Court Dismisses Alcon’s prohibition application against generic TRAVATAN-Z

On August 11, 2014, Justice Kane dismissed Alcon’s prohibition application against Apotex in respect of Apotex’s version of the Alcon’s TRAVATAN-Z and  Alcon’s Canadian Patent No. 2,606, 370.

The 370 patent generally relates to formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system, to permit multi-use application and avoid microbial contamination. Justice Kane construed the claims at issue as follows:

• Claim 13 is an independent claim directed to topical ophthalmic solutions containing travoprost. The solutions also contain a preservative system that includes boric acid, propylene glycol, sorbitol and zinc chloride at concentrations from 0.04 to 0.4 mM. These solutions are free of BAK or other antimicrobial preservatives. The solutions have limited concentrations of anionic species, that is, concentrations of less than 15 mM, and have osmolality values between 250 and 330 mOsm/kg. The solutions also contain polyoxyl 40 hydrogenated castor oil
• Claim 10 is a dependent claim which depends on cascading dependencies among Claims 1 to 9.  Claim 10 claims a multi-dose, self-preserved ophthalmic composition containing travoprost and a preservative system that includes zinc chloride, propylene glycol and sorbitol, and limited concentrations of anionic species, multivalent buffering anions, multivalent metal ions and ionized salts.

Obviousness – Inventive Concept

Alcon argued that each aspect of the formulation set out in the claims is a separate inventive concept and also that the resolution of the particulate problem is an inventive concept.  Apotex submitted that the inventive concept was more general and did not include “bells and whistles” such as limits on the anionic species. Justice Kane rejected both Alcon’s and Apotex’s position on the inventive concept holding that the inventive concept of both asserted claims to have the following essential elements: a self-preserved, multi-dose ophthalmic composition or formulation containing travoprost that uses a non-conventional preservative system that did not include benzalkonium chloride (BAK)

Based on the evidence that one of Alcon’s own prior art products, SYSTANE FREE, used a similar non-conventional preservation system, Justice Kane found that it was more or less self evident that the invention would work.  In addition, all the experts agreed that there was a motivation in the prior art to remove BAK from ophthalmic solutions. Therefore, Justice Kane ruled that it would have been obvious to extend the same preservation system to travoprost, given the motivation to avoid using BAK.

Utility

The issue of utility turned solely on the construction of the promise of the patent. Alcon argued that the utility was simply to be useful and to meet the USP preservative efficacy testing standards or to provide an alternative choice, and that this utility was soundly predicted.  Apotex, on the other hand, asserted two promised utilities: (i) the minimization or reduction of side-effects; and (ii) an acceptable formulation, without particulate matter. Justice Kane held that the second promised utility was outside the scope of Apotex’s NOA and therefore did not consider it.

Justice Kane held that the promised utility is to provided a self preserved ophthalmic formulation without BAK that passes the USP preservative efficacy testing and provides another choice for ophthalmic formulations. In coming to its ruling, the Court relied on: (a) the Federal Court of Appeal’s ruling in Apotex v. Sanofi-Aventis for the proposition that promised utility must be explicit, and that “not every statement of advantage in the specification rises to the level of promised utility”; and (b) Justice Zinn’s finding in Fournier Pharma that the focus should be on the claims. Since there was no promise of reduced side effects in the claims at issue, Justice Kane held in favour of Alcon’s interpretation of the promise. As Apotex’s submissions were directed solely towards an incorrect formulation of the promised utility, Justice Kane held that Apotex’s allegation of inutility was not justified.

A copy of Justice Kane’s Reasons for Judgment may be found here.