Supreme Court Preview: Will “Skinny Labels” Get a Weight Check?

by Dennis Crouch

The Supreme Court will soon be asked to weigh in on the the skinny-label debate -- particularly the question of how much a generic drug manufacturers can say about their products without inducing patent infringement? The case is Hikma v. Amarin.

It is very common for a drug to follow the following innovation-patent pathway:

  1. First the composition is discovered and patented along with a particular therapeutic use.
  2. Later a more effective treatment regimen is discovered and patented.

Once the first set of patents expire, generic manufactures should be permitted to begin marketing the drug -- except for uses still patented.  But, this gets tricky.  We know that there will be a very $trong incentive for insurance companies, doctors, and patients to use the cheaper generic drug for the still-patented treatment regime.  The question is whether the generic manufacture can be blamed for inducing this infringement.


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