Sherry M. Knowles is an intellectual property attorney with 30 years of experience in global corporate and private practice, and is a member of the inaugural class of the IPWatchdog Masters™ Hall of Fame.
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.
The United States Patent and Trademark Office (USPTO) issued a Notice on the “Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board” on July 29, 2022 (87 FR 45764-67), without a big reaction from the IP community. Patent attorneys mostly scratched their heads wondering what it means, especially as it was created in the backdrop of an attack on drug companies and drug pricing. The attack was motivated by a now largely discredited disinformation campaign by the advocacy group I-MAK (Initiative for Medicines, Access and Knowledge; an oxymoron), based on non-peer reviewed erroneous patent data analysis (see supporting false analyses by Univ. of Calif. Hastings Law School “Evergreen Drug Patent Search” and R. Feldman, “May your drug price be evergreen” J. Law and Biosciences Vol 5(3) Dec 2018, 590-647). Notwithstanding, the White House and certain members of Congress picked up I-MAK’s “Overpatented, Overpriced” faulty advocacy piece (2018; updated Sept 2022), and without checking the integrity of the data, quoted to it, and got to work.
In a June 20, 2022, article on IPWatchdog, I addressed a portion of the June 8, 2022, letter from Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun to U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal requesting the USPTO to issue a notice of rulemaking or request for comments in the Federal Register by September 1, 2022, on curbing continuation practice as a means to address “patent thickets.” As of the date of this article, the USPTO has not issued the notice. In this article, I, along with co-author Anthony Prosser, address the other issue raised in the Senators’ June 8 letter—whether elimination of terminal disclaimers that “allow” patents to issue that are “obvious variations of each other” would increase patent quality and whether patents that are tied by a terminal disclaimer should be considered an admission of obviousness and stand or fall together in litigation.
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.
As the summer winds down, it is time again to focus on how to fix the U.S. patent system. In June, the Senate Judiciary’s IP Subcommittee held unprecedented hearings on patent eligibility. They are now back in closed door sessions with selected stakeholders to further consider language to amend Section 101, having received extensive feedback. My testimony in part addressed the unconstitutionality of the U.S. Supreme Court’s cases on patent eligibility, which have created judicial exceptions that arrogantly ignore the plain wording of Congress’ statute (“invention or discovery” in the disjunctive in Sections 100(a), (f) and (g) and Section 101) and its legislative history, and despite the fact that the U.S. Constitution gives Congress the sole power to create patent law. The doctrine of judicially-created non-statutory obviousness-type double patenting is the flip side of the coin of the patent eligibility issues. A rejection for “non-statutory obviousness-type” double patenting is based on a “judicially-created doctrine” grounded in public policy and which is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinct from claims in a first patent. This is problematic for at least the following reasons.
This morning, the American Civil Liberties Union (ACLU), which will be represented in Wednesday’s hearing on Section 101 reform by Senior Legislative Counsel Kate Ruane, announced an urgent phone briefing for members of Congress and staff to address the contention that the “Proposed Patent Bill Would Jeopardize Health Care and Harm Medical Research.” The phone briefing, which all interested stakeholders should join, takes place today at 2:30 pm EST and will be jointly held by representatives from the ACLU, the Association for Molecular Pathology, a breast cancer survivor and patient, My Gene Counsel, and Invitae. Anyone who would like to listen should dial in to the number provided here. Below, Sherry Knowles, a well-known patent attorney, policy expert and also a breast cancer survivor, rebuts the arguments made in both the ACLU’s briefing announcement and associated letter to Congress on this topic.