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Certified Licensing Professionals, Inc., 2021
This blog, Patents4Life, does not contain legal advice and is for informational purposes only. Its publication does not create an attorney-client relationship nor is it a solicitation for business. This is the personal blog of Warren Woessner and does not reflect the views of Schwegman Lundberg & Woessner, or any of its attorneys or staff. To the best of his ability, the Author provides current and accurate information at the time of each post, however, readers should check for current information and accuracy.
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Warren D. Woessner
Tag Archives: FDA
Is the “Blocking Patent” Doctrine Part of the Obviousness Analysis?
Last year, in a lengthy split decision, a Fed. Cir. panel affirmed the district court’s ruling that four “add-on” patents that Acorda owned were invalid as obviousness in view of a number of prior art references (Acorda Ther., Inc. v. … Continue reading
Posted in Section 103 Tagged Acorda Therapeutics, Ampyra, FDA, Hatch-Waxman, judge dyk, Judge Taranto, Merck v Teva, Roxanne Labs, Supreme Court Leave a comment
FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants
The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this … Continue reading
Why Did the Chicken Cross the Road? To Get New Genes!
Jay Cormier has a new post on the FDA Law Blog called “Tastes Like Chicken: Second ‘BioPharm’ Animal Approved to Produce Biological to Treat Orphan Disease Includes 6th Rare Pediatric Disease Priority Review Voucher.” He writes: On December 8, 2015, … Continue reading
Posted in Supreme Court News Tagged BioPharm, FDA, intellectual property, ip, Jay Cormier, Patent Law, patents, Warren Woessner Leave a comment
FDA Finalizes Biosimilar Guidance
The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.” The article includes links to the final guidance documents. You can find the article here.