5 Key Takeaways | Rolling with the Legal Punches: Resetting Patent Strategy to Address Changes in the Law
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
The Federal Circuit’s recent decision in Google LLC v. Sonos, Inc. (24-1097) offers a compelling look at the evolving doctrine of prosecution laches, the written description requirement, and the practical realities of patent...more
The US Court of Appeals for the Federal Circuit reversed a district court’s decision upholding patent validity, finding that the subject patent’s specification clearly established that the written description failed to...more
Mondis Technology Ltd., et al. v. LG Electronics Inc., et al., Nos. 2023-2117, -2116 (Fed. Cir. (D.N.J.) Aug. 8, 2025). Opinion by Hughes, joined by Taranto and Clevenger....more
MONDIS TECHNOLOGY LTD., HITACHI MAXELL, LTD., NKA MAXELL HOLDINGS, LTD., MAXELL, LTD. v. LG ELECTRONICS INC., LG ELECTRONICS USA, INC. - Before Taranto, Clevenger, and Hughes. Appeal from the United States District Court...more
The US Court of Appeals for the Federal Circuit recently held that cancellation of a claim during prosecution may give rise to prosecution history estoppel, precluding the patentee from recapturing the surrendered subject...more
Nature of the Case and Issue(s) Presented: Astellas sued Lupin and Zydus based on the generics manufacturers’ ANDA filing and their efforts to make and sell generic mirabegron. In the leadup to the 2023 bench trial, the...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that a software term was a “nonce” term that invoked 35 U.S.C. § 112, sixth paragraph (i.e., a means-plus-function claim element). The Court...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
The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...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
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd....more
Before Lourie, Prost, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A patent was not invalid for lack of written description for failing to describe the specific infringing embodiment...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
Not surprisingly, the Federal Circuit visited upon Plaintiff/Appellant PureCircle two of the Four Horsemen of the Biotech Patent Apocalypse* in a decision affirming the District Court's invalidation of the claims asserted...more
On September 21, 2023, the PTAB denied United Services Automobile Association’s petition to institute inter partes review of Auto Telematics’s U.S. Patent No. 9,633,487. IPR2023-00519, Paper 10....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
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
In a recent appeal from the PTAB, the Federal Circuit held that claims of a patent were inherently anticipated where the patent and prior art incorporated the same reference to describe a process for making the claimed...more
Hosted by C5, the 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns 23-24 May, at the DoubleTree by Hilton Amsterdam Central Station, Amsterdam with curated programing for you to gain the knowledge and...more
As part of the recovery from the global COVID-19 pandemic, the U.S. Court of Appeals for the Federal Circuit took steps to return to normal operations. It began requiring live oral arguments in August 2022 and, by November,...more
On June 21, 2022, the Court of Appeals for the Federal Circuit (“CAFC”), in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., granted petition for panel rehearing, vacated its prior decision, and reversed the...more
ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more
The consequences of joint development agreements, particularly under circumstances where later development is pursued independently by the parties, can create, inter alia, allegations of improper ownership and infringement if...more