12 July 2016Americas

Federal Circuit confirms ‘on-sale’ patent rules in MedCo v Hospira

An en banc US Court of Appeals for the Federal Circuit said yesterday that two patents owned by The Medicines Company (MedCo) are valid in a case setting the rules for ‘on-sale’ product-by process patents.

The Federal Circuit affirmed a ruling of the US District Court for the District of Delaware on the dispute with Hospira.In the case, centering on US patent numbers 7,582,727 and 7,598,343, both belonging to MedCo, the Federal Circuit decided that MedCo was not considered as having put its Angiomax (bivalirudin) product “on sale”, as “a product on sale must be subject of a commercial sale or offer for sale”.

The  ruling of the Federal Circuit further defined a commercial sale as “one that bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code”.

The patents were therefore ruled to be valid.

In 2014, the district court ruled that the patents were valid but not infringed and that the on-sale bar had not been triggered. Last year, a panel at the Federal Circuit reversed the ruling on the on-sale bar but did not rule on infringement. The Federal Circuit then agreed to hear the case en banc.

MedCo filed the complaint after Hospira had submitted two Abbreviated New Drug Applications (ANDAs) to seek approval to sell a generic version of Angiomax before the expiration of the two patents.

The patents claim pH-adjusted pharmaceutical batches of a drug product comprising bivalirudin, which is used to prevent blood from clotting and is also regarded as highly effective for use in coronary surgery.

After a batch of bivalirudin by MedCo failed to pass US Food and Drug Administration guidelines, MedCo discovered a method of adjusting the level of acidity.

The company then hired Ben Venue, an external company, to complete batches with the new method.

It was a year after MedCo had bought batches of Angiomax from Ben Venue that MedCo applied for the two patents, in 2008.

This was followed by a complaint from MedCo alleging that Hospira infringed the patents by filing ANDAs.

As previously reported, Hospira countered that the patents were invalid because MedCo commercially exploited the patented method in its arrangement with Ben Venue before applying for protection at the US Patent and Trademark Office.

Clive Meanwell, chief executive officer of MedCo, said: “We are pleased that the district court decision on invalidity has been upheld. We continue to believe that our patents are valid and infringed by the ANDA filers, and are now considering all of our options with respect to Hospira, Mylan, and other generics.”

A spokesman from Hospira said: “We remain confident in our IP position with respect to bivalirudin.”

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