News & Analysis as of

Amgen

FDA Accepts Sandoz aBLA for Adalimumab Biosimilar

by Goodwin on

Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab...more

State Law Cannot Circumvent Congress’s Scheme for Biologics

In Amgen v. Sandoz, No. 2015-1499, the Federal Circuit affirmed the Northern District of California’s decision that Sandoz had not waived its preemption defense and that the Biologics Price Competition and Innovation Act of...more

Amgen Moves to Dismiss Genentech’s Misrepresentation Claim

by Morgan Lewis on

Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act. Shortly after Amgen received US Food and Drug Administration (FDA)...more

Bristol Myers Squibb, Bavarian Nordic, and Enzo Biochem file amicus brief supporting Amgen’s petition for en banc consideration of...

by Goodwin on

As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more

Year in Review: Top 5 Biosimilars Deals of 2017

by Goodwin on

Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017...more

Year in Review: Top Five Legal Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Federal Circuit Rules BPCIA Preempts State Law

by Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Biosimilars: Strategic Considerations for 2018

by Polsinelli on

2017 was an eventful year for biosimilars in the U.S. As the number of biosimilar filings increased, important legal and regulatory decisions changed the strategic landscape of the biosimilars market for both innovators and...more

Federal Circuit Finds Preemption Of State Law Penalty For Sitting Out Biosimilar Patent Dance

by Foley & Lardner LLP on

The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more

Judge Sleet Denies Macleods Defendants’ Motion For Judgment On The Pleadings In ANDA Action

by Fox Rothschild LLP on

By Memorandum Order entered by The Honorable Gregory M. Sleet in Amgen Inc. v. Macleods Pharmaceuticals, Ltd., Civil Action No. 17-817-GMS (D.Del. December 19, 2017) (consolidated), the Court denied the Motion for Judgment on...more

Federal Circuit Speaks Regarding State Law Remedy for BPCIA’s “Patent Dance”

On December 14, 2017, the Federal Circuit issued a unanimous decision in Amgen Inc. v. Sandoz Inc., No. 2015-1499, interpreting whether the Biologics Price Competition and Innovation Act (BPCIA) is subject to state law...more

Federal Circuit Simplifies BPCIA Disputes by Finding State Remedies Preempted

by Fish & Richardson on

The Amgen v. Sandoz battle continues to make new law regarding the Biologics Price Competition and Innovation Act (“BPCIA”), this time in a December 14th ruling from the Federal Circuit finding that “the BPCIA preempts state...more

US Biosimilar Approvals Soar in 2017

Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s...more

Federal Circuit: BPCIA Preempts State Law In Biosimilar Litigation

The Federal Circuit on Thursday issued an opinion in Amgen v. Sandoz holding that that the Biologics Price Competition and Innovation Act (BPCIA) preempts state-law claims that are based on a biosimilar applicant’s failure to...more

Federal Circuit Rules Out State-Law Remedies for Failure to Participate in the Biosimilars "Patent Dance"

by Perkins Coie on

On December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit...more

Antibody Patents Are Not Immune to § 112: Amgen Inc. v. Sanofi, Aventisub LLC

by K&L Gates LLP on

In Amgen v. Sanofi, the Federal Circuit held that evidence that first came into existence after the priority date may be considered in determining whether a genus patent claim satisfies the written description requirement...more

Magistrate Judge Recommends Dismissal of Amgen v. Coherus (Pegfilgrastim) Suit

by Goodwin on

We have been following the Delaware Amgen v. Coherus (pegfilgrastim case). In response to Amgen’s Complaint, Coherus filed a motion to dismiss the entire suit arguing that Amgen’s Complaint failed to state a plausible claim...more

Amgen Seeks En Banc Consideration of Written Description and Enablement Issues in Praluent® Litigation

by Goodwin on

In October, a Federal Circuit panel vacated a permanent injunction (which the Federal Circuit had earlier stayed pending appeal) that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more

Updates on Coherus pegfilgrastim and other biosimilar efforts

by Goodwin on

We previously posted that Coherus had filed a motion to stay discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss. On September 13, Coherus withdrew its motion to stay. ...more

Federal Circuit Clarifies Probative Value of Patent Dance Statements

by Jones Day on

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more

Amgen Files Reply in Support of Motion to Transfer Bevacizumab Action to California

by Goodwin on

We previously reported on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents and Amgen’s motion to transfer that complaint to the Central...more

Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s...more

Genentech Moves To Dismiss Amgen’s California Bevacizumab DJ Action

by Goodwin on

We previously reported on Amgen’s complaint in the Central District of California seeking a declaratory judgment that 27 Genentech patents are not infringed by Genentech’s bevacizumab biosimilar (Mvasi®). On November 15,...more

Federal Circuit Evaluates Import of Factual Statements Made During BPCIA Pre-litigation Patent Dance

In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for biosimilar versions of Neulasta® and Neupogen® did...more

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