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:
Diane Jones
February 12, 2026
On November 18, 2025, an inter-partes review IPR2024-01014 between Inari Agriculture, Inc., Petitioner and Corteva Agriscience LLC, Patent Owner, received a Final Written Decision from the Patent Trial and Appeal Board asserting that no challenged claims were unpatentable of U.S. Patent 8,901,378 B2.<... Read more
Author:
David Inglefield
March 10, 2025
On February 13, the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed the decision of the International Trade Commission (ITC) in US Synthetic Corp. v. International Trade Commission, issuing a precedential decision regarding subject matter eligibility important to the pharmaceutical and other life science industries. The ITC had previously ruled that US Synthetic’s composition of matter claims reciting measured properties of a composition were directed to a patent-ineligible abstract idea under 35 U.S.C. § 101. The CAFC found that the claims were indeed related to concrete structures, not patent-ineligible abstract ideas, and affirmed the lower court’s finding regarding enablement.<... Read more
Author:
Xiaohua (Joyce) Guo, Ph.D.
February 18, 2025
In a precedential opinion issued on January 10, 2025, the United States Court of Appeals for the Federal Circuit reversed a district court’s ruling that had invalidated claims 1-4 of U.S. Patent No. 8,101,659 (“the ’659 patent”) for lack of written description.<... 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:
Derek Lightner, Ph.D.
December 30, 2024
In the matter Ex parte MICHAEL J. WEST, in Technology Center 1700 (USSN 16/078,845; Appeal 2023-003903) rejections for an alleged lack of patentable subject matter, a lack of enablement, indefiniteness, and obviousness by a primary examiner, Lore Jarrett, were reversed by a panel of the Patent Trial and Appeal Board (PTAB) made up of Jeffrey R. Snay, Whitney Wilson, and Jane E. Inglese. The first appealed claim recited (with the underlined portions added after the first rejection): <... Read more
Author:
Richard D. Kelly
October 2, 2024
In Astellas Pharma Inc. v. Sandoz Inc,, et al, following a five-day patent claims bench trial the court found asserted claims 5, 20, and 25 invalid under 35 U.S.C. § 101 even though Sandoz had not asserted 101 as defense at any time during the case. The parties had agreed to limit the issue to claims 5, 20, and 25 and the defense to invalidity under 35 U.S.C. § 112. Neither party had notice that patent eligibility was an issue. In making his ruling Judge Bataillon relied upon a statement in Astellas post-trial brief that the “inventive concept of the ’780 Patent was discovering the dissolution rate that would address the food effect and achieving it using previously known formulation technology.” Thus, because the claimed invention “reflects merely the discovery of the food-effect-resolving dissolution profile,” the district court deemed the asserted claims invalid as patent ineligible. Not only had the issue of patent eligibility not been raised by the defendant, but the claims were also to a specific composition. Recognizing the district court had gone on astray Sandoz moved the court to make additional findings of fact advising the court that the § 101 defense had not been raised as a defense and that the decision must be based on the language in the claims. The motion was denied.<... Read more
Author:
Nicholas Rosa, Ph.D.
September 17, 2024
The Patent Trial and Appeal Board (PTAB) recently reversed a final rejection based on § 101 by finding that a method for selecting individuals for a breeding program that recited the steps of “growing, selecting, and crossing” did integrate an “optimized [genome] estimation data set” judicial exception into practical application. These actionable steps and the distinct advantages the method represented over conventional breeding methods involving other types of genomic prediction described in the specification were instrumental in the PTAB’s findings. The inclusion of such actionable steps and description of the advantages of the subject matter of the application may be useful to support amendments that may be necessary to overcome § 101 rejections.<... Read more
Author:
Derek Lightner, Ph.D.
June 11, 2024
In Ex parte Freeman (USSN 16/270,259; TC 1600; Appeal 2023-000512, the underlying application being referred to herein as the “Freeman application”), a finding of obviousness and obviousness-type double patenting (ODP) was reversed on May 24, 2024. Freeman’s application was examined by Devang Thakor initially, but the case was taken over by another primary examiner, Nicole Babson, whose position was supported by Supervisor Patent Examiners, David Blanchard and Bethany Barham.<... Read more
Author:
Richard D. Kelly
December 18, 2023
Recently Judge Connolly, Chief Judge of the District Court of Delaware had an opportunity of deciding three motions for summary judgment filed by CareDX in its litigation with Natera, Natera, Inc. v. CareDX, Inc, Dist. DE, CA 20-38, that one patent was invalid as being directed to patent ineligible subject matter. The patents are U.S. Patent Nos. 10,597,724 (‘724), 10,655,180 (‘180), and 11,111,544 (‘544). The ‘724 and ‘180 patents are directed to methods of observing DNA in samples taken from patients. The ‘544 patent is directed to a method of “preparing a preparation of amplified DNA” from the sample of an individual to observe the DNA of a second individual in the sample. The Court found that one claim in each patent was representative of all claims in the respective patent. These representative claims are:<... Read more