May 30, 2019
On May 8, 2019, in Les Laboratoires Servier v. Apotex Inc., 2019 FC 616, the Federal Court dismissed Les Laboratoires Servier and Servier Canada Inc.’s (“Servier”) application for an order of prohibition pursuant to the Patented Medicines (Notice of Compliance) Regulations (the “NOC Regulations”). Apotex Inc. (“Apotex”) was seeking a Notice of Compliance for its Apo-perindopril/amlodipine tablets.
Servier markets a pharmaceutical product known as VIACORAM®. The active ingredient in VIACORAM® is perindopril, which is an angiotensin-converting enzyme (ACE) inhibitor. Perindopril is used for the treatment of hypertension and heart failure.
Servier is the owner of Canadian Letters Patent No. 2,423,825 (the “825 Patent”). The patent is in respect of a “new perindopril salt and pharmaceutical compounds containing it”. The 825 Patent is not concerned with perindopril per se, but rather with a new salt.
Alleged Grounds of Invalidity
Apotex sought to challenge the validity of the 825 Patent. In its Notice of Allegation, among other grounds, Apotex alleged that the 825 Patent was invalid on the bases of obviousness, overbreadth, insufficiency and inutility.
After a thorough analysis, the Court concluded that Apotex’s allegation of obviousness was justified.
The Court specifically noted that the “blinded” expert evidence tendered by Apotex added to the weight of the evidence and was “impressive”. Apotex’s expert witness offered his opinion that a skilled person would have arrived at the solution taught by the patent “completely blind to the issues of the case” and thus unbiased by hindsight knowledge of that solution.
While the Court conceded that not every new salt form of a known active pharmaceutical ingredient will necessarily be obvious, in this case, given the prior art and common general knowledge, routine experiments would have generated the invention.
The Court found that the claims of the 825 Patent were overbroad — in other words, the patent claimed more than had been invented. Apotex referenced two aspects of the 825 Patent, which it alleged supported a finding that the claims of the 825 Patent were overbroad:
Servier claimed the arginine salt of perindopril, which includes the D-arginine and racemate arginine salts of perindopril; and
Servier claimed the hydrates of perindopril arginine.
In both cases, Apotex argued that there was no evidence that Servier made the D-arginine or the racemate arginine salts of perindopril or that Servier made a hydrate of perindopril arginine. The Court concluded that these were clear examples of “overclaiming”, thereby rendering the claims invalid.
Apotex also alleged that the disclosure of the 825 Patent was insufficient as it did not teach how to make perindopril arginine. The Court noted that the disclosure requirement stems from the bargain at the heart of our patent system: in exchange for a valuable monopoly, the inventor discloses the invention. For this bargain to have meaning, a pre-requisite is that the disclosure must be adequate.
After considering the evidence, the Court concluded that the disclosure in the 825 Patent was sufficient because the person of skill in the art would know how to make perindopril arginine without undue effort.
The Court concluded that all of the claims of the 825 Patent were useful, as the new salt exhibited greater stability to heat and humidity than the pharmaceutical product already marketed by Servier containing perindopril erbumine.