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Rival's lawsuit could delay launch of new Lilly insulin

January 31, 2014

Eli Lilly and Co. may have to wait an extra year or more to launch a once-a-day insulin for diabetics after a rival drugmaker said Lilly’s plans violate the patents it holds on the drug Lantus.

Paris-based Sanofi sued Lilly on Thursday in federal court in Delaware. That suit triggers an automatic 30-month delay on Lilly’s plans to launch a similar version of Lantus—unless Lilly can win in court before that time.

Indianapolis-based Lilly had planned to launch its generic-like version of Lantus—which is known as insulin glargine—next year after Lantus’ patents expire on Feb. 12, 2015.

Sanofi, in a statement, said it decided to sue after a Lilly regulatory filing in December challenged the validity of six of the seven patents Sanofi holds on Lantus.

Lantus currently generates $7 billion a year in sales, making it one of the best-selling drugs in the world. Lilly’s failure to launch a similar drug—even 14 years after Lantus hit the market—has been a financial hindrance and an embarrassment to Lilly, which pioneered the first insulin in the 1920s.

Lilly sells insulins that must be taken multiple times per day, but diabetic patients prefer to limit the number of injections they must take, giving the once-a-day Lantus an edge. Lilly rival Novo Nordisk A/S launched its once-a-day insulin, called Levemir, in 2005.

Lilly filed for market approval of its insulin glargine from the U.S. Food and Drug Administration using a regulatory pathway that allows it to refer to the safety and efficacy studies conducted for Lantus, as well as submitting some of its own clinical trial data of its drug. Lilly’s insulin glargine would be a “biosimilar” version of Lantus.

"Lilly respects the intellectual property of others and does not believe the application for approval of its new insulin glargine product infringes any valid claim of the asserted patents," said Doug Norman, Lilly’s general patent counsel, in a prepared statement.

According to a report by Reuters, a research analyst recently said that a 30-month delay would raise Sanofi's earnings per share from 2015 through 2020 by about 6 percent and lower Lilly's earnings per share for the period by about 2 percent.

A delay in the launch of a cheaper, generic-like version of Lantus would also give Sanofi more time, Reuters noted, to switch patients to a new and yet-to-be-approved long-acting drug known as U300.

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