Amgen

News & Analysis as of

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more

Supreme Court to Review BPCIA -- Amgen v. Sandoz Petitions for Writs of Certiorari Granted

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 on February 16, 2016...more

Breaking News: Supreme Court Grants Petition and Cross-Petition for Certiorari in Amgen v. Sandoz

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...more

Update: Praluent® Permanent Injunction Stay Extended to 45 Days

We reported last week that a permanent injunction against the sale of Praluent® (alirocumab) was issued in Amgen v. Sanofi/Regeneron. The day after the court’s order, defendants filed a motion to stay the injunction while...more

Breaking News: Court Grants Permanent Injunction Against Sale of Praluent® in AMGEN V. SANOFI/REGENERON

For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab), a biologic that competes...more

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

Confidentiality 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 litigation, bringing...more

Year In Review: The Top-Five U.S. Market Developments of 2016

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a...more

When 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 cert petitions this year...more

Good Things Come in Small Packages: M.D. Fla. Rejects Plaintiff’s Discovery Gotcha Gamesmanship

This is the time of year for Best and Worst lists. Our own lists of the best and worst drug and device law decisions of 2016 will be coming out soon. Meanwhile, we have no doubt that the worst moments in our own day-to-day...more

Biosimilars: 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. 15-1039 & 15-1195)....more

Solicitor 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 Act (BPCIA) set forth...more

Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen

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 provisions of the law. The...more

Amgen and Allergan Submit European Application for Avastin® Biosimilar

We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more

Claim Terms Are Construed In Erythropoietin Case

Andrews, J. Claim construction opinion issues regarding two terms from one patent. A Markman hearing took place on September 21, 2016. The disputed technology relates to pharmaceutical compositions containing isoforms...more

Rx IP Update - November 2016

Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more

BPCIA 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 previous quarterly update...more

Apotex Files Reply in Support of Its Petition for Certiorari

On November 21, 2016, Apotex submitted a reply brief in support of its petition for certiorari. A procedural note: the case was also distributed on November 21 for consideration at the Supreme Court’s private conference...more

Scheduling Order Entered in AbbVie v. Amgen

On Thursday, Judge Robinson entered a scheduling order in the AbbVie v. Amgen (adalimumab) case. Among other things, the order sets a 20-day bench trial beginning November 4, 2019....more

Amgen 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 whether, during...more

Amgen Opposes Apotex’s Petition for Certiorari

On November 8, 2016, Amgen asked the Supreme Court to deny Apotex’s September 9, 2016 petition for review in Apotex v. Amgen, No. 16-332. Apotex had asked the High Court to clarify 42 U.S.C. § 262(l)(8)(A) of the Biologics...more

Amgen and Allergan Submit BLA for Avastin® Biosimilar

As we previously reported, Amgen and Allergan are currently collaborating on four oncology biosimilars, including an Avastin® (bevacizumab) biosimilar, ABP 215. Yesterday, the companies announced the submission of a...more

New Developments in AbbVie’s BPCIA Suit Targeting Amgen’s Humira® Biosimilar

On August 4, 2016, AbbVie filed a complaint against Amgen alleging that Amgen’s Humira® biosimilar Amjevita® infringes ten AbbVie patents. Humira® received FDA approval in 2002 to treat rheumatoid arthritis, juvenile...more

Amgen 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) of the BPCIA allows an...more

FDA Approves Expanded Use of Amgen’s Enbrel®

Amgen recently announced that the FDA has approved its supplemental Biologics License Application for the expanded use of Enbrel® (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque...more

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