By Andrew Williams --
On Wednesday, in Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., the Federal Circuit affirmed a finding that claims of Lilly's U.S. Patent No. 5,464,826 ("the '826 patent) were invalid for obviousness-type double patenting over U.S. Patent No. 4,808,614 ("the '614 patent"). The '614 patent claims gemcitabine, and methods of using gemcitabine to treat viral infections, while the '826 patent claims methods of using gemcitabine for treating cancer. Lilly markets the drug GEMZAR, which contains gemcitabine as the active ingredient, for the treatment of various forms of cancer. Correspondingly, both the '614 patent and the '826 patent were listed in the Orange Book with respect to GEMZAR. Sun filed an ANDA in 2006 to market a generic version of GEMZAR, and filed a declaratory judgment action in 2007, asserting, among other things, that the '826 patent was invalid. Ultimately, the U.S. District Court for the Eastern District of Michigan granted Sun's motion for partial summary judgment because the asserted claims of the '826 were invalid based on obviousness-type double patenting.
Lilly's '614 patent was a continuation-in-part ("CIP") application of U.S. Application No. 06/473,883 ("the '833 application"). The original '833 application only described gemcitabine's antiviral activity. However, when the CIP application was filed, the specification was amended to include the observation that "certain compounds of the present invention have also demonstrated excellent oncolytic activity in standard cancer screens" ('614 patent, col. 17, ln. 54-56). Nevertheless, the '614 patent did not claim any methods of treating cancer. In fact, Sun and Lilly did not dispute that the '614 patent was entitled to the benefit of the '833 application filing date. On the same date that Lilly filed the application that resulted in the '614 patent, it also filed an application that gave rise to the '826 patent. Because both of these applications were filed prior to 1995 (December 4, 1984 to be exact), the patent term was calculated based on the issue date. Lilly obtained patent term extension for the '614 patent, and as a result, the patent expired on May 15, 2010. The '826 patent was set to expire two-and-a-half years later, on November 7, 2012. Lilly did not file a terminal disclaimer.
The Federal Circuit agreed with the District Court in finding that this case was analogous to the prior decisions in Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In Geneva Pharm., an earlier patent claimed the compound potassium clavulanate, and the specification disclosed its utility in inhibiting B-lactamase, while a later patent claimed the method of using the compound to inhibit B-lactamase. Because the second patent did no more than claim the previously disclosed utility of a previously claimed compound, the two patents were not patentably distinct. In Pfizer, an earlier patent claimed several COX-2 inhibitors, and disclosed that they could be used to treat both inflammation and inflammation-associated disorders. A later patent claimed these previously disclosed methods of use. Again, the Court found that these two patents were not patentably distinct.
Lilly asserted two reasons why the present case was different from both Geneva Pharm. and Pfizer. First, Lilly pointed out that in the earlier cases, there was only one disclosed utility -- the methods of use that were claimed in the later patents. In contrast, Lilly's earlier patent disclosed more than one utility -- treating viral infections and cancer. Because the treatment of cancer was not the "essential utility," Lilly argued, the two patents were patentably distinct. The Court rejected this argument because the Pfizer case, in fact, did involve more than one essential utility -- the treatment of inflammation, and the treatment of inflammation-associated disorders. Of course, the Court does not address whether these were results of the same utility, namely, whether the treatment of the inflammation-associated disorders would flow naturally from the treatment of the inflammation. But, on the other hand, it is not clear from the discussion whether the anti-cancer properties of gemcitabine would not naturally result from the treatment of the viral infections. Nevertheless, the Court determined that the holdings of Geneva Pharm. and Pfizer extend to any and all uses disclosed in the earlier specification.
The Federal Circuit also rejected Lilly's second argument that the trial court erred in consulting the specification of the issued patent instead of the specification of the priority document, the '833 application. In support of this argument, Lilly relied on claim construction concepts as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005). Specifically, Lilly argued that a claim term should be given its ordinary and customary meaning as understood by one of ordinary skill in the art at the time of invention. Gemcitabine's anti-cancer properties were unknown at the time the '614 patent was invented. However, the Federal Circuit pointed out that its claim construction precedent establishes that claim terms must be construed in light of the entire issued patent, and therefore found no support for Lilly's argument.
Ultimately, the Federal Circuit appears to justify its decision on the policy considerations as articulated in both Pfizer and Geneva Pharm.:
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, . . . and then prevent the public from making any beneficial use of such product by securing patent upon each of the uses to which it may be adapted.
Pfizer, 518 F.3d at 1368 n.8; Geneva Pharm., 349 F.3d at 1386.
Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co. (Fed. Cir. 2010)
Panel: Circuit Judges Bryson, Gajarsa, and Prost
Opinion by Circuit Judge Prost