Eli Lilly wins patent case against Teva in Federal Circuit

The US Court of Appeals for the Federal Circuit has affirmed a ruling by a district court giving a win to Eli Lilly in a patent case against Teva.

The case, decided yesterday, January 12, was an appeal by Teva, which lost in the US District Court for the Southern District of Indiana.

Other companies which were also sued and appealed are App Pharmaceuticals, Pliva Hrvatska, and Barr Laboratories.

Eli Lilly previously filed suit against the companies to prevent them from launching a generic version of a chemotherapy drug, Alimta (pemetrexed), claiming that the companies would infringe claims of US patent number 7,772,209.

The ‘209 patent, issued in 2010, relates to methods of administering the chemotherapy drug after pre-treatment with two common vitamins—folic acid and vitamin B12.

Following the suit, the district court found that the patent was infringed and valid.

The case arose back in 2008 when the generic companies notified Eli Lilly that they had submitted Abbreviated New Drug Applications (ANDAs) seeking approval from the Food and Drug Administration to market generic versions of Alimta.

After the ‘209 patent was issued, the companies sent Eli Lilly additional notices regarding their ANDAs, and claimed that the patent was invalid and unenforceable.

Eli Lilly alleged that the patent would be infringed because of the way the generic drugs would be administered to the patient with folic acid and vitamin B12 pre- treatments.

Two bench trials were held by the district court, one on infringement and one on validity.

The Federal Circuit stated in the ruling: “We agree with Eli Lilly that defendants’ arguments fail to raise reversible error with respect to at least the findings that a skilled artisan would not have been motivated to use vitamin B12 pretreatment with pemetrexed, let alone the appropriate doses and schedules of such vitamin B12 pretreatment.”

It added: “We are therefore not convinced that the district court committed clear error in concluding that defendants failed to carry their burden of proving that it would have been obvious to a person of ordinary skill to use vitamin B12 pretreatment to reduce pemetrexed toxicities.”

A spokesperson for Teva said that the company is disappointed with the court's decision.