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Obviousness-Type Double Patenting Does Not Invalidate Section 156 Patent Term Extension
On Dec. 7, 2018, a Federal Circuit panel consisting of Judges Moore, Chen and Hughes affirmed the District of Delaware decision upholding the validity of Novartis's patent term extension (PTE) in Novartis AG et al. v. Ezra Ventures LLC, No. 2017-2284. Novartis AG (Novartis) filed suit against Ezra Ventures LLC (Ezra), alleging infringement of claims 9, 10, 35, 36, 46 and 48 of U.S. Patent No. 5,604,229 (the '229 patent), in response to Ezra's Abbreviated New Drug Application (ANDA) for a generic of Novartis's Gilenya® multiple sclerosis drug. On Sept. 22, 2016, the district court denied Ezra's motion for judgment on the pleadings. Ezra subsequently stipulated to infringement of the asserted claims to the extent such claims are not invalid, expired or unenforceable. The district court issued judgment on June 9, 2017, finding the '229 patent valid, enforceable and infringed, and imposed an injunction on the Ezra generic until the '229 patent expires in 2019. Ezra appealed.
Novartis' '229 patent and unasserted U.S. Patent No. 6,004,565 (the '565 patent”) cover Gilenya®. The '229 patent was filed in 1993, issued in 1997, and received a patent term of 17 years from issuance. The '565 patent, which was filed after the effective date of the Uruguay Round Agreements Act of 1994 (URAA), received a patent term of 20 years from the earliest effective filing date, and expired in 2017. Novartis obtained a five-year PTE for the '229 patent under 35 U.S.C. §156, a part of the Hatch-Waxman Act. Section 156 allows patent owners to obtain a term extension of up to five years for patents that require regulatory approval prior to marketing products covered by those patents. Subsection 156(c)(4) further limits the patent owner to a PTE grant for only one patent for any particular product.
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