Covering method of medical treatment does not make pharmaceutical patent invalid: Federal Court

Making, constructing, using, selling generic version would infringe patent's claims

Covering method of medical treatment does not make pharmaceutical patent invalid: Federal Court

The Federal Court of Canada has found that a Montreal-based generic pharmaceutical company failed to establish that a Belgium-headquartered corporation’s Canadian patent for a schizophrenia drug was invalid due to either obviousness or a lack of patentable subject matter relating to the patent’s setting out of dosage regimen elements.

The case of Janssen Inc. v. Pharmascience Inc., 2022 FC 1218 involved two patent infringement actions under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.

Janssen Pharmaceutica N.V. was the registered owner of Canadian Patent No. 2,655,335 (the 335 Patent), which was titled “Prolonged-Release Injectable Suspensions of Paliperidone Palmitate and Dosage Forms and Delivery Systems Incorporating Same” and which was intended to treat schizophrenia and related disorders.

In 2020, Pharmascience Inc. asked the court for approval to market and sell in Canada doses of its proposed pms-PALIPERIDONE PALMITATE, a generic version of Janssen’s INVEGA SUSTENNA® product. It asserted that the 335 Patent was invalid or void.

Last March, Janssen filed a s. 6(1) action against Pharmascience seeking the following: first, a declaration that the making, constructing, using, or selling of Pharmascience’s proposed drug would infringe the 335 Patent; and second, a permanent injunction restraining Pharmascience from making, constructing, using, selling, marketing, importing, exporting, and distributing its proposed drug and from otherwise infringing the 335 Patent.

Federal Court rules in Janssen’s favour

The making, constructing, using, or selling of Pharmascience’s proposed product would infringe the claims of the 335 Patent, the Federal Court of Canada held.

First, the Federal Court rejected Pharmascience’s argument that the claims of the 335 Patent were invalid for being obvious under s. 28.3 of the Patent Act. The combination of the dosing regimen elements in the patent’s claims was inventive, the court said.

Though the court accepted that the added formulation elements in the dependent claims of the 335 Patent might not be inventive, it determined that each of its independent claims incorporated one of the dosing regimens as essential elements. As a result, all of the claims were not obvious.

To assert that the claims were obvious, Pharmascience relied on the Dr. Pardeep Gupta’s expert opinion evidence. However, the court found that Dr. Gupta gave rise to credibility issues by failing to agree with or admit to simple, straightforward propositions. Further, the doctor never conducted or designed a clinical or pharmacokinetic trial for humans and offered evidence that was conclusory and driven by hindsight, the court said.

Second, the Federal Court rejected Pharmascience’s argument that the claims of the 335 Patent were invalid for a lack of patentable subject matter under s. 2 of the Patent Act because they covered a method of medical treatment.

Claims 17 to 32 were at issue. The court said that these claims did not prevent physicians from practising in the way that they previously have been, as Dr. Joel Jeffries, Pharmascience’s expert witness, agreed.

The court added that these claims did not require the exercise of professional skill and judgment since there were no choices regarding possible ranges for the dosage amounts, which were fixed.

“A physician can choose to implement a claimed specific dosing regimen or not; however, skill and judgment are not required to implement the claimed dosing regimens,” wrote Justice Michael Manson for the Federal Court.

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