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Current written description jurisprudence can make it difficult to obtain broad antibody patents, leading practitioners to explore alternative claiming strategies in an effort to bypass the limited scope afforded under the...more
On March 24, 2025, the US Court of Appeals for the Federal Circuit (Federal Circuit) issued a decision titled In Re: Riggs (the Riggs decision) that vacated a decision of the Patent Trial and Appeal Board (PTAB) of the US...more
In In re: Xencor, Inc., the US Court of Appeals for the Federal Circuit confirmed that the limiting preamble of a Jepson claim must be supported by the specification with “sufficient written description.” In its decision, the...more
Last week a remarkably interesting Federal Circuit case was decided concerning whether an asserted reference was properly shown to qualify as prior art in the rejection of a pending patent application. The pending application...more
On March 24, 2025, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion vacating and remanding a decision of the U.S. Patent Trial and Appeal Board (the “Board”) that a published patent application...more
The US Court of Appeals for the Federal Circuit found a Jepson claim unpatentable where the specification did not provide adequate written description for the portion of the claim purporting to recite what was already well...more
In re: Xencor, Inc., Appeal No. 2024-1870 (Fed. Cir. Mar. 13, 2025) Our case of the week is an appeal from a decision of the Appeals Review Panel of the Patent Trial and Appeal Board, concerning Xencor’s patent application...more
Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more
The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents...more
Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more
In re Entresto (Sacubitril/Valsartan), Appeal Nos. 2023-2218, -2220, -2221 (Fed. Cir. Jan. 10, 2025) In our Case of the Week, the Federal Circuit revived Novartis’s US Patent No. 8,101,659 by reversing the district...more
Since serving as a Federal Circuit clerk, Michael Hawes has monitored that court's precedential opinions and prepares a deeply outlined index by subject matter (invalidity, infringement, claim construction, etc.) of relevant...more
Addressing invalidity due to obvious-type double patenting (ODP) based on later-filed-related patents, the US Court of Appeals for the Federal Circuit reversed a district court’s application of In re Cellect (Fed. Cir. 2023)...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s holding that the asserted method of treatment patent was valid and infringed because safety and efficacy are not patent concerns. The Federal Circuit...more
This case concerns determining the prior art status of certain references in an inter partes review. The Federal Circuit considered whether the Patent Trial and Appeal Board (the “Board”) was correct in declining to consider...more
United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more
The US Court of Appeals for the Federal Circuit affirmed two Patent Trial & Appeal Board decisions holding the challenged claims unpatentable as obvious, even though the Board declined to consider evidence of antedating and...more
The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement...more
The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that there was insufficient written description in the asserted priority applications to support a genus claim because of...more
Regents of the University of Minnesota v. Gilead Sciences, Inc., Appeal No. 21-2168 (Fed. Cir. Mar. 6, 2023) The Federal Circuit’s only precedential patent opinion this week focuses on the written description requirement...more
The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s (Board) interference decision finding that priority belonged to the junior party based on sufficiently corroborated reduction to...more
CareDx, Inc. v. Natera, Inc., Appeal Nos. 2022-1027, -1028 (Fed. Cir. July 18, 2022) - In its only precedential patent opinion this week, the Federal Circuit held patents directed to the detection of organ transplant...more
Addressing the issue of negative claim limitations, the US Court of Appeals for the Federal Circuit granted a petition for panel rehearing, vacated its prior decision (authored by now-retired Judge O’Malley) and reversed the...more
In Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) held patent claims invalid for lack of written description where a negative limitation was...more