Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical

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Federal Circuit Summary
 
Before Prost, Wallach, and Chen.  Appeal from the United States District Court for the District of Delaware.
 

Summary: A post-URAA patent that issues after but expires before a related pre-URAA patent is not a double-patenting reference against the pre-URAA patent. 

A patent filed before the June 8, 1995 effective date of the Uruguay Round Agreements Act (URAA) has a 17 year term that begins on its issuance date.  A patent filed after the effective date of the URAA has a 20 year term that begins on its earliest effective filing date.  Here, Novartis owned a later-filed post-URAA patent (“Patent B”) and an earlier-filed pre-URAA patent (“Patent A”).  However, Patent B, the later-filed post-URAA patent, expired before Patent A.  The district court held that Patent B was a double-patenting reference against Patent A. 

The Federal Circuit disagreed.  The Federal Circuit held that where one patent was filed pre-URAA and the other patent was filed post-URAA, the issuance dates of the patents control whether one patent is a double-patenting reference of the other.  In a prior decision in the Gilead Sciences, Inc. v. Natco Pharma Ltd. case, the Federal Circuit held that a later filed but earlier-expiring post-URAA patent was a double-patenting reference against an earlier-filed and later-expiring post-URAA patent, and that the expiration date was the benchmark of obviousness-type double-patenting.  753 F.3d 1208, 1212 (Fed. Cir. 2014).  The Federal Circuit stated that because Gilead dealt with two post-URAA patents it did not control the present situation.  The Federal Circuit reasoned that its holding in this case was consistent with the URAA transition statute, which gives pre-URAA patents the longest term possible under either the pre or post-URAA rules.  It also reasoned that its holding was consistent with the purposes of the double-patenting doctrine, which is to limit a patent owner to one full term of patent rights.  As a result of the Federal Circuit’s ruling, Novartis will enjoy one 17-year term of exclusive rights arising from Patent A. 

 
Editor: Paul Stewart

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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