Pemetrexed – USA

On Dec. 30, 2019, Southern District of Indiana court granted Lilly’s Motion for Summary Judgment of infringement & found Apotex’s product infringing under DOE as prosecution history estoppel did not apply.

Lilly owns U.S. Patent No. 7,772,209, titled “Antifolate Combination Therapies.” The ‘209 patent concerns a method of administering pemetrexed disodium along with folic acid and vitamin B12, a methylmalonic acid lowering agent, in order to reduce the toxicities associated with the administration of pemetrexed disodium. The US’209 patent covers Lilly’s ALIMTA® product which was approved by USFDA on Feb 4, 2004 in 500mg vial as lyophilized powder for intravenous administration. Apotex filed New Drug Application with USFDA & later Lilly sued Apotex. Both parties filed Cross-Motions for Summary Judgment regarding Lilly’s claim of infringement of the ‘209 patent. As an initial matter, the Court noted that Lilly argued in its opening brief that “Apotex’s only defense to infringement under the doctrine of equivalents is prosecution history estoppel. If the Court determines that Lilly is not barred from pursuing the doctrine of equivalents, Apotex has conceded that its product will infringe.”

Apotex argued that prosecution history estoppel bars Lilly from asserting infringement under the doctrine of equivalents. Apotex asserted that, beginning with Lilly’s January 2005 amendment, the claim term “ALIMTA” was amended to be “pemetrexed disodium,” and that amendment was a narrowing amendment. Specifically, Apotex contended the claims and the specification do not define the term “ALIMTA,” and the term would have been understood to mean “pemetrexed,” not “pemetrexed disodium.” Thus, when Lilly amended the claims from “ALIMTA”—meaning “pemetrexed”—to “pemetrexed disodium,” Lilly narrowed its claims from “pemetrexed” to “pemetrexed disodium.” Therefore, because the amendment of the claims from “ALIMTA” to “pemetrexed disodium” was a narrowing amendment, prosecution history estoppel applies.

Court said that it has carefully reviewed the evidence submitted by the parties, reviewed the patent claims, specification, and prosecution history record, and concludes that Lilly’s amendment from “ALIMTA” to “pemetrexed disodium” was not a narrowing of Lilly’s claims. Court further said that while the term “ALIMTA” was used throughout the patent applications to refer to an “antifolate,” the patent applications did not use “ALIMTA” to refer to “pemetrexed” in isolation. And the ‘209 patent claims and specification do not use the term “pemetrexed” without combining it with “disodium.” The June 2000 patent application referred to “pemetrexed disodium (Alimta®, Eli Lilly and Company, Indianapolis, IN).” Then in September 2004, the patent examiner rejected the “ALIMTA” claims because using the trademark or trade name was improper and rendered the claims indefinite. The patent examiner understood “ALIMTA” to mean “pemetrexed disodium.” Directly responding to the September 2004 rejections, Lilly canceled the “ALIMTA” claims to moot the rejections concerning the use of the trademark or trade name. The language in the specification and the prosecution history record indicate that “ALIMTA” means “pemetrexed disodium,” and when Lilly amended its claims, it was not narrowing its claims from “pemetrexed” to “pemetrexed disodium.” Therefore, prosecution history estoppel does not apply & Apotex has conceded the merits of doctrine-of-equivalents infringement.

Thus, Court granted Lilly’s Motion for Summary Judgment of infringement.