Are Your Granted Patents in Danger of a Post-Grant Double Patenting Challenge?
The Briefing: A Prototypical Corporate Salesperson is Not Patentable
Podcast: The Briefing - A Prototypical Corporate Salesperson is Not Patentable
Ways to Amend the Claims in the Patent Invalidation Proceedings
Patent Right Evaluation Report in China’s Patent System
Stages of Patent Invalidation Proceedings
On August 20, 2025, the U.S. District Court for the District of Delaware (court) found inequitable conduct when Applicant, Lindis Biotech, GMBH (Lindis), relied on data from hastily performed experiments to obtain a patent...more
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more
Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...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
Recently, the Federal Circuit issued a decision in Immunex Corp. v. Sanofi-Aventis U.S. LLC addressing the different claim construction standards used by the Patent Trial and Appeal Board (“PTAB”) (broadest reasonable...more
Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine, made the following statement regarding enforcement of its patents: We feel a special obligation under the current...more
In Illumina, Inc. v. Ariosa Diagnositcs, Inc., (Fed. Cir. Slip Op. 2019-1419, March 17, 2020) the Federal Circuit held that process claims that exploit the discovered size differences between fetal and maternal DNA in serum...more
PATENT CASE OF THE WEEK - Celgene Corporation v. Laura A. Peter, Appeal Nos. 2018-1167, -1168, -1169, -1171 (Fed. Cir. July 30, 2019) - In this week’s Case of the Week, the Federal Circuit held that the retroactive...more
In a precedential decision delivered this week, the Federal Circuit shot down arguments from Appellants BTG International Limited; Janssen Biotech, Inc.; Janssen Oncology, Inc.; and Janssen Research & Development, LLC (BTG),...more
In Cleveland Clinic Foundation, Cleveland Heartlab, Inc. v. True Health Diagnostics LLC, (Cleveland Clinic II)[1], a unanimous panel of the Federal Circuit provided yet another guidepost illustrating what is not...more
Barry v. Medtronic, Inc. (No. 2017-2463, 1/24/19) (Prost, Moore, Taranto) - Taranto, J. Affirming judgement of no invalidating public use of patents related to methods for correcting spinal column anomalies. Also...more
On Monday, May 14, 2018, the Federal Circuit affirmed the determination by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board in an inter partes review that claim 6 of U.S. Patent No. 7,582,621 is...more
In a 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron...more
Contrary to USPTO guidance, invention details need not be publicly disclosed to trigger on-sale bar for AIA patents. The Leahy-Smith America Invents Act (AIA)1 is widely considered the most significant overhaul of US...more
Since Kyle Bass founded Coalition for Affordable Drugs X LLC (CFAD) to challenge pharmaceutical patents, CFAD has filed numerous petitions with the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office...more
The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
The U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the district court regarding the five asserted patents. Cubist Pharmaceuticals, Inc. v. Hospira, Inc., 805 F.3d 1112, 1115 (Fed. Cir. 2015)....more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
When inter partes review (IPR) proceedings became effective in September 2012, few people would have predicted the transformative effect it would have on patents and the litigation landscape. Three years in, IPR has become...more
On July 28, 2015, Celgene filed a motion for sanctions in IPR Nos. 2015-01092 and 2015-01103, proceedings challenging the validity of Celgene patents covering Thalomid®, Revlimid® and Pomalyst®. Celgene specifically...more