Tag Archives: FDA

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

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

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FDA Publishes “Purple Book” for Biologicals/Biosimilars

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

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FDA’s New Biosimilars Guidance

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

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FDA Accepts First Biosimilar Application for Review

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

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