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
On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No....more
Pegfilgrastim 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
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
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...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
Insulin Glargine 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
Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...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
On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...more
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more
On February 28, Amgen, Inc. (“Amgen”) filed three petitions for inter partes review, challenging the validity of all claims in three patents assigned to Bristol-Myers Squibb Co. (“BMS”). The claims of all three patents are...more
On February 28, 2025, Amgen filed three IPRs against Bristol-Myers Squibb’s patents covering methods of treatment using a combination of Opdivo® (nivolumab), an anti-PD-1 antibody, and Yervoy® (ipilimumab), an anti-CTLA-4...more
A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection afforded by section viii carve-outs, a mechanism that allows Abbreviated New Drug...more
On February 4, 2025, HyClone Laboratories, LLC (“HyClone”), a cell culture media supplier, filed a Motion to Quash a subpoena issued by Amgen, Inc. (“Amgen”). The underlying subpoena was issued in Amgen’s ongoing denosumab...more
On January 15, 2025, Celltrion filed IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging claims 1-17, 19-42, 44-50 as anticipated and claims 1-50 as obvious....more
In a judgment of 23 December 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024, ruling that (i) manufacturers are not obliged to provide the reference number of...more
The safe harbor exception in 35 U.S.C. § 271(e)(1) applies “solely for uses reasonably related to the development and submission of information” to the Food and Drug Administration (FDA). The Federal Circuit interpreted the...more
Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more