Accurate diagnosis of disease, early detection of disease, and personalized medicine stand to introduce much-needed efficiencies in the health care systems in Canada.
Personalized medicine holds the possibility of an individualized approach to the treatment of disease based on the unique (often genetic) parameters of a patient and/or the subtype of the disease afflicting the patient. The appropriate drug(s), dose, timing of dosing, etc. for a given disease, or subtyped of the disease, may be determined, thereby providing the option of tailoring of treatment. This is in contrast to, for example, those treatments which are provided to a population of patients, but only a subset of which may benefit from treatment. Ideally, personalized medicine technologies will maximize the likelihood of successful treatment of a unique patient.
The demand for new discoveries and inventive approaches in personalized medicine is great. The risk involved in the development of personalized medicine technologies may be worth the rewards of success. However, one of the incentives to invent new diagnostic approaches is under threat in Canada and elsewhere: the option of seeking patent protection to maintain a proprietary position during development may no longer be an option.
Canadian patent examination guidelines for diagnostic inventions were release in June of 2015, entitled : "Patent Notice: Examination Practice Respecting Medical Diagnostic Methods – PN 2015-02". This Notice is an open letter to Canadian Examiners, outlining the way in which they are to approach examination of diagnostic-related inventions. For 3 years prior to the release of this Notice, the examination of patent applications for diagnostic inventions had ground to a halt at the Canadian Patent Office. Patent Agents noticed this lack of examination activity in the diagnostic area and we made inquiries and launch complaints at the Patent office, out of concern for the prejudice to Applicants for these delays in the Examinations of patent applications by the Patent Office.
The patent term is 20-years from filing regardless of the date of issuance. This term was ticking away for all pending diagnostic applications while the Patent Office carried out internal deliberations about what should be patent-eligible subject matter. Unlike the United States, Canada offers no patent term adjustment for delays in Examination attributable to the Patent office.
It was soon revealed that the Patent Office was trying to interpret a Federal Court of Appeal decision regarding computer-implemented inventions (Canada (Attorney General) v Amazon.com Inc, 2011 FCA 328 [Amazon]) for implications relevant to diagnostic methods. Until the interpretation by the Patent Office could be entrenched in a Notice, Examination of diagnostic inventions would not occur based on current practice. Although the Amazon decision had a favorable result to the patentee, it did not adequately counter statements made in the lower court decision regarding patent eligibility of personalized medicine method claims per se. It is widely believed among Patent Agents in Canada that the analysis offered in the Practice Notice regarding diagnostic inventions is flawed.
Ultimately, the Patent Office decided it was time for a change in the examination of diagnostic invention. The uncertainty provided by the Notice places a chill on the patentability of diagnostic methods in Canada, even for useful inventions that would permit early detection, personalized treatment, or identification of susceptible individuals for disease prevention.
The Notice teaches a problem: solution approach (or "contribution analysis"), in place of the standard of purposive construction, which it purports to employ. Under the Notice, Examiners are now advised to assess a claim based on its essential elements. Under this approach, Examiners may ignore features they deem not to be critical to the solution offered by the invention, and if merely left with data acquisition and data analysis steps, the claim can be deemed "disembodied" and thus ineligible for patent protection. Inventions pertaining to diagnosis typically require that a sample be acquired from a patient and be tested for one or more parameters of interest (data acquisition) and subsequently that the level or presence of the parameters detected in the sample be compared with a level indicative of the condition to be diagnosed (data analysis). We are finding that diagnostic claims which represent true advances in the field, which are novel and inventive absent any "prior art" objection, are now rejected as ineligible subject matter on the basis of this examination approach.
Recent high profile situations have come to light in which diagnostic tests are considered unaffordable. It is possible that the Patent Notice was formulated in a manner that reflects a direction in public policy, more than an objective interpretation of intellectual property laws. It is not an uncommon sentiment that inventions relating to a new biomarker, a genetic variant, or a biological correlation indicative of a health condition should made freely available to the public, regardless of the effort expended in arriving at the invention.
Canada has leading researchers active in the field personalized medicine technologies. However the research efforts leading to these inventions, and taking them through the validation process is a lengthy and expensive path. Rarely is the expense borne entirely by public funding. The private sector involvement in commercial aspects of testing and developing diagnostic assays and kits is inevitable. Would industry concede to doing such testing if there was no option for a proprietary position for the 20-year patent term, when it is available to all other categories of invention? Are diagnostics simply too important to be patented? Has the Patent Office permitted the popular public outcry for unrestricted access to diagnostics to influence its Examination guidelines?
The approach of the Canadian Patent Office to patenting diagnostic inventions is not consistent with other countries. In the European Patent Office, there is no subject matter restriction that would exclude diagnostics from patent eligibility, claimed as either kits or methods. While there is a similar trend in the United States Patent Office away from granting patents for diagnostic-related inventions, in practice diagnostic kit and method claims are still eligible subject matter, provided adequate tangible details of a test to be conducted are recited in the claims. Patent decisions in the U.S. courts have refined the subject matter restrictions pertaining to diagnostic inventions, but importantly, these have not resulted in a ban on an entire subject matter classification. The 2012 US Supreme Court decision in the case of Mayo Collaborative Servs. v. Prometheus Labs., Inc. deemed a method pertaining to personalized medicine to be patent-ineligible. Further, the US Supreme Court ruled certain claims pertaining to genetic markers of breast cancer susceptibility to be ineligible for patenting, in the controversial 2013 case of Association for Molecular Pathology v. Myriad Genetics. Nevertheless, including tangible components in such claims can render diagnostic claims patent eligible, in the view of the U.S. Examiners. In Canada, the addition of similar tangible components, according to the position of the Practice Notice, may have no impact, as the Examiner may rule out such components as "inessential elements", unless the tangible component is entirely novel in itself. This approach would put Canada at odds and out of step with other jurisdictions.
Personalized medicine technologies have the potential to transform health care, by specifically identifying and targeting treatments to those patients that will benefit most. We are in the early days of the implementation of the "Patent Notice: Examination Practice Respecting Medical Diagnostic Methods" of the Canadian Patent Office, and are only now starting to Respond to the Examiner's recent objections under this Practice Notice. It remains to be seen how personalized medicine technologies will fare in the Canadian Patent Office. We expect that there will be an evolution in what the Patent Office considers patent eligible as experience is gained in implementing the Practice Notice, and from the Responses submitted by the Applicants through their Patent Agents.
This article first published by Biotechnology Focus in the February/March 2016 edition.
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