Hatch-Waxman Act. Legal news and articles for October 18 - 31, 2011

Safe-Harbor Provision Of Hatch-Waxman Act Does Not Protect Post-Approval ...Their View: Generic drugs: How to cure a headacheNoven Files Patent Infringement Lawsuit against Watson PharmaceuticalsImpax Laboratories Confirms Patent Challenge Relating to Generic JALYN® 0.5 mg ...Big drugmakers delaying access to genericsAIA Overview: Supplemental ExaminationFTC staff report attacks branded-generic patent settlementsSafe-Harbor Provision of Hatch-Waxman Act Does Not Protect Post-Approval ...Safe-harbor provision of Hatch-Waxman Act does not protect post-approval ...Ending drug companies' pay-for-delay dealsSANOFI-AVENTIS v. APOTEX INC.Perrigo Confirms Filing For Generic Version Of PATANASE Nasal Spray And ...Watson confirms generic Atelvia patent challengePerrigo Confirms Filing for Generic Version of PATANASE® Nasal Spray and ...Watson files ANDA for Atelvia with FDA

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Hatch-Waxman Act. News and Stories

Safe-Harbor Provision Of Hatch-Waxman Act Does Not Protect Post-Approval ...
Mondaq News Alerts (registration)October 31, 2011

As part of that decision it held that the safe-harbor provision of the Hatch-Waxman Act is limited to activities reasonably related to obtaining pre-marketing FDA approval of generic counterparts, and does not protect post-approval research activities. ...more »

Their View: Generic drugs: How to cure a headache
Silver City Sun NewsOctober 30, 2011

The Hatch-Waxman Act of 1984 meant to address this problem by allowing generics to market bio-equivalent drugs as long as they did not infringe on the brand-name drug s patent; the generic could also proceed if it proved the brand-name patent was ...more »

Noven Files Patent Infringement Lawsuit against Watson Pharmaceuticals
Benzinga (press release)October 29, 2011

Under the Hatch-Waxman Act, because Noven filed this patent infringement lawsuit within 45 days of receiving a Paragraph IV notification letter from Watson, the FDA cannot approve Watson's ANDA for 30 months (until March 2014), unless the district ...more »

Impax Laboratories Confirms Patent Challenge Relating to Generic JALYN® 0.5 mg ...
Benzinga (press release)October 29, 2011

This action formally initiates the patent challenge process under the Hatch-Waxman Act. Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, intends to commercialize the product. JALYN® is indicated for the treatment of ...more »

Big drugmakers delaying access to generics
Fort Wayne Journal GazetteOctober 28, 2011

The Hatch-Waxman Act of 1984 meant to address this problem by allowing generics to market “bio-equivalent” drugs as long as they did not infringe on the brand-name drug's patent; the generic could also proceed if it proved the brand-name patent was ...more »

AIA Overview: Supplemental Examination
Patent DocsOctober 27, 2011

... by the patentee under the provisions of the Hatch-Waxman Act (§ 505(j)(2)(B)(iv)(II) of the Federal Food, Drug, and Cosmetic Act, codified at 21 USC § 355(j)(2)(B)(iv)(II)) before the filing of the supplemental examination request (§ 257(c)(2)(A)). ...more »

FTC staff report attacks branded-generic patent settlements
Drug Store NewsOctober 25, 2011

Under the Hatch-Waxman Act of 1984, a generic drug company that wishes to launch its version of a branded drug after the latter's market exclusivity period has expired but before its loss of patent protection, may file a regulatory approval application ...more »

Safe-Harbor Provision of Hatch-Waxman Act Does Not Protect Post-Approval ...
JD Supra (press release)October 25, 2011

As part of that decision it held that the safe-harbor provision of the Hatch-Waxman Act is limited to activities reasonably related to obtaining pre-marketing FDA approval of generic counterparts, and does not protect post-approval research activities. ...more »

Safe-harbor provision of Hatch-Waxman Act does not protect post-approval ...
Lexology (registration)October 25, 2011

As part of that decision it held that the safe-harbor provision of the Hatch-Waxman Act is limited to activities reasonably related to obtaining pre-marketing FDA approval of generic counterparts, and does not protect post-approval research activities. ...more »

Ending drug companies' pay-for-delay deals
Washington PostOctober 24, 2011

The Hatch-Waxman Act of 1984 meant to address this problem by allowing generics to market “bio-equivalent” drugs as long as they did not infringe on the brand-name drug's patent; the generic could also proceed if it proved the brand-name patent was ...more »

SANOFI-AVENTIS v. APOTEX INC.
Leagle.comOctober 19, 2011

Under the provisions of the Hatch-Waxman Act in effect at the time Apotex filed its ANDA, Apotex was entitled to a 180-day period of exclusivity during which the FDA would not approve other generic clopidogrel bisulfate products once Apotex received ...more »

Perrigo Confirms Filing For Generic Version Of PATANASE Nasal Spray And ...
Daily MarketsOctober 18, 2011

This action formally initiates the process under the Hatch-Waxman Act. PATANASE® (olopatadine hydrochloride) nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children six years of age and older. ...more »

Watson confirms generic Atelvia patent challenge
Drug Store NewsOctober 18, 2011

The suit was filed under the Hatch-Waxman Act, Under the Hatch-Waxman Act, which puts a stay of FDA approval on Watson's drug for 30 months, or until the companies settle the matter. Watson, however, said it believes it may be a "first applicant" to ...more »

Perrigo Confirms Filing for Generic Version of PATANASE® Nasal Spray and ...
PR Newswire (press release)October 18, 2011

This action formally initiates the process under the Hatch-Waxman Act. PATANASE® (olopatadine hydrochloride) nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children six years of age and older. ...more »

Watson files ANDA for Atelvia with FDA
Pharmaceutical Business ReviewOctober 18, 2011

The lawsuit which was filed under the provisions of the Hatch-Waxman Act resulted in a stay of final FDA approval of Watson's ANDA. Following the approval of ANDA for the drug, the company hopes to be entitled to 180 days of generic market exclusivity.more »

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