Posts Tagged: "Sherry Knowles"

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.

Through the first half of June, a series of hearings on the state of patent eligibility in America held by the Senate Intellectual Property Subcommittee rendered a variety of interesting exchanges regarding current U.S. subject matter eligibility under Section 101 relating to various important sectors of the U.S. economy. During the second hearing, Senator Richard Blumenthal (D-CT) talked to panelists regarding his concerns about patent abuses in the pharmaceutical industry. During his period of questioning, Blumenthal grilled witnesses on the subject of whether the expansion of subject matter eligibility that would result from the proposed Section 101 draft text would exacerbate issues related to “patent thicketing,” a process by which drug companies attain large patent portfolios covering various aspects of a single drug formulation. Along with Senators Thom Tillis (R-NC) and Mazie Hirono (D-HI), Senator Blumenthal entered a series of questions for the record to be answered by panelists attending the recent patent eligibility hearings. Although the questions don’t overtly single out the pharmaceutical industry, panelist answers largely indicate that this sector was on most people’s mind while responding.

The presently pending petition for en banc review in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC has been addressed by Sherry Knowles and Meredith Addy and is supported by a number of amicus briefs. The patent in issue has been described by the present author as a paradigm of patent eligibility, supporting the argument that en banc review is merited. Mayo has now filed its response brief, submitted on May 7, and argues that the panel’s decision invalidating the asserted claims as ineligible properly applied the two-step Alice framework in light of precedent, that the full Court need not re-examine it, and accordingly, that Appellants’ petition should be denied.

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.

April 22 was the deadline for filing amicus briefs with the Court of Appeals for the Federal Circuit in Athena Diagnostics’ petition for an en banc rehearing by the court. The petition comes after a 2-1 panel decision in early February affirmed a district court’s ruling that patent claims covering methods of diagnosing myasthenia gravis (MG), an autoimmune disorder that causes weakness in skeletal muscles, were directed toward laws of nature and were thus unpatentable subject matter under 35 U.S.C. § 101. In an invitation to file briefs with the Federal Circuit in this case, Knowles IP Strategies Founder Sherry Knowles and AddyHart Partner Meredith Addy discussed the need for amici to hold the Federal Circuit accountable regarding its duty to apply a strict statutory construction of the literal language of Section 101 to ensure that patent eligibility cases are decided in a way that is consistent with Constitutional statutes. Knowles and Addy filed a brief on behalf of Freenome Holdings and Achillon Pharmaceuticals (discussed below). Theirs and other briefs that have now been filed raise concerns about the inability to patent life-saving diagnostic methods that are found ineligible under Section 101 using the Alice/Mayo framework simply because the invention or discovery involves monitoring natural processes.

Yesterday, members of congress announced in a press release a proposed framework to fix patent eligibility law in the United States.Reactions to the framework were mixed. While many are delighted that the issue seems to be getting real attention on Capitol Hill, others are skeptical of some of the proposals. For example, Russ Slifer, former Deputy Director of the United States Patent and Trademark Office (USPTO), described the framework as “a big swing and a miss.” Having attended the meeting on the Hill yesterday in which the framework was released and discussed prior to being circulated to the public, Todd Dickinson of Polsinelli, and the former USPTO Director, said that he can understand how those seeing the proposal without having taken part in the dialogue might be alarmed. “There are still some big questions to answer, but I left the meeting encouraged by the momentum,” Dickinson told IPWatchdog. The discussion, which he described as decidedly “more lawyerly” than previous meetings on the topic, included staffers for both the House and Senate, and from both political parties, which “is a good sign that there is a continued intention to do something,” he said.

Athena Diagnostics filed a petition for en banc rehearing of the United States Court of Appeals for the Federal Circuit’s decision in Athena Diagnostics v. Mayo on April 8, 2019. Amicus briefs are due April 22, 2019. The Athena decision continues to apply U.S. Supreme Court-created common law to the analysis of 35 U.S.C. §101. In its brief requesting rehearing, Athena argues that the decision is “precisely the evisceration of patent law against which the U.S. Supreme Court has long warned” and that the claims at issue were patent eligible, as they are “novel, man-made substances”, “do not preempt natural laws” and “serve a new and useful purpose of diagnosing serious diseases”. Knowles IP Strategies LLC (Sherry M. Knowles) and AddyHart (Meredith Addy) intend to file an amicus brief in support of neither party requesting that the Federal Circuit carry out its constitutional duty to apply strict statutory construction of the literal words of 35 U.S.C. §101 to decide the case (See, Unconstitutional Application of 35 U.S.C. § 101 by the U.S. Supreme Court; 18 J. Marshall Rev. Intell. Prop. L. 144 (2018)).

Scott Elmer is Director, Office of Technology Licensing, at St. Jude Children’s Research Hospital, one of the leading pediatric cancer hospitals in the country. The institution is focused on treatment of and research on children’s catastrophic diseases, particularly leukemia and other cancers. The hospital costs about $2.8 million a day to run and is 100% free to patients. St. Jude and more than 46 of its staff have been the recipients of prestigious awards and achievements, including the 1996 Nobel Prize in Physiology or Medicine, which went to St. Jude faculty member, Peter C. Doherty. Recently, Elmer read Sherry Knowles’ John Marshall Intellectual Property Law Review article, Unconstitutional Application of 35 U.S.C. §101 by the U.S. Supreme Court and was inspired to write her in support of her argument that the Supreme Court’s misreading of the patent statute is causing real harm to inventors and industry on the ground. “I reached out to Sherry because I thought her article was well written and took a different approach to something that’s been a concern for a long time,” Elmer told IPWatchdog. “Sherry made the point that the Supreme Court’s more recent patent eligibility decisions have failed to recognize the patent statute’s reference to the term ‘discovery’ as a basis for the generation of patent-eligible subject matter, which particularly impacts diagnostics.”

The Supreme Court has brazenly admitted it is not following Congress’ statutory instructions on patent eligibility in several cases. And it has carried out virtually none of the required statutory construction. It is judicial activism in the extreme… [I]t is hard to imagine a more unconstitutional statement than that discoveries cannot be patented when the statute the Court is applying states that any invention or discovery can be patented.

For my wishes, I’ll make three. First, as I did last year and the year before, I again continue to wish for patent eligibility reform in Congress that would overrule Mayo, Myriad and Alice. My second wish is for Congress to amend the statutes that created post grant challenges and provide for a real presumption of validity that requires invalidity to be proven by clear and convincing evidence. Finally, as I did last year, I again hope the Federal Circuit dramatically significantly decreases its use of Rule 36 affirmances, and specifically stops using this docket management tool when cases are appealed from the PTAB and also with respect to appeals dealing with 101 patent eligibility issues.

There is near unanimity that the Supreme Court’s decisions in Oil States Energy v. Greene’s Energy Group, 138 S.Ct. 1365 (2018) was among the most significant events of the year. Several also point to the Federal Circuit’s decisions in Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) and Aatrix Software v. Green Shades Software, 882 F.3d 1121 (Fed. Cir. 2018), the impact Director Iancu has had on the USPTO and the patent system, and Congress passing the The Music Modernization Act. Beyond those events, there were others identified by this diverse panel that might have gone unnoticed if we were to focus only on the top-line events of the year.