Category Archives: Hatch-Waxman

Fed. Cir. in Helsinn v. Teva Declines Limiting the Requirements of the “On Sale” Bar

Posted on May 4, 2017 by Warren Woessner

In Pfaff v. Wells Electronics, 525 US 55 (1988), the Supreme Court attempted to focus the factors invoking the on-sale bar of s.102, by holding that the claimed invention must both be the subject of a “commercial sale”(including offers for … Continue reading →

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“We Don’t Need No Stinkin’ Patents” – Antibiotic and Antifungal Drugs Gain Non-Patent Exclusivity

Posted on June 23, 2014 by Warren Woessner

Posted on the FDA Law Blog by Kurt Karst on June 19, 2014. After years of relative quiet, the Orange Book list of exclusivity terms has gotten quite a workout over the past year with the addition of several new terms … Continue reading →

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Supreme Court Reverses In Caraco Appeal

Posted on April 17, 2012 by Warren Woessner

Today, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk, in an opinion authored by Justice Kagan (a copy can be found at the end of this post), the Court reversed the Fed. Cir.’s divided 2010 decision that an ANDA filer … Continue reading →

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Bayer v. Lupin – Patenting The Label Redux

Posted on February 28, 2012 by Warren Woessner

In my post of January 13, 2011, I discussed AstraZeneca LP v. Apotex, a Fed. Cir. decision in which AZ argued successfully that the proposed  Apotex labeling for an anti-asthma drug would induce infringement if the generic were marketed with … Continue reading →

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