In the second trial judgment under the new Patented Medicine (Notice of Compliance) Regulations, the Federal Court (FC) found for the Plaintiffs, Janssen Inc. and Janssen Pharmaceutica N.V., and enjoined Teva Canada Limited (Teva) from making, constructing, using or selling paliperidone palmitate (paliperidone) in accordance with its abbreviated new drug submission. The Court rejected Teva’s argument that the claimed dosing regimens were obvious, as well as its arguments against direct infringement of certain of the claims.

Background

Paliperidone is marketed in Canada as INVEGA SUSTENNA and is used to treat schizophrenia and related disorders (collectively schizophrenia). This action concerned Canadian Patent 2,655,335 (335 Patent), which is listed on the patent register against INVEGA SUSTENNA and claims a set of dosing regimens of paliperidone to treat schizophrenia.

The claimed dosing regimens relate to depot formulations, which are administered intramuscularly to patients at regular intervals. Depot formulations release drug slowly from injection sites, providing patients with a prolonged dose intended to reduce the side-effects of paliperidone and improve patient adherence.

The 335 Patent has three sets of claims. Claims 1 to 16 relate to prefilled syringes adapted for administration according to the claimed dosing regimens, claims 17 to 32 relate to a use of a dosage form according to the claimed dosing regimens, and claims 33 to 48 are “Swiss-type” claims relating to use of paliperidone in the manufacture/preparation of a “medicament” adapted for administration according to the claimed dosing regimen.

Claim construction & prosecution history evidence

The parties largely agreed on the construction of the claim terms. One area they disagreed was on the construction of “continuous schedule”. The FC found that the plain meaning of “continuous schedule” means maintenance dosing on an ongoing basis, not one dose.

Although the FC found that the plain meaning of “continuous schedule” was enough to dispose of the issue, it also supported its conclusion with a finding that the Plaintiffs’ proposed construction of this term was inconsistent with statements made during the prosecution of the 335 Patent. The FC concluded that the prosecution history was consistent with what it had found to be the plain meaning of the term.

Obviousness

The FC began its obviousness analysis by finding that validity of the asserted claims turned on whether the dosing regimens were inventive.

The FC determined that there were several differences between the state of the art and the inventive concept of the asserted claims. Applying the “obvious to try” test, the FC concluded that the differences amounted to an inventive step that could not have been bridged using only the CGK and prior art:

  • Even though the number of dosing regimen variables was finite, there was not a finite number of identified, predictable solutions. Studies were needed to simply understand paliperidone’s pharmacokinetic profile and therapeutic plasma concentration range prior to undertaking any dosing regimen design.
  • It would not have been self-evident that some combination of the disclosed dose amounts, dose schedule, and injection site would quickly and safely achieve therapeutic plasma concentrations of paliperidone.
  • The trials leading to the invention were not “routine”, given that numerous prolonged and arduous steps were required to evaluate possible dosing regimens.
  • While there might have been general motivation to develop a depot formulation of paliperidone, there was not necessarily a specific motivation to develop the dosing regimens of the 335 Patent.

The claimed dosing regime was inventive, and the asserted claims of the 335 Patent were non-obvious.

Teva would infringe the 335 Patent

The FC concluded that Teva’s proposed paliperidone product would infringe claims 1–16 and 33–48 of the 335 Patent. These claims are for products with an intended use.

The FC found that all of the essential elements of the claimed dosing regimens were present in Teva’s product monograph. It specified the diseases the product is intended to treat, the way the product is to be administered, and all of the aspects of the claimed dosing regimens. By making or selling its proposed paliperidone product for the claimed uses, Teva would directly infringe these claims—there was no need to use, or to induce the use, of the product.

The case is: Janssen Inc. v Teva Canada Ltd, 2020 FC 593