Vortioxetine - USA

Claim Construction (District of Delaware): July 16, 2019

Plaintiffs (Lundbeck) brought this suit against Defendants^* asserting infringement of U.S. Patent Nos. 8,772684 (the '"684 patent"), 8,969,355 (the '"355 patent"), 9,227,946 (the '"946 patent"), and 9,861,630 (the "'630 patent") (the "Crystalline Form Patents"), among others. The Court held a claim construction hearing on May 29, 2019, at which both sides presented oral argument.

Construction of Disputed Terms:

A. "characterized by an XRPD [pattern] as shown in [any of] FIG[S] ...

Plaintiffs: No construction necessary. Alternatively, "identifiable by reference to an x-ray powder diffraction pattern as shown in any of FIG[S] ...

Defendants: "having an XRPD pattern with all the peaks and corresponding relative intensities shown in the recited Figure[ s ]". Alternatively, the claim is indefinite

Court: "identifiable by reference to an x-ray powder diffraction pattern as shown in [any of] FIG[S] ... "

B. "1-[2 [ (2,4-dimethylphenylsulfanyl)-phenyl]piperazine hydro bromide salt [alpha form, beta form, gamma form]"

Plaintiffs: a crystalline form of vortioxetine hydro bromide, referred to in the patent specification as r"alpha" /"beta" / "gamma"l, that can be distinguished from other forms ...

Defendants: vortioxetine hydrobromide salt crystalline form described in the specification as the [alpha / beta / gamma] form and having all characteristics assigned to the [ alpha / beta / gamma] form in the specification

Court: vortioxetine hydrobromide salt crystalline form described in the specification as the [alpha / beta / gamma] form and being identifiable by reference to the [ alpha / beta / gamma] form in the specification

C. "mixtures thereof”

Plaintiffs: No construction necessary. Alternatively, "mixtures including vortioxetine hydrobromide salt alpha form, vortioxetine hydrobromide salt beta form, vortioxetine hydrobromide salt gamma form, vortioxetine hvdrobromide salt hemihydrate, and vortioxetine hydrobromide salt ethyl acetate solvate".

Defendants: "mixtures of only the foregoing listed forms"  

Court: "mixtures of only the foregoing listed forms"

D. "alleviates/ alleviating"

Plaintiffs: No construction necessary. Alternatively, "mitigates/ mitigating"

Defendants: Indefinite

Court: "mitigates / mitigating"

*The following defendants join in the proposed constructions of all disputed terms: Alembic, Alkem, Apicore, Apotex, Macleods, MSN, Sigmapharrn, Torrent, and Unichem.

The following two defendants join in all proposed constructions, but do not join the argument that the term "alleviates/alleviating" is indefinite: Cipla and Sandoz.

The following four defendants do not join in any of the proposed constructions: Hetero, Lupin, Prinston, and Zydus.