Friday, August 24, 2012

CAFC rules against Teva in folate case involving Lilly and Princeton

On the legal issue:

The sole disputed issue in this appeal is whether the asserted claims of the ’932 patent are invalid for obvious- ness-type double patenting. The doctrine of obviousness- type double patenting is intended to “prevent the exten- sion of the term of a patent . . . by prohibiting the issu- ance of the claims in a second patent not patentably distinct from the claims of the first patent.” In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985). “A later patent claim is not patentably distinct from an earlier claim if the later claim is obvious over, or anticipated by, the earlier claim.” Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001). As with statutory obviousness under 35 U.S.C. § 103, obviousness-type double patenting is an issue of law premised on underlying factual inquiries. Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1290 (Fed. Cir. 2012). Accordingly, we consider the district court’s ultimate conclusion on obviousness-type double patenting without deference, but we review any predicate findings of fact for clear error. Id.

Teva's position:

On appeal, Teva contends that the district court erred by failing to invalidate the claims for obviousness-type double patenting. Teva’s primary argument concerns the appropriate legal standard for evaluating obviousness- type double patenting. Relying on our decision in Amgen Inc. v. Hoffmann-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009), Teva contends that the correct analysis involves only the differences between the claims at issue, so that any features held in common between the claims—in this case, all but the aryl regions of the ’608 Compound and pemetrexed—would be excluded from consideration. In Amgen, we explained that once the differences between claims are established, the obviousness-type double patenting analysis entails determining “whether the differences in subject matter between the claims render the claims patentably distinct.” 580 F.3d at 1361. But those differences cannot be considered in isolation—the claims must be considered as a whole. Amgen expressly noted that “[t]his part of the obviousness-type double patenting analysis is analogous to an obviousness analy- sis under 35 U.S.C. § 103.” Id. And just as § 103(a) requires asking whether the claimed subject matter “as a whole” would have been obvious to one of skill in the art, so too must the subject matter of the ’932 claims be con- sidered “as a whole” to determine whether the ’608 Com- pound would have made those claims obvious for purposes of obviousness-type double patenting. Gen. Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1278 (Fed. Cir. 1992) (“Claims must be read as a whole in analyzing a claim of double patenting.”). Thus, the district court did not err by examining whether one of ordinary skill in the art would have been motivated to modify the ’608 Com-On the merits, Teva also disputes the district court’s findings and conclusions in view of the evidence pre- sented. Specifically, Teva contends (1) that placing a phenyl group in the aryl position represented inescapable “conventional wisdom” in the field based on antifolate structures known at the time, (2) that the district court erred in finding that one of skill in the art would have considered a phenyl group undesirable within the struc- tural context of the ’608 Compound, and (3) that the district court erred by discounting its theory that princi- ples of bioisosterism6 would have suggested replacing the ’608 Compound’s thienyl with phenyl.

Teva's argument did not go well:

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.

The district court's analysis was proper:

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 pe- metrexed, 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, al- though not controlling, we further note that its analysis comports with PTO guidelines on the patentability of related products. See Manual of Patent Examining Pro- cedure § 806.05(j) (8th ed., rev. 8, 2010) (“[A]n intermedi- ate 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.

link to case


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