Leo Pharma Inc v Teva Canada Limited, 2015 FC 1237

The Federal Court (“FC”) heard an application by Leo Pharma Inc. (“Leo”) to prohibit Teva Canada Inc. (“Teva”) from being issued a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations. [1] The application was in relation to Leo’s patent, Canadian Patent No. 2,370,565 (“the ‘565 Patent”), [1] an ointment used in the treatment of psoriasis. [2] Teva alleged that the ‘565 Patent was invalid for obviousness, lack of utility and insufficiency, and would not be infringed by its own generic ointment. [4]

The FC found that Teva’s allegations of invalidity on the grounds of obviousness, lack of utility and insufficiency were not justified, [7] and granted the application in favour of Leo, preventing Teva from marketing and selling its generic version until the expiration of Leo’s patent. [7]

Background: The ‘565 Patent

The ‘565 Patent, entitled “Dermally Applicable Vitamin D-Containing Pharmaceutical Compositions,” is set to expire on January 27, 2020. [14] It described and claimed a combination of two preexisting psoriasis drugs: 1) at least one vitamin D or vitamin D analogue (“Component A”), and 2) at least one corticosteroid (“Component B”), with the addition of a solvent (“Solvent C”). [15] Teva sought to sell its own generic version of the patented 50 mcg/g calcipotriol and 0.5 mg/g betamethasone ointment, [1] where betamethasone is a corticosteroid and calcipotriol is a vitamin D analogue. [54] The addition of Solvent C solved the previous instability problems that resulted when the two drugs were mixed together, caused by their pH incompatibility. [127]

Non-Obviousness

Teva argued that the ‘565 Patent was obvious because it alleged that the simultaneous use of Components A and B for the treatment of psoriasis was common knowledge at the relevant date. [121] However, the FC found that the patented combination was not obvious to try. [154] The FC acknowledged that the use of the combination was known, but neither common nor obvious. [124] The FC held that there was motivation in the prior art to attempt to find a way to combine the two components, but that in light of the many other possible combinations that might also be tried, the claims in the ‘565 Patent were not obvious. [134]

Utility

Teva alleged that the ‘565 Patent failed to satisfy the doctrine of sound prediction on two grounds: 1) that it lacked drug-release or skin-penetration data so that a person of skill in the art (“POSITA”) could not soundly predict that all formulations would be effective; and 2) that it claimed millions of formulations, not all of which could be soundly predicted to be stable and effective. [167] The FC rejected the first allegation as Teva did not raise it in the Notice of Allegation. [168] The second allegation was rejected as the FC found that at least one of the claims was soundly predicted. [178]

Sufficiency

The FC rejected Teva’s argument that the ‘565 Patent lacked sufficiency because it was silent as to which Component, A or B, had to be dissolved in Solvent C. [188] The FC found that a POSITA would be able to make the claimed formulation and would not have to be explicitly told that the calcipotriol had to be dissolved in the solvent. [191]

In a subsequent costs decision, Teva was ordered to pay Leo’s costs in the amount of $419,729.92. [Leo Pharma Inc v Teva Canada Limited, 2016 FC 107]