5 Key Takeaways | Best Practices in Patent Drafting: Addressing 112 and Enablement after Amgen
In January 2026, the Federal Circuit issued a nonprecedential opinion in Guardant Health, Inc. v. University of Washington (Slip Op. 2024-1129, Jan. 23, 2026) that, while not binding precedent, is nevertheless highly relevant...more
Innovation is accelerating at an unprecedented pace, especially in today’s world where artificial intelligence can instantly answer questions and generate content. While this presents exciting opportunities for inventors...more
As discussed in our previous article, Comcast sought mandamus relief after Judge Gilstrap of the Eastern District of Texas denied the company’s motion to dismiss or transfer for improper venue....more
While the U.S. Supreme Court rejected Amgen's functionally defined anti-PCSK9 antibody claims based on its high bar for enablement, the European Patent Office ("EPO") found such broad antibody claims allowable. Amgen's battle...more
Consistent with standing precedents, the U.S. Court of Appeals for the Federal Circuit (the court) invalidated Seagen’s US10,808,039 patent (the ’039 patent) claims directed to antibody-drug conjugates (ADCs) comprising a...more
Our Patent Case Summaries provide a weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial...more
On December 2, 2025, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Seagen Inc. v. Daiichi Sankyo Company Ltd., which further clarifies the amount of disclosure a US patent must contain...more
On December 2, 2025, the Federal Circuit issued two related decisions concerning Seagen’s U.S. Patent No. 10,808,039 (“the ’039 patent”), asserted against Daiichi Sankyo and AstraZeneca in litigation over the antibody–drug...more
The US Court of Appeals for the Federal Circuit reversed a district court’s denial of a motion for judgment as a matter of law (JMOL), finding that the patent specification failed to provide an adequate written description to...more
In Re: Gesture Technology Partners, LLC, Appeal No. 2025-1075 (Fed. Cir. Dec. 1, 2025) - In our Case of the Week, the Federal Circuit affirmed the denial of a motion to terminate ex parte reexamination proceedings on a...more
The explosive growth of artificial intelligence has created unprecedented challenges for patent protection. While AI may be "the most transcendent and transformative technology of our time," as USPTO Director John Squires...more
In Brita LP v. Int’l Trade Comm’n, No. 24-1098 (Fed. Cir. Oct. 15, 2025), the Federal Circuit, in a precedential opinion, affirmed the International Trade Commission’s (“ITC” or “Commission”) decision that certain claims of...more
As artificial intelligence (AI) becomes a fixture across a broad range of technological fields, AI technology continues to evolve at rapid rates. This highly compressed development lifecycle for AI products presents novel...more
The US Court of Appeals for the Federal Circuit affirmed the US International Trade Commission’s (Commission) decision that a water filtration patent was invalid for lack of written description and enablement because the...more
As we wrote about recently here, Examiners continue to rely on the USPTO’s current guidance on the definiteness standard set forth by the Court of Appeals for the Federal Circuit (“Federal Circuit”) in In re Maatita, 900 F.3d...more
Beginning in November 2024, Merck Sharp & Dohme, LLC (“Merck”) requested post-grant review (“PGR”) of 14 patents owned by Halozyme, Inc. (“Halozyme”), with claims directed to modified PH20 hyaluronidase polypeptides,...more
Nature of the Case and Issue(s) Presented: Tymlos is used to treat osteoporosis. The API in Tymlos, abaloparatide, is a synthetic analog of the first 34 amino acids of parathyroid hormone related protein (“PTHrP”). Early...more
The Supreme Court in Amgen v. Sanofi affirmed the invalidation of Amgen's antibody patents for lack of enablement. The patents at issue claimed "the entire genus" of antibodies capable of (1) binding specific amino acid...more
A magistrate judge in the District of Delaware issued a Report and Recommendation, that found the sole asserted claim was a “single means” claim and therefore invalid for lack of enablement. In reaching that conclusion, the...more
In Agilent Techs., Inc. v. Synthego Corp., the Federal Circuit addressed the difference between the enablement standard for an anticipatory prior art reference (under 35 U.S.C. § 102) and that for an applicant/patentee’s own...more
Nature of the Case and Issue(s) Presented: Myrbetriq is a drug used to treat overactive bladder. It utilizes a hydrogel-based sustained-release oral tablet formulation to control the rate at which the active ingredient,...more
On July 16 2025, the Court of Appeal dismissed AstraZeneca’s appeal and upheld the first instance decision, finding that AstraZeneca’s compound patent for dapagliflozin, an SGLT2 inhibitor used to treat diabetes, was invalid...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 U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025)....more
In an appeal from an inter partes review, the Federal Circuit recently clarified that the enablement inquiry applied to prior art references in the context of an anticipation defense differs from the enablement inquiry...more