News & Analysis as of

Amgen

Delaware Court Declines to Enter “Judgment” in Genentech v. Amgen

by Goodwin on

We have previously reported on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint. In its letter, Genentech requested entry of judgment without...more

Amgen Responds to Genentech’s Letter in Bevacizumab Case

by Goodwin on

As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of...more

Genentech Will Not File Amended Complaint in Case Against Amgen

by Goodwin on

As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal...more

Immunex Files Complaint Against Sanofi and Regeneron

by Goodwin on

On April 5, Immunex (a wholly-owned subsidiary of Amgen) filed a complaint against Sanofi and Regeneron related to Sanofi and Regeneron’s Dupixent® (dupilumab) product, which received FDA approval last week. Immunex’s...more

Further Recent Biologics Applications

by Goodwin on

We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced today both the submission of a supplemental BLA to the FDA and an...more

Spotlight on Upcoming Oral Arguments – April 2017

In the first BPCIA case after Amgen v. Sandoz, the Federal Circuit has been asked to determine whether Sandoz should be interpreted to allow discovery of manufacturing information required under 42 U.S.C. § 262 (l)(2)(A). ...more

Amgen Obtains FDA Priority Review for BLINCYTO (blinatumomab)

by Goodwin on

Amgen announced last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab). BLINCYTO received approval in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell...more

Sanofi and Regeneron Take Aim on Amgen IL-4 Receptor Patent

by Goodwin on

This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S....more

EC Approves Amgen’s Biosimilar Adalimumab

by Goodwin on

Amgen announced yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases. ...more

PTAB Institutes Two IPRs in Hospira v. Genentech Avastin Dispute

Bevacizumab (Avastin®) is the subject of the widely watched “patent dance” dispute between Genentech and Amgen regarding Amgen’s proposed biosimilar. Hospira, however, (now owned by Pfizer) has chosen a different path in...more

BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more

Amgen Has Filed for EU Approval for Herceptin® (Trastuzumab) Biosimilar

by Goodwin on

During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU...more

Dismissal Demonstrates Need for Clarity on BPCIA Disclosure Steps

by Fish & Richardson on

On March 1, Judge Sleet of the District of Delaware granted Amgen’s Motion to Dismiss for lack of subject matter jurisdiction Genentech’s Complaint for Declaratory Judgment. The Complaint sought a declaration that Amgen...more

Will The Avastin Biosimilar Patent Dance Go On?

by Foley & Lardner LLP on

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more

Genentech’s BPCIA Complaint Against Amgen Dismissed

Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that...more

Delaware District Court Dismisses Genentech v. Amgen

by Goodwin on

As we previously reported, yesterday Judge Sleet, United States District Court for the District of Delaware, heard arguments on Amgen’s motion to dismiss in Genentech v. Sandoz. The court orally granted Amgen’s motion under...more

Genentech v. Amgen: Amgen Seeks Dismissal Under Amgen v. Sandoz

by Goodwin on

As we previously reported, Genentech earlier this month filed a declaratory judgment action against Amgen. In this litigation, Genentech claims that Amgen has violated the patent dance provisions of the BPCIA by disclosing...more

Biosimilar Litigants Dispute Probative Value of Statements Exchanged During the Patent Dance

by Fish & Richardson on

Patent owner Amgen has appealed to the Federal Circuit seeking to overturn a non-infringement ruling with respect to Apotex’s manufacturing processes for its biosimilar versions of Amgen’s NEULASTA® (pegfilgrastim) and...more

Genentech Files DJ Action Against Amgen Regarding Avastin Biosimilar

by Goodwin on

Big Molecule Watch frequently posts on BPCIA litigation. As our readers know, the interpretation of various provisions of the BPCIA is currently before the Supreme Court in Sandoz v. Amgen, which we most recently covered...more

Biosimilar Litigants Square Off Before the Supreme Court

by Fish & Richardson on

Last week, Sandoz filed its opening Supreme Court brief, asking the Court to determine (1) whether notice of commercial marketing under Subsection (l)(8)(A) of the Biologics Price Competition and Innovation Act (“BPCIA”) is...more

Hurdles for Neulasta Biosimilars

A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far...more

Amgen Reports on Neulasta, Neupogen Biosimilar Competition and Acceptance of Avastin Biosimilar aBLA

by Goodwin on

On yesterday’s earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta® (pegfilgrastim) product to face biosimilar completion in the U.S. by the end of the year. According to Amgen Executive Vice...more

Supreme Court Grants Certiorari in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Supreme Court to Consider BPCIA Requirements for Biosimilars

by McDermott Will & Emery on

The Supreme Court of the United States has granted certiorari in a case involving the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the context of a biosimilars dispute. Sandoz, Inc. v. Amgen Inc. and...more

Amgen Receives Positive CHMP Opinion for its Biosimilar Adalimumab

by Goodwin on

Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has “adopted a positive opinion” for marketing of Amgen’s biosimilar adalimumab, “recommending...more

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