On November 13, 2015, the U.S. Court of Appeals for the Federal Circuit granted a petition for rehearing en banc filed by Frommer Lawrence & Haug LLP (FLH) on behalf of its client The Medicines Company.  The Federal Circuit’s Order vacated an earlier invalidity ruling against certain claims of two patents, and reinstated The Medicines Company v. Hospira, Inc. appeal.  The full Federal Circuit will consider the following issues:

  1. Whether contract manufacturing services confidentially performed by a third party to make experimental validation batches of a claimed product on behalf of a patentee constitute a commercial sale under the on-sale bar of 35 U.S.C. § 102(b), including:
    1. whether there was a sale for the purposes of § 102(b) despite the absence of a transfer of title; and
    2. whether the sale was commercial in nature for the purposes of § 102(b) or an experimental use?
  2. Whether the Court should overrule or revise the principle in Special Devices v. OEA that there is no “supplier exception” to the § 102(b) on-sale bar.

The Federal Circuit invited the U.S. Department of Justice to file a brief expressing the views of the United States as amicus curiae.  The Order also stated that the Court will entertain other amicus briefs, which may be filed without consent and leave of Court.

The patents-in-suit are U.S. Patent Nos. 7,582,727 and 7,598,343, which cover The Medicines Company’s Angiomax® (bivalirudin) product, an anticoagulant used during catheterization procedures including coronary angioplasty (a procedure that opens a blocked artery in the heart). 

The Medicines Company’s litigation team at FLH includes Ed Haug, Porter Fleming, Angus Chen, Robert Colletti, Jason Lief, David Zwally, Richard Kurz, Laura Krawczyk, Jason Kanter, Sam Desai, Erica Selli, and Sebastian Zonte.

To view the IP360 Article, please click here.

To view the Federal Circuit’s Order, please click here.

To view the Medicines Company’s en banc petition, please click here.