Laboratoires Servier v Canada (Health), 2015 FC 108

Patent drafters are required to provide adequate disclosure of an invention in patent applications to reduce the likelihood that the granted patent will be litigated and invalidated years down the road. This Federal Court (“FC”) decision dismissed an application for a prohibition order on the grounds of non-infringement and found the patent to be obvious and lacking in utility. Notably, the FC criticized the patent for its lack of adequate disclosure. Commenting on the bargain theory, the FC stated that “[w]here the law required a full, clear, and exact description of the nature of the invention and most importantly the manner in which it can be practised in order to benefit from the bargain, the patent as written says very little and it cannot satisfy the burden.” [225] In order to maintain the integrity of the patent system and maintain their end of the bargain, patents must provide sufficient disclosure.

The FC held that the generic’s allegations of non-infringement were justified, as its product did not contain a binder, which was an essential element of the patent. Furthermore, the in-vitro dissolution profile of the generic’s product was not identical to that in the patent. The FC conducted the obviousness analysis and concluded that the skilled worker would have been able to combine the mosaic of prior art into the claimed invention, as “[t]he step was not high” and “[t]he gap was not broad.” The FC then considered the inutility allegations, holding that as of the filing date, the patent must either disclose demonstrated utility or a basis for a sound prediction of utility.

Background

Servier Canada (“Servier”) sold 60 mg of modified release gliclazide tablets in Canada under the brand name DIAMICRON MR to treat diabetes. Servier brought an application under the Patented Medicines (Notice of Compliance) Regulations, to prohibit Apotex Inc. (“Apotex”) from being issued a Notice of Compliance for the generic version of DIAMICRON MR until after the expiration of Canadian Patent No. 2,629,670 (the “’670 patent”). At issue were the allegations of non-infringement, obviousness and lack of utility.

Gliclazide is a hypoglycemic agent that works to maintain sugar levels in the blood of diabetic patients by releasing insulin. The ‘670 patent claimed a new formulation that covered the 60 mg gliclazide modified release divisible tablet. [7] The claimed formulation would permit portions of the divisible tablet to have a similar or identical dissolution profile as the whole tablet. The tablet claimed in the ‘670 Patent had three components: gliclazide (the active pharmaceutical ingredient), a cellulose derivative, and a binder. [7]

Non-infringement: Apotex Product Contains no Binder

Apotex argued that two essential elements of its tablets were different from the ‘670 Patent and that it thus did not infringe it. Apotex argued that its tablets did not contain a binder, and that they would not show an identical dissolution profile to that of the ‘670 Patent. [9] Servier was unable to prove that Apotex’s product contained a binder. Apotex was successful in arguing that that the in vitro dissolution profiles of its subdivided and undivided tablets were not identical. The Apotex product therefore did not contain an essential element of the ‘670 Patent, which claimed an identical dissolution profile as between the whole table and fractions of it. [8, 139]

The ‘670 Patent is Obvious

The difference between the inventive concept of the ‘670 Patent and the prior art was determined to be a gliclazide tablet capable of being divided but maintaining the desired dissolution profile. [176] The FC found that it was plain and more or less self-evident for a person skilled in the art to attempt to obtain claimed invention. The difference between the inventive concept and the prior art did not require inventive ingenuity. The FC held that after a modified release, divisible gliclazide tablet was created, the precise formulation would have been obtained through routine experimentation and adjustment.

The ‘670 Patent Lacks Utility

The FC found that the ‘670 Patent promised “a divisible modified release gliclazide tablet where the whole and subdivided portions of the tablet will exhibit identical in vitro dissolution kinetics.” [208] Servier relied on two studies as evidence of demonstrated utility. However, the FC pointed out that these studies were not referenced in the specification of the patent. [213] The study that was included in the ‘670 Patent only tested a single tablet. The FC held that this was not sufficient for utility to be demonstrated and that the ‘670 Patent failed to demonstrate its utility because there was “no evidence whatsoever of utility.” [212] The Court then held that the patent was not soundly predicted. There was no sound and articulated line of reasoning in the ‘670 Patent “bridging the gap between the factual basis and the predicted utility (i.e., that all tablets falling within the claimed invention will exhibit the necessary dissolution profiles).” [224] Additionally, the FC stated that there was no proper disclosure in the ‘670 patent which was the main issue with the ‘670 Patent. The FC commented that the lack of disclosure left it “with the general impression that was played a game of hide-and-seek.” [225]

The Federal Court dismissed the application.