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 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
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...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
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
Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
In an appeal, Novartis Pharmaceuticals v. Accord Healthcare, Inc., the issue of whether a patent provides sufficient written description of a negative limitation split the panel at the Federal Circuit. Novartis...more
The PTAB Strategies and Insights newsletter provides timely updates and insights into how best to handle proceedings at the USPTO. It is designed to increase return on investment for all stakeholders looking at the entire...more
After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had...more
When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim? This is a question that comes readily to mind...more
NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. Before Moore, Linn, and O’Malley. Appeal from the United States District Court for the District of Delaware. Summary: A patent application that was silent about a...more
On December 8, 2021, the Federal Circuit in AztraZeneca AB v. Mylan Pharms. Inc. held that the claim construction of a percentage term should “‘most naturally align[] with the patent’s description of the invention,’ as...more
AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021) - Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was...more
Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more
Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more
The Federal Circuit invalidated Juno Therapeutics, Inc.’s T cell therapy patent for cancer treatment and erased a billion dollar judgment in Juno’s favor. The court held that the jury verdict regarding the patent’s written...more
JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. Before Moore, Prost, and O’Malley. Appeal from the United States District Court for the Central District of California. Summary: Knowledge of a common general structure and the...more
A recent Supreme Court petition for certiorari alleges that genus claims are no longer viable under the Federal Circuit’s recent application of enablement and written description law.The petition has huge ramifications not...more
One of the most interesting and promising areas of medical research today involves the use of T-Cell therapies, which offer hope and promise as a new approach to cancer treatment. It has also made for a robust climate for...more