NOVARTIS AG v. EZRA VENTURES LLC

Summary: Obviousness-type double patenting does not invalidate an otherwise validly obtained patent term extension under 35 U.S.C. § 156.

Novartis owns at least two patents covering the multiple sclerosis drug Gilenya®, the ‘229 patent and the ‘565 patent.  The ‘229 patent, a pre-URAA patent, is set to expire on February 18, 2019, due to five years of patent term extension (“PTE”) granted pursuant to 35 U.S.C. § 156, which allows for extension of the term of one patent of a product that has been subject to regulatory review.  The ‘565 patent, a post-URAA patent, expired on September 23, 2017.  Ezra filed an Abbreviated New Drug Application (“ANDA”) relating to a generic version of Gilenya® and Novartis filed an infringement suit, asserting claims of the ‘229 patent.

In a motion for judgment on the pleadings, Ezra argued that the ‘229 patent should be ruled invalid, or otherwise terminally disclaimed for the portion of the patent term past the expiration date of the unasserted ‘565 patent.  Ezra argued that the granted extension of the ‘229 patent’s term beyond the life of the ‘565 is impermissible because it violates 35 U.S.C. § 156(c)(4)’s requirement that only “one patent be extended.”  Further, Ezra argued that the ‘229 patent is invalid for statutory- and obviousness-type double patenting because Novartis’s ‘229 patent claims are not patentably distinct from the ‘565 patent.  The district court denied Ezra’s motion, concluding that Ezra’s argument required reading “effectively” as a modifier of “extended” into 35 U.S.C. § 156(c)(4) which states, “in no event shall more than one patent be extended … for the same regulatory review period for any product.”  After the district court denied Ezra’s motion for judgment on the pleadings that the ’229 patent is invalid or be terminally disclaimed, Ezra did not present any further evidence on the issue of double-patenting and stipulated to infringement if the asserted claims are not invalid, expired, or unenforceable.  The district court entered judgment that Ezra infringed the ‘229 patent, and Ezra appealed.

On de novo review, the Federal Circuit affirmed the finding of the district court.  The Federal Circuit agreed that there is no reason to read “effectively” into the language of 35 U.S.C. § 156(c)(4).  The Federal Circuit stated “[t]hat 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.” 

The Federal Circuit also addressed the issue of whether the ’229 patent was invalid due to obviousness-type double patenting because the ’229 patent expired after the indistinct ’564 patent as result of the term extension.   The Federal Circuit held, as an extension of its holding in Merck & Co. v. Hi-Tech Pharmacal Co., that obviousness-type double patenting does not invalidate a validly obtained PTE.  In Merck, the Court concluded that a terminally disclaimed patent could still have its term extended with a PTE.   The Federal Circuit noted that “if a patent is terminally disclaimed to another patent to overcome an obviousness-type double patenting rejection and then term-extended under § 156, it necessarily will expire after the patent to which it had been subject to an obviousness-type double patenting rejection.”  This situation which was already found acceptable by the Federal Circuit in Merck was similar to the present case in which the extension of the ‘229 patent’s term effectively extends the life of the related ‘565 patent.