Wockhardt Certified Para IV for Comtan

Wockhardt has filed an Abbreviated New Drug Application (ANDA) No. 78-941 seeking the US FDA approval to market a generic version of entacapone before the expiration of the Orange Book listed Patent Nos. 5,446,194 (the ‘194 patent) titled ‘Pharmacologically active catechol derivatives’ and 5,135,950 (the ‘950 patent) titled ‘Stable polymorphic form of (E)-N, N-diethyl-2-cyano-3-(3, 4-dihydroxy-5-nitrophenyl) acrylamide and the process for its preparation.’ Entacapone is marketed in the US by Orion, through its partner Novartis under the brand name Comtan for treatment of Parkinson’s disease. In response to Wockhardt’s submission of the ANDA, Orion filed a civil action for patent infringement in the US District Court for the District of Delaware, alleging infringement of the ‘194 and ‘950 patents under 35 USC § 271 (e)(2)(A) and subsequently seeking declaratory judgment.

Sanofi Defending Patent Rights in China

Sanofi-Aventis, world’s third largest pharmaceutical company has cleared its intention to defend its patent rights in China by filed a patent infringement lawsuit in the Beijing High Court against Chinese anti-tumor drug manufacturer Jiangsu Hengrui Medicine Co Ltd. In its complaint, Sanofi has alleged that Jiangsu has infringed upon a patent for docetaxel, a cytotoxic injectable issued by the China’s State Intellectual Property Office on December 27, 2006 and is seeking RMB 45 million ($ 5.98 million) in patent fees, RMB 55 million ($ 7.31 million) in compensation for economic loss, and RMB 200,000 ($ 26,595) in sampling and notarization fees. Earlier in 2003, Aventis filed a lawsuit against Jiangsu for infringing a process patent for manufacturing of docetaxel, which Shanghai No. 2 Intermediate People’s Court later in September 2006 ruled in favor of Sanofi-Aventis, and ordered Jiangsu to pay a total of RMB 230,000 ($30,616) in compensation and legal cots. Jiangsu appealed to the Shanghai Higher People’s Court, which withdrew the previous judgment.

Anticancer drug Tarceva received Patent Term Extension

OSI Pharmaceuticals Inc. has received a patent term extension for the US Pat. 5,747,498 (the ‘498 patent) covering anticancer drug Tarceva, generically known as erlotinib indicated for second-line advanced Non-Small Cell Lung Cancer (NSCLC) and for combination therapy for first-line advanced pancreatic cancer. The term of the ‘498 patent is extended by 1,251 days under 35 USC § 156, extending expiration date from June 06, 2015 to November 08, 2018. OSI has already received Supplementary Protection Certificates (SPCs) for Tarceva extending exclusivity to March 2020 in 14 Contracting States including France, Germany, Italy, Switzerland and the United Kingdom.

With Opportunities Come Challenges!

My recent article for pharmabiz pull-out edition read here.

Sepracor Suing Sun Pharmaceutical Over Desloratidine Patent

Sepracor jointly with University of Massachusetts has filed a civil action for patent infringement against Sun Pharmaceutical Industries alleging infringement of Orange Book listed US Patent Nos. 7,211,582 (the ‘582 patent), 7,214,683 (the ‘683 patent) and 7,214,684 (the ‘684 patent) for Clarinex tablets, generically known as Desloratidine. The complaint is filed in the US District Court for the District of New Jersey in response to Sun’s filing of an Abbreviated New Drug Application (ANDA) No. 78-359 under Para IV certification with the US FDA seeking approval of commercially market a generic version of Clarinex tablets prior to the expiration of the ‘582, ‘683 and ‘683 patents. Sepracor alleged that Sun’s ANDA product constitutes infringement of one or more of the claims of the ‘582, ‘683 and ‘684 patents under 35 USC § 271 (e) (2) (A).

Lupin Knock-down Altace Patent

Indian-based pharmaceutical manufacturer Lupin Ltd. has finally tasted the success of the knocking down King’s US Pat. 5,061,722 (the ‘722 patent) covering blockbuster drug Altace, generically known as Ramipril. The US Court of Appeals for the Federal Circuit ruled in the favor of Lupin holding that the ‘722 patent is invalid. Earlier, the US District Court for the District of Columbia concluded at summary judgment that claims of the ‘722 patent are valid and infringed by Lupin’s Abbreviated New Drug Application No. under the doctrine of equivalence. Accordingly Lupin appealed to Court of Appeals. The Court of Appeals invalidated the ‘722 patent over obviousness holding that claims 1 and 2 of the ‘722 patent are invalid over the SCH 31925 mixture (referring to work conducted by Dr. Smith), the US Pat. 5,348,944, and the enalapril references in the prior art.

Wyeth v. Teva | Protonix ‘Generic’ Lawsuit

On September 06, 2007 judge Jose L. Linares of the US District Court rejected Wyeth’s request for an injunction order against the generic challenger Teva Pharmaceutical Industries Ltd. that would have barred Teva from selling its generic version until a patent dispute between the companies get resolved. Generically known as pantoprazole, Protonix is Wyeth’s leading pharmaceutical products worth US $ 1.8 billion in sales in 2006 for which Teva had already bagged first-to-file status, giving 180-days market exclusivity for the US market. Pantoprazole is broadly covered within the scope of the US 4,758,579 (the ‘579 patent) for which Teva has filed a Para IV certification challenging its validity and enforceability.

Indian Automobiles Players Tussle Over DTS-i Technology Patent

Digital Twin Spark Plug Ignition (DTS-i) Technology has made its way into first-major patent fight between two Indian automobiles (two-wheeler) major --- Bajaj Auto Ltd. and TVS Motors, with Bajaj alleging TVS of patent infringement over its DTS-i technology patent and threatening to initiate a legal action against TVS Motors if TVS schedule to launch its 125 CC Flame which uses a technology similar to Bajaj’s patented DTS-i technology. In its company statement, TVS contended that Flame is very different from any of the bikes that Bajaj makes and the patent does not hold for it. TVS’s Senior Vice President H.S. Goindy argued that “Bajaj has a patent for twin spark technology only for two valve engine. Flame for the first time in the country sports a three valve heart and is thus outside the purview of the patent.” He further added that “the technology is prepared by Austrian company AVL specifically for us and we are licensee to it.” Bajaj has to still wait for launch of Flame before zeroing down to file a lawsuit for patent infringement. On the other hand, TVS has filed a petition for revocation of Bajaj’s DTS-i technology patent contending that the patent is wrongly issued by the Indian Patent Office as it was already been patented in the US by Japanese Automobile major Honda Motor Co.