Sun Pharmaceutical v. Eli Lilly (CAFC 2010-1105) precedential

In 2006, Sun filed an ANDA to market a generic version of gemcitabine, and smartly filed a declaratory judgment against Lilly. In summary judgment, '826 claims were  found invalid for obviousness-type double patenting over '614. Lilly appealed.

"The doctrine of double patenting is intended to pre-vent a patentee from obtaining a timewise extension of [a] patent for the same invention or an obvious modification thereof." In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1375 (Fed. Cir. 2008). The proscription against double patenting takes two forms: (1) statutory double patenting, which stems from 35 U.S.C. § 101 and prohibits a later patent from covering the same invention, i.e., identical subject matter, as an earlier patent, and (2) obviousness-type double patenting, which is a judicially created doctrine that prevents a later patent from cover-ing a slight variation of an earlier patented invention. Perricone, 432 F.3d at 1372-73; see Geneva, 349 F.3d at 1377-78.

The second type of double patenting, obviousness-type double patenting, prohibits "claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent." In re Basell, 547 F.3d at 1375. An obviousness-type double patenting analysis, which "compares claims in an earlier patent to claims in a later patent or application," Geneva, 349 F.3d at 1378 n.1, consists of two steps, Pfizer, 518 F.3d at 1363. First, the court "construes the claim[s] in the earlier patent and the claim[s] in the later patent and determines the differences." Id. Second, the court "determines whether those differences render the claims patentably distinct." Id. "A later claim that is not patentably distinct from," i.e., "is obvious over[] or anticipated by," an earlier claim is invalid for obviousness-type double patenting. Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001).

Our prior obviousness-type double patenting decisions in Geneva and Pfizer, which addressed factual situations closely resembling that presently before the court, control this case. In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. We held that 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, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86.

Lilly's argud that the facts of this case were somehow different. The CAFC panel found that "factually erroneous."

Thus, the holding of Geneva and Pfizer, that 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," extends to any and all such uses disclosed in the specification of the earlier patent. Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. Indeed, as both cases recognized,

[i]t 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 patents upon each of the uses to which it may be adapted.

Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 (CCPA 1931)).

Both Geneva and Pfizer make clear that, where a patent features a claim directed to a compound, a court must consider the specification because the disclosed uses of the compound affect the scope of the claim for obviousness-type double patenting purposes. In Geneva, we acknowledged the general rule that an earlier patent's specification is not available to show obviousness-type double patenting. 349 F.3d at 1385. We have held, however, that there are "certain instances" where the specification of an earlier patent may be used in the obviousness-type double patenting analysis. In re Basell, 547 F.3d at 1378. Specifically, the specification's disclosure may be used to determine whether a claim "merely define[s] an obvious variation of what is earlier disclosed and claimed," "to learn the meaning of [claim] terms," and to "interpret[] the coverage of [a] claim." Id. As we recognized in Geneva, a court considering a claim to a compound must examine the patent's specification to ascertain the coverage of the claim, because a claim to a compound "[s]tanding alone . . . does not adequately disclose the patentable bounds of the invention." 349 F.3d at 1385. In examining the specification of the earlier patent, the court must consider "the compound's disclosed utility." Id.

We affirmed this holding in Pfizer by rejecting the patentee's objection to our reliance on the specification of the earlier patent that claimed the compounds at issue and explaining that "[t]here is nothing that prevents us from looking to the specification to determine the proper scope of the claims." Pfizer, 518 F.3d at 1363 (citing Geneva, 349 F.3d at 1386). Thus, we have expressly held that, where a patent claims a compound, a court performing an obviousness-type double patenting analysis should examine the specification to ascertain the coverage of the claim.

Lilly had an insensible argument to ignore context and all relevant subject matter. The Court retort: "[T]he double patenting doctrine is concerned with the issued patent and the invention disclosed in that issued patent, not earlier drafts of the patent disclosure and claims."

In response to Lilly's arguments, we determine that where such examination of the specification is appropriate in an obviousness-type double patenting analysis, the specification that must be considered is that of the issued patent. Lilly contends that the district court should have evaluated the '614 patent's claim to gemcitabine based on the specification that existed as of the undisputed effective filing date of the '614 patent, namely the specification of the original '883 application. The original '883 application disclosed only gemcitabine's antiviral use, not its anticancer use; Lilly added a description of gemcitabine's anticancer use to the specification in a continuation-in-part application that eventually resulted in the '614 patent. Lilly therefore asks this court to ignore the '614 patent's description of gemcitabine's use in cancer treatment, because this disclosure was not part of the original '883 application.

To support this argument, Lilly cites only the basic tenet of claim construction, as stated in Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005), that claim terms should be given their ordinary and customary meaning and this meaning is the one that "the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips, however, does not support the proposition that a court should ignore portions of the patent specification in construing claims. Instead, Phillips makes clear that claim terms must be construed in light of the entirety of the patent, including its specification, and that the specification to be consulted is that of the issued patent, not an earlier application.

Specifically, Phillips, as well as the rest of our claim construction precedent, expounds that a "person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1374 (Fed. Cir. 2009) (emphasis added); Aquatex Indus., Inc. v. Techniche Solutions, 419 F.3d 1374, 1380 (Fed. Cir. 2005); Phillips, 415 F.3d at 1313. In other words, "the 'ordinary meaning' of a claim term is its meaning to the ordinary artisan after reading the entire patent." ICU Med., 558 F.3d at 1375 (emphasis added); Phillips, 415 F.3d at 1321. Phillips further explains the "fundamental rule" that claim terms "are construed with the meaning with which they are presented in the patent document." 415 F.3d at 1316 (emphasis added). As such, "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be . . . the correct construction." Id. (emphasis added).

In sum, our claim construction precedent establishes that claim terms must be construed in light of the entire issued patent. This precedent leaves no room for debate that the relevant specification for claim construction purposes is that of the issued patent, not an early version of the specification that may have been substantially altered throughout prosecution. There is no support for Lilly's argument that the district court should have consulted the specification of the original '883 application, which was changed before the '614 patent issued, to construe the issued patent claims. Lilly cannot avoid portions of the specification of the '614 patent by resorting to the specification as originally filed.

Affirmed.