United States: Federal Circuit Protects Novartis Gilenya Patent From Obviousness-Type Double Patenting

In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed "the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine." In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to "effectively" block the practice of an earlier-expiring method patent, and refused to elevate the judicially-created doctrine of obviousness-type double patenting over the statutory grant of PTE. Pharmaceutical patent owners will welcome this decision as reinforcing the validity of patents during their PTE term, and may consider how it might apply to similar circumstances raised by a patent term adjustment (PTA) award.

The Novartis Gilenya Patents At Issue

This decision arose from ANDA litigation relating to Novartis's Gilenya® product for treating multiple sclerosis. The asserted/challenged patent was U.S. Patent No. 5,604,229, which claims the active ingredient in Gilenya® (fingolimod). The '229 patent is 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 '229 patent under 35 USC 156, based on FDA approval of Gilenya®.

The other patent discussed in this case was Novartis's U.S. Patent No. 6,004,565, which claims therapeutic methods using fingolimod. The '565 patent was a post-GATT/post-URAA patent having a term of 20 years from its filing date.

The District Court Decision

At the district court, Ezra sought a motion for judgment on the pleadings based on invalidity of the '229 patent, asserting that the PTE award should not have extended the term of the '229 patent beyond the expiration date of the '565 patent. In particular Ezra argued that the PTE award:

  1. "de facto extends the life of the '565 patent, and thereby violates § 156(c)(4)'s requirement that only "one patent be extended"
  2. "renders the '229 patent invalid for statutory- and obviousness-type double patenting" in view of the claims of the '565 patent
  3. "violates the 'bedrock principle' that the public may practice an expired patent"

The district court denied the motion.

Ezra stipulated that its ANDA product infringed the '229 patent, and the district court found the '229 patent "valid, unexpired, and enforceable," and issued an injunction against Ezra's ANDA product until the '229 patent expires in 2019.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Chen and joined by Judges Moore and Hughes. The decision addressed each of Ezra's arguments.

(1) No Violation of § 156(c)(4)

The Federal Circuit agreed with the district court that the PTE award did not violate § 156(c)(4), which holds that only one patent may be granted PTE. Ezra argued that the PTE award to the '229 product patent "effectively" extended the term of the '565 method of use patent, since the claimed methods could not be practiced without using the product claimed in the '229 patent. Both courts declined to read the term "effectively" into the statutory language, and the Federal Circuit emphasized that "only the '229 patent was selected and then legally extended" in accordance with 35 U.S.C. § 156(e)(1). The court emphasized:

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 § 156.

(2) no violation of the doctrine of obviousness-type double patenting

Both the district court and the Federal Circuit cited the 2007 Federal Circuit decision in Merck & Co. v. Hi-Tech Pharmacal Co., as permitting the full PTE award here. In Merck, the Federal Circuit held that "a patent term extension under § 156 may be applied to a patent subject to a terminal disclaimer." As noted by the district court here, in such a case the term of the PTE-extended patent "necessarily will expire after the patent" over which it was terminally disclaimed. Thus, both the district court and the Federal Circuit found that Merck permits a fact-pattern similar to that at issue here, where PTE extends the term of one patent beyond the term of another patent that may raise obviousness-type double patenting issues.

In this regard, the Federal Circuit decision draws a bright line delineating when double patenting issues can arise:

If a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court's obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.

(3) no overriding policy concerns

The Federal Circuit also addressed Ezra's policy arguments, drawing an interesting line between "traditional" obviousness-type double patenting concerns and those addressed in its 2014 decision in Gilead Sciences, Inc. v. Natco Pharma Ltd.

As to "traditional" concerns, the Federal Circuit noted:

This case does not raise the traditional concern with obviousness-type double patenting of a patent owner "extending his exclusive rights to an invention through claims in a later-filed patent that are not patentably distinct from claims in the earlier filed patent." .... Here, it is the earlier-filed, earlier-issued '229 patent ... that has the later expiration date, due to a statutorily-allowed
term extension under § 156.

As to Gilead, the Federal Circuit found "no potential gamesmanship issue through structuring of priority claims as identified in Gilead." Rather, "[b]ut for the § 156 PTE, the '229 patent would have expired before the '565 patent." Also, "there is also no concern that Novartis, once its '229 patent issued, sought to subsequently "secur[e] a second, later expiring patent for the same invention" as in AbbVie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust.

Thus, the Federal Circuit held that "PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension," and affirmed the district court decision.

What About Patent Term Adjustment?

While this decision addressed PTE granted under § 156, "to restore the value of the patent term that a patent owner loses during the early years of the patent" prior to FDA approval, much of the reasoning would apply to PTA granted under § 154 to one member of a patent family sharing the same priority date to compensate for patent term lost due to USPTO examination delays.

The first member of a patent family may be awarded significant PTA, especially if the patent was granted after a successful appeal of the examiner's rejection(s) to the USPTO Patent Trial and Appeal Board, a process that can take several years. Subsequently filed continuation applications often are examined and granted more quickly, resulting in an earlier-filed, earlier-granted patent having a longer term than its later-filed, later-granted continuations. Gilead raised concerns that PTA awarded to the first member of a patent family could be lost if continuation applications can be cited as obviousness-type double patenting references, but this decision raises the possibility that at least this panel of Federal Circuit judges would permit such a first-filed patent to enjoy the full benefit the additional term granted pursuant to the PTA statute.

Indeed, wouldn't this same principle apply to PTA:

[T]his court has described obviousness-type double patenting as a "judge-made doctrine" that is intended to prevent extension of a patent beyond a "statutory time limit." .... Here, agreeing with Ezra would mean that a judge-made doctrine would cut off a statutorily-authorized time extension. We decline to do so.

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