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
Biosimilars 2018 - A Year in Review
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
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
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
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
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
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
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
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
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...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
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...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
On January 24, 2025, Amgen announced it had reached a settlement with Celltrion in Case No. 1:24-cv-06497 (D.N.J.) related to Celltrion’s proposed biosimilar of Prolia® / Xgeva® (denosumab), CT-P41....more
On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen and Celltrion resolving the BPCIA litigation regarding...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
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big...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
In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024....more
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech,...more
UPDATE: The stop-gap spending bill has been revised to remove the provision discussed herein. However, life sciences companies should nonetheless take note of efforts by congress to enact patent-related reforms such as this....more
In Bayer Inc v Amgen Canada Inc, 2024 FC 1849, the Court granted a motion brought by Amgen for a declaration that Canadian Patent No. 3,007,276 (276 patent) was ineligible for inclusion on the Patent Register and that the...more