Author Archives: Warren Woessner

Apotex Petitions Supreme Court to Review Therasense Standards

In Apotex, Inc. v. UCB, Inc., Appeal No. 2013-1674 (Fed. Cir. August 15, 2014) the court affirmed the district court’s ruling that one actor, Dr. Sherman, the chairman of Apotex had committed inequitable conduct by engaging in what the court … Continue reading

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U.S. Patent Commissioner Focarino To Retire

From IPO Daily News, Friday, May 1, 2015 This week U.S. Patent and Trademark Office’s Commissioner of Patents Margaret (Peggy) Focarino announced that she will retire on July 3 as U.S. Patent and Trademark Commissioner. Focarino has been with the … Continue reading

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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.

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“Isolated” Natural Products Still in Purgatory Post-PTO Guidance?

Recently, a new class of antibiotic, teixobactin, was discovered in the soil in a Boston researcher’s backyard via a high throughput in situ screening chip that detected individual bacteria capable of growing in an uncultured state. The resulting isolates were … Continue reading

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