The Thorny Problem of Patentable Eligible Subject Matter: Part 2 of a 10-Part Series: Canada

This is Part 2 of a 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries. To view Part 1 (The Thorny Problem of Patentable Eligible Subject Matter: U.S.), click here

Patentable Subject Matter in Canada 

In Canada, patentable subject matter is circumscribed by the definition of “invention” contained in section 2 of the Canadian Patent Act (Patent Act): RSC 1985, c P-4, which states that an “invention” may be “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter” (emphasis added). Therefore, to be patentable, an invention must be capable of fitting into one of the five broad categories: art, process, machine, manufacture or composition of matter. Canadian Courts and the Canadian Intellectual Property Office have generally interpreted these categories expansively. However, as will be discussed in more detail below, claims to computer software, methods of medical treatment and living organisms have each been treated with some trepidation. 

Several other sections of the Patent Act, both current and repealed, contribute to defining patentable subject matter. For example, section 27(8) provides that: “[N]o patent shall be granted for any mere scientific principle or abstract theorem.” Thus, an automated mathematical calculation (such as a computer software-implemented algorithm) is considered to be a “mere scientific principle or abstract theorem” under Section 27(8). Moreover, mental operations and processes are not the kind of processes referred to in the definition of invention contained in section 2 according to Schlumberger Canada Ltd. v Commissioner of Patents (1981), 56 CPR (2d) 204 (Fed CA). However, the practical application of a business method that incorporates software is patentable subject matter and is not considered to be captured by the prohibition in section 27(8) (see, Canada (Attorney General) v Amazon.com, Inc, 2011 FCA 328).

In addition to section 27(8), long-repealed section 41 still influences Canadian patent law. Although, ultimately repealed, Canadian Courts rely on the jurisprudence under Section 41 to justify, in part, a prohibition on certain claims for uses of compounds to treat disease. Specifically, former section 41(1) stated:

41. (1) In the case of inventions relating to substances prepared or produced by chemical processes and intended for food or medicine, the specification shall not include claims for the substance itself, except when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents.

Section 41 was enacted for the purpose of restricting the scope of patents “relating to substances prepared or produced by chemical processes and intended for food or medicine.” In practice, this meant that all claims to compounds that could be used for food or medicine could only be claimed in conjunction with their methods or processes of manufacture. Thus, by implication, the Canadian Supreme Court extended coverage of section 41 to methods of treatment using compounds for food or medicine:

this [Section 41] necessarily implies that, with respect to such substances, the therapeutic use cannot be claimed by a process claim apart from the substance itself. Otherwise, it would mean that while the substance could not be claimed except when prepared by the patented process, its use however prepared could be claimed as a method of treatment. In other words, if a method of treatment consisting in the application of a new drug could be claimed as a process apart from the drug itself [authors’ note: meaning that the method or use can be claimed without a process limitation], then the inventor, by making such a process claim [authors’ note: a method of treatment claim without a process limitation], would have an easy way out of the restriction in s. 41(1) (see, Tennessee Eastman Co v Commissioner of Patents (Tennessee Eastman), [1974] SCR 111).

Tennesee Eastman has since been held as providing a general prohibition against claims for methods of medical treatment despite the repeal of Section 41 (see, Axcan Pharma Inc v Pharmascience Inc, 2006 FC 527; Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2014 FCA 17). Specifically, Canadian Courts have held that the critical question is whether a claim encompasses a vendible product, namely, the commercial embodiment of the invention. If the answer is in the affirmative, the claim is deemed no longer to be within the scope of methods of medical treatment (see, Janssen Inc v Mylan Pharmaceuticals ULC, 2010 FC 1123). For example, in Canada, a claim to an effective dosage range would not be permissible because such a claim would encompass the exercise of a physician’s professional skill and judgment (which is not a vendible product). Consequently, a physician would infringe such a claim when prescribing an amount of a medicine within the claimed range (see, Axcan Pharma Inc v Pharmascience Inc, 2006 FC 527; Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2014 FCA 17).

Apart from the above statutory prescriptions, a determination of what constitutes patentable subject matter is largely a matter of common law. For instance, in a series of cases, the Canadian Supreme Court first appeared to deny the patentability of life forms only to subsequently allow such patents in a limited but functionally equivalent form. Specifically, in a 5-to-4 decision in Harvard College v Canada (Commissioner of Patents) (2002 SCC 76), the Supreme Court refused the patentability of Harvard’s oncomouse because it would grow up according to the “laws of nature” rather than as a result of human intervention. Just two years later, in Monsanto Canada Inc v Schmeiser (2004 SCC 34), a slightly differently constituted Supreme Court held, again 5-to-4, that both genes, once isolated or developed, and single cells containing these genes were patentable as “compositions of matter”, notwithstanding that the cells may grow into full living organisms without human intervention. The result is that under Canadian common law, higher life forms are not patentable as such, but each cell within that life form may be patentable (see, Monsanto Canada Inc v Schmeiser, 2004 SCC 34; Re Application of Abitibi Co (1982), 62 CPR (2d) 81 (Pat App Board)).

Additionally, under common law, and wholly apart from the prohibition against patenting methods of medical treatment, the exercise of professional skill (such as those of a lawyer, accountant, architect, engineer, doctor, or patent agent) is generally not considered to be patentable subject matter (see, Lawson v Commissioner of Patents (1970), 62 CPR 101 (Ex Ct)).

New uses for known compounds (see, Shell Oil Co v Commissioner of Patents, [1982] 2 SCR 536) and selections of particularly preferred compounds from a previously disclosed or patented class of compounds also constitute patentable subject matter (see, Apotex Inc v Sanofi‑Synthelabo Canada Inc, [2008] 3 SCR 265; In the Matter of IG Farbenindustrie [1930] 47 RPC 289 (Ch D); EI Du Pont De Nemours & Co (Witsipie’s) Application [1982] FSR 303 (HL)).

Analysis of Examples under the U.S. PTO Guidance 

In view of recent U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., the U.S. Patent and Trademark Office (U.S. PTO) on March 4, 2014, issued a guidance for evaluating subject matter eligibility under Section 101 (Guidance). The Guidance superseded the June 13, 2013 memorandum issued on the day of the Myriad decision. While the Guidance was issued without public notice or opportunity for the public to comment, the U.S. PTO is holding a forum on May 9, 2014 to receive feedback from organizations and individuals regarding the Guidance. 

The Guidance is divided into 4 sections. Part I discusses the 3-part test for determining subject matter eligibility. Part II explains how to determine whether a claim (as a whole) is “significantly different”. This portion of the Guidance provides a list of 12 factors – six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference). Part III provides seven examples explaining the application of the factors. Part IV provides a new form paragraph for Examiners to use when rejecting claims in accordance with the guidance. 

In addition to the Guidance, the U.S. PTO prepared detailed training materials (containing 93 PowerPoint slides) for Examiners. The detailed training materials contain numerous examples not provided for in the Guidance. 

We at the BRIC Wall thought it would be insightful to examine the analysis of subject matter eligibility under Canadian patent law for several of the examples contained in the Guidance and training materials. 

Composition/Manufacture Claim Reciting A Natural Product – Example A – U.S. PTO Guidelines 

Claim 1: A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.

Claim 2: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

Background: Stable energy-generating plasmids exist within certain bacteria in nature. Pseudomonas bacteria are naturally occurring bacteria. Naturally occurring Pseudomonas bacteria containing a stable energy-generating plasmid and capable of degrading a single type of hydrocarbon are known. 

Analysis of claim 1: Patentable per se, as long as the plasmid meets novelty and inventive step requirements. According to Monsanto Canada Inc v Schmeiser, 2004 SCC 34, useful genes once developed or isolated are deemed to be patentable. 

Analysis of claim 2: Patentable provided that the addition of the second plasmid makes the bacterium novel and inventive over the known naturally occurring Pseudomonas bacteria. According to Monsanto Canada Inc v Schmeiser, 2004 SCC 34, single cells containing previously isolated or developed useful genes are individually patentable. However, a multi-cellular organism, each cell of which contains these genes, would not be patentable (see, Harvard College v Canada (Commissioner of Patents), 2002 SCC 76). Nonetheless the same result can be obtained by claiming the individual cells of the organism containing the genes. 

Composition vs. Method Claims, Each Reciting A Natural Product – Example B – U.S. PTO Guidelines 

Claim 1. Purified amazonic acid. 

Claim 2. Purified 5-methyl amazonic acid. 

Claim 3. A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid. 

Background: The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon basin region of Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in treating breast cancer, however, to be effective, a patient must eat 30 pounds of the leaves per day for at least four weeks. Many have tried and failed to isolate the cancer-fighting chemical from the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has named it amazonic acid. The purified amazonic acid is structurally identical to the amazonic acid in the leaves, but a patient only needs to eat one teaspoon of the purified acid to get the same effects as 30 pounds of the leaves. Applicant has discovered that amazonic acid is useful to treat colon cancer as well as breast cancer, and applicant has also created a derivative of amazonic acid in the laboratory (called 5-methyl amazonic acid), which is structurally different from amazonic acid and is functionally different, because it stimulates the growth of hair in addition to treating cancer. 

Analysis of claim 1: Patentable. Because the particular cancer-fighting compound, amazonic acid, was previously unknown (only the use of Amazonian cherry tree leaves, eaten in large quantities, to treat breast cancer was known), the purified compound constitutes patentable subject matter. 

Additionally, it would be advisable to claim the use of amazonic acid for the treatment of breast and colon cancer in the form of Swiss-type claims as well as the product amazonic acid produced according to Applicant’s process of purification (namely, from leaves). 

Analysis of claim 2: Patentable. 5-methyl amazonic acid is a novel compound with the unobvious benefit of stimulating hair growth. 

Additionally, it would be advisable to claim the use of 5-methyl amazonic acid for the stimulation of hair growth in the form of Swiss-type claims as well as the product 5-methyl amazonic acid according to Applicant’s process of methylation from purified amazonic acid. 

Analysis of claim 3: Likely not patentable as drafted. This claim that would run afoul of the prohibition against claiming methods of medical treatment, since it claims both a duration and dosage range (see, Tennessee Eastman Co v Commissioner of Patents, [1974] SCR 111; Axcan Pharma Inc v Pharmascience Inc, 2006 FC 527; Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2014 FCA 17). Deciding the duration and dosage within the specified ranges would likely require the exercise of a doctor’s professional skill. 

It would be advisable to maintain this claim and to supplement it with use claims in both German and Swiss-type form. Because the use of amazonic acid for the treatment of colon cancer was previously unknown, these claims would likely not be objectionable as claiming a method of medical treatment.

E. Composition vs. Method Claims, Each Reciting Two Natural Products – Example E – U.S. PTO Guidelines 

Claim 1. A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2. 

Claim 2. A method of amplifying a target DNA sequence comprising: 

a) providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine; 

b) heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other; 

c) cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; 

and repeating steps (b) and (c) at least 20 times. 

Analysis of claim 1: Patentable. According to Monsanto Canada Inc v Schmeiser, 2004 SCC 34, useful genes once developed or isolated are patentable. 

Analysis of claim 2: Patentable. Although recombinant DNA technology is well-known, if it is being used to amplify target DNA using novel primers SEQ ID NO: 1 and SEQ ID NO: 2 (which it is by reference to claim 1), it should be free of the prior art and patentable. 

It would be advisable to maintain this claim and to supplement it with use claims (such as use of SEQ ID NO: 1 and SEQ ID NO: 2 to amplify a target DNA sequence). 

Process Claims Involving A Natural Principle – Example G – U.S. PTO Guidelines 

Claim 1. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to sunlight, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder. 

Claim 2. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to a synthetic source of white light, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder. 

Claim 3. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: providing a light source that emits white light; filtering the ultra-violet (UV) rays from the white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a predetermined period ranging from 30-60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder. 

Background: It is a well-documented natural principle that white light affects a person’s mood. Exposure to white light changes neuronal activity in the brain, which changes a person’s mood. Sunlight is a natural source of white light. It is well-understood, purely conventional and routine in the art of treating mood disorders to expose a person to white light in order to alter their neuronal activity and mitigate mood disorders. 

Analysis of claim 1: Not patentable as drafted. This claim likely claims the well-documented natural principle that white light affects a person’s mood. Moreover, this claim likely violates section 27(8) which states that: “No patent shall be granted for any mere scientific principle or abstract theorem.” Additionally, as a method claim, it likely violates the rule against claiming methods of medical treatment (see, Tennessee Eastman Co v Commissioner of Patents, [1974] SCR 111; Axcan Pharma Inc v Pharmascience Inc, 2006 FC 527; Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2014 FCA 17). 

Analysis of claim 2: Not patentable as drafted for the reasons given in the analysis of claim 1, above. 

Analysis of claim 3: Not patentable as drafted for the reasons given in the analysis of claim 1, above. 

If the dosage regime of the method defined in claim 3 is inventive, it might be possible to obtain an apparatus claim which embodies the specifications of the method of claim 3, namely, a light source that emits white light, an ultra-violet (UV) ray filter and a positioning device to place the patient adjacent to the light source at a distance between 30-60 cm. The apparatus could potentially contain a timer measuring between 30-60 minutes. 

Diagnostic claim from Mayo Collaborative Services v. Prometheus Laboratories, Inc. – Examiner Training Materials 

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: 

administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and 

determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject, and 

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. 

Analysis of claim 1: Likely patentable if amended to remove the active step of administering the drug. Additionally, it would be advisable to supplement this claim with claims to a vendible product if possible, such as a system or kit for optimizing the blood-serum concentration of 6-thioguanine during treatment of an immune-mediated gastrointestinal disorder. 

Claim from U.S. Patent No. 6,573,103 – Examiner Training Materials 

1. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome, the method comprising the steps of: 

measuring the level of at least one screening marker from a first trimester of pregnancy by:

(i) assaying a sample obtained from the pregnant woman at said first trimester of pregnancy for at least one first biochemical screening marker; and/or 

(ii) measuring at least one first ultrasound screening marker from an ultrasound scan taken at said first trimester of pregnancy; 

measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by: 

(i) assaying a sample obtained from the pregnant woman at said second trimester of pregnancy for at least one second biochemical screening marker; and/or 

(ii) measuring at least one second ultrasound screening marker from an ultrasound scan taken at said second trimester of pregnancy; and 

determining the risk of Down’s syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies. 

Analysis of claim 1: Possibly patentable. This claim would likely face objections relating to claiming (1) a method of medical treatment (see, Tennessee Eastman Co v Commissioner of Patents, [1974] SCR 111; Axcan Pharma Inc v Pharmascience Inc, 2006 FC 527; Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2014 FCA 17); and/or (2) an exercise requiring professional skill, since the claim requires assaying, measuring, and comparing on the part of a lab technician, an ultrasound technician, and a medical doctor respectively (see, Lawson v Commissioner of Patents (1970), 62 CPR 101 (Ex Ct)). It might be arguable that these activities do not require professional skill, if they are routine and there is no exercise of discretion. 

This post was written by Trevor Newton, Jay Zakaib and James Holtom of Gowlings (Canada) and Lisa Mueller of Michael, Best & Friedrich.

 

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