NOVARTIS AG, NOVARTIS PHARMACEUTICALS CORPORATION, MITSUBISHI TANABE PHARMA CORPORATION, MITSUI SUGAR CO. LTD., Plaintiffs-Appellees
EZRA VENTURES LLC, Defendant-Appellant
from the United States District Court for the District of
Delaware in Nos. 1:15-cv-00150-LPS, 1:15-cv-00975-LPS, Chief
Judge Leonard P. Stark.
M. Love, Gibson, Dunn & Crutcher LLP, New York, NY,
argued for all plaintiffs-appellees. Plaintiffs-appellees
Novartis AG, Novartis Pharmaceuticals Corporation also
represented by Robert Trenchard; Alexander N. Harris, San
Francisco, CA; Michael A. Valek, Dallas, TX.
M. O'Malley, Jr., Paul Hastings LLP, New York, NY, for
plaintiffs-appellees Mitsubishi Tanabe Pharma Corporation,
Mitsui Sugar Co. Ltd. Also represented by Eric William
Shashank Upadhye, Amin Talati Upadhye LLP, Chicago, IL,
argued for defendant-appellant. Also represented by Brent
Allen Batzer, Joseph Cwik, Jonathan Jacob Krit, Yixin H.
Moore, Chen, and Hughes, Circuit Judges.
case concerns the interplay between a patent term extension
(PTE) granted pursuant to 35 U.S.C. § 156 and the
obviousness-type double patenting doctrine. The Delaware
District Court concluded that, in accordance with statutory
construction principles and as a logical extension of this
court's holding in Merck & Co. v. Hi-Tech
Pharmacal Co., 482 F.3d 1317 (Fed. Cir. 2007),
obviousness-type double patenting does not invalidate an
otherwise validly obtained PTE under § 156. We agree and
Ezra Ventures LLC (Ezra) filed an Abbreviated New Drug
Application (ANDA) relating to a generic version of
Novartis's branded multiple sclerosis drug
Gilenya®. Novartis filed an infringement suit
against Ezra in response, asserting claims 9, 10, 35, 36, 46,
and 48 of U.S. Patent No. 5, 604, 229.
'229 patent claims a large group of compounds, including
fingolimod, the active ingredient in Gilenya®. Because
the '229 patent was filed before the effective date of
the Uruguay Round Agreements Act of 1994 (URAA), its patent
term is governed by the law in effect at that time-the rule
of 17 years from issuance. Pub. L. No. 103-465, §532,
108 Stat. 4809, 4983-85. The '229 patent thus was set to
expire on February 18, 2014, 17 years from its issuance date,
but Novartis secured a PTE of five years on the patent
pursuant to 35 U.S.C. § 156. Section 156 was part of the
Drug Price Competition and Patent Term Restoration Act of
1984 (Hatch-Waxman Act) and was enacted to restore the value
of the patent term that a patent owner loses during the early
years of the patent because the product cannot be
commercially marketed without approval from a regulatory
agency (e.g., Food and Drug Administration approval). Pub. L.
No. 98-417, 98 Stat. 1585, 1598. Section 156 allows a term
extension of up to five years, equal to the regulatory review
period, on a patent covering a product subject to regulatory
review. See 35 U.S.C. §§ 156(a), (c),
(g)(6). Section 156(a) sets forth the requirements for a
patent to qualify for a PTE, the details of which are not
patent owner often owns multiple patents that cover the same
product that has been subject to regulatory review, but only
one patent's term can be extended. See 35 U.S.C.
§ 156(c)(4). The patent owner makes a choice among its
qualifying patents. "Congress chose not to limit the
availability of a patent term extension to a specific parent
or continuation patent but instead chose a flexible approach
which gave the patentee the choice." Merck, 482
F.3d at 1323; 130 Cong. Rec. 23765 (1984) ("[O]ne patent
on a product, not necessarily the first, can be extended . .
. ."); id. at 24444 ("Under this
amendment, the patent holder would be allowed to select the
patent to be extended. . . . I believe this amendment is
acceptable because it gives the patentholder the flexibility
to select the most important patent for extension.").
Novartis owned at least two patents covering
Gilenya® that could qualify for PTE under
§ 156(a): the '229 patent and U.S. Patent No. 6,
004, 565, which claims a method of administering fingolimod.
Novartis chose to apply for PTE on the '229 patent. With
the PTE granted to the '229 patent, the '229 patent
now expires on February 18, 2019. Because the '565 patent
issued from a patent application filed after the effective
date of the URAA, its term expired on September 23, 2017-20
years from its earliest effective filing date. See Merck
& Co. v. Kessler, 80 F.3d 1543, 1547 (Fed. Cir.
1996) (explaining the post-URAA regime, citing §
154(a)(2) and § 154(c)(1)). The '229 patent is thus
a pre-URAA patent whereas the '565 patent is a post-URAA
patent, governed by different statutory patent term regimes.
Below is a timeline of the relevant dates between the two
September 22, 2016, the district court denied Ezra's
Federal Rule of Civil Procedure 12(c) motion for judgment on
the pleadings, where Ezra argued that the '229 patent
should be ruled invalid, or otherwise terminally disclaimed
for the patent term past the expiration date of the
unasserted '565 patent. Specifically, Ezra argued that
the granted extension of the '229 patent's term
beyond the life of the '565 patent is impermissible
because it: (1) de facto also extends the life of the
'565 patent, and thereby violates § 156(c)(4)'s
requirement that only "one patent be extended"; (2)
violates the "bedrock principle" that the public
may practice an expired patent; and (3) renders the ...