There is more backlash by generic drug companies against the user fees for generic drug reviews proposed in the 2008 budget. The budget proposal would increase funds for FDA by $100 million, including a large increase in user fees for brand-name pharmaceutical companies and the first fees for generic pharmaceutical companies. The $2.1 billion FDA […]

While the Supreme Court ruled that MedImmune could sue Genentech for patent infringement even though MedImmune continues to pay fees to Genentech to use the disputed technology to develop the drug Synagis, the U.S. Patent and Trademark Office may have something to add, too. (Medimmune, Inc. v. Genentech, Inc., et al.; S.Ct. No. 05–608). MedImmune […]

Earlier, Novozymes won a patent infringement suit against Danisco concerning infringement of a Novozymes patent on enzymes for bioethanol. The court ordered Danisco to pay damages of $4 million, which has now been doubled to $8 million as the court found the case to be one of ‘willful infringement’. Novozymes was also awarded a share […]

Representatives Waxman, Emerson, and Pallone, along with Senators Schumer and Clinton, have re-introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve generic biologics or biopharmaceuticals. While generic drugs have been extremely successful in bringing down the high cost of prescription drugs, […]

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 […]

Rep. Xavier Becerra from Southern California, and Rep. Dave Weldon of Florida have introduced the Genomic Research and Accessibility Act, a bill that would end the practice of patenting any and all portions of the human genome. They point out that the Human Genome Project has led to the discovery of approximately 35,000 genes and […]

Sanofi-Aventis SA lost a U.S. patent challenge brought by generic drugmakers Amphastar Pharmaceuticals and Teva Pharmaceutical Industries Ltd. over Sanofi’s blockbuster anticoagulant drug, Lovenox. Lovenox is Sanofi’s best-selling drug, with sales over $2.79 billion in 2005 — even more than Plavix. Lovenox is an injectable drug used in protecting patients against deep vein thrombosis or […]