Sepracor filed patent infringement complaint against Dr. Reddy’s

Sepracor jointly with University of Massachusetts has filed a complaint for patent infringement in the US District Court for the District of New Jersey to safeguard its patent rights over Clarinex, generically extended release tablet containing desloratadine and pseudoephedrine sulfate against the generic manufacturer Dr. Reddy’s Laboratories (DRL) prior to the expiration of the Orange Book listed Patent Nos. 7,214,683 (the ‘683 patent) and 7,214,684 (the ‘684 patent). Earlier, DRL made an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration seeking approval to market generic extended release tablet containing desloratadine and pseudoephedrine along with the Para IV certification, alleging both ‘683 and ‘684 patents invalid. In its complaint, Sepracor alleged submission of DRL ANDA would constitutes infringement of the ‘683 and ‘684 patents under 35 USC 271 (e) (2) (A).

Angola Became Contracting State to PCT

Angola became the 138th contracting state of the Patent Cooperation Treaty (PCT), will enter into force on December 27, 2007. Angola deposited its instrument of accession at WIPO on September 27, 2007 and will be designated AO as country code. Angola will be bound by Chapter II of the Treaty, will automatically be elected in any demand for international preliminary examination filed in respect of an international application filed on or after December 27, 2007.

Lupin Further Assigned Patent Rights Over Antihypertensive Drug

Earlier this year, Pune-based Lupin Ltd. assigned its patent right (process patents) over antihypertensive drug perindopril to French company Laboratories Servier for 20 million euros, now further to the development Lupin has assigned additional patent rights for additional 20 million euros. Perindopril patent assignment is one of the significant commercial transactions made by an Indian company from its intellectual property portfolio.

Sanofi | Torrent – Uroxatral Para IV Certification

Sanofi has filed a civil action for patent infringement in the US District Court for the Western District of Michigan in a move to prevent generic entry of Uroxatral tablet, generically alfuzosin hydrochloride by Indian drug manufacturer Torrent Pharma Inc. prior to the expiration of the Orange Book listed US Patent Nos. 4,661,491 (the ‘491 patent) and 6,149,940 (the ‘940 patent). Alfuzosin is an alpha-adrenergic blocker approved by the United States Food & Drug Administration for the treatment of Benign Prostatic Hyperplasia (BPH) and covered within the scope of the ‘491 patent till early 2011. Earlier Torrent filed an Abbreviated New Drug Application (ANDA) No. 79-054 with the FDA seeking approval to market generic alfuzosin hydrochloride extended release tablet in 10mg strength, alleging both the ‘491 and ‘940 patents are invalid and not infringed by the manufacture, use or sale of the proposed generic version of Sanofi’ Uroxatral tablet. In its complaint, Sanofi alleged that the submission of Torrent ANDA would constitutes infringement of the ‘491 and ‘940 patents under 35 USC § 271 (e) (2) (A). According to Sanofi Business Report 2006 Uroxatral is worth 353 million euros in worldwide sales.

HLR Files Infringement Suit against Indian Generics Over Boniva Patent

Hoffmann-La-Roche has filed patent infringement lawsuits in the US District Court for the District of New Jersey to safeguard its patent rights over Boniva, generically ibandronate sodium against Indian generic drug manufacturers, Dr. Reddy’s Laboratories Ltd. and Orchid Chemicals and Pharmaceuticals Ltd., both filed Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration seeking regulatory approval to market generic ibandronate before expiration of two Orange Book US Patent Nos. 7,192,938 (the ‘938 patent), expiring May 06, 2023, and 6,294,196 (the ‘196 patent), expiring October 07, 2019. However, Dr. Reddy’s has made Paragraph IV certification against the ‘196 patent, not the ‘938 patent. HLR also filed infringement complaints against Cobalt alleging infringement of four Orange Book US Patent Nos. ‘938 patent, ‘196 patent, 6,143,326 (the ‘326 patent), and 4,927,814 (the ‘814 patent).

Eli Lilly Filed Patent Lawsuit against Sun Pharmaceutical

Eli Lilly & Co. has filed a patent infringement lawsuit in the US District Court for the Eastern District of Michigan to safeguard its patent rights over Strattera, generically atomoxetine hydrochloride against the generic drug manufacturer Sun Pharmaceutical Industries, which filed an Abbreviated New Drug Application (ANDA) with the United States Food & Drug Administration seeking regulatory approval to market generic atomoxetine before the expiration of the Orange Book listed US 5,658,590 (the ‘590 patent). The ‘590 patent expires on November 26, 2016, and particularly covers a method of treating attention-deficit/hyperactivity disorder by administrating an effective amount of tomoxetine. Earlier, on August 09, 2007 and August 27, 2007 Eli Lilly filed patent infringement lawsuits for same drug in the US District Court for the District of New Jersey against Actavis Elizabeth LLC and Sandoz Inc.