On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the Solicitor General’s views. See prior post. On December 7, the Solicitor General filed a briefing recommending that certiorari be granted.

Responding to the Supreme Court’s request for its views, see prior post, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). 

The case involves issues central to the application of the Biologics Price Competition and Innovation Act of 2009

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA approval. Section 271(e)(1) exempts certain pharmaceutical-related activities from patent infringement, stating that “[i]t shall not be an act of infringement to make, use,

Two recent conflicting Federal Circuit cases (Classen and Momenta) interpreting the Hatch-Waxman safe harbor provision (35 USC 271(e)(1)) have stirred debate in the biosimilars community.  While the new biosimilars pathway (the Biologics Price Competition and Innovation Act) is different from Hatch-Waxman of course, and its interpretation by FDA is still evolving, the controversy

The August 2012 decision in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, Inc. has expanded the “safe harbor” provisions of Hatch-Waxman, with serious implications for the pharma and biotech industries.

Hatch-Waxman contains a “safe harbor” provision for the use of patented inventions “reasonably related to the development and submission of information under a Federal law which regulates

“People’s fates are simplified by their names” goes the quote from the Bulgarian novelist and playwright Elias Canetti. Whether this is indeed true for people is debatable but for biological drugs names are apparently critical, or so we can gather from recent warring between branded and generic industry organizations. Last week industry organizations BIO and

On April 17, 2012, the U.S. Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, holding that a generic drug manufacturer may file a counterclaim to force correction of an overbroad use code that encompasses unclaimed methods of using the drug at issue. In interpreting the text of

The Prescription Drug User Fee Act (PDUFA) re-authorization wrangling is underway on Capitol Hill. Today the House of Representatives takes up its version of the FDA bill the Senate passed last week. On May 24th the Senate version of the PDUFA bill passed on a 96-1 vote. The current PDUFA will expire on October 1st and debates in the House could, potentially, take all summer. However, legislators and industry observers have expressed hope for a final bill to be presented to the President for signature in early July. We’ll be closely following the progress of the reconciliation of the House and Senate bills.

Estimates vary but the present PDUFA will likely bring in around 6.4 billion dollars to FDA over its active period. Since PDUFA fees account for the majority of the FDA’s drug review budget, the core PDUFA legislative mandate has broad bi-partisan support. While PDUFA itself is fairly non-controversial, the various amendments that were attached at the beginning of the week led to intense debate. Many of those proposed amendments – such as energy drink registration and Canadian drug importation – were dropped from the final version of the Senate bill.

Continue Reading PDUFA Working Its Way Through Capitol Hill