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:
David Inglefield
July 23, 2025
On June 30, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision regarding transitional phrase claim construction, reversing the decision of the Patent Trial and Appeal Board (PTAB) in Eye Therapies, LLC. v. Slayback Pharma, LLC. The PTAB had previously ruled the claims of U.S. Patent No. 8,293,742 (the ‘742 patent) unpatentable as obvious in a inter partes review brought by Slayback. During the inter partes review, the parties had disagreed on the construction of the transitional phrase “consisting essentially of” in the ‘742 patent. The Court found that the Board had incorrectly applied the conventional open construction of the transitional phrase, which was at odds with the prosecution record. This demonstrates how prosecution history can alter a phrase’s typical meaning.<... 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