Eli Lilly And Company v. Apotex, Inc.
PROST, BRYSON, STOLL
December 21, 2020
Brief Summary: DC grant of SJ of infringement under DOE affirmed. Summary: Apotex appealed DC grant of Lilly’s motion for summary judgment (SJ) of infringement of US 7,772,209 claiming methods of administering an antifolate, a particular methylmalonic acid lowering agent, and “an effective amount of pemetrexed disodium” (as in Lilly’s ALIMTA® product for mesothelioma and lung cancer) by Apotex’s ANDA, and that prosecution history estoppel (PHE) does not bar Lilly from asserting infringement under the doctrine of equivalents (DOE). During prosecution of a parental ‘821 application, Lilly “sought dependent claims limiting the antifolate to ‘ALTIMA’” that were rejected by the Examiner for indefiniteness, which Lilly subsequently canceled “and instead prosecuted only claims reciting ‘pemetrexed disodium’.” Lilly took the same steps in a Preliminary Amendment of the ‘329 application that led to the disputed ‘209 patent. The proposed product of Apotex’s ANDA contains pemetrexed dipotassium, not the claimed pemetrexed disodium. This FC panel opinion reviewed its decision in Eli Lilly & Co. v. Hospira (FC 2019, cert. denied 2020) in which it agreed with the DC “that Lilly’s amendment narrowing the ‘821 application’s claims from administration of “an antifolate’ to ‘pemetrexed disodium’ did not give rise to” PHE as it “was merely tangential to pemetrexed ditromethamine because the prosecution history, in view of the ‘209 patent itself, strongly indicates that the reason for the amendment was not to cede other, functionally identical, pemetrexed salts.” Similarly, in this case, the DC found that Lilly’s amendment from ALTIMA to pemetrexed disodium “was not a narrowing amendment and, thus,” PHE “does not apply”. The FC panel agreed since, e.g., “Lilly’s patent applications from the ’209 patent claims priority equate ‘ALIMTA’ with ‘pemetrexed disodium’” (e.g., “Pemetrexed Disodium (ALIMTA)”) and “the prosecution history confirms that the inventors used ‘ALIMTA’ in the original claims-and the Examiner understood the term-as Lilly’s trade name for pemetrexed disodium”; “[t]he Examiner did not…reject the original claims as ‘indefinite’ because there was ambiguity about whether ‘ALIMTA’ has multiple meanings” but “because ALIMTA is a trade name”). Apotex argued Lilly’s European prosecution supported its arguments but the FC panel disagreed as that evidence supports the DC’s conclusion (also noting its “caution against relying on the prosecution of foreign applications in interpreting claim terms of U.S. patents and patent applications” (AIA Eng’g, FC 2011). The FC therefore affirmed the DC decision.