The Federal Circuit Further Clarifies The Obviousness-Type Double Patenting Doctrine For Composition Claims

On Friday, August 24, 2012, the Federal Circuit took another significant step in clarifying the law of obviousness-type double patenting as it relates to composition claims and continued its recent trend of treating obviousness and obviousness-type double patenting as largely the same analysis. See Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., No. 2011-1561 (Fed. Cir. Aug. 24, 2012). Read the decision here. In this decision, the Federal Circuit addressed issues that have been the subject of much discussion and litigation since at least Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009), finding that, in an obviousness-type double patenting analysis involving composition claims: (1) a court must consider the claimed compositions in their entirety, rather than simply the relative differences between the two compositions; (2) except in limited circumstances, a court is not permitted to consider the specification of the earlier-issued patent; and (3) a court must take into account any objective indicia of non obviousness.

Background

The '932 patent-in-suit covers pemetrexed (marketed as Alimta®), which is used to treat mesothelioma and non-small cell lung cancer. Before obtaining the '932 patent, Princeton University and its licensee Eli Lilly (collectively, "Eli Lilly") obtained the '608 patent, which claimed a compound that differed from pemetrexed only in its aryl region ("the '608 Compound"), and the '775 patent, which included within its specification two reactions that together, along with an intermediate claimed in the '775 patent ("the '775 Intermediate"), could be used to make pemetrexed. Slip. Op. at 7-9.

In its defense, Teva argued that the claims of the '932 patent covering pemetrexed were invalid for obviousness-type double patenting over the '608 Compound and the '775 Intermediate. The district court rejected Teva's arguments, and Teva appealed.

A Court Must Consider the Claimed Composition as a Whole

With respect to the '608 Compound, Teva, relying on some arguably loose language in Amgen, asserted that "the correct [obviousness-type double patenting] 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." Id. at 13 (emphasis in original)...