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Archive for the ‘Food and Drug Administration’ Category

Flash Digest: News in Brief

By Mila Owen – Edited by Olga Slobodyanyuk

Senate CISA Debates End

The FDA CDRH released its Regulatory Science Priorities for 2016

Germany requires all Internet companies to make metadata available to its law enforcement agencies


Posted On Nov - 4 - 2015 Add Comments READ FULL POST

Illinois District Court Opinion Shows Uncertainty of the Economics of ANDA litigation

By Yaping Zhang – Edited by Mengyi Wang

The Northern District of Illinois just laid down a Hatch-Waxman opinion, holding that the Mylan Pharmaceuticals Inc. infringed the patent No. 727 Patent held by Medicines Company. Patently-O published a study that demonstrates ANDA Paragraph (iv) cases have increasingly settled, reducing consumer surplus. The case suggests that there are potentially more complicated calculus and players embedded in ANDA litigations than originally thought.


Posted On Nov - 10 - 2014 Comments Off READ FULL POST

Flash Digest: News In Brief
By James Grace

Hershey’s Opposes Mars’ Attempt to Register a Snickers’ Cross-Section as a Design Mark

Medtronic v. Boston Scientific – Oral Argument

Proposed Tweak to Law Would Pull Shield From Generic-Drug Makers


Posted On Nov - 10 - 2013 Comments Off READ FULL POST

Federal Circuit Finds Bayer’s Yaz Birth Control Patent Invalid for Obviousness

Bayer Healthcare Pharm., Inc. v. Watson Pharm., Inc.
By Erica Larson – Edited by Suzanne Van Arsdale

The Court of Appeals for the Federal Circuit reversed the judgment of the Nevada District Court, which ruled that claims 13 and 15 of Bayer Healthcare Pharmaceuticals, Inc. and Bayer Schering Pharma AG (“Bayer”) U.S. Patent RE37,564 were not invalid for obviousness. The patent claimed a combination of synthetic hormones and dosing regimens used by Bayer in the Yaz birth control pill.


Posted On Apr - 30 - 2013 Comments Off READ FULL POST

Federal Circuit Reaffirms Sufficiency of Animal Testing for Medical Device Patents, Makes eBay Test Less Rigid

Edwards Lifesciences v. CoreValve
By David LeRay – Edited by Dorothy Du

The Federal Circuit affirmed in part and remanded in part the United States District Court for the District of Delaware, which had found that CoreValve infringed upon Edwards Lifesciences’ heart valve patent and awarded lost profits damages, but did not issue an injunction.


Posted On Nov - 30 - 2012 Comments Off READ FULL POST
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