News & Analysis as of

Patent Litigation Biologics Price Competition and Innovation Act of 2009

McDermott Will & Emery

In the Weeds? Humira “Patent Thicket” Isn’t an Antitrust Violation

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The US Court of Appeals for the Seventh Circuit affirmed that welfare benefit plans that bought the drug Humira did not have valid antitrust claims against the patent owner. The Court found that amassing patents by itself is...more

Kramer Levin Naftalis & Frankel LLP

Northern District of Illinois Holds That a Biosimilar Applicant Is Not a Necessary Party to a BPCIA Lawsuit

On Aug. 23, 2021, the U.S. District Court for the Northern District of Illinois denied Alvotech hf.’s motion to dismiss AbbVie’s biosimilar lawsuit involving its blockbuster arthritis drug, Humira. AbbVie Inc. et al. v....more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Jones Day

Federal Circuit Clarifies Probative Value of Patent Dance Statements

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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

Patterson Belknap Webb & Tyler LLP

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

Patterson Belknap Webb & Tyler LLP

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

McDermott Will & Emery

Supreme Court Analyzes Key Provisions of Biologics Price Competition and Innovation Act of 2009

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In a unanimous decision, the United States Supreme Court has clarified certain portions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), concluding (1) that biosimilar makers do not have to wait for...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

BakerHostetler

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

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On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

Patterson Belknap Webb & Tyler LLP

Apotex Follows the Pre-Suit Information Exchange Provisions of the BPCIA

In the first skirmishes between biosimilar makers and innovator companies, biosimilar makers attempted to bypass the litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) through the...more

Polsinelli

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

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The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

K&L Gates LLP

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

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AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

Patterson Belknap Webb & Tyler LLP

First Federal Register Notice of BPCIA Suit

Yesterday, FDA published notice of Janssen’s lawsuit against Celltrion and Hospira on March 6, 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the Federal Register. Although Janssen’s lawsuit...more

Foley & Lardner LLP

The Remicade Biosimilar Patent Dispute

Foley & Lardner LLP on

While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

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