Sherry Knowles

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.