Older Patents Get Help As Federal Circuit Sides With Novartis In Gilenya, Everolimus Disputes

US court finds no obviousness-type double patenting under statute that changed patent term from 17 years from issuance to 20 years from filing; decisions will impact other cases involving patents issued prior to statute.

The US Court of Appeals for the Federal Circuit ruled for Novartis AG in a pair of patent rulings Dec. 7 that clarify how older patents are to be treated in patent disputes and may stave off generic competition for its blockbuster multiple sclerosis drug Gilenya (fingolimod) and its everolimus-containing cancer and immunosuppressant drugs Zortress and Afinitor.

The cases involve the Uruguay Round Agreements Act (URAA) of 1994, which changed the patent term from 17 years from issuance to 20 years from filing, and questions regarding obviousness-type double patenting.  Novartis v. Breckenridge Pharmaceutical Inc. involves the application of obviousness-type double patenting to two patents that were filed before and after the URAA. At issue was whether a post-URAA patent that issues after and expires before a pre-URAA could be a double-patenting reference against the pre-URAA patent.

Novartis v. Ezra Ventures LLC addresses the interplay between a patent term extension (PTE) granted under the Patent Act and the obviousness-type double patenting doctrine. 

Both cases involve questions that were left unanswered by the Federal Circuit's 2014 landmark decision in Gilead Sciences Inc. v. Natco Pharma Ltd., said Thomas Hedemann, counsel at Axinn, Veltrop & Harkrider, who represented Natco in that case. He said the issue raised in Novartis v. Breckenridge was explicitly left unanswered in Gilead v. Natco, which involved two post-URAA patents. He said that while it is difficult to say how many disputes involve pre- and post-URAA patents, the decision may be important for anyone dealing with older patents.

Hedemann noted that commentators had worried that the reasoning in Gilead v. Natco might undermine PTEs, a concern that the court has now laid to rest with the Novartis v. Ezra decision.

"The two cases together represent a significant development in the area of obviousness-type double patenting," Hedemann said. "It will give the community more clarity in an area that has been uncertain."

Patent Term Extension Not Invalidated

In Novartis v. Ezra Ventures, the Federal Circuit affirmed the US District Court for the District of Delaware's ruling that the five-year patent term extension on Gilenya's pre-URRA patent, No. 5,604,229, is valid and that it is not double patenting in regards to the post-URRA patent, No. 6,004,565.

Novartis obtained a patent term extension (PTE) of five years on the '229 patent to cover the regulatory review period, so it now expires on Feb. 18, 2019. The district court imposed an injunction on Ezra's abbreviated new drug application product until then.

Ezra, a privately held company based in Little Rock, Arkansas, argued that the '229 patent could not be extended beyond the life of the '565 patent because it would "effectively" extend the life of the '565 patent and that the '229 patent was invalid for obviousness-type double-patenting because its claims are not patentably distinct from those of the '565 patent.

The Federal Circuit agreed with the district court that "effectively" could not be read into the statute. And it concluded that "obviousness-type double patenting does not invalidate a validly obtained PTE" because the term extension causes the '229 patent to expire after the allegedly patentably indistinct '565 patent.

The Federal Circuit said that the Hatch-Waxman Act allows no more than one patent term to be extended for the same regulatory review period for any product and Novartis chose the '229 patent. "That the method of the '565 patent cannot be practiced during the '229 patent's extended term is a permissible consequence" of the legal status conferred upon the '229 patent by the statute, the court stated.

Other Gilenya patents could delay generic competition beyond February 2019. In July, the US Patent and Trademark Office's Patent Trial and Appeal Board upheld a Gilenya patent related to dosing regimens that expires in 2027 in an inter partes review (IPR) challenge by several generic drug manufacturers. (Also see "Gilenya Patent Upheld, But Who's The Biggest Winner – Novartis or Celgene?" - Scrip, 12 Jul, 2018.)

Novartis Has Right To Full Patent Term

Novartis v. Breckenridge involved the question of double patenting in which one patent covering everolimus (No. 5,665,772) issued pre-URAA and the second (No. 6,440,990) issued post-URAA. The '722 patent claims the everolimus compound and the '990 patent is directed at methods of treatment and pharmaceutical compositions comprising everolimus.

Here, the Federal Circuit reversed the Delaware District Court's ruling invalidating the first patent based on obviousness-type double patenting.

Novartis sued Breckenridge, Par Pharmaceutical Inc. and West-Ward Pharmaceuticals Corp. for patent infringement. FDA approved Hikma's ANDA for generic Zortress on Dec. 4 and awarded Par tentative approval for its generic version of Afinitor last June.

"The legal question we confront in this appeal is whether the law of obviousness-type double patenting requires a patent owner to cut down the earlier filed, but later expiring, patent's statutorily-granted 17-year term so that it expires at the same time as the later-filed, but earlier-expiring patent, whose patent term is governed under an intervening statutory scheme of 20 years from that patent's earliest effective filing date," the court stated.

The Federal Circuit concluded that it does not.

"Had the law not changed, regardless of whether Novartis obtained the '990 patent," the '772 patent would have expired on Sept. 9, 2019 with the five-year patent term extension it received, the court stated. "To find that obviousness-type double patenting applies here because a post-URAA patent expires earlier would abrogate Novartis's right to enjoy one full patent term on its invention."

The Federal Circuit said the district court "acknowledged that there was no binding precedent that addressed the precise issue of whether a post-URAA patent may serve as a double patenting reference against a pre-URAA patent." So, the district court applied the Federal Circuit's 2014 ruling in Gilead v. Natco, in which it held that a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent.

But the Federal Circuit said both patents in Gilead were filed after the effective date of the URAA and claimed different priority dates, and thus the decision does not apply to the Novartis case.

No Gamesmanship By Novartis, Federal Circuit Finds

The court also distinguished its Gilead decision and its 2014 ruing in AbbVie Inc. v. The Mathilda & Terence Kennedy Institute of Rheumatology Trust from the Novartis's case, saying Novartis did not engage in patent prosecution gamesmanship.

"The key purpose of obviousness-type double patenting is to prevent a patent owner from extending the exclusivity rights over his invention beyond a full patent term," the Federal Circuit stated. "We saw this impermissible practice in Gilead and in AbbVie, where the patent owners claimed different effective filing dates for different patents to extend the life of patent exclusivity."

Circuit Judge Raymond Chen authored both Novartis opinions, as well as the Gilead decision.