On February 12, the House of Representatives approved a pilot program (HR 5418) to develop an opt-in for specialized patent trial judges. The legislation was introduced by Representatives Issa (R-CA) and Schiff (D-CA). Senator Orrin Hatch (R-UT) and Senator Dianne Feinstein (D-CA) have already introduced S. 3923 as a companion bill to H.R. 5418. The […]

India’s leading Para IV challenger – Dr. Reddy’s Laboratories (DRL) has finally zeroed down to settle its pending Para IV patent litigation with GlaxoSmithKline (GSK) over the blockbuster anti-migraine drug, Imitrex, generically known as Sumatriptan Succinate which is worth around US $ 890 million in sales in the U.S. market. GSK, under the terms of […]

Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu) today announced that they received court decisions on ANDA-related summary judgement motions for Aciphex® (Active Ingredient Name: rabeprazole sodium, Product Name in Japan: Pariet®) on October 6, 2006 (U.S. Eastern time). Eisai won summary […]

Authorized generics — brand pharmaceutical products masquerading as generics — are an increasingly common brand tactic aimed at discouraging generic companies from challenging questionable brand patents. With GlaxoSmithKline (GSK) and Dr. Reddy’s having settled their litigation over generic Imitrexâ„¢, and the parties agreeing that Dr. Reddy’s will sell an authorized generic version of Imitrexâ„¢ in […]

With the expiry of patents for the blockbuster molecules looming large, the camps of big pharma giants are in disarray. The brain-storming strategies and policies pertaining to evergreening of these patents may be seen in the days to come. Some of the big names in the game include the likes of Pfizer Inc., Merck & […]