US court’s decision highlights risk of using a CMO prior to filing a patent application

07-Jul-2015 - Last updated on 08-Jul-2015 at 15:26 GMT

While pharma and biotech companies are increasingly turning to CMO (contract manufacturing organization) partners earlier in the drug development process, they may want to reconsider engaging with a CMO prior to filing a patent after a recent ruling from the US Court of Appeals for the Federal Circuit.

The case between the Medicines Company and Hospira centered on the validity of two patents tied to the anticoagulant Angiomax (bivalirudin), and last week, the US Court of Appeals for the Federal Circuit ruled in favor of Hospira, which is looking to bring a generic version of the drug to market.

Case

The ruling centered on the Medicines Company’s use of CMO Ben Venue Laboratories, which closed permanently in 2013, and whether or not validation batches of Angiomax made by Ben Venue were prepared for an experimental or a commercial purpose.

From 1997 to 2006, the Medicines Company purchased batches of Angiomax from Ben Venue, but in 2005, Ben Venue created a batch of bivalirudin with levels of Asp9-bivalirudin impurity that exceeded the FDA’s approved maximum of 1.5%, which meant the company could not use the batch.

After another batch failure, the Medicines Company hired a consultant who figured out a way to minimize the impurity to less than 0.6%, and in July 2008, the Medicines Company filed applications for two patents related to the discovery. And when Hospira filed its ANDA to bring Angiomax generics to market, the Medicines Company sued over infringements related to the two patents while Hospira said the patents were invalid because the claimed invention was commercially offered for sale.

US law currently precludes attempts by inventor or his assignee to profit from commercial use of an invention for more than a year before a patent application is filed.

And a Delaware district court previously concluded that no commercial sale occurred because: (1) Ben Venue only sold manufacturing services, not pharmaceutical batches; and (2) the batches fall under the experimental use exception.

Ruling

However, in an eight-page opinion unveiled late last week, the US Court of Appeals for the Federal Circuit Court overturned that Delaware district court ruling, concluding that the “court clearly erred in finding that the bivalirudin validation batches prepared by Ben Venue Laboratories before the critical date were not sold to The Medicines Company and were prepared primarily for an experimental purpose.”

And although the appeals court said that Ben Venue’s services were performed to prove to the FDA that the product met the agency’s specifications, Ben Venue “marked the batches with commercial product codes and customer lot numbers and sent them to The Medicines Company for commercial and clinical packaging, consistent with the commercial sale of pharmaceutical drugs. This commercial activity was not insignificant; The Medicines Company admits that each batch had a commercial value of over $10 million,” the court said.

Accordingly, the appeals court said that the district court “clearly erred in finding the Ben Venue sale of services did not constitute a commercial sale. To find otherwise would allow The Medicines Company to circumvent the on-sale bar simply because its contracts happened to only cover the processes that produced the patented product-byprocess.”

The ruling adds to the complex siuation around the selection of a CMO early in the development process.

Clive Meanwell, Chairman and CEO of the Medicines Company, said the company is evaluating the ruling and considering its next steps. “We remain committed to interventional cardiovascular medicine and will continue to support bivalirudin.”