On December 7, 2018, the Federal Circuit held that obviousness-type double patenting must consider the issuance date of the patent as the reference point for rejection where the patent issues from an application filed prior to June 8, 1995. Novartis Pharm. Corp. v. Breckenridge Pharm. Inc., No. 2017-2173 (Fed. Cir. Dec. 7, 2018) Novartis is the owner of two patents US 5,665,772 and 6,440,990 that are directed to the compound everolimus and methods of treatment using the compound, respectively. Everolimus is an active ingredient in Zortress and Afinitor used to treat certain cancers. Both '990 and '772 patents claim the same priority date. The '990 patent was filed after June 8, 1995 and expired on Sept. 23, 2013, i.e., 20 years from earliest effective filing date. The '772 patent was filed before June 8, 1995 and expired on Sept. 9, 2014, 17 years from the issuance date but due to a fie-year patent term extension, the term of the '772 patent expires on Sept. 9, 2019.
Novartis sued ANDA filers Breckenridge, Par, and West-ward Pharma for infringing certain claims of the '772 patent. In the district court, the defendants conceded that their proposed products would infringe the '772 patent and the parties stipulated that the asserted claims would be invalid if the district court found the '990 patent to be a proper double patenting reference to the '772 patent. Relying on the Federal Circuit's decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), which held that a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent, the district court found the '990 patent to be a proper double patenting reference for the '772 patent. Novartis appealed the decision.
On appeal, the Federal Circuit reversed the lower court's decision as it erred in using the '990 patent as a reference for the '772 patent in its obviousness-type double patenting determination. Writing for the panel, Judge Chen reasoned that the change in patent term law under the Uruguay Round Agreements Act of 1994 changed the double patenting analysis and unlike the patents in Gilead which were both post-URAA, the '772 patent is pre-URAA and the '990 patent is post-URAA and the 17-year term granted to the '772 patent is not an unjustified extension of time.
Full text of the opinion is available here.
Novartis sued ANDA filers Breckenridge, Par, and West-ward Pharma for infringing certain claims of the '772 patent. In the district court, the defendants conceded that their proposed products would infringe the '772 patent and the parties stipulated that the asserted claims would be invalid if the district court found the '990 patent to be a proper double patenting reference to the '772 patent. Relying on the Federal Circuit's decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), which held that a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent, the district court found the '990 patent to be a proper double patenting reference for the '772 patent. Novartis appealed the decision.
On appeal, the Federal Circuit reversed the lower court's decision as it erred in using the '990 patent as a reference for the '772 patent in its obviousness-type double patenting determination. Writing for the panel, Judge Chen reasoned that the change in patent term law under the Uruguay Round Agreements Act of 1994 changed the double patenting analysis and unlike the patents in Gilead which were both post-URAA, the '772 patent is pre-URAA and the '990 patent is post-URAA and the 17-year term granted to the '772 patent is not an unjustified extension of time.
Full text of the opinion is available here.
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