An interesting case which revolved around the interplay between differing patent terms, patent term extension under 35 U.S.C. §156, and obviousness-type double patenting was decided on December 7, 2018, in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceuticals Inc.,[1] by the Court of Appeals for the Federal Circuit.
Patent term has changed based on acts of Congress. Prior to June 8, 1995, patent term was 17 years from the issue date. The Uruguay Round Agreements Act (URAA) extended patent term to 20 years from effective filing date, which applied to patent applications filed on or after June 8, 1995 (35 U.S.C. §154(c)(1)). Patent term extensions under §156 allow certain pharmaceutical patents to be extended beyond its patent term to a maximum of five years upon petition. Novartis owns U.S. Patent Nos. 5,665,772 (‘772) and 6,440,990 (‘990). Both are directed to novel derivatives of rapamycin, everolimus, the active ingredient of AFINITOR®, the renal cell carcinoma drug. The effective filing date of the ‘772 patent was September 24, 1993, or before the URAA enactment date, while the effective filing date of the ‘990 patent was also September 24, 1993, or post-URAA. The ‘772 patent’s original term expired September 9, 2014, or 17 years from its issue date, but was extended under §156 by five years, to September 9, 2019. The ‘990 patent’s term expired September 23, 2013, or 20 years from its effective filing date. In other words, because of a change in law, the earlier-filed patent (‘772) actually expired later than the later-filed patent (‘990), regardless of the §156 extension.
Novartis sued Breckenridge for patent infringement of claims 1-3, 7, and 10 of the ‘772 patent in the District of Delaware. The district court held that the ‘990 patent was an invalidating reference against the ‘772 patent for obviousness-type double patenting (ODP) (MPEP 1504.06).[2] ODP is a judicially-created doctrine with the intent to prevent artificially extending a patent term through claims of a second, related patent that are not patentably distinct from the claims in the first patent (MPEP 804). Novartis also conceded that the ‘990 claims were not patentably distinct from the ‘772 claims. As a result, the district court invalidated the ‘772 patent based on ODP. Novartis appealed the decision.
The Fed Circuit panel was composed of Chief Judge Prost, and Judges Wallach and Chen, with Judge Chen writing for the court. Judge Chen noted that the district court relied heavily upon Gilead Sciences,[3] which held for the general proposition that a later-filed but earlier-expiring patent can be an ODP invalidating reference for an earlier-filed but later-expiring patent. Judge Chen criticized this over-generalization, and focused more on the factual differences between Gilead and the present case.
First, he noted that as a judicially-created policy:
Prohibiting double patenting prevents a patentee from obtaining sequential patents on the same invention and obvious variants, to thereby effectively manufacture a timewise extension of its patent exclusivity through a later-expiring patent. The key purpose of obviousness-type double patenting is thus to prevent a patent owner from controlling the public’s right to use the patented invention beyond the statutorily allowed patent term of that invention.
Then, he noted the district court held, and Breckenridge argued, that Gilead is controlling case law because the expiration date-based analysis is appropriate in this case. Judge Chen disagreed:
Gilead addressed a question that is not applicable here. In Gilead, we concluded that, under the circumstances where both patents were post-URAA, a patent that issued after but expires before another patent can qualify as a double patenting reference against the earlier-issuing, but later-expiring patent. Here, however, Novartis owns one pre-URAA patent (‘772 patent) and one post-URAA patent (‘990 patent), and the 17-year term granted to the ‘772 patent does not pose the unjustified time extension problem that was the case for the invalidated patent in Gilead.
In other words, the intervening act of Congress in enacting the provisions of the URAA changed the nature of the ‘772/’990 patent terms, and not an active decision on the part of Novartis. For sure, he underscored this point by noting that Novartis did not improperly capture term through the ‘990 patent when the ‘772 patent issued because the ‘772 patent was limited to a 17-year term as a URAA application. Further, there was no factual basis to conclude that Novartis had purposefully structured the priority claim so that the ‘990 patent could capitalize on extending the ‘772 patent’s term. As a matter of fact, Judge Chen further noted, that ‘990 patent actually expired before the ‘772 patent, even before the §156 extension was applied.
For this reason, the Fed Circuit found that the district court erred in its finding that the ‘990 patent was ODP invalidating reference for the ‘772 patent, and reversed.
[1] ___F.3d___ (Fed. Cir. 2018), rev’g 248 F. Supp. 3d 578 (D. Del. 2017).
[2] This is contrasted with statutory double patenting under 35 U.S.C. §101, which prevents two patents from issuing on the same invention; see also Takeda Pharm. Co. v. Doll, 561 F.3d 1372, 1375 (Fed. Cir. 2009).
[3] See Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1212 (Fed. Cir. 2014).