Pharma & Biotech Global Week in Review 3 March 2010 from IP Think Tank

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

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.

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Highlights this week included:

Cozaar (Losartan), Hyzaar (Hydrochlorothiazide; Losartan) – US: Teva prevails in generic Cozaar/Hyzaar 180-day exclusivity forfeiture litigation: Teva v Kathleen Sebelius (FDA Law Blog) (SmartBrief)

Nexavar (Sorafenib) – India: More on Bayer patent linkage – Supreme Court admits special leave petition filed by Bayer (Spicy IP) (Generic Pharmaceuticals and IP) (Spicy IP) (Spicy IP)

Aranesp (Darbepoetin alfa) – EU: Advocate General opines Kirin cannot be granted SPC because they had not obtained a Lithuanian MA for Aranesp before accession date: Kirin Amgen v Lietuvos Respublikos; (The SPC Blog) (EPLAW)

Colombia/EU/Peru: Tough IP health provisions in Europe’s Colombia/Peru trade deal (IP Watch) (IP tango)

 
General

WTO TRIPS Council considers workshop on public health amendment (IP Watch)

Efficacy of TRIPS public health amendment in question at WTO (IP Watch)

International treaties and national legislation – How far can they go to protect local and Indigenous farmers’ IP rights? (IP Osgoode)

Australia: University of Western Australia’s application to appeal FCAFC’s decision in University of Western Australia v Gray fails (IP Whiteboard)

Colombia/EU/Peru: Tough IP health provisions in Europe’s Colombia/Peru trade deal (IP Watch) (IP tango)

EU: Something more about Swiss type claims: G02/08 (SiNApSE) (SiNApSE)

US: Pharmaceutical patent settlements – and what about patients? (IP Think Tank)

US: Reverse payments in generic drug settlements (Part II – Patent Docs) (Part III – Patent Docs) (Part IV – Patent Docs)

US: Inability of patent examiner and Board to correctly read prior art reference necessitates intervention by Federal Circuit: In re Chapman (Holman’s Biotech IP Blog) (Patent Docs)

US: Patent infringement suit between NexMed and Beta Technologies stayed following determination that plaintiff NexMed may not own one of the patents-in-suit related to method of herpes lesion treatment (Patent Docs)

US: Bio-Reference seeks declaratory judgment of invalidity and noninfringement based on its JAK2 diagnostic testing: Bio-Reference Laboratories, Inc. v. Assistance Publique – Hopitaux De Paris et al. (Patent Docs)

US: Court report – Numerous false marking suits filed by Simonian against various respondents concerning products including: Claritin-D, Hypo Tears, Interceptor, Prevacid, Advil, Heartguard Heartworm Canine Medication (Patent Docs)

US: False marking suit brought over marking of Accu-Chek products: O’Neill v Roche Diagnostics Corp (Patent Docs)

US: President’s health care plan includes pay-for-delay ban and biosimilar regulatory pathway (Patent Docs)

US: OGD’s ANDA backlog and media ANDA approval times are up – way up! ‘The solution lies in resources’ says FDA Commissioner Hamburg (FDA Law Blog)

 
Products

Actoplus MET (Pioglitazone) – US: Takeda files patent infringement suit against Aurobindo following Para IV certification as part of ANDA to manufacture generic Actoplus MET (Patent Docs)

Advair diskus (Fluticasone, Salmeterol) – US: PTO denies PTE for Advair diskus patent; Office again clarifies that PTEs are not availabile for ‘synergistic combinations’ containing previously approved drugs: (FDA Law Blog)

Aldara (Imiquimod) – US: Graceway files patent infringement complaint following Para IV challenge by Perrigo (Patent Docs)

Androgel – US: District Court dismisses FTC challenge to Androgel settlement agreements; President’s Proposed Health Reform Bill would adopt a senate measure to curb settlement agreements (FDA Law Blog)

Aplenzin (Buproprion) – US: Biovail files infringement complaints before Delaware and S D Florida following Para IV challenge by Watson (Patent Docs)

Aranesp (Darbepoetin alfa) – EU: Advocate General opines Kirin cannot be granted SPC because they had not obtained a Lithuanian MA for Aranesp before accession date: Kirin Amgen v Lietuvos Respublikos; (The SPC Blog) (EPLAW)

Clobex (Clobetasol) – US: Galderma files patent infringement complaint following Para IV challenge by Taro (Patent Docs)

Cozaar (Losartan) – UK: EWCA provides first clear guidance on timing and substantive requirements for applying for and obtaining paediatric extension to an existing SPC: EI Du Pont Nemours & Co. v United Kingdom Intellectual Property Office (JIPLP)

Cozaar (Losartan), Hyzaar (Hydrochlorothiazide; Losartan) – US: Teva prevails in generic Cozaar/Hyzaar 180-day exclusivity forfeiture litigation: Teva v Kathleen Sebelius (FDA Law Blog) (SmartBrief)

Detrol (Tolterodine) – US: Teva appeals ruling that Pfizer’s patent covering Detrol is valid and enforceable (Patent Docs)

Erbitux (Cetuximab), Irinotecan – UK: IPO rejects SPC applications for Cetuximab-Irinotecan combination and Cetuxamib alone in accordance with Article 10(4) after applicant was provided with opportunity to correct irregularities in applications (The SPC Blog)

Fentora (Fentanyl) – US: Cephalon files patent infringement complaint following Para IV challenge by Sandoz (Patent Docs)

Fortamet (Metformin) – US: Shionogi files patent infringement suit against Mylan following Para IV challenge (Patent Docs)

Integrilin (Eptifibatide) – US: Millennium Pharmaceuticals files patent infringement complaint following Para IV challenge by Teva (Patent Docs)

Lidoderm (Lidocaine) – US: Endo files patent infringement complaint following Para IV challenge by Watson (Patent Docs)

Mirapex (Pramipexole) – US: CAFC: Ending the doctrine of non-statutory double patenting: Boehringer Ingelheim Int’l v Barr Labs & Mylan Pharma (Patently-O)

Nexavar (Sorafenib) – India: More on Bayer patent linkage – Supreme Court admits special leave petition filed by Bayer (Spicy IP) (Generic Pharmaceuticals and IP) (Spicy IP) (Spicy IP)

Plavix (Clopidogrel) – US: USPTO tentatively rejects claims in key patent for Plavix which is co-marketed by Sanofi-Aventis and Bristol-Myers Squibb (GenericsWeb)

Seasonique (Levonorgestrel/Ethinyl estradiol) – US: Watson seeks declaratory judgment of invalidity and infringement of patent based filing of ANDA to manufacture generic of Teva’s Seasonique (Patent Docs) (The IP Factor)

Januvia (Sitagliptin) – EU: German Federal Patent Court decides to refer question for preliminary ruling on negative term SPCs to ECJ in Sitaglipin case (The SPC Blog)

Tarceva (Erlotinib) – US: OSI gets re-issued patent (Generic Pharmaceuticals and IP)

Tasigna (Nilotinib) – India: Pre-grant opposition rejected (Indian Patent Oppositions)

TriCyclen (Norgestimate, Ethinyl estradiol) – US: Lupin files counterclaims against Ortho-McNeil-Janssen alleging Tri-Cyclen patent invalidity (Patent Docs)

Ultravate (Polyhalogeno steroids) – US: False marking suit based on marking of Ultravate products: Hollander v Ranbaxy Laboratories (Patent Docs)

Viepax (Venlafaxine) – Israel: Wyeth accuses Teva of widening grounds of opposition, but Israel Patent Office Adjudicator refuses to dismiss claims in interim ruling (The IP Factor)

Zinacef (Cefuroxime) – Kenya: SynerMed’s SYNERCEF registration cancelled based on Glaxo’s ZINACEF mark (Afro-IP)

 

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