Intellipharmaceutics International Inc. (IPCI)

[numbersarefun]

Forfeiture of 180-day exclusivity is interpreted by FDA to determine if it is forfeited or not. FDA is not aggressive in taking away exclusivity.

So does any final court decision trigger the exclusivity, under (bb) events, both favorable and unfavorable, to the ANDA filer? Or does only a favorable final court decision that finds the patent invalid trigger the exclusivity?

Back in 2013, the US Court of Appeals for the Federal Circuit found the Seroquel XR patent valid and enforcable against Mylan, Torrent and a few others, which is "any other applicant" that can trigger a (bb) event. Torrent also settled in 2013 a few days before the decision.

Below is 1 of 6 forfeiture provisions. There needs to be both an (aa) event and an (bb) event. Under (aa) events, Handa failed to market within 30 months. There needs to be a (bb) event to complete the formula. Handa settled their patent suit with no final patent decision. So only "any other applicant" can trigger a (bb) event. Does Mylan's final court decision in 2013 count as a (bb) event? Torrent settled in 2013 a few days before the court decision. Does Torrent's settlement count as a (bb) event? Mylan got tentative approval after the court decision.

(D) Forfeiture of 180-day exclusivity period.—

(I)Failure to market.—The first applicant fails to market the drug by the later of—

(aa) the earlier of the date that is—

(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or

(BB) 30 months after the date of submission of the application of the first applicant; or

(bb) with respect to the first applicant or any other applicant (which other applicant has received tentative approval), the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a certification qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at least 1 of the following has occurred:

(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.

(BB) In an infringement action or a declaratory judgment action described in subitem (AA), a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed.

(CC) The patent information submitted under subsection (b) or (c) is withdrawn by the holder of the application approved under subsection (b).