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
1/15/2025
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Celltrion ,
FDA Approval ,
Inflation Reduction Act (IRA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program....more
Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program...more
3/4/2024
/ Abbreviated New Drug Application (ANDA) ,
Administrative Procedure Act ,
AstraZeneca ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Due Process ,
Generic Drugs ,
Inflation Reduction Act (IRA) ,
Lack of Jurisdiction ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Summary Judgment
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more
2/13/2024
/ AstraZeneca ,
Boehringer ,
Bristol-Myers Squibb ,
Centers for Medicare & Medicaid Services (CMS) ,
Chamber of Commerce ,
Department of Health and Human Services (HHS) ,
Dismissals ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Janssen Pharmaceuticals ,
Medicare ,
Medicare Act ,
Merck ,
Novartis ,
Novo Nordisk ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Secretary of HHS
On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA....more
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more
Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case -
On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more
10/3/2023
/ Administrative Procedure Act ,
Amicus Briefs ,
Centers for Medicare & Medicaid Services (CMS) ,
Contract Negotiations ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Due Process ,
Fifth Amendment ,
First Amendment ,
Inflation Reduction Act (IRA) ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
State Attorneys General
HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program....more
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10...more
On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in the litigation, with...more
On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more