Tagged as: BPCIA

Court Grants Amgen’s Motion To Dismiss Genentech’s Declaratory Judgment Counts in Mvasi™ Litigation, and Sets June 2020 Trial Date

We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could begin commercial marketing of its product.  In particular, Genentech had sought a judgment that Amgen could not market its product…

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Filgrastim and Pegfilgrastim Litigation Updates

Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  Below is a summary of these developments. Amgen v. Adello: New BPCIA Complaint First, on March 8, 2018, Amgen filed a complaint against Adello Biologics in the…

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The Biosimilars Litigation Landscape for 2017

Law360 has published an article by three of our contributing editors here at Big Molecule Watch.  As suggested by the title, “The Biosimilars Litigation Landscape for 2017,” the article provides an analysis of the expected BPCIA litigation activity, including potential new litigations, in 2017.  Click here for a link to…

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Update: Obamacare and TPP

While Donald Trump’s victory has made world headlines, what may be less well known to our readers is that the election also gave Trump’s Republican Party majority control of both the House and the Senate.  For the first time in many years, Republicans will control both the White House and…

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Will Trump's Election Impact the BPCIA?

The election last night of Donald Trump as the next President of the United States may have far-reaching consequences on numerous legal and policy issues, including immigration, international trade, and health care. Although we are not aware of President-elect Trump ever directly mentioning biosimilars on the campaign trail, it is…

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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 Federal Circuit has officially ordered that its July  opinion in the case must now be…

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Goodwin's Guide to the Biosimilars Patent Dance

Goodwin released today its Guide to the Biosimilars Patent Dance, which lays out in a user-friendly format the complex statutory scheme of the so-called “patent dance” codified in subsection 262(l) of the Biologics Competition and Innovation Act (BPCIA).  The BPCIA’s patent dance dictates a schedule of timed steps according to…

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Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price Relief, Innovation, and Competition for Essential Drugs Act,” or the “PRICED Act,” the proposed bill…

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House Subcommittee on Health Addresses BPCIA Implementation and FDA Biosimilars Guidance

The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…

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