Prior to 1994, the term of a U.S. patent was 17 years from the date of issuance.  When the Uruguay Round Agreements Act (“URAA”) changed the term to 20 years from the earliest nonprovisional priority date, it appeared that unpatentability due to obviousness type double patenting (“ODP”) would no longer be relevant since the patent term could no longer be extended by filing later applications claiming the same or similar subject matter. If an ODP rejection were made, a terminal disclaimer could be submitted based on a belief that no patent term would be lost.  However, in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014) (hereinafter Gilead), the Federal Circuit reaffirmed the relevance of ODP.

To recap, Gilead Sciences, Inc. owns U.S. Patent Nos. 5,763,483 (“the ’483 patent”) and 5,952,375 (“the ’375 patent”).  Both patents have the same inventors and disclose similar subject matter, but (1) were not examined by the same Examiner, (2) do not claim priority to a common patent application, and (3) have different expiration dates.  During the examination of the ’375 patent, a terminal disclaimer was filed disclaiming the term of the ’375 patent, which would have extended beyond the term of the first issued ’483 patent.  Gilead Sciences, Inc. argued that the ’375 patent could not be used as an ODP reference against the ’483 patent because the ’375 patent issued after the ’483 patent.  The Federal Circuit disagreed, concluding that the determining factor for ODP is the expiration date and not the issue date, since using the issue date as the determining factor would permit significant gamesmanship during prosecution.  In other words, separate applications with different priority claims could be used to ensure that specific claims issued from the application with the later priority date.  The decision in Gilead was affirmed in Abbvie v. Mathilda & Terence Kennedy Institute, 764 F. 3d 1366 (Fed. Cir. 2014) (hereinafter Abbvie) where the Federal Circuit stated that “[w]e now make explicit what was implicit in Gilead: the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates.”  Thus Gilead and Abbvie are different from an ODP analysis before the URAA where the term of a later issuing patent could not be used to shorten the term of an earlier issuing patent.

Two recent Federal Circuit decisions further clarify the ODP doctrine as it is applied post URAA.  In Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018), Novartis’ U.S. Patent No. 5,604,229 (“the ’229 patent”) was filed before the effective date of the URAA and thus had a term of 17 years from issuance (February 14, 2014). A patent term extension of five years pursuant to 35 USC §156, was obtained based on the time required for regulatory review, extending the term to February 18, 2019.  The ’229 patent claims a group of compounds including fingolimod.  Novartis also owns U.S. Patent No. 6,004,565 (“the ’565 patent”) directed to methods for administering fingolimod. The ’565 patent was filed after the effective date of the URAA and thus had a term of twenty years from its effective filing date (September 23, 2017). Ezra Ventures argued that (1) the extension of the ’229 patent  effectively extends the term of the ’565 patent  (since the method cannot be practiced without the product), thereby violating the requirement that only one patent be extended under 35 USC §156(c)(4), (2) the ’565 patent  should be applied as an ODP reference against the ’229 patent, and (3) there is an overriding policy concern that a patent owner should not be able to extend his rights through claims in a later-filed patent when the claims are not patentably distinct from claims in an earlier-filed patent.  The Federal Circuit found that there was no reason to read the term “effectively” as a modifier to “extend” in the language of 35 USC §156.  The court stated that the language in 35 USC §156(c)(4) referred to a legal extension with a certificate of extension recorded in the official file and considered as part of the original patent.  Though the method of the ’565 patent cannot be practiced during the extended term of the patent, this was found to be a “permissible consequence of the legal status conferred upon the ʼ229 patent by §156.”  Regarding the ’565 patent as an ODP reference against the ’229 patent, the Federal Circuit concluded that ODP does not invalidate a validly obtained patent term extension.  The court noted the contrast between 35 USC §156 and 35 USC §154, which expressly excludes patents which have been disclaimed beyond a specified date from term adjustment for PTO delays.  However, the Federal Circuit did not address patent term adjustment for a patent which has not been disclaimed beyond a specified date. The Federal Circuit also found that there was no potential gamesmanship issue through structuring of priority claims as in Gilead, and thus there were no overriding policy concerns.

In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc. (Fed. Cir. 2018), the Federal Circuit found that a post URAA patent was not a proper ODP reference for a pre-URAA patent with a five year patent term extension under 35 USC §156.  U.S.  Patent No. 5,665,772 (“the ’772 patent”) was filed and issued before U.S. Patent No. 6,440,990 (“the ’990 patent”), but both patents claimed the same priority date.  However, the ’990 patent expired before the ’772 patent  due to the post-URAA patent term of 20 years from the earliest effective filing date (September 23, 2013). The ’772 patent was filed before the effective date of the URAA and had a term of 17 years from issuance (September 9, 2014) plus a five year patent term extension under 35 USC §156 (September 9, 2019).  Though the Federal Circuit held in Gilead that the expiration date is the benchmark of obviousness type double patenting, the court found that the traditional obviousness type double patenting analysis based on the issue date should be applied to pre-URAA patents.  Under this analysis, the ’990 patent was not available as a double patenting reference against the ’772 patent.  The court’s reasoning was that the ’772 patent had a longer term due only to the change in the law, and did not involve gamesmanship during prosecution.  The Federal Circuit stated that “to require patent holders to truncate any portion of the statutorily assigned term of a pre-URAA patent that extends beyond the term of a post-URAA patent would be inconsistent with the URAA transition statute.” Thus, the court’s decision in both Gilead and Abbvie is limited to post-URAA patents.

Though none of the recent cases involved patent term adjustment, the decisions suggest that extensions of the term which are based on a statutory right should not be limited by later granted patents as long as gamesmanship is not involved.  Patent term adjustment is based on 35 USC §154(b) and thus following the rationale of the above discussed cases, ODP should not be available to invalidate a validly obtained patent term adjustment.  However, care must be taken to avoid anything which could be interpreted as gamesmanship, such as claiming different priority dates for the same or similar subject matter.