In a recent paper by Yali Friedman of the BiotechBlog, Yali looks at the growth of research capabilities in emerging economies such as India and China. With a substantial increase in the outsourcing of some of the more routine activities involved in pharmaceutical research and development (R&D), such as compound synthesis and preclinical toxicity tests, [...]

Recently, the courts looked at the question of whether separate enantiomers can have “first commercial marketing or use” status for purposes of patent term extension under 35 U.S.C. § 156. The U.S. Patent and Trademark Office, after consulting with the FDA, had granted an extension for US Pat. No. 5,053,407, which is exclusively licensed to [...]

Consumer Reports is using giant jogging pills on treadmills in order to announce its launch of a public campaign in support of comparative effectiveness research to urge policy makers to get behind the effort to provide doctors and patients with independent comparisons of different treatments for medical conditions.The interactive display is set up in Washington’s [...]

Earlier, the Supreme Court ruled that MedImmune could sue Genentech for patent infringement even though MedImmune continued to pay licensing fees to Genentech to use disputed technology to develop the drug Synagis®.  At the same time, the U.S. Patent and Trademark Office decided to have a second review of the patents at issue, U.S. Pat. [...]

The U.S. Court of Appeals for the Federal Circuit handed Eli Lilly a victory over that Teva Pharma in upholding an extension of the statutory thirty-month stay under the Hatch-Waxman Act, thus preventing the U.S. Food and Drug Administration from finally approving Teva’s Abbreviated New Drug Application (ANDA).   Eli Lilly & Co. v. Teva Pharma [...]

The US Court of Appeals for the Federal Circuit affirmed that the patent on Plavix® will remain in force.  The patent at issue is US Pat. No. 4,847,265, owned by Sanofi-Synthelabo, covers clopidogrel bisulfate, the active ingredient in Plavix®.  Sanofi-Synthelabo v. Apotex (07-1438). Clopidogrel is the common name of the dextrorotatory isomer of the chemical [...]

The European Commission has published its preliminary report on the competition inquiry into the pharmaceutical sector, which concludes that competition in this industry does not work as well as it should. According to the preliminary findings there is evidence that brand name companies engaged in delaying or blocking market entry of competing medicines. Delaying tactics [...]

As of July 2008, twenty-five states and the District of Columbia have filed antitrust suits against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier in Delaware District Court, charging them with blocking generic competition by engaging in product hopping, among other “anti-generic strategies.”  Patent Baristas reported the initial filing here. As Stephen [...]