Lilly’s Gemzar Patent Invalid For Double-Patenting

Posted on | December 17, 2009 | No Comments

2010-1105 Sun Pharma v. Eli Lilly

ED/MI 07-cv-15087

Judge George Caram Steeh

Eli Lilly appeals from the grant of partial summary judgment by Judge George Caram Steeh finding that certain claims of its US Patent No. 5,464,826 invalid for double patenting.  The case arose from Sun's ANDA filing seeking to market a generic form of GEMZAR, Lilly's gemcitibine cancer medication.  The matter is on appeal following the entry of this judgment under Rule 54(b).

The prior patent at issue is 4,808,614, titled "Difluoro Antivirals and Intermediate Therefore" and generally discloses certain anti-viral nucleosides.  One of the disclosed (and claimed) compounds is gemcitibine, which the '614 specification further describes as having "excellent oncolytic activity in standard cancer screens.

Sun argued that 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.  Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008); Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003).  

Lilly countered that 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.  In re Kaplan, 789 F.2d 1574 (Fed. Cir. 1986).

An obvious-type double patenting analysis requires construing the relevant claims of the earlier and latter patents and determining their differences, then determining whether the differences render the claims patentable distinct.  The main contention between Sun and Lilly was whether the court could look to the specification of the '614 patent for the "anti-cancer" disclosure.  (Opinion, pp. 5-8.)

After determining that it could look to the specification, the court found an overlap of coverage between claim 12 of the '614 patent and claims 2, 6 and 7 of the '826 patent render the latter invalid:

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.

It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, manufacture and sell it to the public, and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.

Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 668 (CCPA 1931)).

Opinion, p. 8.

2010-1105 Opinion

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