2021 Year in Review: Life Sciences
Despite 2021 feeling like an extension of 2020, there were a number of notable developments related to intellectual property in the life sciences. Here are some brief highlights on significant life science patent-related court decisions rendered in 2021, as well as some legislative changes expected in 2022.
Certificates of Supplementary Protection
In Canada (Health) v. Glaxosmithkline Biologicals S.A., 2021 FCA 71, the Federal Court of Appeal (FCA) overturned a decision of the Federal Court (FC) which held that the Minister’s decision to refuse issuance of a certificate of supplementary protection (CSP) for Canadian Patent No. 2,600,905 (‘905 patent) for the drug SHINGRIX was unreasonable. All the claims of the ‘905 patent were directed to a formulation comprising an antigen and an adjuvant, while the Notice of Compliance (NOC) was directed only to the antigen. The Minister held that an adjuvant was not a medicinal ingredient, and as such, refused to issue a CSP for the ‘905 patent. Upon review, the FC found that the Minister’s decision was unreasonable; however, the FCA overturned the FC, holding that the Minister’s decision was reasonable because her interpretation of the term “medicinal ingredient” should not be set aside merely because there is a logical alternative interpretation.
In Merck Canada Inc v. Minister of Health, 2021 FC 1015, the FC judicially reviewed the Minister’s refusal to issue a CSP for suvorexant, the medicinal ingredient in Merck’s drug product BELSOMRA, for failing to meet the eligibility requirements set out in the Patent Act and CSP Regulations. The FC held that the Minister’s decision was unreasonable because the Minister failed to consider the context and purpose of the provisions of the CSP regime and the role of the Comprehensive Economic and Trade Agreement (CETA) in the context and enactment of the provisions. The Minister’s decision was set aside and Merck’s CSP application was remitted to the Minister for re-determination.
In Merck Canada Inc v. Canada (Health), 2021 FCA 224, the FCA affirmed a FC decision in which it was held that the Minister’s decision to refuse to list Canadian Patent No. 2,830,806 (‘806 patent) on the patent register was reasonable. The ‘806 patent was refused because the associated patent list was filed after the deadline set forth in the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations).
Claim Construction and Validity
In Janssen et al. v. The Minister of Health, 2021 FCA 45, the FCA affirmed that because something is “worth a try” does not mean that it is “obvious to try”. The FC held that while the claimed combination in Canadian Patent No. 2,661,422 (‘422 patent) may have been worth trying, it was not obvious to try. The FCA held that the FC correctly applied each of the factors of the obvious to try test and stated that the FC’s conclusion was one that was open to the FC. The FCA also stressed that the “more or less self-evident” element in the obvious to try analysis is a factor, not a requirement. Finally, in its analysis, the FCA noted that when considering whether a combination is patentable, the key consideration should be whether the combination offers something that was not available to the public before.
In Merck Sharp & Dohme Corp and Merck Canada Inc v. Wyeth LLC, 2021 FC 317, the FC considered the breadth of the term “comprising” in claim construction, as well as clarified the test for an obvious to try analysis. The FC held that even if the term “comprising” can in some cases be construed as open-ended, such a construction requires some justification in the patent, which was not found in this case. Specifically, the FC construed the term “comprising” to be close ended in a claim directed to a composition “comprising 13 distinct polysaccharide protein conjugates…” The FC held that the claim was directed to exactly 13 serotypes because there was no basis in the application for going beyond 13 serotypes, despite the use of the term “comprising”.
The FC also considered the validity of Canadian Patent No. 2,604,363 (‘363 patent), applying the obvious to try test, and demonstrating that the second prong of the test is just as important as the others. Specifically, in applying the first and third prong of the test, the FC held that evidence showed that what would be tried ought to work, and that the prior art provided a motive to find the solution. However, despite those findings, the FC held that the person skilled in the art would not have arrived at the invention without prolonged and arduous experimentation (the second prong of the test), and therefore, the claims were considered non-obvious. An appeal was filed by Wyeth and subsequently discontinued.
In Janssen Inc. et al v. Apotex Inc. et al, 2021 FC 7, the FC held the claims of Janssen’s Canadian Patent No. 2,661,422 (‘422 patent) invalid. The claims at issue were directed to a use of “a therapeutically effective amount of abiraterone acetate and a therapeutically effective amount of prednisone in the treatment of a prostate cancer in a human”. The FC construed these terms to mean that each of abiraterone acetate and prednisone must individually treat prostate cancer, as opposed to the combination of the two active ingredients treating prostate cancer. Further, in construing the term “treatment”, the FC relied on the definition for this term provided in the patent, which was interpreted as only covering effects on the tumour or cancer cells and excluding palliative effects, survival benefits, mitigation of side effects, or reversal of resistance. Based on this construction, the FC held that the use of abiraterone acetate and prednisone in the treatment of prostate cancer was obvious to try, with an expectation of success. This decision is under appeal.
In Hoffmann-La Roche Limited v. Sandoz Canada Inc., 2021 FC 384, the FC held that Swiss-style use claims are properly construed as use claims where the alleged invention resides in the use and not in the manufacture or composition of the medicament. The FC also held that Canadian Patent Nos. 2,667,654 (‘654 patent) and 2,709,997 (‘997 patent) were invalid for obviousness-type double patenting because they were not patentably distinct. Both taught the use of the same daily dose of pirfenidone, at the same frequency with food, and that the ‘997 patent’s additional teaching of rechallenging the patient with pirfenidone following abnormal liver biomarkers would be obvious to the person skilled in the art.
Additionally, the FC held that the dosage regimen taught by the ‘654 patent was obvious to try given that prolonged or arduous experimentation would not have been required to arrive at the dosage regimen, and at the relevant time, pirfenidone was a promising investigational drug for the treatment of idiopathic pulmonary fibrosis (IPF). This decision is under appeal.
In Apotex Inc v. Shire LLC, 2021 FCA 52, the FCA, in affirming a validity decision by the FC, noted that while disclosure of a genus may anticipate claims to individual species of the genus, it does not necessarily do so. Whether a genus disclosure anticipates a species depends on the size of the genus, the language of the claims, and the context and included examples. With respect to obviousness, the FCA noted that while a single inventive concept must exist in a patent, each claim may have a different specific inventive concept that may overlap or replicate those of other claims. The FCA also noted that where a claim does not reveal its inventive concept, properties and beneficial features of the claimed subject matter which are present in the description can be considered in identifying the inventive concept of the claims. Leave to appeal was dismissed by the Supreme Court of Canada.
In Janssen v. Hospira, 2021 FC 42, the FC reconsidered issues of validity for Canadian Patent No. 2,261,630 (‘630 patent). The FCA remitted the case to the trial judge for reconsideration on validity. The FC again held that the claims of the ‘630 patent were valid. Specifically, it held that the claims of the ‘630 patent were not anticipated by the prior art because not all the essential elements were disclosed in the prior art. Moreover, the subject matter of the claims was found not to be enabled in the prior art because the work required to arrive at the claimed subject matter was not routine. In reconsideration of obviousness, the FC, on the direction of the FCA, included additional prior art references in its analysis; however, the FC nonetheless found the claims to be non-obvious, noting that all of the publications, even those not previously considered, did not point to a clear path. Lastly, the FC clarified its analysis with respect to the obvious to try test, finding that the motivation in the prior art to find the claimed solution was strong and, therefore, supported a finding of obvious to try; however, the FC noted that all factors of the obvious to try test must be considered, and in weighing all such factors, the claimed invention was not obvious to try. An appeal was filed by Hospira and subsequently discontinued.
In Seedlings Life Science Ventures, LLC v. Pfizer Canada ULC, 2021 FCA 154, the FCA affirmed a decision that the claims of Canadian Patent No. 2,486,935 (‘935 Patent) were invalid as overbroad. In construing the claims at issue, the FCA applied the principle of claim differentiation, and noted that claim differentiation can be used even between claims that have several differences. The FCA noted that while, overbreadth and insufficiency may be overlapping grounds of invalidity, they are separate grounds of invalidity and overbreadth finds its statutory basis in a combination of subsections 27(3) and 27(4) of the Patent Act. However, the FCA disagreed with the FC’s finding that the claims at issue were not insufficient. Specifically, the FCA held that the claims were insufficient because they did not include a number of essential elements described in the disclosure of the patent, which resulted in the claims being broader than the embodiments described in the disclosure.
Patentable Subject Matter
Dosage Regimen Claims
In Canada, to determine whether a method of medical use claim including a dose regimen is patentable, it is necessary to consider whether professional skill and judgment is part of the invention as claimed.
In Hoffmann-La Roche Limited v. Sandoz Canada Inc., 2021 FC 384, the FC held that medical use claims in two patents were unpatentable methods of medical treatment because both claimed dosage regimens were not appropriate for all patients. One patent claimed a dosage escalation regime in which anticipated adverse effects would need to be monitored and doses may need to be adjusted. The other patent claimed a dosage regimen requiring an assessment of an individual patient’s circumstances. As such, the claims of both patents were considered to require the skill and judgment of a physician and were therefore, directed to unpatentable subject matter. As mentioned above, this decision is under appeal.
As set out below, the Patent Appeal Board (the PAB) has been more lenient in its consideration of dosage regimens than in the past.
In Commissioner’s Decision Re Amgen Research (Munich) GmbH, 2021 CACP 2, the PAB allowed a medical use claim including a dosage range, where the dose was calculated based on a patient’s body surface area. The PAB accepted the Applicant’s argument that calculation of a particular dosage based on body surface area is a mere mathematical calculation that is within the skill of a technician, not a physician, and therefore, does not require professional judgment. The PAB also noted that the description of the application showed that any dosage within the claimed range would be safe and effective and that no adjustment would be required.
In Commissioner’s Decision Re Genentech, Inc., 2021 CACP 8, the PAB allowed a medical use claim reciting a dosage regimen requiring calculation of a dose based on the patient’s body weight. The application at issue included generic statements discussing a physician’s discretion in selecting an appropriate dosage based on patient-specific factors in the specification; however, the PAB found that these statements did not pertain to the invention as claimed. The PAB also noted that for a claim of the type “the use of X for treating Y” to be patentable, the decision to prescribe or to stop treatment must be outside the scope of the claim. Finally, the PAB acknowledged that weighing a patient and calculating a dose based on weight does not require professional judgment.
The PAB also released a number of decisions in 2021 allowing diagnostic method claims following the decision in Choueifaty v Canada (Attorney General), 2020 FC 837 (Choueifaty).
In Re Abbott Molecular Inc., 2021 CACP 19 and Re Genentech, Inc., 2021 CACP 20, the PAB allowed claims directed to diagnostic methods that included data acquisition and data analysis steps. In both, the Examiners alleged that the problem to be solved in each case was a data analysis problem and, as such, construed claim elements directed to data acquisition as non-essential. Based on this construction, the Examiners determined that the essential elements were only those directed to correlation steps and, therefore, the claims were disembodied mental conclusions. The PAB considered the CIPO guidance document released in response to Choueifaty, PN2020-04, and applying the correct approach to claim construction, determined that the claims comprised physical steps of data acquisition and data analysis elements, which cooperate to form a single actual invention that includes steps that are clearly physical and manifest a discernable effect or change.
In another decision favourable to diagnostic method claims, Re Antibodyshop A/S, 2021 CACP 35, the PAB construed the term “determining” to be a physical step. In construing one of the claims at issue which recite
d “determining the concentration of human neutrophil gelatinase-associated lipocalin (NGAL) in urine, plasma or serum sample from the human being”, the PAB concluded that the term “determining” meant “measuring”. As such, in view of the CIPO Choueifaty guidance document, which states that a diagnostic method claim that forms a single invention that includes physical means for measuring is patentable subject matter, the PAB found the claims at issue to be directed to patentable subject matter.
Patented Medicines Prices Review Board
In Alexion Pharmaceuticals Inc. v. Canada (Attorney General), 2021 FCA 157, the FCA held that the Patented Medicines Prices Review Board’s (PMPRB) decision to require the price of a drug to be lower than all seven comparator countries was unreasonable. In coming to its decision, the FCA held that the PMPRB exceeded its statutory powers by pursuing a general price regulation mandate; the case law establishes that the PMPRB’s mandate is to prevent excessive pricing and abuse of patents, not to ensure reasonable pricing, price-regulation, or consumer protection at large. The FCA also noted that the PMPRB had departed from its Compendium of Policies, Guidelines, and Procedures and had failed to adequately explain and justify such an unprecedented departure. As such, the FCA quashed the PMPRB’s decision and remitted the matter to the PMPRB for re-determination, cautioning that in making its decision, a reasoned explanation must be discernable. The Attorney General has applied for leave to appeal to the Supreme Court of Canada.
Legislative Outlook for 2022
Amendments to the Patented Medicines Regulations
On December 23, 2021, the coming-into-force of the amendments to the Patented Medicines Regulations, which include reduced reporting obligations for medicines with the lowest excessive pricing risk, was further delayed until July 1, 2022. These amendments were originally slated to come into force on July 1, 2020.
Amendments to the Patent Rules
On July 3, 2021, the Canadian Intellectual Property Office published proposed amendments to the Patent Rules intended to streamline the examination process. The most notable of such proposed amendments include: 1) introduction of excess claim fees of $100 per claim over 20 claims, 2) introduction of a Request for Continued Examination procedure after 3 examination reports have been issued, and 3) introduction of a new Conditional Notice of Allowance, to be issued at the end of prosecution when only minor defects need to be corrected. It will be especially important for applicants of life sciences patent applications, which often have excess claims and unity of invention objections, to consider strategies to deal with and minimize the effect of these new Rules during patent prosecution.
We look forward to seeing the new developments that 2022 will bring to the field of intellectual property in the life sciences.