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Archive for the ‘Food and Drug Administration’ Category

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.

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Posted On Nov - 10 - 2014 Add Comments 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

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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.

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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.

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Posted On Nov - 30 - 2012 Comments Off READ FULL POST
Written By: Sally Wang Edited By: Charlie Stiernberg Editorial Policy Introduction: Drug marketing faces the problem of an arms race — competitors attempt to out-compete each other by boosting their marketing efforts, at great expense, only to find that the baseline level of marketing needed to maintain the status quo has increased accordingly. These inefficiencies are costly and often harmful to the stakeholders — drug companies, patients, payors (e.g., Medicare/Medicaid or health insurance companies) and physicians. The Food and Drug Administration (“FDA”) is in ... Read More...
Posted On May - 25 - 2012 Comments Off READ FULL POST
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Federal Circuit Flas

By Ken Winterbottom Motion to Dismiss in Hulu Patent Infringement Suit ...

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Spain Passes a “Go

By Michael Shammas — Edited by Yixuan Long Amendments to the ...

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Federal Circuit Tigh

By Kathleen McGuinness – Edited by Sabreena Khalid Azure Networks, LLC ...

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Flash Digest: News i

By Viviana Ruiz Russia’s Intellectual Property Court affirms denial of Ford's ...