Eli Lilly and Princeton University are suing a subsidiary of generic drug maker Teva Pharmaceuticals USA in a federal court for allegedly infringing a US patent that is owned by Princeton and is the basis for Lilly’s lung cancer chemotherapy Alimta.
According to a complaint filed earlier this month by co-plaintiffs Lilly and Princeton, Teva Parenteral Medicines, a subsidiary of Teva Pharmaceuticals USA and Israeli pharma Teva Pharmaceutical Industries, has infringed on US Patent No. 5,344,932 by seeking approval in the US to manufacture and sell a generic version of Alimta prior to the patent’s expiration.
The compound that serves as the basis for Alimta was discovered and developed throughout the 1980s by Edward Taylor, professor of chemistry emeritus at Princeton, under a research collaboration with Lilly.
In 1994, Princeton was awarded the ‘932 patent, on which Taylor is the primary inventor. Lilly had already licensed the technology from Princeton in 1985 while it was still in the early stages of development. Lilly still has an exclusive license to the ‘932 patent, and won approval for Alimta from the US Food and Drug Administration in 2004 for treating advanced lung cancer.
According to the complaint filed in the US District Court for the District of Delaware, where Teva USA is incorporated, Teva notified Lilly and Princeton in a letter dated April 24 that it had submitted to the FDA an abbreviated new drug application for injectable pemetrexed disodium, a generic version of Alimta.
The purpose of the ANDA, according to the complaint, was to obtain approval to manufacture, use, and offer for sale of the generic product prior to the expiration of the ‘932 patent. In the letter, Teva also informed Lilly and Princeton that as part of its ANDA, it had submitted documents asserting that the ‘932 patent is “invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, or sale” of Teva’s generic product.
Anticipating that Teva’s generic will be approved by the FDA, Lilly and Princeton have requested a judgment that Teva has infringed the ‘932 patent; that the effective date of any FDA approval for Teva’s generic not be earlier than the expiration date of the ‘932 patent; and that a preliminary and permanent injunction be enforced that would preclude Teva or other parties from manufacturing and selling the generic product prior to the expiration date of the ‘932 patent, “inclusive of any extension and additional period of exclusivity,” the complaint states.
“[Teva] must feel like it has a pretty strong validity argument [and] must feel like the patent is invalid.”
The latter request for relief might be the key to the entire dispute, as Princeton and Lilly received in April from the US Patent and Trademark Office an extension of the term of the ‘932 patent. Originally, the patent was set to expire 17 years from its 1994 issue, in 2011. However, based on the extraordinarily long time it took for Alimta to receive FDA approval, the USPTO extended the term of the patent 1,783 days, or essentially through 2015.
None of the involved parties has publicly commented on the patent dispute, save for Princeton, which responded to an e-mail from BTW this week.
“From Princeton's perspective, the primary issue here is that Alimta is an anti-cancer drug developed based on basic research [at Princeton],” Cass Cliatt, director of media relations for Princeton, wrote in the e-mail. “Indeed, one of our primary goals is that some of the research performed at the university result in a public benefit. We can't think of a better public benefit than such work that has curative value.”
Richard Gearhart, principal and founder of New Jersey patent services law firm Gearhart Law, told BTW that even if the patent had been set to expire in 2011, “[Teva] must feel like it has a pretty strong validity argument [and] must feel like the patent is invalid.”
Gearhart added that “typically, if it is the same active ingredient as the Lilly product and they’re relying on all the Lilly clinical data, the only basis for [its argument] is maybe there is some indefiniteness in the claims, or they’re going to argue that the patent is invalid in some way.
“If they filed the notification and the patent had six months left on it, that’s one thing,” he continued. “But if there is three years of term left on it, they could be liable for some pretty significant damages.” It turns out that there are actually about seven years left on the patent, which nevertheless would likely leave Teva open to even more damages if its generic were approved and the company were found guilty of infringement. [Gearhart wasn’t aware of the patent extension when he was interviewed by BTW. — Ed.]
However, since the generic version of Alimta has yet to be approved, Teva essentially has nothing to lose by challenging the validity of the ‘932 patent in its ANDA, Gearhart said.
All Princeton and Lilly can do “is get an injunction to keep Teva from selling [the generic],” Gearhart said. “Teva has to kind of gauge when it’s going to gear up and get into a production mode.” For instance, Teva might be assuming that it will take longer to garner FDA approval for its generic than it would take for the patent to expire. “If it’s going to take that long, though, why file a lawsuit at all?” Gearhart asked. “Why not plan to start manufacturing six months before the patent expires?”
Calls to Teva seeking comment were not returned.
Princeton’s stake in Alimta is unclear; Cliatt told BTW that “as a matter of general policy, we don't disclose financial information related to individual patents.” In 2007, Lilly recorded approximately $854 million in sales of Alimta. According to a report earlier this month from Bloomberg, sales of the drug could top $1 billion if, as recent research has suggested, more of the drug can be used earlier at lower doses to stabilize tumors.