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jbog

09/08/17 2:01 PM

#213507 RE: DewDiligence #213505

Allergan's blatant ploy to skirt the rules will come back to hurt pharma, and rightfully so.

biomaven0

09/09/17 1:52 PM

#213521 RE: DewDiligence #213505

>>If this eventually reaches adjudication by the CAFC, I predict that AGN's ploy will fail.

I wonder if this ploy will succeed at all - courts in equity are happy to look beyond the form of a deal and look to substance. AGN still responsible for defending patents and still the overwhelming beneficiary of them, so you could argue they are the real owner.

But I grant it will have a delaying effect

DewDiligence

10/12/17 6:54 PM

#214249 RE: DewDiligence #213505

AGN,PFE settle Restasis-patent litigation—allowing 2024 US launch of generic Restasis by PFE:

http://www.prnewswire.com/news-releases/allergan-announces-settlement-on-restasis-cyclosporine-ophthalmic-emulsion-005-patent-litigation-with-innopharma-inc-300536066.html

Pursuant to the terms of the settlement, Allergan will grant InnoPharma licenses to market a generic version of RESTASIS in the United States beginning on February 24, 2024, or earlier under certain circumstances.

Additionally, under certain circumstances, Allergan will supply and authorize InnoPharma to launch an authorized generic version of RESTASIS on August 28, 2024. Additional details regarding the settlement were not disclosed.

InnoPharma is a unit of PFE, the result of a 2014 acquisition (#msg-104352638).

Three companies other than PFE who have filed paragraph-IV challenges on Restasis—TEVA, MYL, and AKRX—have not (yet) settled with AGN.

The provision in the PR above regarding the launch of an authorized generic is presumably triggered if a company other than PFE launches its own generic Restasis.

Restasis is AGN’s second-largest product (after Botox).