The Medicines Company v. Hospira, Inc.

Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit, in The Medicines Company v. Hospira, Inc., Case Nos. 14-1469; 14-1504, found that the claims of an asserted patent covering “pharmaceutical batches” for making Angiomax (bivalirudin) by a new process were invalid based on an agreement, dated more than one year prior to the application filing date, to have a third party, Ben Venue Laboratories, prepare three batches according to the process (IP Update, Vol. 18, No. 8).

Now, the Federal Circuit has agreed to consider en banc the issue of what constitutes a “commercial offer for sale,” initiating the one-year patent application filing requirement.

Specifically, the Court has asked the parties to brief the following questions:

  1. Do the circumstances presented here constitute a commercial sale under the on-sale bar of 35 U.S.C. §102(b)? 
    1. Was there a sale for the purposes of § 102(b) despite the absence of a transfer of title? 
    2. Was the sale commercial in nature for the purposes of § 102(b) or an experimental use?
  2. 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 specifically invited the U S Department of Justice to file a brief expressing the views of the United States as amicus curiae.