Don’t fence me in: specific treatment regimens are not methods of medical treatment

On December 22, 2014, Justice Kane of the Federal Court of Canada concluded that AbbVie’s Canadian Patent Application No. 2,385,745  was not directed to methods of medical treatment and directed the Commissioner of Patents to allow the claims.

The claims at issue relate to a preloaded syringe containing 40 mg of adalimumab, which AbbVie markets as HUMIRA, administered subcutaneously every 14 days for the treatment of arthritic and inflammatory bowel diseases.

The Commissioner rejected the 745 Application based on the Patent Appeal Board’s finding that the claims were directed to a method of medical treatment, which is not patentable subject matter under section 2 of the Patent Act (see the Commissioner’s decision here). The Board interpreted the jurisprudence as barring claims that interfered with the ability of physicians from exercising their judgment when prescribing a drug. This was consistent with a recent CIPO practice notice that provides “inventions preventing physicians from exercising their skill and judgment in using a known compound for an established purpose effectively cover a method of medical treatment.” Although the 745 Application was limited to a single dosage, dosing schedule, and route of administration, the Board held that physicians’ judgment was impaired by the fact that they would require a license to prescribe the claimed HUMIRA regimen.

The Court reviewed the Commissioner’s decision on a correctness standard because the scope of patentable subject matter is a question of law.

Abbvie argued that any pharmaceutical patent may cause certain treatment regimens to be infringing, but that this did not mean that any pharmaceutical patent related to a non-patentable method of medical treatment. For example, a patent claiming a compound renders any regimen involving that compound infringing. Instead, Abbvie argued that a patent is directed to a method of medical treatment only where the claims are directed to a range of choices from which selection must be made.

The Attorney General argued that HUMIRA was previously available in a syringe and that the 745 Application merely added the specific dose and dosing schedule. This “fenced in” the prescribing practice and interfered with physicians’ exercise of skill and judgment.

Justice Kane reviewed the jurisprudence cited by both parties and concluded, at paragraph 114, that the cases articulated a consistent approach:

a claim which does not restrict, or interfere with, or otherwise engage professional skill or judgment – including a claim for a fixed dosage and or a fixed dosage schedule or interval- is not impermissible subject matter where there is no evidence to contradict that claimed dosage.

Justice Kane concluded that the 745 Application, based on the evidence before her,  claims a fixed regimen that does not require any adjustment; it does not claim the physician’s skill and judgment. Therefore, the 745 Application is not directed to a method of medical treatment.

Finally, the Court noted that the Commissioner had determined that the claims of the 745 Application were neither obvious nor anticipated. Having resolved the only outstanding issue, Justice Kane concluded that there was no reason to send the decision back to the Commissioner and directed that the Commissioner allow the claims of the 745 Application.

A copy of Justice Kane’s Judgment and Reasons may be found here.