Federal Court Dismisses Servier’s Application To Prohibit NOC For Apotex Gliclazide Modified Release Tablets

On February 16, 2015, Roy J of the Federal Court released his public Judgment and Reasons dismissing an application brought by Les Laboratoires Servier and Servier Canada Inc (together, Servier) under thePatented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations or Regulations) for an Order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex Inc (Apotex) for a generic version of Servier’s DIAMICRON® MR (60 mg gliclazide modified release tablet) until the expiry of Canadian Patent No 2,629,670 (the 670 Patent) (Les Laboratoires Servier v Apotex Inc, 2015 FC 108).

The 670 Patent relates to a breakable or divisible modified release gliclazide tablet. Gliclazide is a hypoglycemic agent that helps to maintain sugar levels in the blood of diabetic patients by causing the release of insulin. According to the 670 Patent, the claimed formulation allows portions of the divisible tablet to have a similar or identical dissolution profile as the whole tablet. The claimed tablet formulation has three components: gliclazide, a cellulose derivative, and a binder.

Apotex alleged non-infringement and invalidity on the grounds of obviousness and inutility (no demonstrated utility and lack of sound prediction).

Non-infringement

Apotex raised two grounds of non-infringement: (i) the dissolution profile of its tablet’s divisions is not identical to that of the whole tablet; and (ii) its tablet does not use a binder.

Roy J accepted Apotex’s claim construction that ‘dissolution profile’ meant in vitro dissolution kinetics, since the 670 Patent’s own definition for the term “identical dissolution profile” referred only to in vitro measurements. As a result, he found that Apotex’s allegation of non-infringement on this ground was justified.

Roy J rejected Servier’s construction that the excipient HPMC could be both the cellulose derivative and the binder, noting that nothing in the patent specification taught that the cellulose derivative and the binder could be one and the same. Consequently, he also found that Apotex’s non-infringement allegation by reason of the absence of a binder was justified.

Obviousness

Roy J found that the difference between the prior art and the inventive concept was a gliclazide tablet capable of being divided but maintaining the desired dissolution profile. He concluded that it was plain and more or less self-evident for the skilled person to try to obtain that invention. Roy J reasoned that once the decision was made to have a modified release, divisible gliclazide tablet, obtaining the precise formulation would have only been a matter of routine experimentation and adjustment.

Inutility

Roy J determined that the 670 Patent promised a divisible, modified release gliclazide tablet where the whole and subdivided portions of the tablet would exhibit identical in vitro dissolution kinetics. If the patent claims this utility on the basis of a result actually achieved as of the Canadian filing date, then in Roy J’s view, this required the patent disclosure to make reference to a study demonstrating that the patent does what it promises.

Roy J found that the 670 Patent disclosed results of an in vitro dissolution test on a single formulation, but none of the asserted claims were limited to that specific formulation. Accordingly, this example was insufficient to demonstrate or soundly predict the promised utility across the entire spectrum of the claimed invention. Roy J also found that Servier could not rely on bioequivalence studies they performed prior to the Canadian filing date since these were not referred to or alluded to in the 670 Patent.