News & Analysis as of

Amgen

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In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for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

Amgen Inc. v. Sanofi (Fed. Cir. 2017)

Last month, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a)...more

Federal Circuit Provides Guidance on Probative Value of “Patent Dance” Letters and aBLA Parameters in an Infringement Analysis

by Fish & Richardson on

On November 13th, in an opinion drafted by Judge Taranto, the Federal Circuit affirmed the Southern District Court of Florida’s judgment that Apotex’s biosimilar versions of Neulasta® and Neupogen® do not infringe Amgen’s...more

Biosimilars Update: Amgen, Allergan, Pfenex, Cinfa

by Goodwin on

Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...more

Genentech Opposes Transfer of Deleware MVASI™ (bevacizumab-awwb) Litigation to California

by Goodwin on

We reported earlier 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

Biosimilar Litigation Updates

by Goodwin on

Below is an update on recent developments in several litigations involving biosimilar products. AbbVie v. Boehringer Ingelheim (adalimumab): On October 23, the parties filed a joint status report. ...more

Amgen Considering Petitioning for Rehearing of Praulent Appeal

by Goodwin on

Earlier this month, the Federal Circuit vacated an injunction in the Amgen v. Sanofi litigation that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product in the United States until...more

Genentech to Move to Dismiss Amgen DJ Complaint Regarding Mvasi (Bevacizumab-AWWB)

by Goodwin on

We previously reported on Amgen’s complaint, in the Central District of California, seeking a declaratory judgment that MvasiTM (bevacizumab-awwb) does not infringe 27 Genentech patents, that those patents are invalid, and...more

Amgen and Genentech Break New Ground in Avastin Biosimilar Dispute

Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab). On October 6, in a complaint filed in the Central District of California,...more

Lawsuits Filed on the Same Day Regarding Amgen’s Avastin® Biosimilar

by Morgan Lewis on

The cases show that—even given a recent US Supreme Court interpretation of the statute—uncertainty still exists about complying with the “patent dance" information exchange requirements under the Biologics Price Competition...more

Genentech Files New Complaint Against Amgen in Delaware Regarding MVASI

by Goodwin on

We reported earlier that on October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that MVASITM (bevacizumab-awwb), Amgen’s recently approved biosimilar of...more

Genentech’s Complaint Against Amgen Regarding MVASI® (bevacizumab-awwb)

by Goodwin on

We reported earlier this month that, in early October, Genentech filed a complaint under seal against Amgen in the District of Delaware based on Amgen’s FDA-approved aBLA for MVASI® (bevacizumab-awwb), a biosimilar of...more

Federal Circuit Casts Doubt on Antibodies Claimed by Epitope

In Amgen Inc. v. Sanofi, No. 2017-1480, the Federal Circuit reversed and remanded for a new trial because the district court (1) incorrectly excluded post-priority-date evidence regarding written description and enablement,...more

Genentech Files a Complaint Against Amgen in Delaware Regarding MVASI® (bevacizumab-awwb)

by Goodwin on

We previously reported that on October 6, 2017, Amgen filed a declaratory judgment action against Genentech regarding Amgen’s recently approved biosimilar of Avastin® (bevacizumab-awwb). On the same day, Genentech filed a...more

Amgen Files DJ Complaint Against Genentech Regarding Mvasi® (bevacizumab-awwb)

by Goodwin on

On Friday, October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that Mvasi® (bevacizumab-awwb), Amgen’s recently approved biosimilar of Avastin®, does not...more

Amgen Files Infringement Suit Against Mylan Over Neulasta Biosimilar

Amgen has filed patent infringement claims against Mylan and its subsidiaries over Mylan’s proposed biosimilar version of Neulasta (pegfilgrastim). Neulasta, a long-acting version of Amgen’s Neupogen (filgrastim), is a...more

HUMIRA® Biosimilar Update -- Settlement in AbbVie v. Amgen Case Announced and AbbVie v. Boehringer Ingelheim Litigation Begins

On September 28, 2017, both parties to the AbbVie v. Amgen litigation announced a settlement that resolves all intellectual property-related litigation over Amgen's FDA-approved adalimumab biosimilar AMGEVITA™/AMJEVITA™. ...more

Amgen and AbbVie Settle Adalimumab BPCIA Litigation

by Goodwin on

Amgen has announced that it has settled all pending patent litigation regarding AMJEVITA, its biosimilar version of AbbVie’s Humira® (adalimumab). Amgen reports that AbbVie will grant patent licenses for the use and sale of...more

New BPCIA Litigation: Amgen v. Mylan (W.D. Pa.)

by Goodwin on

On Friday, Amgen filed a complaint for patent infringement under the BPCIA against yet another developer of a biosimilar of Neulasta® (pegfilgrastim). Amgen has sued Mylan in the Western District of Pennsylvania for...more

Federal Jury Awards Amgen $70M In Patent Suit Against Hospira

by Goodwin on

On September 22, 2017, a Delaware federal jury found that Hospira infringed one of Amgen’s Epogen® (EPO) patents. Hospira maintained that its production of EPO was protected by the safe harbor of 35 U.S.C. § 271(e)(1) which...more

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

FDA Approves First Cancer-Treatment Biosimilar -- Amgen's Mvasi

Earlier on September 14, 2017, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple...more

370 Results
|
View per page
Page: of 15
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.