Sherry M. Knowles is an intellectual property attorney with 30 years of experience in global corporate and private practice. Currently the Principal of Knowles Intellectual Property Strategies, Ms. Knowles was the Senior Vice President and Chief Patent Counsel at GlaxoSmithKline from 2006-2010, where she served as the worldwide head of patents for all litigation and transactional matters, and managed a global department of over 200 people in 12 offices. At GSK, Ms. Knowles was a member of the Scientific Advisory Board, the Technology Investment Board, the Product Management Board, the Legal Management Team and she led the Global Patents Executive Team.
Ms. Knowles played a key role in the case of GlaxoSmithKline and Tafas v. Dudas, 541 F. Supp. 2d 805 (E.D. Va. 2008). On October 9, 2007, GSK became the first and only company in the US to file a lawsuit to challenge the Final Rules published by the US Patent and Trademark Office on August 7, 2007. During the course of litigation, 20 amicus briefs were filed by parties in support of GSK and Dr. Tafas, including from the AIPLA, PhRMA, BIO, IPO, Washington Legal Foundation and CropLife America. The litigation concluded in October 2009, when David Kappos made the decision to withdraw the contested regulations and GSK agreed to join with the PTO in a motion to dismiss all litigation.
In 2008, Managing IP Magazine named Ms. Knowles one of the top 10 most influential people in Intellectual Property, referring to her as a “Patent Owner’s Advocate.” In 2010, the New Jersey Intellectual Property Lawyers Association awarded GSK, with Ms. Knowles as the representative, the Jefferson Medal for exceptional contribution to Intellectual Property. In 2010, Managing IP Magazine named the GSK Global Patent Team the “In-House IP Team of the Year” for 2009 for the constructive approach to IP in the developing world, the engagement with public policy in Europe and the successful resolution of the USPTO rules matter in the US.
In November 2011, Intellectual Asset Management Magazine listed Ms. Knowles among the top fifty key individuals, companies and institutions that have shaped the IP marketplace in the last eight years. Ms. Knowles is also listed in the IAM 250 “World’s Leading IP Strategists,” published by IAM Magazine in 2011, the IAM 300 “World’s Leading IP Strategists,” published by IAM Magazine in 2012, 2013, 2014, 2015, 2016 and 2017 as well as the IAM 1000 “World’s Leading Patent Professionals” in 2015, 2016 and 2017. She was also included in the list of Top 250 Women in IP by Managing IP Magazine in 2014, Managing IP’s 2016 and 2017 list of “IP Stars”.
Ms. Knowles was Chair of the IP Subcommittee of PhRMA in 2008, and Chair Emeritus of the PhRMA IP Subcommittees in 2009 and 2010. From 2006-2010, she was a member of InterPat, which is the association of Chief Patent Counsels of the major pharmaceutical companies, and from 2008-2010 was a member of the Executive Committee of InterPat. She was the Chair of the work stream on data exclusivity for InterPat from 2006-2010.
On June 8, 2022, Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun sent a letter to U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal expressing concern about so-called “patent thickets” and requesting that she consider changes to the USPTO regulations and practices to address perceived problems with patent examination. The senators asked the USPTO to issue a notice of proposed rulemaking (which presumably must include new draft regulations) or at a minimum, a public request for comments followed by regulatory action, to address their concern about “the prevalence of continuation and other highly similar patents”.
On April 7, 2021, the European Patent Office (EPO) Opposition Division (OD) issued a comprehensive written decision in the Opposition by Gilead Sciences, Inc. against NuCana plc’s European Patent No. B-2 955 190, upholding amended compound claims that include Gilead’s blockbuster hepatitis C drug, Sovaldi (sofosbuvir). The claims were upheld over various arguments made by Gilead, including an assertion that the NuCana patent did not teach the skilled worker how to make the nucleoside component of Sovaldi (which is a nucleotide phosphoramidate). Gilead alleged, as it did in the myriad of global Idenix litigation cases, that a skilled person in 2003 who tried to make the nucleoside of Sovaldi “would be required to undertake extensive experimentation, if indeed he would be able to succeed at all. This represented an undue burden.”
I was at the JP Morgan Healthcare Conference when I learned a week ago that the Supreme Court of the United States (SCOTUS) had denied Athena Diagnostic’s Petition for Certiorari. I was shocked. We feel the same when as a child we discover there is no Santa Claus—a trusted institution is not as represented. SCOTUS ignored a recommendation from the U.S. Solicitor General in the strongly worded Vanda opinion that the Court’s opinions had veered away from Congress’ law; a desperate plea from the U.S. Court of Appeals for the Federal Circuit that it needed better guidance and thinks the law is on the wrong path; 11 thoughtful amicus briefs; and Athena’s petition. The Court was also referred to my law review article with Anthony Prosser “Unconstitutional Application of 35 U.S.C. 101 by the U.S. Supreme Court” based on almost a year of legal research. During the month after final briefing in Athena and after the U.S. Solicitor’s opinion, we saw a significant uptick in downloads of our article (cited in the amicus brief to the Court I co-authored with Meredith Addy of AddyHart on behalf of Freenome and New Cures for Cancers)—over 30 downloads during the holiday season and prior to the Court’s conference on January 10, when most IP practitioners are otherwise distracted, providing an unconfirmable assumption that the Court was reading it. All to no avail.
On November 1, Meredith Addy of AddyHart P.C. and I submitted an Amici Curiae brief to the U.S. Supreme Court on behalf of Freenome Holdings and New Cures for Cancers in support of the Petition for Certiorari in Athena Diagnostics v. Mayo Collaborative Services. If the Supreme Court does not take this case, it is unlikely to reconsider its decisions on Section 101 of the U.S. patent law. This may be our last gasp judicial effort. The Supreme Court takes cases raising inconsistencies in the law or a circuit split. We knew parties/amici would focus on the Federal Circuit’s “internal circuit split,” so we took a different approach and urged the Court to resolve five critical inconsistencies in the law, summarized below.