IP Law Daily, PATENT NEWS: Whether drug batches triggered on-sale bar to be considered en banc, (Nov 16, 2015)

By Thomas Long, J.D.

The U.S. Court of Appeals for the Federal Circuit has granted a motion for rehearing en banc of a case involving the question of whether two patents relating to the drug bivalirudin—a synthetic peptide used as an anti-coagulant—were invalid for violating the on-sale bar of 35 U.S.C. §102(b) (The Medicines Company v. Hospira, Inc., November 13, 2015, per curiam). In a July 2, 2015, decision, a three-judge panel of the Federal Circuit held that patent-holder The Medicines Company could not go forward with infringement claims against Hospira, Inc. According to the panel, bivalirudin batches prepared by Ben Venue Laboratories before the critical date were sold to The Medicines Company and were not prepared primarily for an experimental purpose.

Medicines sold a bivalirudin drug for injection under the brand name Angiomax®. From 1997 to October 2006, Medicines purchased batches of the drug from Ben Venue Laboratories. In 2005, Ben Venue created a batch of bivalirudin that could not be used because it had levels of impurity that exceeded the Food and Drug Administration’s approved maximum.

After another batch failure, Medicines hired a consultant, who developed new methods of producing the drug’s active compound with a level of impurity below the FDA maximum. In July 2008, Medicines filed applications for two patents that included product-by-process claims describing the consultant’s discovery. These applications were issued as the patents-in-suit.

Over one year before filing these applications, Medicines hired Ben Venue to prepare three batches of bivalirudin using an embodiment of the patented method. Each lot was marked with a commercial product code and a customer lot number and was released to Medicines for commercial and clinical packaging.

On August 19, 2010, Medicines filed suit against Hospira, alleging that two of Hospira’s new drug application filings infringed various claims of the patents-in-suit. The district court found the patents not infringed and not invalid as obvious, indefinite, or under the on-sale bar. On appeal, the Federal Circuit concluded that the district court clearly erred in finding that the bivalirudin batches prepared by Ben Venue before the critical date were not sold to Medicines and were prepared primarily for an experimental purpose. Accordingly, the appellate court reversed the district court’s validity determination and held the asserted claims invalid under the on-sale bar.

Medicines filed a petition for rehearing en banc. The court granted the petition, vacated the July 2 opinion, and reinstated the appeal. The parties were requested to file new briefs addressing the following issues:

(a) Do the circumstances presented here constitute a commercial sale under the on-sale bar of 35 U.S.C. §102(b)?

(i) Was there a sale for the purposes of §102(b) despite the absence of a transfer of title?

(ii) Was the sale commercial in nature for the purposes of §102(b) or an experimental use?

(b) Should this court overrule or revise the principle in Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353 (Fed. Cir. 2001), that there is no “supplier exception” to the on-sale bar of 35 U.S.C. §102(b)?

The court invited the U.S. Department of Justice to file an amicus brief expressing the government’s views.

The case is Nos. 2014-1469 and 2014-1504.

Attorneys: Edgar Haug (Frommer Lawrence & Haug LLP) for The Medicines Company. Bradford Peter Lyerla (Jenner & Block LLP) for Hospira, Inc.

Companies: The Medicines Company; Hospira, Inc.

News: Patent FedCirNews