Sanofi announced that it filed a patent lawsuit against Merck on September 16, 2016 for infringement on 10 Lantus (insulin glargine) patents. The announcement shared that the suit was triggered by Merck’s submission of an FDA New Drug Application (NDA) in early August for its biosimilar insulin glargine MK-1293 (to add to the drama – this submission was announced during the Novo Nordisk 2Q16 conference call just as the company was noting the entrance of Lilly into the basal market). Within the NDA, Merck challenged all 10 of Sanofi’s patents for Lantus and Lantus SoloStar. Sanofi previously settled a patent lawsuit with Lilly/BI for their biosimilar insulin glargine product Basaglar – under the terms of the agreement, Basaglar’s launch is delayed until December 15, 2016 and Lilly will pay undisclosed royalties to Sanofi in exchange for the license to disputed patents. We’re curious if Merck will come to a similar settlement with Sanofi or if the two companies will duke it out in the courts – we can’t imagine that would be very productive. At the time, Sanofi’s lawsuit against Lilly triggered an automatic 30-month hold on FDA approval for the Lilly candidate – it’s unclear if the same hold applies here but such a move would delay the expected approval and launch of MK-1293 from mid-2017 to late 2018. The lawsuit and such a delay would be a major blow to Merck (which has been positioning its expanded diabetes portfolio as offering an array of products to address patients’ needs at every stage of the disease) and a big win for Sanofi (and to some extent Lilly). We assume Biocon/Mylan may face a similar lawsuit for their upcoming submission of their own biosimilar insulin glargine formulation. Lantus remains Sanofi’s single largest revenue stream, despite declining sales, offset by increasing sales of next-gen Toujeo. There is a huge number of people globally who would benefit from being on basal insulin – we hope more of them get access and that they are educated to use the insulin correctly and optimally. The number of people with diabetes (particularly type 2) grows massively each year and we think there is more than enough room for multiple successful basal insulin manufactures.
-- by Helen Gao and Kelly Close