United States: Federal Circuit Says No OTDP Between Novartis Patents That Straddle URAA

In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an OTDP reference against a pre-URAA parent patent having the same priority date, and upheld the validity of an Orange Book-listed patent for Novartis's Zortress® and Afinitor® products. This decision was issued the same day the Federal Circuit held that a patent term extension award does not itself raise OTDP issues, upholding the validity of Novartis's Galenya® product patent.

The Novartis Patents At Issue

This decision arose from ANDA litigation relating to Novartis's Zortress® and Afinitor® products, which are indicated for treating cancer and preventing kidney and liver transplant rejection. The asserted/challenged patent was U.S. Patent No. 5,665,772, a pre-GATT/pre-URAA patent having a term of 17 years from its issue date. Novartis obtained a 5 year patent term extension (PTE) of the '772 patent under 35 USC 156, based on FDA approval of Afinitor®.

(image from Federal Circuit decision)

The other patent discussed in this case was Novartis's U.S. Patent No. 6,440,990, which was a post-GATT/post-URAA child of the '772 patent, filed and granted after the '772 patent, but expiring earlier.

The district court considered the 2014 Federal Circuit decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., and determined that the '990 patent could be cited as an OTDP reference against the '772 patent. The parties stipulated to invalidity on that basis, so the district court held the asserted claims of the '772 patent invalid.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Chen and joined by Chief Judge Prost and Judge Wallach. As noted above, the Federal Circuit held that the post-GATT/post-URAA '990 patent could not be cited as an OTDP reference against the pre-GATT/-preURAA '772 patent.

Gilead Is Not Controlling

The Federal Circuit first explained that the holding in Gilead–that "the expiration date is the benchmark of obviousness-type double patenting"–is "limited to the context of when both patents in question are post-URAA patents." Because the case at hand involved "one pre-URAA patent (the '772 patent) and one post-URAA patent (the '990 patent), governed by different patent term statutory regimes," Gilead is not controlling. The Federal Circuit explained that the potential for gamesmanship discussed in Gilead did not arise here, "because the '772 patent expires after the '990 patent only due to happenstance of an intervening change in patent term law." The Federal Circuit also noted that, "unlike Gilead, Novartis here did not structure the priority claim of its '990 patent to capture additional patent term" beyond the '772 patent–to the contrary, the '990 patent expired earlier.

AbbVie Is Not Controlling

The Federal Circuit also distinguished its 2014 decision in AbbVie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, because it also involved two post-GATT/post-URAA patents, and because "the earlier-filed patent [in AbbVie] had an earlier issuance date and earlier expiration date."

"Traditional" OTDP Doctrine Is Controlling

Having dispensed with recent decisions addressing post-GATT/post-URAA patents, the Federal Circuit determined that "traditional" OTDP doctrine is controlling when a post-URAA patent is cited as an OTDP reference against a pre-URAA patent. Under "traditional" OTDP doctrine, the inquiry focuses on double patenting that may have existed as of the challenged patent's issue date. Under such an analysis, "the '990 patent is not a proper [OTDP] reference for the '772 patent." because "the '990 patent had not yet issued" when the '772 patent was issued.

Giving Full Effect To The Statutorily Granted Term

The Federal Circuit noted that its approach here is consistent with the URAA transition statute, which ensured that existing patent owners and applicants only would benefit from the change in patent term. Under the URAA transition statute, the term of any patent in force on or granted from an application filed before June 8, 1995 was "the greater of the 20-year term ... or 17 years from grant, subject to any terminal disclaimers." According to the Federal Circuit, "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."

The Federal Circuit also found its approach to be "consistent with the core principle underlying the double patenting doctrine: giving one invention and nonobvious variants of that invention the same patent term." The decision explains:

Here, critically, Novartis did not seek to extend its patent rights over its everolimus invention beyond one patent term, in this case, 17 years from issuance of the '772 patent. .... The fact that the law for the term of a patent changed resulting in the later-issued '990 patent having an earlier expiration date than it would have pre-URAA should not affect the '772 patent's statutorily-granted 17-year patent term. Rather than Novartis receiving a windfall with a 17-year term for its '772 patent, its '990 patent's term was truncated by the intervening change in law. 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 court therefore reversed the district court decision.

What About Patent Term Adjustment?

While facts at issue in this decision are not as parallel to the PTA scenario I discussed in my article on the Galenya® decision, the Federal Circuit's willingness to consider whether the patents at issue have the same priority date, and whether the fact pattern could give rise to gamesmanship leaves room for a decision that would not permit a child application to be cited as an OTDP reference against a parent patent that expires later due to a PTA award. Indeed, PTA only is awarded where the USPTO's examination delay exceeded any "delay" by the Applicant, reducing the opportunity for gamesmanship. Perhaps this panel of Federal Circuit judges also would permit a first-filed patent to enjoy the full benefit the additional term granted pursuant to the PTA statute.

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