- Sanofi on Monday said it had filed a lawsuit against Merck & Co. for alleged patent infringements of its blockbuster insulin Lantus (insulin glargine). Merck fired back, saying it is confident its biosimilar diabetes drug, MK-1293, does not “infringe any valid claim” of the Lantus patent.
- The French pharma filed the suit in the U.S. District Court of Delaware. Sanofi said that Merck Sharp & Dohme Corp., a subsidiary of NJ-based Merck, violated as many as 10 patents held by Sanofi, including one for Lantus and its insulin delivery device soloSTAR
- Legal actions were taken after Merck announced earlier this summer that it had filed an application for approval of MK-1293 with the U.S. Food and Drug Administration.
While the diabetes treatment business has long been a staple for Sanofi, its once high-standing position is teetering — the result of lower cost competitors and generic drugs and fussier consumers, especially in the U.S. market. The company expects revenue from diabetes drugs to decline over the coming years in the face of more competition among insulin makers.
Last month, Sanofi’s second-quarter report showed that revenue fell on weaker diabetes drug sales, noting that its net income slipped 11.1% year-over-year to $1.3 billion. Sales of diabetes medicine dropped 6.6% to $2.1 billion. Sales of Lantus, in particular, plunged 14.3% versus a year ago, $1.7 billion, in light of generic competition.
In a further blow, the Food and Drug Administration recently pushed back by three months the deadline for its review of Sanofi’s type II diabetes injection drug iGlarLixi, a fixed ratio combination of Adlyxin (lixisenatide) and Lantus to November.
Even as Sanofi is losing ground in the market for diabetes drugs, it has found one place where it could potentially stall downward turns: the courthouse.
Late last year, Sanofi reached an agreement with Eli Lilly & Co. after filing a lawsuit charging patent infringement for its diabetes biosimilar. The action ostensibly forced Lilly to agree to delay launch of Basaglar to this December, and pay royalties to Sanofi.
And now Sanofi is targeting Merck. Sanofi’s lawsuit against Merck followed Merck’s notification earlier this month that it had filed a New Drug Application (NDA)with FDA for an insulin glargine drug product.
Merck’s NDA included a paragraph IV certification challenging all of the 10 Sanofi patents listed in the FDA Orange Book for Lantus and Lantus SoloStar products.
Merck’s drug is MK-1293, an investigational follow-up biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes. Merck acknowledged the NDA was filed through the 505 (b) (2) regulatory pathway, which allows the FDA to reference previous findings of safety and efficacy for the already approved Lantus.
While Sanofi declined to elaborate on its lawsuit, a Merck spokeswoman had more to say when asked by Biopharma Dive about the legal action.
"We are confident that the NDA for our investigational insulin glargine product, MK-1293, does not infringe any valid claim of the asserted patents for the originator insulin glargine, Lantus," said Merck spokeswoman Lainie Keller.
"The recent FDA acceptance of the NDA for our follow-on biologic, MK-1293, is an important milestone, and brings us closer to offering another treatment option for people in the U.S. with diabetes," she said.