Eli Lilly secures Alimta patent win over Apotex
Eli Lilly has won a victory in a cancer drug dispute after a federal judge ruled that Canadian pharmaceutical company Apotex’s new drug application (NDA) infringed the company’s patent.
In the order, issued December 30, the US District Court for the Southern District granted Eli Lilly’s motion for summary judgment of patent infringement against Apotex.
Eli Lilly said that it expects Apotex to appeal the ruling.
According to the court, Apotex’s NDA infringed the Indianapolis-based company’s patent for an injectable form of cancer drug Alimta (pemetrexed disodium).
Eli Lilly originally filed the patent application in 2001. In 2004, the US Patent and Trademark Office (USPTO) rejected four claims of the patent application in which the company referred to the claimed drug as “Alimta”.
“It is improper claim language to use a trademark or trade name in a claim to identify or describe a material or product. This not only renders a claim indefinite, but also constitutes an improper use of the trademark or trade name,” the USPTO said at the time.
Eli Lilly subsequently amended the patent claims to read “pemetrexed disodium” instead of the word “antifolate”, and cancelled the claims referring to “Alimta”.
The USPTO ultimately published the ‘209 patent in 2010.
Apotex cited these proceedings as evidence against Eli Lilly when the Indiana company sued for patent infringement in 2017. Apotex argued that Eli Lilly was bound by prosecution history estoppel due to its amendment of the patent.
The suit claimed that Apotex’s NDA for Pemetrexed for Injection products infringed the ‘209 patent.
According to Apotex, Eli Lilly’s amendment narrowed the claims of the patent from “pemetrexed” to “pemetrexed disodium”, and barred it from suing for infringement based on the doctrine of equivalents.
In this week’s judgment, the district court dismissed Apotex’s arguments, finding that the Eli Lilly amendment did not narrow the patent claims.
According to the court, it was clear throughout the original patent application that the term “Alimta” was intended to refer to pemetrexed disodium, and that the amendment was to do solely with correcting the improper use of a trade name.
Michael Harrington, senior vice president and general counsel at Eli Lilly, said the company was “pleased with today's District Court ruling finding the Alimta vitamin regimen patent would be infringed by the competitor's proposed products”.
Harringotn added: "Lilly's extensive research to discover the Alimta vitamin regimen patent deserves intellectual property protection. We depend on strong and effective intellectual property protection to support our investment in the next generation of breakthrough medicines."
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