Sankyo Commences Litigation Over Infringement of Benicar HCT Patent

Daiichi Sankyo has commenced litigation on June 22, 2007 against Mylan in the US District Court for the District of New Jersey for infringement of Orange Book listed patent covering olmesartan medoxomil, one of the active ingredients in Sankyo’s antihypertensive drug, Benicar HCT. The lawsuit is pursuant to 35 USC § 271(e) following Mylan submission of Abbreviated New Drug Application (ANDA) with the US FDA seeking marketing approval for generic Benicar HCT prior to expiration of Orange Book listed patent.

Febit Files Infringement Complaint Against Codon

German biotech company Febit Biotech has filed a infringement complaint in the US District Court for the District of Delaware against Codon Devices alleging infringement of the US Patent # 6,586,211 (the ‘211 patent) pursuant to 35 USC § 271(a) and (g). In complaint, Febit alleged that Codon manufactures and uses a gene synthesis platform called the BioFAB platform which infringes literally or under doctrine of equivalents, one or more claims of the ‘211 patent. Febit is seeking compensatory damages under 35 USC § 284 and treble damages for willing infringement.

Dabur Joins Eloxatin Patent Dispute

Delhi-based Dabur Pharma Limited and its subsidiary Dabur Oncology Plc are new to join Eloxatin patent infringement dispute following Sanofi’s complaint in the US District Court for the District of New Jersey alleging infringement of US Patent Nos. 5,338,874 (the ‘874 patent) and 5,716,988 (the ‘988 patent). In separate complaint, Sanofi also extended allegation of patent infringement against Teva Pharmaceutical Industries over the same patents. The complaint is result of Dabur submission of Abbreviated New Drug Application (ANDA) No. 78-811 with the US FDA for the generic approval of Oxaliplatin solution before the expiration of Orange Book listed patents. Earlier, Sanofi filed a patent infringement complaint against Sandoz over the same US patents.

Novartis Object Over Appellate Board Formation

Pharmaceutical major Novartis which dared to challenge the Indian patent system is fighting tooth and nail against the decision of Chennai Patent Office to reject its patent application for beta-crystalline form of Imatinib Mesylate, has now raised an objection against the formation of two-member bench of the Intellectual Property Appellate Board (IPAB), in particularly objecting the presence of S. Chandrashekran as a technical member pursuant to section 116(2) of the Patents Act 1970. Novartis alleged it was under the tenure of S. Chandrashekran as a Controller General of Patents the application for beta-crystalline form of Imatinib Mesylate was rejected, and also that he was acting as a party in the recent court case reviewing the decision of the Indian Patent Office to reject application for beta-crystalline Imatinib Mesylate. However, Chandrasekran denied any conflict of interest stating that the application was rejected at the Chennai Patent Office by the Assistant Controller of Patents & Designs.

Sanofi-Sandoz Fights Over Eloxatin Patent

Sanofi-Aventis, the world’s third largest pharmaceutical company jointly with Debiopharm has filed a patent infringement complaint in the US District Court for the District of New Jersey to keep generic drug maker Sandoz off from the US Eloxatin market till the expiration of Eloxatin Orange Book listed US Patent Nos. 5,338,874 (the ‘874 patent) and 5,716,988 (the ‘988 patent). In its complaint dated June 14, 2007, Sanofi alleged that Sandoz’s Abbreviated New Drug Application (ANDA) No. 78-817 will infringe one or more claims of the ‘874 and ‘988 patents and will constitute an act of an infringement pursuant to 35 USC § 271(e) (2). The The patents-in-suit are two of the four Orange Book listed patents for Eloxatin Injectable Solution exclusively licensed to Sanofi-Aventis from Debiopharm. The other two Orange Book listed patents are US 5,290,961 (the ‘961 patent) and US 5,420,319 (the ‘319 patent).The ‘961 patent particularly covers Oxaliplatin (the active ingredient of Eloxatin) as cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II). The ‘874 patent in particularly claims optically pure cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II) whereas the ‘319 patent exemplifies optically pure cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II) having optical purity of 99.94% or more and a melting point between 198.3 degree centigrade and 199.7 degree centigrade. The ‘988 patent covers pharmaceutically stable parenteral solution of oxaliplatin.

Canadian Court Upheld Levofloxacin Patent

Canadian Federal Appeal Court has affirmed the decision of the Canadian Federal Court which upheld the validity of the Daiichi Sankyo’s Canadian Patent No. 1,304,080 (the ‘080 patent) for antibacterial agent, Levofloxacin and also found the ‘080 patent infringed by generic Levofloxacin tablets manufactured by generic drug maker Novopharm Limited. This decision will enjoin Novopharm from selling, offering for sale a generic version of Levofloxacin tablets in the Canadian market until the expiration of the ‘080 patent will expires on June 23, 2009.

Tata Tea Boils Over Unilever

World’s second largest tea maker – Tata Tea has filed a petition for patent revocation in the Mumbai High Court against an Indian patent issued to Unilever for the process of making instant tea from cold water. The appeal has now referred to the Intellectual Property Appellate Tribunal by the Mumbai High Court. In its petition, Tata Tea alleged that the process of making tea has been known to Indian for centuries and is not an invention and cannot be patented in India. The process is already been patented in Europe and the US and later issued by Indian Patent Office in 1997. According to Hindustan Unilever, an Indian Subsidiary of Unilever the invention relates to a method of treating cold water with soluble solids derived from tea leaves.

Sandoz to Step in as Authorized Generic

Novartis is likely to launch an authorized generic for Lotrel through its generic division Sandoz after the US District Court for the District of New Jersey vacated a restraining order against Teva Pharmaceuticals to halt shipments of generic versions of the drug in the US, which means now Teva can resume shipments of generic Lotrel. The New Jersey court also denied a Novartis motion for a preliminary injunction in an ongoing patent dispute. However, Novartis will continue pursuing its defense of patent rights as Lotrel has a US patent valid until 2017. Lotrel is combination of ACE inhibitor benazepril with calcium channel blocker amlodipine besylate, and had sales of US $ 1.35 billion in 2006.

Updates: Indian Patents

New Drug Compounds Sun Pharmaceuticals secured an Indian Patent No. 204126 (the ‘126 patent) titled 4-(Diarylmethyl)-1-piperazinyl derivatives against its application number 302/MUM/2002 (Equivalent US Publication No. 20050107393). World’s leading pharma major Pfizer obtained an Indian Patent No. 204132 (the ‘132 patent) titled CCR5 Modulator Compounds against its application number 885/MUM/1999 (Equivalent US Patent Nos. 6,586,430 and 7,041,667) and an Indian Patent No. 204344 titled 1-Thifluoromethyl-4-Hydroxy-7-Piperidinylaminomethylchroman derivatives against its application number 456/MUM/2000 (Equivalent US Patent No. 6,239,147). Janssen Pharmaceutica N.V. received an Indian Patent No. 204144 (the ‘144 patent) titled Benzimidazoles and imidazopyridines having Inhibitory Antiviral Activity against its application number IN/PCT/2001/01539/MUM. Glaxo secured an Indian Patent No. 204151 (the ‘151 patent) titled Substituted oxazoles and thiazoles derivatives as HPPAR ALPHA Activators against its application number IN/PCT/2002/00583/MUM. World’s third largest company AstraZeneca obtained an Indian Patent No. 204158 (the ‘158 patent) titled Imidazo Pyridine Derivatives which inhibit Gastric Acid Secretion against its application number IN/PCT/2000/00496/MUM (Equivalent US Patent Nos. 6,313,136 and 6,313,137). New Form Pfizer secured an Indian Patent No. 204325 (the ‘325 patent) titled An Eletriptan Hydrobromide Monohydrate and a process for the preparation of the same against its application number 841/MUM/1999. Pfizer obtained an Indian Patent No. 204343 (the ‘343 patent) titled Polymorph of (2R, 3S, 4R, 5R, 8R,10R, 11R, 12S, 13S,14R)- 13- [[2,6-dideoxy-3-cmethyl-3-0-methyl-4-(-[(propylamino)methyl]-a-l- ribohexopryanosyl]- 2-ethyl-3,4,10- trihydroxy-3,5,8,10,12,14-examethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- b-d-xylohexopyranosyl] oxa]-1-oxa-6-azacycopentadecan-15-one diphosphate

Teva Joins Lipitor Generic Battle

On June 07, 2007 world’s leading pharmaceutical company Pfizer filed a patent infringement complaint in the US District Court for the District of Delaware against Teva Pharmaceutical Industries alleging infringement of the US Patent No. 5,273,995 (the ‘995 patent) in response to Teva submission of Abbreviated New Drug Application (ANDA) No. 78-773 with US FDA for generic Lipitor tablets seeking marketing approval prior to the expiration of the ‘995 patent. With this Teva has joined Ranbaxy in a million-dollar generic Lipitor battle!

Roche Faces More Opposition Heat!

Sankalp, a Mumbai-based non-governmental organization has filed a post-grant opposition against Roche’s Indian patent covering Hepatitis C drug Pegasys pursuant to section 25(2) of the Patents Act 1970. This is the second post-grant opposition filed against Pegasys patent, after Mumbai-based biopharmaceutical company Wockhardt filed a similar post-grant opposition two months back. Pegasys is the first drug to secure product patent protection status in India after India brought third patent amendment to extend patent protection to pharmaceutical and biopharmaceutical drug products. Pegasys patent will be valid in India until May 16, 2017. Sankalp alleges that Pegasys involves combining interferon with polyethelyene glycol (PEG) which helps the interferon to remain in the bloodstream, and also that the technology of combining interferon and other biologically active proteins with PEG had been known for years prior to Pegasys patent. They further alleged that Roche ‘invention’ is at most a ‘mere admixture’ of known substances and thus not patentable under section 3(e) of the Patents Act 1970, and is just a ‘new form of a known substance’ and not patentable under section 3(d) of the Act.

Torrent secured US patent for five-membered heterocyclic compound

Ahmedabad-based Torrent Pharmaceuticals has secured a US Patent No. 7,223,777 (the ‘777 patent) for a new class of five membered heterocyclic ring compounds useful for the management of diabetes and aging related vascular complications, having markush structural formula I and independent claims. The ‘777 patent particularly exemplifies list of 56 compounds as recited in table 1.

Prozac Litigation Voluntarily Dismissed

Generic drug maker Barr Pharmaceuticals Inc. and NDA applicant Eli Lilly have voluntarily dismissed all claims stemming from a patent infringement lawsuit over Prozac Weekly Capsules, the lawsuit was filed in May last year by Lilly to prevent generic competition for its Prozac Weekly Capsules. According to Barr, Barr is the first to file an abbreviated new drug application (ANDA) with the US FDA for the 90mg capsules and, consequently, will be entitled to 180 days exclusivity when its application receives FDA final approval. Barr made ANDA submission in November 2001 along with Para IV certificate to Prozac Orange Book listed patents. However, on receiving the receipt of notice for Para IV certification from FDA, Lilly failed to sue Barr within 45 days. On March 21, 2006 Lilly obtained a reissue US Patent No. RE39, 030 (the ‘030 patent) and subsequently listed the patent with Orange Book. Accordingly Barr amended its ANDA to include Para IV certification for the ‘030 patent and notified Lilly. On May 10, 2006 after receiving notice from Barr, Lilly filed a patent infringement lawsuit against Barr alleging infringement of the ‘030 patent in the US District Court, Southern District of Indiana, to prevent Barr from proceeding with the commercialization of the generic Prozac.

Teva Moves Action for Declaratory Judgment Against Torrent

Teva has moved an action for declaratory judgment of patent infringement in the US District Court for the District of Delaware against Torrent Pharmaceuticals Ltd. alleging that Torrent’s US DMF No. 18311 for sertraline hydrochloride and Torrent ANDA No. 77-765 for generic sertraline hydrochloride tablet would infringe one or more claims of Teva’s US Patent Nos. 6,600,073 (the ‘073 patent), 6,500,987 (the ‘987 patent), 6,495,721 (the ‘721 patent), and 6,897,340 (the ‘340 patent) covering methods for manufacturing certain crystalline forms of sertraline hydrochloride. In its complaint, Teva further moved declaratory judgment of inducement of patent infringement under 35 USC § 271.

Sandoz Sued by Aventis over Fexofenadine Patent

On May 24, 2007 one of the leading global pharmaceutical major – Sanofi-Aventis has filed a patent infringement lawsuit in the US District Court for the District of New Jersey against Novartis generic arm – Sandoz alleging that Sandoz’s amended Abbreviated New Drug Application (ANDA) Nos. 76-707 and 77-999 for Allerga and Allerga-D respectively would be an act of infringement pursuant to 35 USC § 271 (e)(2), and would infringe Orange Book listed US Patent Nos. 6,399,632 (the ‘632 patent), 6,187,791 (the ‘791 patent), and 6,037,353 (the ‘353 patent). In its amended ANDAs submission, Sandoz changed its Para III certification for ‘632, ‘791 and ‘353 patents to Para IV certification. Earlier, in its original ANDAs submission, Sandoz made Para IV certification with respect to Orange Book US Patent Nos. 6,113,942 (the ‘942 patent), 5,855,912 (the ‘912 patent) and 5,932,247 (the ‘247 patent) and Para III certification for ‘632, ‘791 and ‘353 patents. In response to original ANDAs submission, Aventis filed a patent infringement complaint in same court on January 20, 2004, alleging infringement of ‘942, ‘912 and ‘247 patents and seeking declaratory judgment of infringement of the US Patent No. 5,738,872 (the ‘872 patent). Sandoz later amended and filed its amended ANDAs on April 11, 2007 extending Para IV certification to ‘632, ‘791 and ‘353 patents. In the meantime, the US District Court for the District of New Jersey denied Aventis motion for preliminary injunction on January 30, 2006 which Aventis subsequently appealed to the US Court of Appeals for the Federal Circuit which affirmed the district court judgment.

Mylan Up! Up! And Away!

In one of the major development, the US District Court for the Southern District of New York has ruled that Mylan’s 10mg and 20mg generic version of omeprazole delayed-release capsules do not infringe AstraZeneca’s blockbuster Prilosec Orange Book listed patents, preventing Mylan from paying triple damages to AstraZeneca. Mylan launched its omeprazole generic products on August 04, 2003 despite the patent infringement litigation, which at the time was unprecedented in the generic pharmaceutical industry. However, the Court also found that Apotex and Impax generic omeprazole products do infringe the same patents asserted against Mylan. Earlier in December 2002, Schwarz/Kudco launched their generic version of omeprazole capsules after District Court Judge Barbara S. Jones ruled that Schwarz’s formulation did not infringe AstraZeneca’s Orange Book listed patents, the decision later appealed by AstraZeneca which subsequently in December 2003 affirmed by the US Court of Appeals for the Federal Circuit.