Monday, September 19, 2016

After Striking A "Pay For Delay" Deal With Lilly -- On Lantus® -- Sanofi Now Sues Merck For Infringement: MK-1293

Since early 2014, we'd been watching, and waiting very patiently -- as Merck's MK-1293 candidate was added to the Samsung Bioepis JV mix, and the pair took aim at Sanofi's space in diabetes. Since then, however, Sanofi had sued Lilly for patent infringement, and then settled in early 2016 -- effectively creating a "pay for delay" deal, on a biosimilar version of its insulin glargine construct until at least Christmas 2016, with Lilly, in cahoots.

In August, Merck filed at the US FDA -- on MK-1293 -- its Samsung-partnered biosim version, which might otherwise allow for an as early as Q1 2017 launch date.

So, this morning, it is no surprise to learn that Sanofi has now sued Merck in the federal courts in Delaware, claiming MK-1293 infringes several of Sanofi's Lantus® patents, as well. Thus the Sanofi suit. [This whole convoluted dance is exactly what was contemplated by the Hatch-Waxman amendments to the patent process. Except that US House Reps. Hatch (R) and Waxman (D) did not expect that branded manufacturers would pay to keep biosimilars off market. Oh well -- that's unbridled capitalism at work. Enough editorializing, right? Right.]

Here's a bit -- from The Wall Street Journal, this morning:

. . . .The French drugmaker’s all-important diabetes business is under siege, as a flurry of pharmaceutical companies seek to sell knockoffs of its blockbuster insulin Lantus in the U.S. The expected launch of lower-cost copies of Lantus and growing pricing pressure on diabetes drugs in the U.S. is rapidly eroding earnings at Sanofi’s diabetes division, which accounts for about 20% of the firm’s total revenue. . . .

In January 2014, Sanofi filed a suit against Eli Lilly & Co. to defend its patents on Lantus. It had reached a deal with the U.S. drugmaker nearly two years later, under which Lilly agreed to delay the launch of its insulin to December 2016 and pay royalties to Sanofi. . . .

With the election cycle in full swing, expect to hear only crickets about how some large multinational life-science companies effectively game the system, to keep cheaper generics (and biosimilars, in this case) off-market for years at a time.

Now you know. Onward -- on a sunny Chicago morning.


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