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10 Dec 2010, 2:54 pm by Anna Christensen
Mensing (Granted )Docket: 09-993Issue(s): Whether the Eighth Circuit abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the labeling approved by the Food and Drug Administration for the listed (or branded) drug.Certiorari-Stage Documents:Opinion below (8th Circuit)Petition for certiorariBrief in oppositionSupplemental brief of petitionersPetitioners'… [read post]
10 Dec 2010, 2:23 pm by Lyle Denniston
Mensing (09-993), Actavis v. [read post]
9 Dec 2010, 1:10 pm by Christa Culver
Mensing (Granted )Docket: 09-1039Issue(s): Whether the Eighth Circuit abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the labeling approved by the Food and Drug Administration for the listed (or branded) drug.Certiorari-Stage Documents:Opinion below (8th Circuit)Petition for certiorariBrief in oppositionPetitioner's supplemental briefAmicus brief… [read post]
6 Dec 2010, 8:26 am by John Elwood
Mensing, 09–993/ Actavis Elizabeth LLC v. [read post]
5 Dec 2010, 3:02 pm
Next was Mr Justice Floyd, who considered the validity of intent-based claims – claims for products distinguished by the purpose or intent for which they are used, as discussed in Adhesive Dry Mounting (Ch 1910), Actavis v Merck (CA 2008) and Mobil/friction reducing additive (EBA 1989) – and the impact of claim categories on the inherent patentability of products more generally. [read post]
1 Dec 2010, 5:54 pm by Christa Culver
MensingDocket: 09-993Issue(s): Whether the Eighth Circuit abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the labeling approved by the Food and Drug Administration for the listed (or branded) drug.Certiorari-Stage Documents:Opinion below (8th Circuit)Petition for certiorariBrief in oppositionSupplemental brief of petitionersPetitioners'… [read post]
1 Dec 2010, 12:15 am by Kelly
Apotex, Inc (Patently-O) Simcor (Niacin/Simvastatin) – US: Impax Laboratories confirms patent challenge relating to Simcor extended-release tablets (SmartBrief) Taxotere (Docetaxel) – EU: Actavis launches Docetaxel single vial on patent expiry in major European markets (GenericsWeb) Temodar (Temozolide) – US: Cancer Research Technology files patent infringement suit against Accord following Para IV certification filing (Patent Docs) Tri-Cyclen Lo (Norgestimate/ethinyl… [read post]
17 Nov 2010, 1:48 am by Kelly
(FDA Law Blog) Crestor (Rosuvastatin) – US: AstraZeneca defeats Teva’s claim that Crestor infringes Teva’s patent (Orange Book Blog) Crestor (Rosuvastatin) – US: AstraZeneca files patent infringement suit against Watson in response to Para IV certification (Patent Docs) Efexor (Venlafaxine) – Australia: Federal Court blocks generic Efexor-XR: Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth Australia Pty Ltd (Patentology) (BAZPAT) (GenericsWeb) Fipronil – UK:… [read post]
10 Nov 2010, 3:21 am by Legal Intern
Actavis Inc. today announced a voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis by Corium International in the United States. [read post]
10 Nov 2010, 1:11 am by Kelly
Roche (Filewrapper) (Property, intangible) US: Senator Sanders letter to FDA: U.S. needs an ethical pathway for biological products (KEI) (FDA Law Blog) US: Daiichi Sankyo seeks review and correction of patent term adjustment calculation for patent relating to ‘nucleoside and oligonucleotide analogues’ (Patent Docs) US: CAFC in Abraxis v Navinta: remembering Stanford/Roche (IPBiz) Products Alimta (Pemetrexed) – US: Eli Lilly files patent infringement complaint against Teva in… [read post]
3 Nov 2010, 6:55 am by Anna Christensen
Mensing (09-993) and Actavis Elizabeth, LLC v. [read post]
27 Oct 2010, 3:38 am by Kelly
General GSK forms alliance for development of gene therapy techniques for rare diseases (Patent Docs) Emerging economies’ new initiative on falsified and substandard medicines (IP Watch) Michèle Rivasi asks question about ACTA and Access to Medicine (KEI) As negotiators launch talks on biodiversity, industry requests IP protection (IP Watch) Negotiators persist on biodiversity benefit-sharing treaty despite slipping deadlines (IP Watch) New draft biodiversity treaty text shows much work… [read post]
26 Oct 2010, 6:23 am by Mark Zamora
The product is manufactured for Actavis by Corium International in the United States.RECOMMENDATION: Wholesalers and retailers are being asked to return the product they have on hand or in stock. [read post]