Federal Circuit Provides Clarity For Contract Manufacturing On-Sale Invalidity Claims

The case arose in the context of Hospira's Abbreviated New Drug Application (ANDA) submissions seeking FDA approval to sell generic versions of The Medicines Company's (TMC) Angiomax', an anticoagulant used in heart surgery. In the ensuing litigation, alleging that Hospira's ANDA submissions infringed two of TMC's patents, Hospira raised several grounds of invalidity, including that TMC's inventions were sold or offered for sale before the critical date under '102(b).

TMC is a specialty pharmaceutical company that does not have its own manufacturing facilities. Therefore, it contracted with a third-party provider, Ben Venue Laboratories (Ben Venue), to manufacture commercial quantities of Angiomax'. The active pharmaceutical ingredient in Angiomax', bivalirudin, is an acidic compound that requires processing before it can be injected into patients. A potential adverse effect of the compounding process used to adjust bivalirudin's pH is the formation of certain impurities such as Asp⁹-bivalirudin. Id. at 4-5. In June 2005, Ben Venue manufactured a batch of bivalirudin with an Asp⁹ level that exceeded the FDA's allowable limit. In 2006, another batch was manufactured that again had an unacceptable level of Asp⁹. TMC's subsequent investigation to resolve the issue led to the development of a new compounding process. U.S. Patent Nos. 7,582,727 (the '727 patent) and 7,598,343 (the '343 patent) contain product and product-by-process claims for pharmaceutical batches of the improved drug product with a maximum Asp⁹ impurity level of 0.6%. The applications for the '727 and '343 patents were filed on July 27, 2008. Thus, the critical date for purposes of the on-sale bar of '102(b) is July 27, 2007. Id. at 5-6.