and private practice. From 2006 to 2010, whe was the Senior Vice President and Chief Patent Counsel at GlaxoSmithKline, where she served as worldwide head of patents for all litigation and transactional matters; managed a global department of more than 200 people in 12 offices; was a member of GSK’s Scientific Advisory Board, Technology Investment Board, Product Management Board, and Legal Management Team, and led the Global Patents Executive Team.