On November 13, 2015, the United States Court of Appeals for the Federal Circuit decided to take a case en banc that will require the court to resolve issues relating to the on-sale bar of pre-AIA 35 U.S.C. § 102(b).
The case is The Medicines Company v. Hospira, Inc., which was decided by Judges Dyk, Wallach, and Hughes on July 2, 2015. The original panel decision, which was authored by Judge Hughes, has been vacated and the appeal reinstated.
The Medicines Company filed a combined petition for panel rehearing and rehearing en banc. The petition was considered by the panel that heard the appeal and thereafter referred to those judges on the full court who are in regular active service (i.e., judges on senior status who did not participate in the panel hearing do not participate in en banc petitions). A response was invited by the court and filed by defendant/cross-appellant Hospira, Inc.
The Federal Circuit has instructed the parties to brief 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)?
The Federal Circuit instructed the parties that briefing should be limited to the issues set forth above.
Given that Hospira, Inc. was the original cross-appellant on the issues to be addressed, Hospira’s en banc brief is due 45 days from the date of the order. The Medicines Company’s response brief is due within 30 days of service of Hospira, Inc.’s en banc brief, and the reply brief within 15 days of service of the response brief.
The court also specifically invited the United States Department of Justice to file a brief expressing the views of the United States as amicus curiae. The Federal Circuit further said that other 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.
Oral argument may be held at a time and date to be announced later.
Tags: CAFC, en banc, Federal Circuit, on sale bar
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