Federal Court Says Patent Commissioner Went Too Far with New Policy: AbbVie Biotechnology v Canada

The definitions of what is a method of medical treatment and what is an invention were under scrutiny in a recent Federal Court decision. In AbbVie Biotechnology Ltd. v Canada (Attorney General), 2014 FC 1251 [Abbvie], a judicial review of an appealed patent decision, the federal judge found that recent guidelines issued by the Patent Commissioner (“Commissioner”) were too broad and that they erroneously included patentable subject matter in a definition of medical methods of treatment.

One of the issues the appellant and respondent disagreed on was what method of judicial review that the federal court should apply. The appellant argued that no facts were in dispute, just the application of case law, and therefore the appropriate standard of review was correctness. The respondent argued that what was at issue in this case was a mixture of fact and law, which required statutory interpretation of section 2 of the Patent Act, RSC 1985, c P-4. For these reasons, the Patent Appeal Board’s decision should be granted deference because of its special expertise.

Background of the Case

The appellant owns a patent for a drug called Humira. This drug is used to treat auto-immune diseases. The patent is in force until February 2017. In May 2002, the appellant applied for a new patent for this drug, which claims the use of Humira as a treatment using a fixed dosage (40 mg) on a fixed (bi-weekly) schedule.

In March 2011, a Patent Examiner issued a final action rejecting the application. The appellant then amended its claims. The Examiner maintained that the patent still had defects and referred the application to the Patent Appeal Board (“Board”). The Board invited the appellant to submit a set of claims to address all outstanding defects. The appellant did so. The Board found there were still defects and the Commissioner, acting on its recommendation, refused the new patent application.

Issues

The issues of this case were (1) whether the appropriate standard of review for the Federal Court should be correctness or reasonableness; and (2) whether the Commissioner was incorrect in determining that the patent under review included a method of medical treatment and therefore covered unpatentable subject matter.

Analysis

In her decision, Justice Kane of the Federal Court dealt first with issue of standard of review. She found that the appropriate standard of review for this matter was the standard of correctness. She noted that there were no facts in dispute in this case, so it was purely a matter of law that needed review: “[T]he only issue is the Commissioner’s interpretation of patentable subject matter, and more specifically, the scope of the prohibition on methods of medical treatment” (para 48). In the remainder of the judgment, she went on to find that an error in the Commissioner’s interpretation of past jurisprudence had led to a misapplication of the law.

In Canada, patents must be new, inventive and useful. The Humira patent had been accepted as meeting these three separate criteria. As well, a patent must cover subject matter that is eligible for patenting. In her analysis of whether the new Humira patent covered patentable subject matter, Justice Kane reviewed the case law relied on by both parties. She found that a misinterpretation of past case law had led the Commissioner to issue a misleading policy guideline to examiners. That guideline told examiners to interpret some inventions as claiming methods of medical treatment when they in fact did not. This error led to patentable inventions incorrectly being refused patents on the grounds that they covered unpatentable subject matter.

The review of patent law included a discussion of the decision on Tennessee Eastman Co et al v Commissioner of Patents, [1974] SCR 111, a leading case that outlines the principle that, in Canadian law, “claims to the exercise of professional skill are not inventions and cannot be patented and monopolized” (para 56). Justice Kane affirmed that this is still good law.

The case Merck & Co, Inc v Pharmascience inc, 2010 FC 510 [Merck], also came under review. In that case, as in Abbvie, the patent included a claim for a specific dose on a fixed schedule. In that case, Justice Hughes stressed that “a distinction must be made between claims that rely upon the skill and judgment of a medical practitioner and those that deal with a vendible product” (para 114, Merck). If no skill or judgment is brought to bear, the invention is a vendible product.

Another important case discussed in the reasons was Janssen Inc v Mylan Pharmaceuticals ULC, 2010 FC 1123 [Janssen]. Justice Kane found that is was a misinterpretation of comments made by Justice Barnes in Janssen that led to the misapplication of the case law by the Patent Office. The Commissioner misinterpreted comments within the judgment as a change in law. The comments at issue in Janssen expressed policy concerns about a pure form of medical treatment. Justice Kane clarified that what is at issue in every medical patent case is whether the invention is a vendible product or a form of medical treatment. The fact that Abbvie’s new patent included a specific dose and a fixed schedule did not make it a form of medical treatment. She notes:

The concern expressed by Justice Barnes [in Janssen] about the restrictions such a patent would impose does not arise in every claim and is not a new principle. The principle remains the same – where the patent claims a method of treatment or the exercise of professional (in this context, the physician’s) skill and judgment, such that it restricts or interferes with it, it is not patentable. (para 120)

She found that the current claims for Humira did not require a physician to exercise his or her skill within the claim. This finding allowed them to be patentable. She concluded, “The Commissioner incorrectly determined that the claims covered a method of medical treatment and were not patentable. The claims are patentable and should, therefore, issue” (para 135).

Conclusion

This decision stresses the important relationship that courts have with administrative decision-making bodies. The ability for courts to assess the appropriate standard of review is a critical part of the administrative law system. As well, the ability of courts to correct errors in law is an important power of oversight. Here, the court performed a critical correction. Without the court’s intervention, all of the Patent Office’s examiners would have continued to follow the guidelines set out by the Commissioner, and continued to replicate an error in law. The role of the Patent Office and the Patent Act should be to foster innovation in Canada. With the help of this oversight from the court, examiners will now be able to consider a broader range of inventions as patentable subject matter.