NEWS

Sanofi's patent infringement lawsuit in the United States is aimed at Mercadon.

Release time:

2017-09-01 13:41

French pharmaceutical giant Sanofi (Sanofi) said recently that it has filed a patent infringement lawsuit with the United States District Court of New Jersey, accusing Merck & Co (Merck & Co) of infringing its insulin product Lantus (Lantus, generic name: insulin glargine, insulin glargine) 2 patents.

The lawsuit was initially triggered by a notice from Mercadon in June this year. Mercadon claimed that it had submitted a new drug application (NDA) for insulin glargine vial products to the U.S. Food and Drug Administration (FDA), and claimed that its NDA included a category IV declaration (paragraph IV certification), which challenged all patents of Sanofi Lantus and Lantus SoloStar products in FDA's orange peel book.

MSD's insulin glargine was jointly developed with Samsung Bioepis. The two sides submitted the NDA of insulin glargine injection (100U/mL) pre-filled injection pen (brand name: Lusduna Nexvue) to FDA in August last year, and obtained temporary approval from FDA in July this year (tentative approval).

In September last year, Sanofi filed a patent infringement lawsuit against Merck, accusing its products of infringing 10 Sanofi patents, including one related to Lantus and insulin injection device soloSTAR. According to the Hatch-Waxman Act, the FDA cannot make a decision to fully approve the Lusduna of Nexvue within 30 months after the original drug developer filed a patent lawsuit, so Merck's Lusduna Nexvue cannot be sold yet. If it goes on the market, it is foreseeable that the product will grab Sanofi Lantus's market share.

Lantus is currently the world's best-selling basal insulin product with annual peak sales of more than $7 billion. With the listing of other new hypoglycemic drugs and the expiration of patents, Lantus's sales began to decline from 2016, but it still recorded sales of US $6.6 billion in that year, making it Sanofi's 6th star product last year.

In fact, long before Mercadon, a generic insulin glargine drug had been approved by FDA. The generic drug came from Boehringer Ingelheim/Lilly Diabetes Alliance. Its product brand name was Basaglar and was temporarily approved by FDA in August 2014. However, Sanofi's lawsuit delayed the launch of the product by 30 months. Until October 2015, the two sides reached a settlement, basaglar was agreed to be listed in the United States by the end of 2016, and as part of the settlement Lilly has agreed to pay royalties to Sanofi.

From this point of view, if Merck's insulin glargine wants to be successfully listed in the United States, it is likely to follow the same path as Boehringer Ingelheim/Lilly.