Tag Archives: Hatch-Waxman

“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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In re Rosuvastatin Calcium Patent Litigation – Making “Therasense” out of Confusion

Posted on December 20, 2012 by Warren Woessner

Recently, a divided three judge panel sorting out a multi-party Hatch-Waxman suit, ruled that the patentee, Shinonogi, had not committed inequitable conduct in obtaining the patent that was subsequently reissued so as to obtain narrow claims focused on Rosuvastatin, or … 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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Legal Challenge To “ObamaCare” Threatens Generic Biologicals

Posted on March 29, 2012 by Warren Woessner

What should not be lost on pharma/biotech patent attorneys or their clients, amidst all the attention given to the Supreme Court’s review of the “Patient Protection and Affordable Health Care Act” – public law 111-48, is that it contains the … Continue reading →

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