Amgen

News & Analysis as of

Humira® Update: Big Guns Take Aim at Top-Selling Biologic

AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015. Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market. We provide this update on three events...more

Amgen v. Hospira: Amgen’s Appeal to the Fed. Cir. Will Proceed on the Merits

As we reported, in a litigation regarding Hospira’s planned biosimilar for Amgen’s epoetin alfa, sold under the brand names Epogen and Procrit, in May, 2016, the District Court (D.Del., J. Andrews) denied Amgen’s motion to...more

Federal Circuit Denies Motion to Dismiss Appeal of BPCIA-Related Discovery Order

The Federal Circuit has denied Hospira’s motion to dismiss Amgen’s appeal of a discovery order in an underlying BPCIA district court litigation (Civil Action No. 15-cv-00839, D. Del.) and has instructed the parties to address...more

Apotex Files Petition for IPR On Amgen’s Neulasta Patent

On August 5, Apotex filed a petition for an IPR on Patent No. 8,952,138, owned by Amgen. The ’138 patent is the same patent that is being challenged in the District Court for the Southern District of Florida, in a case in...more

UPDATE Amgen v. Apotex: Amgen argues they have met their burden to prove infringement

As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written...more

Apotex Takes Aim at Amgen Patent in IPR Petition After Being Sued Under the BPCIA

Many biosimilar applicants have resorted to inter partes review (IPR) proceedings to challenge innovator patents as an alternative forum to district court litigation under the BPCIA. For those biosimilar applicants that...more

BPCIA Litigation Updates: Amgen v. Apotex, Immunex v. Sandoz, Janssen v. Celltrion

A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: ..The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the...more

AbbVie Sues Amgen On 10 Of 100 Humira Patents

On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more

AbbVie v. Amgen: The Litigation Phase for a HUMIRA® Biosimilar Begins

To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price...more

EMA Accepts Mylan and Biocon’s Application for Authorization to Market a Pegfilgrastim Biosimilar

Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). In Europe,...more

AbbVie Sues Amgen to Prevent Launch of Humira Biosimilar

As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61...more

Amgen Can Enforce Notice of Commercial Marketing for Epogen® Biosimilar

Hospira’s motion to dismiss Count I of Amgen’s complaint has been denied, and Amgen will be able to seek declaratory judgment relief in the form of an injunction requiring Hospira to comply with the notice of commercial...more

Court Denies Hospira’s Motion to Dismiss BPCIA Notice Claims in Amgen v. Hospira

The District Court (D. Del., J. Andrews) has denied Hospira’s Motion to Dismiss in Amgen v. Hospira. As we’ve covered previously (see our posts here and here), Hospira moved to dismiss Count I of Amgen’s amended...more

Breaking News: AbbVie Files Complaint Against Amgen

AbbVie has filed a complaint against Amgen related to AbbVie’s Humira (adalimumab). The complaint asserts patent infringement and also seeks a declaratory judgment to compel Amgen to comply with the BPCIA’s notice of...more

Amgen’s Appeal of District Court Discovery Rulings in Amgen v. Hospira

As we covered in a previous post, the Court in Amgen v. Hospira ruled on some novel issues relating to litigation under the BPCIA during a hearing on discovery issues a few months ago. Background: To recap: this...more

Judge Dismisses Amgen’s BPCIA Declaratory Judgment Action Against Sandoz

Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act...more

Amgen’s Neulasta Declaratory Judgment Action Dismissed in District of New Jersey

On July 22, 2016, the District Court for the District of New Jersey granted Sandoz’s motion to dismiss Amgen’s declaratory judgment action related to Sandoz’s biosimilar of Amgen’s Neulasta (pegfilgrastim). As...more

Can Reference Product Sponsor Forfeit Right To Sue Under BPCIA?

Originally posted in Law360, July 25, 2016. In Amgen Inc. v. Apotex Inc., the Federal Circuit addressed the 180-day notice provision of the Biologics Price Competition and Innovation Act of 2009 where the parties had...more

Amgen DJ to Compel Patent Dance Dismissed

On July 22, 2016, the Hon. Stanley R. Chesler of the United States District Court for the District of New Jersey dismissed Amgen’s complaint against Sandoz seeking declaratory judgment to enforce the “patent dance” provisions...more

Courts Answer Key Questions Over the Reach of the BPCIA

Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more

Biosimilars Development Updates

We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed...more

Amgen and Allergan Report Progress in Herceptin® Biosimilar Clinical Trial

In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human beast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”) and...more

Federal Circuit Patent Updates - July 2016 #2

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

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