Friday, June 24, 2022

Power-Alley: Hatch-Waxman -- Merck Has Agreed, In A Cost Saving Move, Along With The Generics, That "Deep" Discovery (Millions Of Pages Worth) Isn't Needed.


We have followed this case since April. What's new is that Merck is likely going to agree to forego the vastly expensive "what we ate for breakfast in third grade" type of email discovery, in this case. So too are the generics. This is a nice practice point: not every issue need be fought to the "Scorched Earth" end.

While Merck has significantly more to spend on such maneuvers than Zenara or Aurobindo. . . it all boils down to one question, under Hatch-Waxman (one Merck cannot change much, and one that affects Merck essentially equally, no matter which of the generics wins): Which generic will get the 180 day exclusivity incentive, when the dust settles. That is, Merck will see a generic version on market -- but one of these companies will be the exclusive generic cleared in the US for a half year. . . then all the others will be let in. Either way, Merck's margins on its ertugliflozin (branded as Steglatro®). . . will go south rapidly. Here's that bit, from an agreed letter in the federal district court in Delaware, overnight:

. . .Checklist items were as follows: (1) whether the parties could agree to forgo email collection, which is still being considered; (2) whether the parties could agree to reduce certain discovery limits, which was agreed to and is reflected in the parties’ Proposed Scheduling Order; and (3) whether the cases should be consolidated, which was agreed to and is reflected in the parties’ Proposed Scheduling Order. . . .


Now you know -- all of this turned up, overnight and into this morning.

So, onward the world turns. . . and state by state, THERE WILL BE safe legal abortions, usually within a day's drive from the Luddites now ruling in Missouri, Louisiana, Oklahoma, Texas, Florida and Mississippi. So it goes. Illinois and New York and Colorado, Oregon and California (among dozens of others) will remain. . . respectful of a woman's autonomy over her own body and reproductive choices. Out.

नमस्ते

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