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16 November 2015Americas

CAFC to hear The Medicines Company v Hospira dispute en banc

The US Court of Appeals for the Federal Circuit will consider en banc whether a “supplier exception” should be included in laws that prevent the patenting of inventions that have already been on sale.

The question has arisen in a row between The Medicines Company and Hospira over two product-by-process patents owned by The Medicines Company. The patents cover the addition of a pH-adjusting solution to the bivalirudin compounding process.

Between 1997 and 2006, Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim, supplied The Medicines Company with batches of bivalirudin, used for its Angiomax injection.

Angiomax is an anti-coagulant used to treat angina and percutaneous transluminal coronary angioplasty.

After a batch failed to pass US Food and Drug Administration safety guidelines, The Medicines Company discovered a method of adjusting the level of acidity and hired Ben Venue to complete batches with the new method. After a year of The Medicines Company’s buying batches from Ben Venue and selling Angiomax, it applied for the two patents in 2008.

In 2010 The Medicines Company sued Hospira, alleging infringement of the patents through two Abbreviated New Drug Applications.

Hospira countered that the patents were invalid because The Medicines Company had commercially exploited the patented method in its arrangement with Ben Venue before applying for protection at the US Patent and Trademark Office.

The US District Court for the District of Delaware ruled in 2014 that the patents were valid  but not infringed. The mixed ruling led both parties to appeal against the decision.

Earlier this year, a three-judge panel at the federal circuit found the patent to be invalid, stating that the district court erred “in finding that the claimed invention was not commercially offered for sale” from Ben Venue and that the “on-sale bar limitation” does apply.

But on Friday, November 13, following an appeal from The Medicines Company, the decision was vacated by the federal circuit and will be heard en banc.

The key question raised is whether the court should overrule the Special Devices v OEA precedent that said there is no “supplier exception” under section 102 of the US Patent Code.

The court has requested that both parties, as well as the US Department of Justice, submit briefs on the question.

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