Opinion ID: 807367
Heading Depth: 2
Heading Rank: 2

Heading: The ’775 Intermediate

Text: As with the ’608 Compound, Lilly’s claim covering the ’775 Intermediate was issued before the ’932 patent. As ELI LILLY v. APP PHARMA 16 an independent basis for holding the ’932 claims invalid for obviousness-type double patenting, Teva similarly contends that pemetrexed is not patentably distinct from the ’775 Intermediate. Teva’s arguments regarding the ’775 Intermediate can be summarized as follows. According to Teva, the ’775 Intermediate is used to make pemetrexed, and Lilly disclosed that use in the ’775 patent. By later claiming pemetrexed itself, Teva maintains, the ’932 patent appropriates a previously disclosed use for a previously patented compound, which renders the asserted ’932 claims invalid for obviousness-type double patenting under a line of our precedent including In re Byck, 48 F.2d 665 (CCPA 1931), and Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010). We conclude that Teva’s reliance on Byck, Sun, and related cases is unsound and that the district court did not err when it upheld the asserted claims of the ’932 patent over the ’775 Intermediate. As a general rule, obviousness-type double patenting determinations turn on a comparison between a patentee’s earlier and later claims, with the earlier patent’s written description considered only to the extent necessary to construe its claims. E.g., In re Avery, 518 F.2d 1228, 1232 (CCPA 1975). This is so because the non- claim portion of the earlier patent ordinarily does not qualify as prior art against the patentee and because obviousness-type double patenting is concerned with the improper extension of exclusive rights—rights conferred and defined by the claims. The focus of the obviousnesstype double patenting doctrine thus rests on preventing a patentee from claiming an obvious variant of what it has previously claimed, not what it has previously disclosed. See generally Gen. Foods, 972 F.2d at 1280–82. 17 ELI LILLY v. APP PHARMA The cases on which Teva relies represent a limited exception to this customary framework. In Byck, our predecessor court considered obviousness-type double patenting rejections against claims to an insulated coil made up of a conductive winding material coated with an “infusible, flexible, phenol-fatty oil composition.” 48 F.2d at 665. The patent applicant, Byck, had earlier obtained a patent claiming the same phenol-oil composition, and the prior art disclosed similar coils coated with other insulating compositions. Id. at 665–66. Moreover, Byck’s earlier patent had discussed using his phenol-oil composition to produce adherent insulating films on metal substrates. Id. at 666. The court concluded that, in view of the prior art and Byck’s earlier patent, the pending claims were drawn not to a second, distinct invention “but only . . . an obvious use of the composition there patented.” Id. The court explained: It would shock one’s sense of justice if an inventor could receive a patent upon a composition of mat- ter, setting out at length in the specification the useful purposes of such composition, manufacture and sell it to the public, and then prevent the pub- lic from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Id. Thus, even though Byck’s earlier patent was not prior art, the court held that its disclosure of an intended use for the previously claimed phenol-oil composition could be used in the obviousness-type double patenting analysis to reject a later claim directed to that use of the same compound. Id. at 667. A trio of our more recent decisions applied the same exception to allow limited consideration of teachings in an earlier-issued patent’s specification. In Geneva PharmaELI LILLY v. APP PHARMA 18 ceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), the plaintiff had patented methods of using clavulanic acid to mitigate antibiotic resistance when treating bacterial infections. The plaintiff then acquired a preexisting patent that claimed clavulanic acid compositions and disclosed their utility for treating patients harboring antibiotic-resistant bacteria. Id. at 1377, 1385. In that case, we relied on Byck to hold the plaintiff’s method claims invalid for double patenting: “Our predecessor court recognized 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.” Id. at 1385–86 (citing Byck, 48 F.2d at 666). Similarly, in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008), we held claims to methods of administering a particular anti-inflammatory drug invalid for obviousness-type double patenting where the patentee’s earlier patent claimed the drug itself and disclosed the same methods of administering the drug. And in Sun, the patent holder had developed an antiviral compound, gemcitabine, that also proved useful for treating cancer. An initial patent issued with composition claims covering gemcitabine as well as method claims drawn to using the drug to treat herpesvirus infections; also mentioned in the specification, but not claimed, was gemcitabine’s potential anticancer activity. Sun, 611 F.3d at 1383. As in Geneva and Pfizer, we held the patentee’s subsequent claims to methods of using gemcitabine to treat cancer invalid for double patenting, looking to the disclosure of anticancer utility in the first patent’s specification. Id. at 1386–89. Byck, Geneva, Pfizer, and Sun thus “address the situation in which an earlier patent claims a compound, disclosing the utility of that compound in the specification, and a later patent claims a method of using that 19 ELI LILLY v. APP PHARMA compound for a particular use described in the specification of the earlier patent.” Sun, 611 F.3d at 1389. Furthermore, in each of those cases, the claims held to be patentably indistinct had in common the same compound or composition—that is, each subsequently patented “use” constituted a, or the, disclosed use for the previously claimed substance. That is not the case before us. Rather than a compo- sition and a previously disclosed use, the claims at issue recite two separate and distinct chemical compounds: the ’775 Intermediate and pemetrexed, differing from each other in four respects. That alone suffices to undermine Teva’s argument regarding the ’775 Intermediate, for the asserted claims of the ’932 patent do not recite a use of the same compound, but a different compound altogether. The cited cases therefore do not govern. Furthermore, even if one composition could somehow be considered a “use” of another, the record makes clear that, unlike in the cited cases, Lilly’s successive claims are wholly independent of one another. For example, pemetrexed and the ’775 Intermediate exhibit substantial structural differences, and neither embodies or subsumes the other. Moreover, pemetrexed can be made via any of several synthetic techniques, many of which do not involve the ’775 Intermediate. The ’775 Intermediate and pemetrexed are thus separate and independent chemical compounds; Lilly’s original claim to the ’775 Intermediate offered no protection for pemetrexed, and its claims to pemetrexed do not incorporate or require use of the ’775 Intermediate. The particular concerns motivating our prior decisions are thus absent here. In sum, although the specification of the ’775 patent discloses one method for deriving pemetrexed using the ’775 Intermediate, we agree with the district court’s conclusion that that discloELI LILLY v. APP PHARMA 20 sure does not render Lilly’s claims to pemetrexed invalid for obviousness-type double patenting. As the district court recognized, the correct double patenting analysis in this case turns on an evaluation of what Lilly has claimed, not what it has disclosed. Putting aside the teachings in the ’775 patent’s specification, Teva’s double patenting contentions evaporate. The evidence of record characterizes the ’775 Intermediate as a versatile compound from which a skilled chemist could derive innumerable final products beyond just pemetrexed, and the district court found that there would have been “no reason” to pursue pemetrexed among the various other avenues that would have been considered possible at the time. We see no error in the district court’s findings or its conclusion on this point, and, although not controlling, we further note that its analysis comports with PTO guidelines on the patentability of related products. See Manual of Patent Examining Procedure § 806.05(j) (8th ed., rev. 8, 2010) (“[A]n intermediate product and a final product can be shown to be distinct inventions if the intermediate and final products are mutually exclusive inventions (not overlapping in scope) that are not obvious variants, and the intermediate product as claimed is useful to make other than the final product as claimed.”). In sum, the district court correctly concluded that the asserted claims are not invalid for obviousness-type double patenting over the ’775 Intermediate.