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Lilly and Princeton File Third IP-Infringement Suit Against Generic Makers for Alimta Patent

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Eli Lilly and Princeton University are suing generic drugmaker Barr Laboratories in a federal court for allegedly infringing a US patent owned by Princeton and exclusively licensed to Lilly as the basis for its blockbuster lung cancer chemotherapeutic Alimta.

The suit is the third filed by co-plaintiffs Lilly and Princeton against generic drug makers looking to manufacture a knock-off of the drug prior to the patent's expiration in an effort to protect their interest in a compound that generated more than $1 billion in revenues last year.

For Princeton's part, the school is looking to protect its stake in Alimta, which recently helped finance a new chemistry building on campus, and last year may have been worth anywhere between $11 million and $103.5 million as a result of its royalty agreement with Lilly.

According to the most recent complaint, filed last week in the US District Court for the District of Delaware, Lilly and Princeton allege that Barr, which is incorporated in Delaware but headquartered in Montvale, NJ, has infringed 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 patent-in-suit covers compounds that serve as the basis for Alimta, a lung cancer chemotherapy agent approved by the US Food and Drug Administration in 2004 for treating advanced lung cancer and sold by Lilly.

Specifically, Alimta is indicated for treating patients with malignant pleural mesothelioma or locally advanced or metastatic nonsquamous non-small cell lung cancer, in combination with cisplatin; and patients with locally advanced or metastatic nonsquamous non-small cell lung cancer that have previously received chemotherapy.

Edward Taylor, professor of chemistry emeritus at Princeton, is the primary inventor on the Princeton-owned patent, for which Lilly has an irrevocable, exclusive worldwide license for the lives of the patents, according to Lilly SEC filings.

Until early last year, the patent was set to expire in 2011, 17 years from its 1994 issue. However, in April of last year the US Patent and Trademark Office granted Princeton and Lilly an extension of the patent essentially through 2015 due to the extraordinarily long time it took for Alimta to win FDA approval.

According to the complaint filed last week, Barr notified Lilly and Princeton in a letter dated March 19 of this year that it had submitted to the FDA an abbreviated new drug application for injectable pemetrexed disodium, a generic version of Alimta.

In the letter, Barr also notified the co-plaintiffs 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 Barr's manufacture, use, or sale of its generic product.

Anticipating that Barr's generic might be approved by the FDA, Lilly and Princeton are requesting judgment that Barr has infringed the '932 patent; that the effective date of any FDA approval of the generic not be earlier than the patent's expiration date; and that a preliminary and permanent injunction be enforced that would preclude Barr or other parties from manufacturing or selling such a generic before the patent's expiration date.

The nature of the complaint largely follows that of two other lawsuits Lilly and Princeton have filed against generic drugmakers in regards to the Alimta patent: in June the co-plaintiffs filed two separate related lawsuits against a US subsidiary of Israel's Teva Pharmaceuticals and Schaumburg, Ill.-based APP Pharmaceuticals (see BTW, 6-25-2008).

Both Teva and APP filed similar ANDAs with the FDA seeking approval of a generic version of Alimta and asserting that the '932 patent was invalid, unenforceable, and/or would not be infringed by the generic.

In July, Teva announced it would acquire Barr for approximately $7.5 billion, an acquisition that closed in December. It is unclear as to why Barr, now a subsidiary of Teva, filed a generic ANDA after the acquisition; why Lilly and Princeton filed a separate suit against Barr; or whether the Barr and Teva lawsuits will be consolidated.

A Teva spokesperson this week told BTW that it does not comment on ongoing litigation; and calls to both Lilly and the law firm of Richards, Layton & Finger, which is representing the co-plaintiffs in the case, were not returned in time for this publication.

According to Lilly regulatory filings, a trial is scheduled for Nov. 2010 against Teva and APP. No trial date has been set yet in the action against Barr.

It is clear that Lilly is seeking to protect the significant revenues it derives from sales of Alimta; and Princeton the royalties it receives from the drug through its licensing agreement with Lilly.

According to Lilly financial statements, in 2008 the company sold approximately $561.9 million worth of Alimta in the US and $592.8 million outside the US for total worldwide sales of $1.15 billion — approximately 5.6 percent of the company's total 2008 sales.

Also, according to SEC filings, Lilly's agreement with Princeton calls for it to pay the university "royalties of a single-digit percentage of net sales" of Alimta. On the low end, a 1 percent royalty would have netted Princeton $11.5 million last year; while on the high end, a 9 percent royalty rate would have yielded the school $103.5 million.

Whatever the royalty stream, a portion of it was used to finance a four-story, 263,000-square-foot building currently under construction on Princeton's campus and scheduled to be occupied in fall 2010. The total estimated cost of the project is unknown. A Princeton spokesperson told BTW that the cost of the project would only be released upon its completion and that as policy, the school does not provide cost estimates during interim phases of the project.

And Alimta's sales are climbing. The 2008 sales figures were a 35 percent increase over the $854 million Lilly netted for the therapeutic in 2007. In addition, Alimta sales rose 36 percent year over year to $335 million for the first quarter of 2009 from $247 million in Q1 2008, with US sales alone spiking 42 percent.

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