SCC affirms 7-2 that methods of medical treatment cannot be patented in Canada

The court decisions

The Federal Court sided with Janssen, finding that Pharmascience’s drug would infringe Janssen’s patent for its dosing regimens. Pharmascience then appealed on the grounds that Janssen’s patent covered unpatentable subject matter. When the Federal Court of Appeal dismissed the appeal, Pharmascience brought the same argument before the SCC.

The SCC also dismissed Pharmascience’s appeal.

In the high court’s decision on Friday, Jamal said Canadian law has long considered methods of medical treatment to be unpatentable. He pointed to the high court’s 1974 decision in Tennessee Eastman Co. v. Commissioner of Patents, which found that patents cannot extend to methods of medical treatment. The high court based its conclusion on s. 41(1) of the Patent Act, which barred patents for substances intended for food or medicine, except when they are prepared or produced by specific methods or processes.

S. 41(1) was repealed in 1993. Jamal noted that the repeal merely removed restrictions on patenting pharmaceutical substances. It did not make methods of medical treatment patentable.

Throughout the years, the SCC and other courts have recognized that professional skills cannot be patented, Jamal said. He added that Canada does not have legislation that explicitly excludes methods of medical treatment as a patentable invention, because it has been settled law since Tennessee Eastman Co.

The justice characterized proposed patents for methods of medical treatment as attempts to “monopolize professional medical skill and judgment.” To determine whether Janssen’s dosing regimens count as methods of medical treatment, the question is whether they amount to professional medical skill and judgment.

Jamal said courts can answer this question using a three-pronged analysis. First, courts should focus on whether the regimens, the subject matter in question, amount to professional medical skill and judgment, not whether medical skill and judgment would be used to select them for a specific patient or use.

Second, courts should keep in mind that subject matter is more likely to be considered a method of medical treatment if it is more tailored to individual patients.

Third, courts should understand that the more medical professionals are expected to develop or improve any given subject matter, the more likely it is to be considered a method of medical treatment.

However, Jamal emphasized that these guidelines are not exhaustive and do not establish bright-line rules. “Cases involving methods of medical treatment are factually suffused and must be decided accordingly, drawing on the considerable expertise of the federal courts in patent matters,” he wrote.

The justice agreed with the Federal Court’s conclusion that Janssen’s dosing regimens do not amount to professional medical skill and judgment. Quoting the Federal Court, Jamal wrote that “‘skill and judgment are not required to implement the claimed dosing regimens’ after a physician has chosen a specific dosing regimen.”

“In my view, the trial judge correctly focused on professional skill and judgment when applying the test for methods of medical treatment,” Jamal wrote. “His findings disclose no reviewable error.”