Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
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
Adalimumab 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
Rituximab 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
Etanercept 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
Simbrinza® (brinzolamide / brimonidine) - Case Name: Alcon Inc. v. Padagis Israel Pharms. Ltd., Civ. No. 22-1422-WCB, 2025 WL 457119 (D. Del. Feb. 5, 2025) (Bryson, C.J.) Drug Product and Patent(s)-in-Suit: Simbrinza®...more
In a formulation claim, if elements are listed separately, does this necessarily entail that those elements are “separate and distinct components”? This was the question before the district court in Regeneron...more
On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s denial of a preliminary injunction against Amgen Inc. (“Amgen”) in the ongoing...more
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On...more
In June 2021, the US Patent and Trademark Office (USPTO) published an update to its study of America Invents Act (AIA) trials involving challenges to Orange Book-listed and biologic patents from September 16, 2012, through...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
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the second wave suit, on December 21, 2021,...more
On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s...more
In the context of Immunex’s patent on IL-4 antibodies, the Federal Circuit says yes. On October 13, 2020, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (the “Board”) final written decision in...more
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more
The late Gilda Radner's character, Emily Latella, would consistently misapprehend something ("violins on television," "saving Soviet jewelry"), give a guest editorial on Weekend Update, and when corrected would say "Never...more
The US Court of Appeals for the Federal Circuit affirmed a summary judgment non-infringement ruling, finding that where both the claim language and the specification require that the disclosed steps be performed in the order...more
As we previously reported, Mylan recently filed a motion for judgment on the pleadings regarding Amgen’s assertion of the ’707 Patent, which covers methods related to producing the biosimilar pegfilgrastim. Mylan’s motion...more
Last week, the Patent Trial and Appeal Board (“Board”) denied institution of four IPR petitions on biologics-related patents. First, the Board denied institution of IPR2017-01987 and IPR2017-01988, both filed by Sandoz Inc. ...more
This year was a significant year for intellectual property cases at the Supreme Court level. In fact, the Supreme Court granted certiorari for seven patent cases, and decided five of these cases before the end of the year....more
Core Wireless v. LG affirms the denial of summary judgment as to unpatentable subject matter, ruling that the asserted claims are directed to an improved user interface for computing devices, not to the abstract idea of an...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more