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Archive for the ‘Food and Drug Administration’ Category

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
Supreme Court Expands Generic Drug Manufacturers’  Right to Challenge Scope of Patents By Elettra Bietti – Edited by Lauren Henry Caraco Pharmaceutical Laboratories, Ltd. v Novo Nordisk A/S, No. 10–844 (U.S. April 17, 2012) Slip opinion The Supreme Court reversed the Federal Circuit Court of Appeals’ ruling that denied a generic manufacturer the right to compel a brand manufacturer to correct misstatements regarding uses covered by a patent when those corrections would have allowed the generic manufacturer to market their ... Read More...
Posted On Apr - 23 - 2012 Comments Off READ FULL POST
Federal Circuit Rules Federal Law Trumps State Law in Interpretation of Patent Ownership Rights By Flora Amwayi – Edited by Jonathan Allred Abraxis Bioscience, Inc. v. Navinta LLC, 2009-1539, 2011 WL 873298 (Fed. Cir. Mar. 14, 2011) Slip Opinion The Federal Circuit denied a petition for an en banc rehearing of a Federal Circuit panel order dismissing Abraxis’ patent infringement case against Navinta. The court dismissed the case on the grounds that Abraxis did not have standing to sue for ... Read More...
Posted On Mar - 28 - 2011 Comments Off READ FULL POST
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By Yaping Zhang – Edited by Mila Owen On April 6, ...