Here is Think IP Strategy’s weekly selection of top Pharma & Biotech intellectual property news breaking in the blogosphere and internet.

 

Highlights this week included:

India yet to notify a list of ‘International Non-Proprietary Names’ (Spicy IP)

NuvaRing (Etonogestrel / Ethinyl estradiol) – US: Domestic industry requirement and small business – ALJ Pender denies motion for summary determination in Certain Vaginal Ring Birth Control Devices (337-TA-768) (ITC 337 Law Blog)

 

Please join the discussion by adding your comments on any of these stories, and please do let us know if you think we’ve missed something important, or if there is a source you think should be monitored.

 

General

India yet to notify a list of ‘International Non-Proprietary Names’ (Spicy IP)

Portugal redefines scope of patent infringement, dispute resolution with new medicines law (PatLit)

US: If patents become irrelevant in a biosimilars future, what about university patents and startups? (Patent Docs)

US: CMS physician sunshine proposal finally sees light of day; HP&M issues summary memorandum (FDA Law Blog)

US: GAO reports on approval of pediatric medical devices (FDA Law Blog)

US: CDRH issues draft guidance on substantial equivalence determinations (FDA Law Blog)

US: ULTRA Bill introduced in the House; legislation seeks to permit broader use of scientific data to support surrogate endpoints for “ultra orphan” drug approvals (FDA Law Blog)

 

Products

Acuvail (Keterolac tromethamine) – US: Allergan files patent infringement complaint against Akorn in response to Para IV challenge (Patent Docs)

Crestor (Rosuvastatin) – US: CAFC guidance on requirements for establishing prior invention: Teva v AstraZeneca (Pharma Patents)

Epirubicin hydrochloride, Idarubicin hydrochloride – US: Synbias Pharma files for declaratory judgment of non-infringement, invalidity and unenforceability of Solux patents (Patent Docs)

Fipronil – US: Fidopharm files for declaratory judgement and invalidity of Merial’s patent ahead of planned launch of fipronil-based products (Patent Docs)

Humira Pen – UK: Patents County Court: Experiments supporting non-infringment defence satisfy the cost-benefit test: Liversidge v Mumford (EPLAW)

Lipitor (Atorvastatin) – Spain: Supreme Court delivers judgment in Cinfa v Warner-Lambert (EPLAW)

NuvaRing (Etonogestrel / Ethinyl estradiol) – US: ALJ Pender denies motion for summary determination in Certain Vaginal Ring Birth Control Devices (337-TA-768) (ITC 337 Law Blog)

NuvaRing (Etonogestrel / Ethinyl estradiol) – US: ALJ Pender rules on motion to quash subpoena in Certain Vaginal Ring Birth Control Devices (337-TA-768) (ITC 337 Law Blog)

Replagal (Alpha-galactosidase) – UK: EWHC (Pat): Mount Sinai allowed to access requested experiment samples and use in parallel EPO opposition proceedings: Shire v Mount Sinai (EPLAW)

Sibutramine – Spain: Supreme Court reassesses doctrine of production of damages in patent infringement litigation: Abbott v Roig Farma (EPLAW)

Singulair (Montelukast) – US:Merck Frosst Canada files patent infringement complaint against Mylan in response to Para IV challenge (Patent Docs)

Torisel (Temsirolimus) – US: Pfizer, Wyeth file separate patent infringement suits against Intas Pharmaceuticals and others and Sandoz in response to Para IV certification filing (Patent Docs)

Valcyte (Valganciclovir) – US: Roche Palo, Genentech file patent infringement complaint against Dr Reddy’s in response to Para IV challenge (Patent Docs)

Veramyst (Fluticasone) – US: GlaxoSmithKline files patent infringement complaint against Sandoz in reponse to Para IV challenge (Patent Docs)

Xalatan (Latanoprost) – Canada: Sound prediction & the case for Xalatan (IP Osgoode)

Zaltrap (Aflibercept) – US: Genentech files patent infringement suit against Regeneron in response to its intended launch of Zaltrap (Patent Docs)

Zegerid (Omeprazole / Sodium bicarbonate) – US: MSD Consumer Products files patent infringement complaint against Zydus in response to Para IV certification filing (Patent Docs)

Zegerid (Omeprazole, Sodium bicarbonate) – US: Santarus files patent infringement complaint against Zydus following Para IV certification filling (Patent Docs)