Supreme Court Affirms Federal Circuit Decision in Amgen v. Sanofi

Attorney: Richard D. Kelly
May 18, 2023

In a unanimous opinion the Court decided that the Federal Circuit’s decision was correct.<... Read more

Supreme Court Denies Cert in Patent Eligibility Cases and the Skinny Label Case

Attorney: Richard D. Kelly
May 15, 2023

Today the Supreme Court denied cert in GSK v. Teva in which the Solicitor General filed a brief in support of granting cert. The Solicitor argued that the decision in GSK’s favor threatened the availability of lower cost generic drugs. <... Read more

Amgen v. Sanofi – Impermissible Functional Claiming?

Attorney: Richard D. Kelly
May 12, 2023

On April 28 the Supreme Court heard oral arguments on Amgen’s petition of the Federal Circuit’s decision affirming the district court’s decision on JMOL that Amgen’s antibody claims lacked an enabling disclosure. Much of the argument revolved around what was the quantum of experimentation that was too much for a claim to be enabled. At the end of Sanofi’s argument its counsel cited the Morse case where the Supreme Court invalidated Morse claim 8 which defined the transmission of symbols in solely functional terms:<... Read more

A Broad Outline of a Genus's Perimeter Is Insufficient For Written Description of the Members of the Genus

Attorney: Marina I. Miller, Ph.D.
April 7, 2023

The Regents of the University of Minnesota (“Minnesota”) appealed from a final decision of the U.S. PTO Patent Trial and Appeal Board (“the Board”) holding that the claims of U.S. Patent 8,815,830 were unpatentable as anticipated. The Court of Appeals for the Federal Circuit (“the Court”) affirmed.<... Read more

Anticipation Under the Public Use Bar

Attorney: Marina I. Miller, Ph.D.
April 4, 2023

Minerva Surgical, Inc. sued Hologic, Inc. and Cytyc Surgical Products, LLC in the District of Delaware for infringement of U.S. Patent No. 9,186,208. After discovery, the district court granted summary judgment that the asserted claims were anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b). Minerva appealed. The Court of Appeals for the Federal Circuit (the Court) affirmed.<... Read more

PIV Notice Need Not Address All Claims to Preserve Rights

Attorney: Richard D. Kelly
April 3, 2023

In Bausch Health Ireland v. Mylan Pharms. N.D. WV., 1:22CV20 Bausch moved for judgment of infringement on the pleadings under Rule 12(c) to prevent Mylan’s launch of its generic equivalent to Bausch’s drug Trulance® for treating chronic idiopathic constipation and irritable bowel syndrome with constipation.  Bausch’s motion was predicated on the failure of Mylan to assert in its Paragraph IV notice (PIV) non-infringement of two claims of the asserted patents. Bausch also moved to strike Mylan’s affirmative defenses under Rule 12(f). In its answer Mylan denied infringement of all asserted claims.<... Read more

Risk Evaluation and Mitigation Strategy Patent Not listable in Orange Book

Attorney: Richard D. Kelly
March 6, 2023

The Federal Circuit on February 24th affirmed the Delaware District order in Jazz Pharm., Inc. v. Avadel CNS Pharm., LLC., 2023-1186, that Jazz delist from the Orange Book its Patent 8,731,963 directed to a REMS to control access to its drug Xyrem, also known as gamma hydroxyl butyrate (GHB) which was misused to facilitate rape, the “date rape” drug.” The decision considered whether to list a drug in the Orange Book was proper.   Patents may be listed in the Orange Book if it either claims the drug or methods of using the drug. 21 U.S.C. § 355(b)(FDCA) and 21 C.F.R. § 314.53(b)(1). Jazz contended that patent law did not provide the correct framework determining whether a patent should be listed in the Orange Book. Both the statute and rule look to the patent claims to determine if a patent claims either the drug or a method of using the drug.  Here the issue was whether the ‘963 claims were directed to a method of using Xyrem.<... Read more

Federal Circuit Reiterates: Isolated Natural Products Alone Are Not Patent Eligible Without A Markedly Different Characteristic

March 3, 2023

co-authored by Sara Pistilli, PharmD. and Richard D. Kelly<... Read more

Claims Directed to Detecting Natural Phenomena Using Conventional Techniques Are Patent Ineligible

Attorney: Marina I. Miller, Ph.D.
February 22, 2023

CareDx is the exclusive licensee of U.S. Patents 8,703,652, 9,845,497, and 10,329,607 entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients” owned by Stanford. The patents describe diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (“cfDNA”). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, thus releasing cfDNA from the donated organ’s dying cells into the blood. The increased levels of donor cfDNA, which occur naturally as the organ’s condition deteriorates, can be detected and used to diagnose the likelihood of an organ transplant rejection. Claim 1 of the ’652 patent reads (simplified):<... Read more

CAFC Affirms Obviousness Rejections Regarding Lack of Motivation to Combine

Attorney: Grace Kim
January 23, 2023

Update by Kasumi Kanetaka & Grace Kim

Last month, the Federal Circuit issued a non-precedential decision affirming the PTAB’s holdings in two final written decisions. P Tech, LLC (herein “P Tech”) appealed the PTAB decisions holding that claims 1 and 4 of U.S. Patent 9,192,395 (herein “’395 patent”) and claims 1-20 of U.S. Patent 9,149,281 (herein “’281 patent”) are unpatentable because they would have been obvious over the cited prior art, U.S. Patent 6,331,181 (herein “Tierney”) in view of U.S. Patent 5,518,163 (herein “Hooven”).P Tech, LLC, v. Intuitive Surgical, Inc., No. 22-1102, No. 22-1115 (December 15, 2022)<... Read more