- The U.S. Court of Appeals for the Federal Circuit in Washington, DC will convene tomorrow in a rare session in which all 12 judges participate to hear arguments in a case that could have profound implications for the biopharmaceutical industry. The Court, which has national jurisdiction over all patent case appeals, will decide if an inventor's use of a third-party manufacturing service can invalidate the patentability of the invention, in this case the heart medication Angiomax (bivalirudin), an injectable anti-coagulant used during heart surgery.
- Inventor The Medicines Company (NASDAQ:MDCO) lost its patent infringement suit against generics firm Hospira (NYSE:PFE) when a three-judge panel ruled that two patents covering Angiomax, '727 and '343, were invalid due to a concept called "on-sale bar" which says that a product that is sold for at least a year before the patent application is submitted is not patentable. It was enacted to prevent inventors from extending their monopoly beyond the patent period. In this case, MDCO used a third-party manufacturer, Ben Venue Laboratories, to produce three batches of bivalirudin more than one year before submitting its patent applications because it was having difficulty making the drug in house.
- If the Court does not overturn the lower court's ruling, then it could have far-reaching implications for drugs/biologics makers since the use the manufacturing services firms is commonplace, even among large caps. Groups backing an overturn include the U.S. Department of Justice, the American Intellectual Property Law Association, the Intellectual Property Owners Association and the Pharmaceutical Research and Manufacturers of America.