Federal Court Prohibited Issuance of a NOC for Generic Version of Lumigan

Federal Court Prohibited Issuance of a NOC for Generic Version of Lumigan

Allergan Inc v Apotex Inc, 2014 FC 567

Allergan sought an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Apotex to market a generic version of Allergan’s Lumigan covered under Canadian Patent No 2,585,691 (the ‘691 patent). [1] Apotex, in turn, claimed that the ‘691 patent was invalid on the grounds of obviousness, lack of utility, and anticipation. [2]

The Court granted the prohibition order, and rejected Apotex’s allegations of patent invalidity. [3]

“The ‘691 patent relates to a formulation for eye drops primarily for use in treating glaucoma. The formulation contains a single active ingredient…[bimatoprost (Bp)] in a concentration of between 0.005% and 0.02%. The other main ingredient is…[benzalkonium chloride (BAK)] at concentrations from 100 to 200 ppm.” [8]

“Allergan previously owned a patent for formulations of ocular products [henceforth “old Lumigan”] with the same purpose as, and similar ingredients to, new Lumigan (Canadian Patent No 2,144,967 – the ‘967 patent). The ‘967 patent, which expired in 2013, covered a wide range of concentrations of active ingredients and preservatives and included within that range a product containing 0.03% bimatoprost (Bp) and 50 parts per million (ppm) benzalkonium chloride (BAK), as the preservative.” [5]

The claims of the ‘691 patent at issue were:

16. A composition comprising by weight 0.01 % bimatoprost, 0.02% benzalkonium chloride, 0.268% sodium phosphate dibasic heptahydrate, 0.014% citric acid monohydrate, 0.81% sodium chloride, water, and wherein said composition is an aqueous liquid with a pH adjusted to 7.3.

19. Use of a composition according to any one of claims 1 to 16 for treating glaucoma or intraocular hypertension in a mammal.

The Court found the construction of these claims to be clear: “[c]laim 16 relates to a product with lower Bp (.01%) and higher BAK (200 ppm) than old Lumigan (which had .03% and 50 ppm, respectively). Claim 19 relates to the use of that product for treating glaucoma in humans.” [13]

Addressing the issue of obviousness, the Court applied the Sanofi test. [14] In identifying the inventive concept, Allergan argued that the inventive concept was different for purposes of obviousness and utility/promise, whereas Apotex argued that “the patent should be given only one interpretation for all purposes.” [21-23] The Court stated that “the interpretation of the patent should be as consistent as possible across the various issues in play” [24], but went on to say that “[h]owever, that does not mean that construction of the claims necessarily determines the inventive concept for purposes of the obviousness analysis…Identifying the inventive concept is a separate exercise forming part of the analysis of whether the patent claims something that is truly inventive, and therefore not obvious. Where the patent relates to a bare chemical formula, the court must refer to the claim and the specification to determine what the claim’s inventive concept is.” [25]

The Court went on to hold that “the inventive concept…[is] a formulation with a fairly low concentration of Bp (.01%) that has a comparable effect in lowering…[interaocular pressure] to old Lumigan (at .03%), due to the penetration enhancing effect of 200 ppm BAK”, and that “[n]othing in the state of the art suggested such a possibility.” [31]

The Court found that “there are significant differences between the inventive concept of the claims in issue and the state of the art at the relevant time. Those differences would not have been obvious to the skilled person” [34], and duly rejected Apotex’s allegation of obviousness. [36]

Next, the Court addressed the issue of sound prediction. The Court determined that “the stated utility of the claims in issue is that new Lumigan would have a comparable effect to old Lumigan, with less Bp (and, therefore, fewer side effects).” [37] The Court held that the stated utility was soundly predicted upon finding that “[t]he factual basis consists of the data described…[in the patent, and that] The sound line of reasoning is implicit in the data itself and would be apparent to the skilled reader; it did not have to be explicitly laid out.” [40], [45] The Court went on you reject Apotex’s allegation of inutility. [45]

Finally, on the issue of anticipation of the ‘691 patent by the ‘967 patent, the Court assumed that Apotex’s position was correct that the ‘691 patent is a selection patent of the ‘967 patent. [48] The Court relied on Sanofi and arrived at the conclusion that since ‘967 failed to disclose the “special advantage[s]” of the ‘691 patent, the ‘967 did not anticipate the ‘691 patent. [46-49]


In terms of claim construction, this case shows (again) the tension between construing claims based solely on the wording of the claims versus peering beyond the wording of the claims to distill an underlying invention.  Free World (2000 SCC 66) seemed to clearly eschew the latter, yet present day obviousness analyses seem to require it. This case attempts to resolve the tension, though even so, this approach to interpretation of claims is difficult without legal counsel and can raise the need for litigation to resolve differing viewpoints of those counsel.