On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require…
As has been widely reported over the past few days, the federal district court for the Northern District of Texas has issued an order declaring that the individual mandate of the Affordable Care Act (ACA, commonly referred to as “Obamacare”) is unconstitutional, that the remaining provisions of the ACA are not severable…
Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents—the draft guidance titled “The ‘Deemed to be a License’ Provision of the BPCI Act Questions and Answers” and the final guidance “Interpretation…
On November 6th, Goodwin’s Elaine Blais, Scott Lassman and Alex Valenti will be hosting a Biosimilars Market Update webinar, discussing key issues and recent legal and regulatory developments in the biosimilars space. Topics will include recent antitrust claims filed against biologic manufacturers, new strategies in BPCIA litigation, updates on legal…
The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry. Collectively referred to in the comments as AAM, and the “sole association representing America’s generic pharmaceutical sector in the United States,”…
Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808…
Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems. According to…
Today, Amgen filed a complaint for patent infringement under the BPCIA against Hospira and its parent Pfizer concerning their proposed biosimilar of Neupogen® (filgrastim). According to the complaint, the parties engaged in the patent dance, during which the parties negotiated and ultimately agreed that, of the seven patents that Amgen…
Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in favor of the biosimilar applicants. The other five appeals are from final written decisions of the…