Author:
Richard D. Kelly
March 19, 2026
In our January Newsletter (here) we reported on the non-precedential Federal Circuit decision in Daiichi Sankyo Co. v. Seagen Inc., Fed. Cir. Dec 02, 2025, appeal 2023-2424, holding that Seagen’s U.S. Patent 10,808,039 (‘039) was invalid for lack of written description and enablement, over turning a jury verdict and JMOL to the contrary. This was the second time in a two-week period that the Court had overturned jury verdicts in favor of the patentee on written description. As the Court recognized in the earlier decision Duke Univ. et al. v Sandoz, Inc., 160 F.4th 1305 (2025) “a district court’s refusal to grant judgment as a matter of law may be reversed only if the evidence is such that without weighing the credibility of the witnesses the only reasonable conclusion is in the moving party’s favor.” This is a high burden to meet.<... Read more
Author:
David Inglefield
March 11, 2026
On February 20, 2026, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision regarding recombinant DNA subject-matter eligibility, reversing a decision by the United States District Court for the District of Delaware in REGENXBIO, Inc. v. Sarepta Therapeutics. The district court had previously ruled claims of U.S. Patent No. 10,526,617 (the ‘617 patent) covering a cultured host cell containing a recombinant nucleic acid molecule patent ineligible under 35 U.S.C. § 101 during a patent infringement suit in which both parties moved for summary judgment of patent eligibility under 35 U.S.C. § 101. The district court agreed with Sarepta and held the claims ineligible under § 101 as directed to a natural phenomenon. The CAFC held the claims as not being directed to a natural phenomenon and reversed the district court’s decision, remanding the case for further proceedings.<... Read more
Author:
Robert W. Downs
February 7, 2025
Personalized medicine is especially intriguing, as a problem with most drugs are the potential side effects. From a naive perspective, administering drugs may appear to be a trial and error process: take this for two weeks and come back with a follow up visit. If you have any side effects, contact me immediately. Wouldn’t it be nice if a drug had the effect it was meant to have without the possibility of side effects?<... Read more
Author:
Marina I. Miller, Ph.D.
January 12, 2024
Baxalta Inc. and Baxalta GmbH (Baxalta) appealed a district court decision that the claims of U.S. Patent No. 7,033,590 were invalid for lack of enablement. The Federal Circuit (the Court) affirmed the decision.<... Read more
Author:
Richard D. Kelly
July 11, 2023
The Federal Circuit on June 30 granted a petition for re-hearing en banc of its per curiam decision in LKQ Corp. v. GM Global Tch. Operations, LLC. finding the PTAB had correctly decided that GM’s design patent D797,625 was not unpatentable, i.e., valid. The issue raised was whether the Federal Circuit’s rulings in Durling v. Spectrum Furniture Co., Inc., 101 F.3d 100 (Fed. Cir. 1996); In re Rosen, 673 F.2d 388 in (C.C.P.A. 1982) followed by the PTAB in its decision created a “rigid” rule for obviousness in design patent in violation of Supreme Court’s 2007 KSR decision overturning the Federal Circuit’s rigid rule for obviousness of utility patents, the “teaching, suggestion motivation“ (TSM) test for obviousness. <... Read more
Author:
Richard D. Kelly
July 5, 2023
Amgen provides a window on the Supreme Court approach to patent issues - look to history and established policy as our patent law is not code based but rather common law based. The Court noted that the “enablement requirement” is found essentially unchanged in every version of the patent law since 1790. While Amgen concerned the enablement provision, the same approach applies to patent eligibility, the “judicial exceptions,” which have existed in our case law since the early 19th century. In deciding Amgen the Supreme Court did not consider previous Federal Circuit decisions but looked to history of the enablement provision which involved Court decisions from the 19th and early 20th century. While Amgen was the Court’s first antibody case, it found analogous cases which provided guidance as to how the enablement requirement had been interpreted. Since U.S. patent law is based on common law, this is the appropriate approach to provide the needed predictability. Without understanding the policy behind the exceptions, one will continue to wander aimlessly from one case to the next.<... Read more
Author:
Richard D. Kelly
May 30, 2023
On May 16, the Supreme Court distributed the CareDX cert petition for consideration at the June 1 conference since the Respondents waived filing a reply. The CareDX family of three patents, licensed from Stanford University, U.S.Ps. 8,703,652, 9,845,497 and 10,329,607, are directed to the noninvasive diagnosis of the state of a transplanted organ. The test provides the doctor with information on whether everything is okay, or that the organ is showing signs of being rejected. Both the district court and the Federal Circuit held the patent to be patent ineligible based primarily on admissions appearing in the specification of all three patents which are identical. Given the low success rate (recently zero) of requests for certiorari in the diagnostic/biomarker area, this raises the question as to the possibility the petition will be granted. The CareDx petition’s chances seem better than recent certiorari petitions. <... Read more
Author:
Richard D. Kelly
May 18, 2023
In a unanimous opinion the Court decided that the Federal Circuit’s decision was correct.<... Read more
Author:
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
Author:
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