Federal Circuit to Revisit on Sale Bar Triggered by Contract Manufacture

16 November 2015 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

Friday the 13th may have been The Medicines Company’s lucky day, since the Federal Circuit granted its petition for rehearing en banc in The Medicines Company v. Hospria, Inc. In  the court’s original decision, which I discussed in this article, the court found that the use of a contract manufacturer gave rise to an on sale bar under 35 USC § 102(b) that invalidated two Orange Book-listed patents for Angiomax® (bivalirudin). 

The court has asked for briefing on the following issues:

  • Do the circumstances presented here constitute a commercial sale under the on-sale bar of 35 U.S.C. § 102(b)?
    • Was there a sale for the purposes of § 102(b) despite the absence of a transfer of title?
    • Was the sale commercial in nature for the purposes of § 102(b) or an experimental use?
  • 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)?

At the IPO annual meeting in September, Chief Judge Prost noted how important amicus briefs can be to the court’s decision making process. This order notes that “briefs of amici curiae will be entertained, and any such amicus briefs may be filed without consent and leave of court but otherwise must comply with Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29.” Companies that may want use contract manufactures early in the development process, before a patent application is filed, may want to consider submitting amicus briefs to advise the court of how this decision may conflict with their research and development processes.

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