News & Analysis as of


Amgen’s Motion to Dismiss Genentech’s Complaint in the Delaware Mvasi Litigation

by Goodwin on

As we previously reported, Genentech has filed two pending cases (Case Nos. 1:17-cv-01407 and 1:17-cv-01471) in the District of Delaware related to Amgen’s proposed Mvasi (bevacizumab-awwb), a biosimilar of Genentech’s...more

Healthcare Law Update: February 2018

by Holland & Knight LLP on

Antitrust - FTC Announces Revised Hart-Scott-Rodino Thresholds for Acquisitions and Exclusive Licenses - The Federal Trade Commission (FTC) has announced this year's revisions to the thresholds under the...more

February 2018: Life Sciences Litigation Update

Amgen Inc. v. Sandoz Inc., No. 2015-1499, 2017 WL 6375146 (Fed. Cir. Dec. 14, 2017). This Federal Circuit decision is a remand from the June 2017 Supreme Court decision addressing the consequences when the proposed marketer...more

Declaratory Judgment Litigation Brought by Biosimilar Manufacturers

by Fish & Richardson on

Courts have begun to shape the contours of the Biologics Price Competition and Innovation Act (“BPCIA”) and the progress of biosimilar litigation, but the use of declaratory judgment actions by biosimilar manufacturers...more

Biosimilars 2017 Year in Review

by Fish & Richardson on

Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), 2017 has been the most active year yet for drug manufacturers. Fish attorneys Tasha Francis, Jenny Shmuel, and Brianna Chamberlin addressed the...more

No State Law Remedies for Failure to Comply with BPCIA Notice

by McDermott Will & Emery on

On remand from the Supreme Court of the United States, the US Court of Appeals for the Federal Circuit held that under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), state law claims and remedies are not...more

New BPCIA Litigations Regarding Celltrion’s Trastuzumab and Rituximab Biosimilars

by Goodwin on

On January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District Court for the Northern District of California. Case No. 3:18-cv-00274 relates to Celltrion’s Herzuma®, its trastuzumab biosimilar. ...more

Biosimilar Market Developments Continue Apace in 2018

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....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

Top Stories of 2017: #5 to #9

After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories. For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe...more

Year in Review: Top 5 Foreign Market Developments in 2017

by Goodwin on

Here are our picks for the top-five most significant foreign 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

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

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...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

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .

Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more

Analysis of Amgen v. Sandoz Federal Circuit Opinion

by Goodwin on

The Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court. In that decision, the Federal Circuit held that Amgen’s state law claims, based on the...more

Federal Circuit Affirms Sandoz Win on Preemption Grounds

by Goodwin on

The Federal Circuit today ruled decisively in favor of Sandoz in the long-running battle with Amgen over whether state law can be used to compel a biosimilar applicant to participate in the BPCIA’s “patent dance.” The panel...more

FDA Approves Ixifi® (infliximab-qbtx), Third Biosimilar of Remicade® in U.S.

by Goodwin on

The FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated for the treatment of most of the same conditions as its reference product: Crohn’s disease, pediatric...more

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