IP Law Daily Gilead double patenting rule only applies to patents filed after URAA’s 1995 effective date (1)
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Friday, December 7, 2018

Gilead double patenting rule only applies to patents filed after URAA’s 1995 effective date

By Cheryl Beise, J.D.

The federal district court in Wilmington, Delaware, erred by finding that a patent owned by Novartis AG directed to everolimus compositions that was filed after the June 8, 1995 effective date of the Uruguay Round Agreements Act (URAA)—which extended patent terms from 17 to 20 years from the filing date—was an invalidating obviousness-type double patenting reference for a related patent that expired earlier, the U.S. Court of Appeals for the Federal Circuit has ruled. The court clarified that its prior opinion in Gilead Sciences, Inc. v. Natco Pharma Ltd.—holding that the expiration date is the benchmark of obviousness-type double patenting—was limited to the context when both patents in question are post-URAA patents. This case was distinguishable because it involved one pre-URAA patent and one post-URAA patent governed by different patent term statutory regimes. Under the circumstances, the correct framework was to apply the traditional pre-URAA framework and look to issuance date as the reference point for obviousness-type double patenting (Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical, Inc., December 7, 2018, Chen, R.).

Novartis AG owns U.S. Patent No. 5,665,772 ("the ’772 patent"), titled "O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants." The patent claims the compound 40-0-(2-hydroxyethyl)-rapamycin, also referred to as everolimus, a derivative of rapamycin. Everolimus is the active ingredient in Novartis’s Zortress® and Afinitor® products used to treat certain cancers and prevent rejection in kidney and liver transplantations. Novartis AG and Novartis Pharmaceuticals Corporation (collectively, Novartis) sued Breckenridge Pharmaceutical Inc., Par Pharmaceutical, Inc., and West-ward Pharmaceuticals International Ltd. (collectively, defendants) for infringing claims 1–3, 7, and 10 of the ’772 patent after the defendants sought FDA approval to market generic versions of Zortress® and Afinitor®.

The district court held that claims 1–3, 7, and 10 of the ’772 patent were invalid based on obviousness-type double patenting. The invalidating reference was Novartis’s U.S. Patent No. 6,440,990 ("the ’990 patent"). The ’772 patent was filed on April 7, 1995, and issued on September 9, 1997. The expiration date of the ’772 patent was September 9, 2014, 17 years after the issuance date. Novartis later obtained a five-year patent term extension under 35 U.S.C. § 156. The ’990 patent was filed on May 23, 1997, was issued on August 27, 2002, and claims the same October 9, 1992 priority date as the ’772 patent. However, the ’990 patent expired before the ’772 patent because it was filed after the June 8, 1995 effective date of the Uruguay Round Agreements Act of 1994 (URAA). The URAA changed the term of a U.S. patent from 17 years from the issuance date to 20 years from the filing date of the earliest U.S. or Patent Cooperation Treaty (PCT) application to which priority is claimed, excluding provisional applications. The ’990 patent expired on September 23, 2013, 20 years from its earliest effective filing date. And due to the intervening change in law through the implementation of the URAA, the lifespan of the ’772 patent encompasses that of the ’990 patent. The defendants appealed.

Application of Gilead. In finding that the ’990 patent was a proper double patenting reference for the ’772 patent, the district court relied on the Federal Circuit’s decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., 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. 753 F.3d 1208, 1212 (Fed. Cir. 2014). The district court also cited other post-Gilead district court decisions reaching the same conclusion in cases with similar fact patterns. The district court rejected Novartis’s argument that there is no unjustified extension of patent rights or public harm because the ’772 patent’s expiration date is the same as it would have been had the ’990 patent never issued. The district court also was not persuaded by Novartis’s argument that it did not engage in any gamesmanship such as the structuring of priority claims among related patents.

The Federal Circuit reversed, concluding that the ’990 patent does not qualify as a double patenting reference for the ’772 patent. The court took this occasion to clarify that its opinion in Gilead was limited to the context when both patents in question are post-URAA patents. This case was distinguishable from and not controlled by Gilead because it involved one pre-URAA patent (the ’772 patent) and one post-URAA patent (the ’990 patent), governed by different patent term statutory regimes.

The facts in this case also did not give rise to the type of patent prosecution gamesmanship present in Gilead because the ’772 patent expires after the ’990 patent "only due to happenstance of an intervening change in patent term law," the court noted. "Novartis did not structure the priority claim of its ’990 patent to capture additional patent term beyond the term it was granted for its ’772 patent." If both patents had been pre-URAA patents, the ’990 patent would have expired on the same day as the ’772 patent by operation of a terminal disclaimer Novartis filed on the ’990 patent, tying its expiration date to that of the ’772 patent. If both patents had been filed post-URAA, then they would have also both expired on the same day. "Thus, the current situation does not raise any of the problems identified in our prior obviousness-type double patenting cases," the court observed.

The court also found that AbbVie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014) was inapplicable to the facts at hand. AbbVie presented the scenario where an inventor, seeking to prolong his exclusivity rights over his invention, applied for a second patent on an obvious variant of his invention protected by a first patent but choosing a different, later priority date than the one relied on for the first patent so that the second patent would expire later than the first patent. Thus, AbbVie was inapposite for two reasons, according to the court. First, it involved two post-URAA patents. Second, the earlier-filed patent had an earlier issuance date and earlier expiration date.

Pre-URAA framework. The court explained that under the present facts, the correct framework is to apply the traditional obviousness-type double patenting practices used in the pre-URAA era to the pre-URAA ’772 patent and look to the ’772 patent’s issuance date as the reference point for obviousness-type double patenting. "This approach is most consistent with the URAA transition statute, which ensures that patent owners, like Novartis with its pre-URAA ’772 patent, enjoy the greater of a 20-year from earliest effective filing date or 17-year from issuance patent term," the court reasoned. The court declined to consider other fact patterns that could arise from hybrid situations in which one patent is pre-URAA and the other is post-URAA, but it reiterated that the key purpose of obviousness-type double patenting is 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.

Under the traditional, pre-URAA framework, the ’990 patent did not qualify as a proper double patenting reference for the ’772 patent. To hold otherwise would abrogate Novartis’s right to enjoy one full patent term on its invention. The district court’s decision was reversed.

This case is Nos. 2017-2173, 2017-2175, 2017-2176, 2017-2178, 2017-2179, 2017-2180, 2017-2182, 2017-2183, and 2017-2184.

Attorneys: Nicholas Nick Kallas (Venable LLP) for Novartis Pharmaceuticals Corp. and Novartis AG. Rachel C. Hughey (Merchant & Gould PC) for Breckenridge Pharmaceutical Inc. Daniel Brown (Latham & Watkins LLP) for Par Pharmaceutical, Inc. Keith A. Zullow (Goodwin Procter LLP) for West-Ward Pharmaceuticals International Ltd.

Companies: Novartis Pharmaceuticals Corp.; Novartis AG; Breckenridge Pharmaceutical Inc.; Par Pharmaceutical, Inc.; West-Ward Pharmaceuticals International Ltd.

MainStory: TopStory Patent FedCirNews

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