As a Monday morning patent litigation round-up of interesting proceedings, I put together a list of recent actions. You just can’t tell the players without a program:
Eli Lilly has filed a lawsuit to block Teva Pharmaceuticals from selling generic Symbyax after Teva filed for an Abbreviated New Drug Application (ANDA) for generic Symbyax on January 10, 2005. This is currently the only option open to the innovator company under the process outlined in the Hatch-Waxman Act, despite the fact that Lilly has just emerged successfully from a similar patent court battle over Zyprexa. On April 14, 2005, the federal court upheld Zyprexa’s patent which was under fire by Ivax, Dr Reddy’s and Teva. This precedent would suggest that Teva’s second attempt to bring a product containing olanzapine to the market will also be unsuccessful. Unfortunately for both, the FDA has recently issued a warning of fatal adverse events in patients treated with certain atypical antipsychotic drugs including Abilify (aripiparozole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone). Manufacturers were asked to place a “black box” warning (the FDA’s most severe labeling option) on drug labels. Opinion leader research carried out by Datamonitor had indicated a concern about the long-term use of Symbyax at the time of its approval, with only an eight week trial having been carried out. More here.
Sandoz, Inc. notified Cephalon Inc. that it will no longer challenge Cephalon’s U.S. particle-size modafinil patent. Instead, Sandoz said it intends to convert its abbreviated new drug application (ANDA) for approval of a generic equivalent of modafinil, the active ingredient contained in PROVIGIL® Tablets [C-IV], from a paragraph IV certification to a paragraph III certification. Sandoz will certify to the U.S. Food and Drug Administration (FDA) that it does not intend to market a generic form of modafinil until the applicable patent for modafinil listed in the Orange Book has expired in 2014. Therefore, it will no longer be necessary for Cephalon to continue to pursue its patent infringement litigation against Sandoz. More here.
Schering AG announced on Friday that it filed a patent infringement action in the U.S. District Court for the District of New Jersey against Barr Pharmaceuticals Inc. over its Yasmin oral contraceptive. Barr Laboratories Inc. is currently seeking approval from the Food and Drug Administration to produce and market a generic version of Yasmin. More here.
Medtronic Inc. has agreed to settle a lawsuit by paying biotechnology company Cytomedix royalties to use the company’s therapy for wound healing. Cytomedix filed a lawsuit against Medtronic in November, alleging that Medtronic was infringing on Cytomedix’s patent for a treatment that uses a patient’s own blood platelets to treat tissue damage and diabetic foot ulcers. More here.