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
Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception...more
In the landmark Amgen v. Sanofi case (previously covered here), the Supreme Court affirmed that patent claims drawn to a genus of monoclonal antibodies, which were claimed in terms of their function and the epitope to which...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
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
The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v....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
In a unanimous decision, the Supreme Court has affirmed the lower court’s ruling that Amgen’s broad genus claims to cholesterol-lowering antibodies are invalid for lack of enablement....more
The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more
ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more
On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 2 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...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
The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is necessary to support genus claims....more
Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...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
Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification...more
BIOGEN INTERNATIONAL GMBH V. MYLAN PHARMACEUTICALS INC. Before O’Malley, Reyna, and Hughes. Appeal from the United States District Court for the Northern District of West Virginia. Summary: A specification may not...more
The recently reversed jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno...more
On Aug. 26, 2021, the Federal Circuit held the asserted claims of Sloan Kettering’s CAR-T patent invalid for lack of written description, reversing the final judgment of a California district court awarding Sloan Kettering...more
Dominating the entering gallery of the Impressionists exhibit at the Art Institute of Chicago is Georges Seurat's A Sunday on La Grande Jatte (see below). Painted in the pointillist style, the work comprises millions of...more
Perfect Your Patent Prosecution Strategies and Master the Patent Application Process in the U.S and Around the World. ACI’s 18th Global Summit on Life Sciences Patents virtual conference this August will provide practical...more
On January 9th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its motion in opposition to Senior Party the Broad Institute (joined by...more