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

Top Picks in News

Covington & Burling LLP Announces 10 New Partners
Main JusticeOctober 3, 2011

He received his JD from Georgetown University Law Center and his BA from Connecticut College. Miranda Cole (Antitrust/Communications) practices in the areas of competition and communications law and policy. Her competition law expertise includes merger ...more »

Perrigo Company Confirms FDA Tentative Approval for Clobetasol Propionate ...
Sacramento BeeOctober 6, 2011

This action, which is still pending, formally initiated the process under the Hatch-Waxman Act. The product is the AB-rated equivalent to Stiefel Laboratories' Olux® -E Foam, 0.05%, a topical corticosteroid indicated for the treatment of moderate to ...more »

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 »

123

Archive

Legal and Criminal News in 2017
Legal and Criminal News in 2016
Legal and Criminal News in 2015
Legal and Criminal News in 2014
Legal and Criminal News in 2013
Legal and Criminal News in 2012
Legal and Criminal News in 2011
Legal and Criminal News in 2010
Legal and Criminal News in 2009
Legal and Criminal News in 2008
Legal and Criminal News in 2007
Legal and Criminal News in 2006
Legal and Criminal News in 2005
Legal and Criminal News in 2004
Legal and Criminal News in 2003
Legal and Criminal News in 2002
Legal and Criminal News in 2001
Book of the Day in our Store
Share it on TwitterFacebook
Culture in Law and Development: Nurturing Positive ChangeCulture in Law and Development: Nurturing Positive Change
by Lan Cao
  • Price: $135.00
from $111.96
View
Lawrence M CirelliAttorney at LawPRACTICE AREA: Consumer Protection, Litigation
Gary E GillAttorney at LawPRACTICE AREA: Elder Law, Real Estate Law, Wills & Probate, Trusts & Estate Planning, Litigation