Teva Para IV Punch to MSD’s SINGULAIR

Merck Sharp & Dohme Pharmaceuticals (MSD) has filed a patent infringement complaint in the US District Court for the District of New Jersey against Teva Pharmaceutical Industries alleging infringement of the US 5,565,473 (the ‘473 patent) protecting Montelukast sodium, the active ingredient of MSD’s SINGULAIR. The complaint is to prevent the US FDA from approving Teva’s abbreviated new drug application (ANDA) No. 78-605 for generic montelukast sodium tablets before expiry of the ‘473 patent. In its complaint, MSD argued that Teva has no adequate good faith basis for filing its ANDA containing certification of the invalidity, unenforceability, and/or non-infringement of the claims of the ‘473 patent.

Para IV Move: SEROQUEL™ (AstraZeneca/Sandoz)

AstraZeneca has filed a patent infringement complaint in the US District Court for the District of New Jersey against Novartis generic unit – Sandoz alleging infringement of the US 4,879,288 (the ‘288 patent) protecting Quetiapine fumarate, the active ingredient of SEROQUEL, and methods of using that compound. The complaint is result of Sandoz’s Para IV certification for generic SEROQUEL tablets in 25mg strength prior to expiration of the ‘288 patent. On March 22, 2007 Sandoz notified AstraZeneca that it had submitted abbreviated new drug application (ANDA) No. 78-679 to the US FDA seeking approval for commercial manufacturing, using and selling of quetiapine fumarate tablets. The ‘288 patent earlier received a patent term extension under 35 U.S.C. § 156 extending its term for a period of 1,651 days from March 20, 2007 to September 26, 2011.

Barr Eye Generic Ambien CR

Barr Laboratories has submitted abbreviated new drug application for insomnia drug Ambien CR, generically Zolpidem Tartrate Extended-Release tablets with Para IV certification challenging Sanofi’s Orange Book listed patents. Subsequent to Barr Para IV move, Sanofi, on April 05 2007 filed a patent infringement lawsuit in the U.S. District Court of New Jersey to prevent Barr from proceeding with the commercialization of its generic Ambien. According to IMS sales data, Ambien CR had sales of approx. $ 659 million for the twelve months ended February 2007.

Bayer Sues Teva over Generic Avelox

Bayer HealthCare AG has filed a patent infringement lawsuit against Teva Pharmaceuticals USA Inc. for infringing its Orange Book listed US Patent Nos. 4,990,517 (the ‘517 patent) and 5,607,942 (‘942 patent) for antibiotic drug Avelox, generically known as moxifloxacin hydrochloride. The infringement action is in response to Teva’s ANDA No. 77-437 with Para IV certification, seeking approval from the US FDA to manufacture and sell a generic Avelox before expiry of ‘517 and ‘942 patents. The lawsuit is filed in the US District Court for the District of Delaware.

Lupin Makes Patent Assignment worth $ 27 million

In one of the significant transaction made on intellectual property assignment, Indian drug manufacture Lupin has received 20 million euros (US $ 26.7 million) from a patent assignment made with French drug company Servier. According to Lupin’s Managing Director Kamal Sharma, “the company has received 20 million euros from Laboratories Servier of France for the sale of certain patent applications and other related intellectual property from perindopril for multiple countries.” He further added, “the income from this sale significantly boosts our performance for the previous quarter. It obviously goes a long way to demonstrate our Research and IP capabilities.”

Product Patent Update

Novartis has obtained an Indian Patent Number 202283 titled Benzothiadiazoles and derivatives against Indian Application Number IN/PCT/2000/233/CHE filed February 01, 1999 claiming earliest priority from British patent application dated February 03, 1998 published as GB 9802251. The ‘283 patent has equivalent US Patent Number 6,756,367 (the ‘367 patent). The compounds exemplified in the ‘367 patent disclosures exhibits antagonistic activity at CRF1 receptors. Chennai Patent Office has issued an Indian Patent Number 203560 titled New heterocyclic compounds, process for their preparation and pharmaceutical compositions containing them. The ‘560 patent is assigned to Dr. Reddy’s Laboratories against its Indian Application Number 1147/MAS/1998. F. Hoffman La Roche has received an Indian Patent Number 203568 titled Dihydro-benzo [b][1, 4] diazepin-2-one derivatives as MGLUR2 antagonists II against Indian Application Number 1610/CHENP/2003 filed April 02, 2002. The ‘568 patent claims earliest priority from European patent application dated April 12, 2001 against which EP 1379511 (the ‘511 patent) is published. The compounds exemplified in the ‘511 patent disclosure are metabotropic glutamate receptor antagonists and used for the treatment or prevention of acute and/or chronic neurological disorders.

Patent Appellate Board Goes Functional

On April 02, 2007 the Central Government issued a notification which triggered Section 117G of the Patents Act, 1970 providing that all pending appeals in high court shall be transferred to the Appellate Board set up under Section 116 of the Act, effective from the date of the issue of notification. Till this notification the Appellate Board existed in theory, and not operational with Technical Members to deal with patent matters. Section 117G read as follow – All cases of appeals against any order or decision of the Controller and all cases pertaining to revocation of patent other than on a counter-claim in a suit for infringement and rectification of register pending before any High Court shall be transferred to the Appellate Board from such date as may be notified by the Central Government in the Official Gazette and the Appellate Board may proceed with the matter either de novo or from the stage it was so transferred. Following the notification, Justice R. Balasubramanian and Justice Prabha Sridevan of the Madras High Court yesterday ordered to transfer the case to Appellate Board regarding rejection of Novartis’s patent application for beta-crystalline form of imatinib mesylate – a polymorphic form likely used is marketed formulation of Novartis’s blockbuster anticancer drug Gleevec. The Appellate Board will likely to decide the merit of the patentability of beta-crystalline form of imatinib mesylate under the Patents Act, 1970. But it is still need to be seen that whether Appellate Board will proceed with the matter either de novo or from the stage where the Madras High Court had left. However, the Madras High Court will continue to proceed and deal with the constitutional validity of Section 3 (d) of the Patents Act, 1970. Moreover, in yesterday hearing the Madras High Court did not fix a date when it would hand down its ruling on the Novartis challenge and reserved its order on the constitutional validity of Section 3(d).

Generic Lipitor: Hard Target

The US Supreme Court has rejected an appeal by Ranbaxy over a judge’s ruling that information withheld by Pfizer during a Lipitor patent case was immaterial. The Supreme Court, without comment, turned down arguments from Ranbaxy to block a patent term extension for the U.S. 4,681,893 (the ‘893 patent) that protects Lipitor through March 2010. Ranbaxy argued that Pfizer forfeited its right to an extension as Pfizer withheld information when the U.S. Patent & Trademark Office extended one of the patents for more than three years. However, Pfizer urged the Supreme Court not to hear the appeal. Moreover, Pfizer has also approached federal patent examiners to re-issue the U.S. 5,273,995 (the ‘995 patent) that would prevent generic penetration until June 2011.