Replies to post #157556 on Biotech Values

[biomaven0]

The following from the brief seems to me to be MNTA's strongest argument by a long way:

The word “solely” in the statute makes clear that
even if the patented invention is used for a purpose
reasonably related to the development and submission
of information to the FDA, other uses of the
invention are not protected under the safe harbor.
For example, a drug manufacturer may use a patented
invention both to sell a drug commercially and to
conduct a post-approval clinical trial. The clinical
trial is protected under the plain terms of the safe
harbor. But use of the patented invention for commercial
manufacturing and sale of the drug is not
exempted from infringement liability because such
use is not reasonably related to the development and
submission of information to the FDA.

Here, Amphastar’s “infringing activity is not
solely for developing and submitting information to
the FDA. Instead, Amphastar uses this method for
the purpose of manufacturing a product to sell on the
market in commerce

It boggles my mind that the court below dismissed this argument.

Peter

[DewDiligence]

Law360 blog writes about MNTA v. Amphastar (registration required):

http://www.law360.com/ip/articles/420121/momenta-sandoz-ask-justices-to-clarify-safe-harbor-rule