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2010-1105 Opinion
2010-1105 Opinion
Plaintiff,
Defendant.
_____________________________/
the asserted claims of defendant Eli Lilly and Company's U.S. Patent 5,464,826 ("'826
Patent"). A hearing was held on July 24, 2009. For the reasons set forth below, Sun
I. Background
submitted an Abbreviated New Drug Application ("ANDA") with the FDA to market its
generic version of Eli Lilly's cancer medication "Gemzar" (gemcitabine). Eli Lilly holds the
'826 Patent, a patent listed in the FDA's "Orange Book." Sun Pharmaceuticals wants to
market its generic version of the patented drug before Eli Lilly's '826 Patent expires. The
Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
355(j), required Sun Pharmaceuticals to: (1) certify to the FDA that its generic drug will not
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infringe the '826 Patent; and (2) notify Eli Lilly of this certification. Sun Pharmaceuticals
seeks declaratory relief that the '826 Patent is invalid, and alternatively, that its generic drug
does not infringe the '826 Patent. Eli Lilly filed counterclaims of infringement of its '826
Sun Pharmaceuticals moves for partial summary judgment of its claim that Eli Lilly's
'826 Patent is invalid pursuant to the judicially created doctrine of "obviousness-type double
patenting," a doctrine that "prohibit[s] a party from obtaining an extension of the right to
exclude through claims in a later patent that are not patentably distinct from claims in a
commonly owned earlier patent." Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d
1353, 1363 (Fed. Cir. 2008) (quoting Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967
(Fed Cir. 2001)). The patents at issue here are the commonly owned earlier '614 Patent
A. '614 Patent
The '614 Patent issued on February 28, 1989 and is titled "DIFLUORO ANTIVIRALS
the '614 Patent describes the "specific nucleosides . . . to assure that every reader
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understands the type of antivirals which this invention makes available." (emphasis
added). After giving eleven examples of compounds, the '614 Patent continues:
(emphasis added).
B. '826 Patent
The '826 Patent issued on November 7, 1995 and is titled "METHOD OF TREATING
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of the compound of the formula [formula diagram] . . . ." The "SUMMARY OF THE
diagram]." After giving seven examples of compounds, the '826 Patent continues:
R1 is hydrogen;
R2 is a base defined by one of the formulae [formula diagrams];
X is C-R4
R3 is hydrogen;
R4 is hydrogen, C1-C4 alkyl, bromo, fluoro, chloro or iodo; and the
pharmaceutically-acceptable salts thereof.
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(emphasis added).
On March 10, 1983, Lilly filed U.S. Patent Application No. 473,883 ("'883
Application, which ultimately lead to the '614 Patent. On December 4, 1984, Lilly also filed
U.S. Patent Application No. 677,783, which ultimately lead to the '826 Patent. Lilly
1985. The '614 Patent issued on February 28, 1989, while the '826 Patent issued on
November 7, 1995.
II. Argument
Sun Pharmaceuticals argues Lilly obtained the '614 Patent for the compound
gemcitabine as an anti-viral and anti-cancer drug, then improperly extended its monopoly
over the compound by obtaining the '826 Patent claiming a method of using gemcitabine
to treat cancer. Sun Pharmaceuticals argues that, if a compound claim fails to adequately
disclose the patentable bounds of the invention, the court may look to the patent
Lilly responds that Pfizer and Geneva are inapplicable because those cases involved
initial compound patents that disclosed only a single utility in their specifications, and the
subsequent patents claimed the earlier disclosed utility. Lilly argues that its earlier '614
Patent claimed the compound gemcitabine and its essential utility as an anti-viral agent,
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and that the '826 patent claimed the new use of gemcitabine as an anti-cancer agent. Lilly
asserts it disclosed the anti-cancer use in the '614 Patent specification to avert any "best
mode" challenges to the validity of the '614 Patent, but relied on the anti-viral utility of
gemcitabine to obtain the '614 Patent. Lilly maintains that, because the anti-cancer use of
gemcitabine set forth in the '614 Patent specification was unnecessary to support the '614
Patent, the anti-cancer use was eligible for later patenting in the '826 Patent. Lilly argues
that the court may not rely on the earlier patent specification as prior art to determine
whether the later patent resulted in double patenting. Lilly maintains that In re Kaplan, 789
III. Analysis
An obviousness-type double patenting analysis involves a two step process: (1) the
court construes the claims of the earlier and later patents and determines their differences;
and (2) the court determines whether those differences render the claims patentably
distinct. Pfizer, 518 F.3d at 1363. Double patenting is an issue of law for the court to
decide. Id.
Claim 12 of the '614 Patent claims the compound gemcitabine, a claim that is not
dependent upon Claims 13 or 14, which claim, respectively, the method and use of treating
Herpes viral infections. Claim 12 is a compound claim that, standing alone, does not
adequately disclose the patentable bounds of the invention. Therefore, this court may
examine the specifications of both patents to determine any overlap in the claim scope for
double patenting purposes. Geneva, 349 F.3d at 1385. Such was not the case in In re
Kaplan, where a panel of the Federal Circuit ruled there was adequate support to determine
the scope of a patent claim limitation "organic solvent" (as opposed to "organic solvents")
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from the claim language itself without resorting to the "mixed solvent" examples disclosed
in the patent specification. In re Kaplan, 789 F.2d at 1575, 1580. The Kaplan court
reasoned that the United States Trademark and Patenting Office ("PTO") erred in its double
patenting analysis by treating the "mixed solvent" specification disclosure as prior art in
rejecting a subsequent patent application claiming a process using a "solvent mixture." Id.
Reversing the PTO's decision, the Kaplan court cited In re Vogel, 422 F.2d 438 (CCPA
1970) for the rule that treating a patent disclosure as prior art in performing an
obviousness-type double patenting analysis "has repeatedly been held in our precedents
Recently, a panel of the Federal Circuit explained the contours of Vogel when
rejecting an argument that Kaplan forbids reading limitations from a patent specification into
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In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1378-79 (Fed. Cir. 2008).
Claim 12 of the '614 Patent fails to adequately describe the bounds of the claimed
invention, and therefore, this court may use the specification disclosure in the '614 Patent,
using gemcitabine for cancer chemotherapy treatment, to interpret the coverage of Claim
12. Id.; Geneva, 349 F.3d at 1385. Clearly, when properly considering the anti-cancer use
Claim 12 of the '614 Patent and Claims 2, 6 and 7 of the '826 Patent. Indeed, there is an
overlap of the identical "pharmaceutically effective amount" for anti-cancer treatment in the
'614 Patent is repeated in the '826 Patent. A "claim to a method of using a composition is
not patentably distinct from an earlier claim to the identical composition in a patent
disclosing the identical use." Pfizer, Inc., 518 F.3d at 1363 (quoting Geneva, 349 F.3d at
1385-86). Construing Claim 12 of the earlier '612 Patent and Claims 2, 6 and 7 of the later
'826 Patent, the court finds they are not patentably distinct as a matter of law. Pfizer, 518
F.3d at 1363.
Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 668 (CCPA 1931)).
The court has limited its non-statutory double patenting analysis to a comparison of
the Claims in the earlier '612 Patent to the Claims in the later '826 Patent, and does not rely
on Lilly's motivations. Geneva, 349 F.3d at 1377 n.1. The timing of when Lilly discovered
gemcitabine's uses for treating viral infections and treating cancer is irrelevant to the instant
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double patenting analysis. Lilly's assertion that it included the anti-cancer use of
gemcitabine in the '612 Patent to avoid a later "best mode" challenge supports a conclusion
that anti-cancer use was "contemplated by the inventor of carrying out [the] invention" set
forth in Claim 12. See Pfizer, 518 F.3d at 1364 (quoting 35 U.S.C. § 112). While Lilly may
Pharm. Corp. v. Smith, 959 F.2d 936 (Fed. Cir. 1992); In re Maxwell, 578 F.2d 479 (CCPA
1951), it may not, as here, claim the same use of a compound in a later patent. Geneva,
349 F.3d at 1386. Lilly's argument that it was unnecessary to disclose the anti-cancer use
in the '614 Patent because it relied on the anti-viral utility to secure the '614 Patent does
not displace the court's double patenting analysis. Although Lilly may not have been
required to disclose the anti-cancer utility in the '614 Patent, it did make such a disclosure
under circumstances which allow the court to interpret the coverage of Claim 12 using that
disclosure. In re Basell Poliolefine, 547 F.3d at 1378 (quoting Vogel, 422 F.2d at 441-42).
The court agrees with the reasoning in Boehringer Ingelheim International GMBH v. Barr
Laboratories, Inc., 562 F.Supp.2d 619, 639 (D. Del. 2008), that, although Geneva and
Pfizer involved single utility compounds, the rationale of Geneva and Pfizer are not limited
to that circumstance. Construing Claim 12 of the '612 Patent along with the other Patent
Claims, Lilly claimed two utilities for the compound gemcitabine - anti-viral and anti-cancer -
and cannot now claim the same anti-cancer utility for the same compound. Boehringer,
562 F.Supp.2d at 639. Contrary to Lilly's argument, the court has not confused double
patenting with "domination." See In re Kaplan, 789 F.2d at 1577. As opposed to a broad
or "generic" claim, Claim 12 of the '612 Patent covers the specific anti-cancer use of
gemcitabine as is also claimed in Claims 2, 6 and 7 of the '826 Patent. Based on clear and
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convincing evidence, these claims are not patentably distinct as a matter of law. Pfizer,
Sun Pharmaceuticals motion for partial summary judgment of invalidity of Eli Lilly's
'826 Patent is hereby GRANTED to the extent the '826 Patent claims the method of treating
salt thereof. Such claims are invalid as a matter of law under the doctrine of obviousness-
type double patenting. Judgment shall enter in favor of Sun Pharmaceuticals on its claim
that the '826 Patent is invalid. Eli Lilly's counterclaim of infringement of its '826 Patent is
hereby DISMISSED.
SO ORDERED.
CERTIFICATE OF SERVICE
s/Josephine Chaffee
Deputy Clerk
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