Biotech Values

[palindromy]

Re: Norvasc exclusivity

More relevant part I should have put in -

The proposed rule containing § 314.107(c)(1), published in the Federal Register of July 10, 1989
(54 FR 28872, 28929), proposed the requirement that the first ANDA applicant submitting a
paragraph IV certification be sued for patent infringement to obtain the 180-day exclusivity. This
interpretation was believed to be most consistent with the language of the Hatch-Waxman
Amendments and furthered the congressional intent to encourage challenges to patents that may
be invalid or unenforceable (54 FR 28872 at 28894). In response to a comment on the proposed
rule, FDA added a requirement to the final rule that the first ANDA applicant submitting a
paragraph IV certification successfully defend a patent infringement suit to be entitled 180-day
exclusivity. The "successful defense" requirement was established to eliminate "an incentive for
frivolous claims of patent invalidity or noninfringement because it would give ANDA applicants
exclusivity even if the applicant was unsuccessful in defending against the patent owner's lawsuit"
(59 FR 50338 at 50353).