Tag Archives: FDA

Patents4Life is Six Years Old this Month. Happy Birthday to Us!

Posted on March 3, 2015 by Warren Woessner

Six years ago, In re Kubin caused a flurry of concern among biotech practitioners, and a short article on this decision was the first post on Patents4Life. That was a pretty big “story” at the time but we all had … Continue reading →

Posted in Miscellaneous | Tagged Amgen, biotechnology, FDA, Kimble v. Marvell, Nautilus, Patent Law, s. 101, Teva v. Sandoz, Tharasense, USPTO | 4 Comments

FDA Publishes “Purple Book” for Biologicals/Biosimilars

Posted on September 11, 2014 by Warren Woessner

In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked … Continue reading →

Posted in 2017 Patent Review | Tagged bio, FDA, intellectual property, Purple Book, Warren Woessner | Leave a comment

FDA’s New Biosimilars Guidance

Posted on August 11, 2014 by Warren Woessner

The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog. *** August 09, 2014 FDA’s New Biosimilars Guidance Has Sponsors … Continue reading →

Posted in Patent Eligible Subject Matter | Tagged Biosimilars, biotechnology law, FDA, FDA Law Blog, intellectual property, ip, James Shehan, James Valentine, Patent Law, patents, Warren Woessner | Leave a comment

FDA Accepts First Biosimilar Application for Review

Posted on July 28, 2014 by Warren Woessner

In an important step forward for the introduction of “generic biological,” the FDA announced that it has accepted Sandoz’s application to market a generic version of Amgen’s Neupogen®, which stimulates white blood cell production. As you may recall, about two years … Continue reading →