Hospira Fires Back in Appeal of BPCIA Discovery Dispute
In a corrected brief filed October 25, 2016, defendant-appellee Hospira responded to Amgen’s opening brief on the merits seeking to overturn a discovery ruling that kept Hospira’s cell culture media...
View ArticleAmgen Files Opposition to Apotex’s Petition for Certiorari
On November 8, 2016, Amgen submitted a brief in opposition to Apotex’s petition for certiorari challenging the Federal Circuit’s application of its holding in Amgen v. Sandoz that subsection (l)(8)(A)...
View ArticleAmgen Crystallizes Disagreement in Appeal of Discovery Row
Amgen advanced further arguments in a November 8, 2016 brief before the Federal Circuit, crystallizing the point of disagreement between it and defendant-appellee Hospira. The issue before the court is...
View ArticleBPCIA Litigation Roundup (Fall 2016)
Below is our Fall 2016 update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our...
View ArticleLitigation Update: Amgen and Sandoz Stipulate to Dismiss ‘784 Patent
The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim, pegfilgrastim) have submitted a joint stipulation to dismiss, without prejudice, Amgen’s U.S. Patent No. 5,824,784 patent from the litigation....
View ArticleSolicitor General Files Brief Recommending Supreme Court Hear Sandoz v. Amgen
The Acting Solicitor General has just filed an amicus brief recommending that Sandoz’s cert petition and Amgen’s cross-petition be granted. The Acting Solicitor General also argues that the decision by...
View ArticleAnalysis of Solicitor General’s Brief in Sandoz v. Amgen
As we posted earlier this week, the Acting Solicitor General (“SG”), on December 7th, filed an amicus brief in which it (a) recommended that the Supreme Court grant Sandoz’s cert petition and Amgen’s...
View ArticleSolicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v....
The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two...
View ArticleSolicitor General Claims Error in Federal Circuit’s Sandoz Holding
On Monday, December 12, 2016, the Supreme Court denied certiorari in Apotex v. Amgen, No. 16-332. Apotex had petitioned the Court to clarify provisions of the Biologics Price Competition and Innovation...
View ArticleSolicitor General Supports Cert in Amgen v. Sandoz, Supreme Court Denies Cert...
Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’...
View ArticleBiosimilars: Solicitor General Recommends Granting Certiorari in Amgen v. Sandoz
Responding to the Supreme Court’s request for its views, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos....
View ArticleAMGEN Files Supplemental Brief in Sandoz v. AMGEN
On Tuesday, Amgen filed its supplemental brief opposing Sandoz’s petition for writ and responding to the Solicitor General’s brief, which we discussed here. In sum, the Solicitor General sided with...
View ArticleWhen Time is Money
As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed...
View ArticleSolicitor General Sides With Sandoz On Interpretation Of Biosimilar Statute
The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one...
View ArticleYear in Review: The Top-Five Legal Developments of 2016
Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: ..Congress passed and President Obama signed the 21st Century Cures Act. Among other things,...
View ArticleConfidentiality in BPCIA Cases
The Biologics Price Competition and Innovation Act (“BPCIA”) contemplates the exchange of highly sensitive information from the pre-suit “patent dance” (see, e.g., 42 U.S.C. 262 (l)(2)(A)) throughout...
View ArticleTop Stories of 2016: #11 to #15
After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories. For 2016, we identified twenty stories that were covered on Patent Docs...
View ArticleBreaking News: Supreme Court Grants Petition and Cross-Petition for...
The Supreme Court has granted Sandoz’s petition for certiorari, and Amgen’s cross-petition for certiorari in Amgen v. Sandoz. The Order is excerpted below and can be found here......By: Goodwin
View ArticleSupreme Court to Review BPCIA -- Amgen v. Sandoz Petitions for Writs of...
On Friday, the Supreme Court granted both petitions for writs of certiorari and consolidated the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals. Sandoz had petitioned the Court...
View ArticleAmgen v. Sandoz: SCOTUS to Solve the Riddle Wrapped in a Mystery Inside an...
Last week, the United States Supreme Court granted certiorari review of the Amgen v. Sandoz decision. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1351 (Fed. Cir. 2015), cert. granted, (U.S. Jan. 13,...
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