The recent Amazon.ca decision of the Federal Court of Appeal in 2011 reverses the Commissioner of Patent's long-held belief that business method patents are unpatentable subject matter. The implications of this decision for life sciences companies are far-reaching. The Amazon. ca decision has implications to medical use claims. Additionally, as a result of the Amazon.ca decision, life sciences companies should now consider taking advantage of business method patent protection generally associated with technologies relating to telecommunications, computer devices, software and e-commerce.

However, with advances in computer technology, an increasing number of life science companies are incorporating sophisticated hardware and software into their diagnostic, therapeutic or surgical products. In order to maximize revenues, it is critical that life science companies understand the issues relating to patenting software and business method technologies in Canada. The area of personalized medicine is particularly ripe for advances in software and hardware driven products that can be tailored to develop patient-specific treatments.

The guiding case on business method patents is a 2011 decision of the Federal Court of Appeal in Amazon.com Inc. v. Commissioner of Patents (2011 FCA 328). In 1998, Amazon applied to patent its "one-click" technology. The application relates to a method of simplifying the online ordering process. The "one-click" invention allows the user to subsequently purchase items with a single mouse click without repeatedly entering security and payment information. The Canadian Commissioner of Patents refused the application on the basis that a claim to a business method is unpatentable in Canada. The Federal Court and Federal Court of Appeal disagreed, finding that there is no prohibition on business method claims under Canadian law per se.

Specifically, the Federal Court of Appeal found that a business method can qualify as an "art" under s. 2 of the Patent Act if it satisfies the following three-part test:

  1. It must not be a disembodied idea but have a method of practical application;
  2. It must be a new and inventive method of applying skill and knowledge; and
  3. It must have a commercially useful result.

The Court of Appeal further held that the rationale for each of these conditions is grounded in the Patent Act, in that they reflect the statutory requirements of novelty, utility, non-obviousness, and the prohibition on the granting of a patent for a mere scientific principle or abstract theorem. As a result, the Court of Appeal ordered the Commissioner to reexamine the application to determine whether the claims of the "one-click" application met the three-part test. Subsequently, the Commissioner granted Amazon's "one-click" patent.

The Court of Appeal also reiterated that, when construing the claims of a patent, one cannot simply look at "what has been invented" and ignore the invention as a whole. Claims are to be interpreted in a purposive manner as set out by the Supreme Court of Canada in Free World Trust v. Électro Santé Inc., (2000) 2 S.C.R. 1024.

Finally, the Court of Appeal provided additional guidance that is helpful to life science companies. The definition of invention under s. 2 of the Patent Act is broad and encompasses "unforeseen and unanticipated technology." The Patent Act is not static. It must be applied in a manner that permits advances in technology to permit inventors to move from the industrial age to the electronic age. Technology is in a constant state of fl ux. Any attempt to define it would serve to defeat the flexibility which is so crucial to the purpose of the Patent Act.

The Amazon.ca decision has clearly had an impact on the availability of patent protection for technologies related to telecommunications, computer devices, software and e-commerce. By extension, patent protection is now available for innovations in software and business methods in the life sciences industry.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.