Harvard Mouse Revisited:  Canadian Patentability Issues in Biotechnology

Research institutions and companies who are devoting large amounts of capital to research in the biotechnology sector demand the ability to protect and exploit their inventions in the same way that other intellectual property rights holders can.  Needless to say with the increased public awareness of such biotechnology issues or initiatives as the Human Genome DNA sequencing project, and the cloning or production of transgenic animals, there is a heightened public debate of the socio-economic issues associated with the patenting of inventions in this field.  Leaving those issues for another day, however, the purpose of this paper is to outline the current state of the law in Canada with respect to the patentability of biotechnology-related subject matter.  The law in this area, particularly with respect to transgenic animals, is still in a nascent stage, but promises to be clarified or solidified by the Supreme Court of Canada upon hearing and decision of the Harvard Mouse case, should they grant leave to appeal in that case.  The appellate consideration of that case to date has shown that there are arguments both for and against the patentability of lower life forms.

The first problem faced by biotechnology companies in their encounters with the intellectual property legal system appears at this time to be one of definition. The term "biotechnology" itself has been held by the Federal Court of Canada to be a term of unsettled meaning.[1]  If the definition of that term is unsettled at the judicial level, it flows therefrom that the courts interpreting the rights of biotechnology companies in light of current established statutory regimes and case law might be less likely to adopt a progressive stance with respect to this area of the law, at least until the judicial comfort level with the terminology of the industry has increased and some of these terms gain acknowledged judicial scope.

One of the methods of intellectual property protection available to researchers or inventors is the patent system.  A patent is a statutory monopoly that is granted to an inventor or their assignee in exchange for the disclosure of the invention by the patentee.  The patentee obtains a limited-term monopoly, and society gains knowledge through the disclosure of the invention. 

Patents fall under federal jurisdiction in Canada, and specifically are governed by the Patent Act[2] and associated regulations.  There are also several international treaties that affect the processing of patents in Canada.  Provided that the conditions set out by the Patent Act are satisfied, an inventor can obtain patent protection in Canada for an “invention”, which is defined by the Act to mean “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”.[3] 

In order to be patentable, an invention must possess novelty and utility.  Within the broad scope of the term ‘biotechnology’, there are several different categories of inventive subject matter that are treated separately and distinctly under Canadian patent law.  The following outlines the state of the Canadian law with respect to patentability with respect to certain of these categories. 

Methods of medical treatment:

A patent includes a specification describing the invention, and which supports the claims.  The claims outline the scope of protection afforded by the patent.  Many different types of claims are possible, and several different species of claims are generally speaking included in biotechnology patent applications. 

Methods of medical treatment are currently not patentable in Canada.[4]  Methods of medical treatment extend beyond those practiced in a clinical situation and include any method claims for treatment of the human body in any medical manner with a substance, whether chemically derived or not.[5]  Applicants from other jurisdictions outside of Canada where methods of medical treatment are patentable, for example, the United States, need to either remove those species of claims from their patent applications in Canada or redraft them in accordance with Canadian practice to avoid the prohibition.

There are ways of avoiding the prohibition against patenting of methods of medical treatment in the drafting of a patent application, in certain circumstances.  For example, where a surgical method using novel apparatus is claimed, the apparatus can be claimed in traditional apparatus-style claims, or where chemical or other substances are discovered for use in medical treatment, the claiming of the compound itself may still be permissible and the method may be claimed without reference to the treatment itself.  Also, a new medicinal use of known matter may be patentable,[6] and diagnostic methods may not be considered to be methods of medical treatment.[7]  As such, another potential method of avoiding the prohibition in the right circumstances is to cast the invention as a diagnostic method rather than a treatment. 

Food:

Canadian patent laws over the years have not favored the patentability of food or medicines.[8]  In 1991, however, the restrictions on the types of claims which were allowable on food or drugs products were lifted.  Prior to the repeal of these provisions it would have been necessary to claim in a product-by-process format, but this is no longer necessary for products falling into this category.  As is pointed out in Hughes on Patents, “since the repeal of these provisions, the jurisprudence appears to be that chemical compositions intended for medicines can be the subject of claims in a patent formulated in an acceptable carrier. The Patent Appeal Board has stated that any patent issued after November 19, 1991, regardless of when it was filed, will be allowed to contain claims to naturally occurring substances with no process limitations.”[9] 

Plants:

The Plant Breeders’ Rights Act[10] provides a type of statutory intellectual property protection to new plant varieties.  A plant variety is “new” if, as defined by section 4(1) of the Act, it:

1. is, by reason of one or more identifiable characteristics, clearly distinguishable from all varieties the existence of which is a matter of common knowledge at the effective date of application for the grant of the plant breeders’ rights respecting that plant variety; 

2. is stable in its essential characteristics in that after repeated reproduction or propagation or, where the applicant has defined a particular cycle of reproduction or multiplication, at the end of each cycle, remains true to its description; and

3. is, having regard to the particular features of its sexual reproduction or vegetative propagation, a sufficiently homogeneous variety.

It may also be possible to obtain patent protection for plant matter in certain circumstances.  The leading case on the patentability of plants in Canada under the Patent Act is the decision of the Supreme Court of Canada in Pioneer Hi-Bred Ltd. v. Commissioner of Patents.[11]  That decision, dealing with the patentability of a new soybean variety, dealt primarily with the enablement requirements of a patent disclosure, but Lamer J. (as he then was) made the following statement regarding the patentability of genetically engineered material:

Genetic engineering can occur in two ways. The first involves crossing different species or varieties by hybridization, altering the frequency of genes over successive generations. … Naturally, the genes only offer a reasonable prospect that the traits will be acquired from one generation to the next. It should further be remembered that acquiring a certain characteristic does not automatically mean developing that characteristic: some effects in gene development and the influence of environment can cause genetic mutation. …  There is thus human intervention in the reproductive cycle, but intervention which does not alter the actual rules of reproduction, which continue to obey the laws of nature.

This procedure differs from the second type of genetic engineering, which requires a change in the genetic material -- an alteration of the genetic code affecting all the hereditary material -- since in the latter case the intervention occurs inside the gene itself. The change made is thus a molecular one and the "new" gene is thus ultimately the result of a chemical reaction, which will in due course lead to a change in the trait controlled by the gene. While the first method implies an evolution based strictly on heredity and Mendelian principles, the second also employs a sharp and permanent alteration of hereditary traits by a change in the quality of the genes. …

The intervention made by Hi-Bred does not in any way appear to alter the soybean reproductive process, which occurs in accordance with the laws of nature. Earlier decisions have never allowed such a method to be the basis for a patent. The courts have regarded creations following the laws of nature as being mere discoveries the existence of which man has simply uncovered without thereby being able to claim he has invented them. Hi-Bred is asking this court to reverse a position long defended in the case-law. To do this we would have, inter alia, to consider whether there is a conclusive difference as regards patentability between the first and second types of genetic engineering, or whether distinctions should be made based on the first type of engineering, in view of the nature of the intervention. The court would then have to rule on the patentability of such an invention for the first time.[12]

The case was disposed of on other grounds, but it is against the background of this statement that the present dispute over the patentability of life forms is taking place.

The Harvard Mouse case:

The President and Fellows of Harvard College (“Harvard”) filed Canadian Patent Application Serial No. 484,723 on June 21, 1985.  The subject matter of the application is a transgenic mouse which is predisposed to beneficial use in cancer research.  The application as amended in prosecution in the Canadian Intellectual Property Office contained two species of claims.  Claims 1 through 12 of the application dealt with the transgenic mammal itself and Claims 13 through 26, in a different format, were eventually allowed by the Examiner.  The patent has been issued in the United States, and has to my knowledge been allowed in Europe as well. 

The process of invention is described as follows:

Claims 1 through 12 of the ‘723 application relate to a transgenic mammal, that is a mammal containing a gene that has been artificially introduced into the chromosomes of the mammal or its ancestor at the embryonic stage (preferably at the single cell stage).  The fertilized eggs were then transferred to a female mouse (“foster” mouse) and allowed to gestate naturally.  The gene introduced predisposes the mammal to developing neoplasms, ie. malignant tumors.  This gene is referred to as an oncogene or a myc gene.  The mice born of this process (“founder” mice) are tested to determine if they carry the myc gene.  Two males of 28 founder mice which were tested were found to have retained the artificially introduced gene.  These two male mice passed along these genes “in a ratio consistent with Mendelian inheritance of single locus”.  The offspring of these two founder males were tested.  The genes were not detected in all of the organs anticipated.  The inventors were able to “back-cross” and inbreed in order to obtain offspring with more widely varying sites of the new myc gene, but even this generation had “qualitatively different patterns with respect to the more minor myc hybridizing fragments”.[13]

  The Examiner rejected the species of claims directed to the mouse on the basis that they were non-statutory subject matter.  Rejecting the mammal claims, the Examiner stated, inter alia, that “The Commissioner has both a right and an objection to consider the public interest in the granting of a patent.  There is some implication in this interpretation of the Commissioner’s duty under the Patent Act that the Commissioner can decide that a particular invention can be found unpatentable as a matter of policy or discretion rather than as a result of an interpretation of the provisions of the Act.”[14]  The appeal decision of the Commissioner of Patents rejects this position as follows:  “in order to reject an application as being directed to unpatentable subject matter, [the Commissioner]…must be satisfied that by law the applicant is not entitled to a patent and be able to give reasons based on interpretation of the Patent Act and any applicable jurisprudence.” [15] [Emphasis in original]

Having disposed of the supposition by the Examiner that there was a public interest in rejecting these types of patent applications, the Commissioner’s decision then resolves the issue to actually be a determination of whether or not non-human mammals are patentable subject matter as defined by the definition of the term “invention” in Section 2 of the Patent Act.  In considering whether or not a non-human mammal falls within the term “manufacture or composition of matter” in the definition of “invention” in the Patent Act.  The Commissioner held in his decision that two distinct ‘phases of invention’ could be identified in the development of the Harvard transgenic mouse.  Specifically, the first stage involved the preparation of the genetically engineered plasmid for implantation in the mouse, and the second stage being the development of a genetically engineered mouse in the uterus of the host mouse into which this genetically engineered myc gene was implanted.  The Commissioner finds that in the first phase, the engineering of the plasmid itself, it was completely human intervention that controlled the production of the plasmid and, as such, claims to that phase of the process were directed to patentable subject matter.  However he points out that in the second phase, namely the development of the genetically engineered mouse itself which contained the myc gene, in his opinion the laws of nature take over to produce the mammalian end product and in that case the laws of nature are responsible for at least one step in the process which took the process at that point beyond the direct control of the inventors.  On this basis it was held that the resulting mouse was not patentable subject matter since “the inventors do not have full control over all of the characteristics of the resulting mouse, since the intervention of man ensures that reproducibility extends only as far as the cancer-forming gene”.[16]

The Federal Court Trial Division upheld the decision of the Commissioner of Patents that the subject matter of Claims 1 to 12 of the Harvard application was not patentable.  Specifically, the Judge stated:

A complex life form does not fit within the current parameters of the Patent Act without stretching the meaning of the words ‘the breaking point’, which I am not prepared to do.  However, if Parliament so wishes, it clearly can alter the legislation so that mammals can be patented….The inventor has already received a patent for the creation of the plasma and the injection thereof into the mouse oocyte.  The Appellant can exclude all others from participating in any activity which infringes that which is already patented.  Even to stretch the definition of invention would not enhance the protection already accorded the Appellant.[17]

The Federal Court of Appeal heard an appeal from the decision of Nadon, J., in December of 1999, rendering their decision in August of 2000.[18]  Linden and Rothstein, JJ.A., allowed the appeal, holding in general that the transgenic mouse or any transgenic mammal falling within the scope of Claims 1 to 12 of the application were patentable subject matter.  Isaac, J.A., dissented, choosing to defer to the Commissioner of Patents decision. 

Rothstein, J.A., states that despite the fact that there was “considerable fanfare” associated with this appeal and that there are numerous policy issues associated with it, he is of the opinion that “all that is at issue in this appeal is the interpretation of the patent, a determination of whether on the basis of the evidence the Appellant’s product is patentable in accordance with that interpretation.”[19]  He goes on to conclude that “the oncomouse is both unobvious and a new and useful composition of matter.  Therefore, it is an invention within the meaning of that term in Section 2 of the Patent Act.”[20]

In dealing with the position taken by the Commissioner of Patents and others that discoveries following the laws of nature must specifically be excluded from the definition of “invention” in the Patent Act, Rothstein, J.A., points out that the reason that such discoveries may not meet the requirements of patentability would be because they are not considered new and unobvious and not because there is some prohibition against their patenting.  Discoveries following the laws of nature that would not be novel or patentable are considered to have existed and only to have been uncovered by man rather than being invented.  In order to come up with patentability, “a non-naturally occurring composition of matter arising from the application of inventiveness or ingenuity”[21] is required.  Since the oncomouse in this case was a mouse with a genetic structure that would not have been found in nature, but was in fact non-naturally occurring and arose from the application of inventiveness and ingenuity, was found to be sufficient to satisfy the test of patentability for the Harvard oncomouse.  The Commissioner’s initial allowance of Claims 13 to 26 in the application, for the creation of the myc cell, supports the proposition that the mouse itself is not a naturally occurring phenomenon, but would require human intervention at the very least in the form of creation and injection of the plasmid to yield the transgenic mammal.  The decision goes on to point out:

In my opinion, the oncomouse must be considered to be the result of both ingenuity and the laws of nature – ingenuity in the initial genetic engineering involving the assembly of the oncogene and incorporating it into the plasmid and injecting the plasmid into the zygote; and the laws of nature, with the oncogene then affecting all the cells of the oncomouse in the course of gestation, the subsequent mating of an oncomouse and an uninjected mouse, and the reliance on Mendelian laws of inheritance to obtain offspring oncomice.  However, the use of the laws of nature by inventors does not disqualify a product from being an invention, providing inventiveness or ingenuity is also involved.[22]

He likens the invention in this particular case to the “second-type” of genetic engineering discussed by Lamer, J., as he then was, in the Supreme Court of Canada decision in Pioneer Hi-Bred.[23]  The decision goes on finally to say that the definition of “invention” in the Patent Act could not be extended to human beings.  The basis for this is that Section 7 of the Charter of Rights and Freedoms would be violated by granting someone property in another human being.

Leave to appeal this case to the Supreme Court of Canada was applied for by the Commissioner of Patents on October 2, 2000.  It would appear that this case, if accepted by the Court for hearing, will result in a specific judicial pronouncement on the patentability of transgenic non-human mammals or other animals in Canada. 

International Issues and Alternative IP Protection Strategies in Biotechnology:

To say then that parties generally seeking intellectual property protection of their inventions in Canada and abroad, and biotechnology companies in particular, face difficult questions in determining the appropriate protective strategies for their inventions is definitely the case. The availability, accessibility and propriety of various legislative protection measures in various market countries might in certain cases mandate different approaches be taken in different countries with respect to the same invention.  Companies seeking multi-national protection of particular inventions often end up with 'checkerboard' protection.   Some countries have no protective scheme whatsoever in place and companies are left to find alternative methods of maintaining control over the exploit of their research – other methods of protection such as contracts or the physical control of the breeding of the animal may be necessary to control the invention. Another situation, which might result in companies taking different approaches to patenting or other forms of IP protection, are situations where governments have attempted to piggy-back other legislative schemes onto the patent system. An obvious example of this in Canada lies in pharmaceuticals, and the Patented Medicines Price Review Board. While a pharmaceutical company may focus on patenting their work in other countries, they may wish to avoid the legislative regime associated with patented medicines in Canada and may therefore end up looking for other alternative methods of protection.

The import and implications of the Harvard Mouse case are such that leave to appeal will be granted and the matter heard by the Supreme Court of Canada.  It is submitted that Harvard will be successful and their claims be found to be patentable, on the basis of a reasonable reading of the Patent Act and the similar legislation in place in the United States and Europe, where the Harvard application has been or is to be allowed to issue to letters patent.  As we move forward and researchers continue to expand their inquiries into new technologies and fields the issue will remain whether or not intellectual property laws can keep up with these scientific developments.  The resolution of the Harvard Mouse case by the Supreme Court of Canada will be a good indicator of how the existing laws can be interpreted to protect biotechnology inventions, and subject to intervening legislation it is submitted that the laws as they exist today can be applied to protect new biotechnology platforms within reasonable limits and a reasonable reading of the Patent Act.

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