Tag Archives: FDA

Biotech’s PR Problems Continue

Posted on February 15, 2013 by Warren Woessner

Maybe “Fish gotta swim” but the FDA has extended the approval period for transgenic Salmon genetically engineered to reach market weight sooner. No evidence at all has been presented that filets from these fish would present a danger human consumers … Continue reading →

Posted in Govt Policy/PTO Policy, Transgenics | Tagged biotechnology, FDA, Supreme Court, Warren Woessner | Leave a comment

Edwards Lifesciences v. Corevalve – Pig Valve Implants Enabling

Posted on November 19, 2012 by Warren Woessner

In Edwards Lifesciences AB v. Corevalve, Inc. (now a part of Medtronic), Appeal No. 2011-1215-1257 (Fed. Cir. Nov. 13, 2012), Corevalve challenged the validity of US Pat. No. 5,411,552 directed to a “transcather heart valve” on the basis that the … Continue reading →

Posted in Enablement | Tagged Corevalve, Edwards Lifesciences AB, Enablement, FDA, Federal Circuit, Inc., Medtronic, Patent Law, Warren Woessner | 1 Comment

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 →

Posted in Follow-On Biologics | Tagged biotechnology law, FDA, Hatch-Waxman, Supreme Court, Warren Woessner | 1 Comment

Bayh-Dole Act Turns Thirty – Dec. 1st Fete Planned

Posted on November 18, 2010 by Warren Woessner

With major litigation looming over invention ownership rights affected by the Bayh Dole Act (see my post of November 3rd on Stanford v. Roche), the link below is to a site created by AUTM and a number of other organizations … Continue reading →