In January 2009, the Canadian Intellectual Property Office (“CIPO”) updated its Manual of Patent Office Practice (“MOPOP”) to include a revised version of chapter 17, which concerns biotechnology. This marks the first time the chapter has been amended since its initial release in 1998. Whereas the previous chapter 17 dealt merely with procedural aspects of patenting biotechnological inventions, such as deposits of biological material and nucleotide and amino acid sequence listings, the revised chapter is considerably expanded to cover substantive issues, including patentable subject matter, utility, sufficiency and novelty as they relate to biotechnology. In particular, chapter 17 now addresses a variety of subjects peculiar to biotechnology, such as the patentability of higher and lower life forms, methods of medical treatment and polyclonal and monoclonal antibodies. The new chapter 17 also provides numerous exemplary patent claims intended to clarify CIPO practice.
Summarizing the law as it relates to patenting biotechnology is a major undertaking, and CIPO is to be commended for its efforts in establishing publicly available examination guidelines in this area. Regardless of whether there is general agreement as to the correctness of CIPO’s position on the topics covered, chapter 17 is a useful tool, as it provides patent applicants in Canada with an improved degree of certainty as to the examination process in this rapidly developing field in which the law remains in flux in many areas. Some of the more contentious topics addressed in chapter 17 are discussed below.
Higher life forms. CIPO’s position respecting the patentability of higher versus lower life forms reflects its earlier policy statement in a 2006 notice titled “Office Practice Regarding Fertilized Eggs, Stem Cells, Organs and Tissues” (Canadian Patent Office Record, Vol. 134, No. 25, June 20, 2006). Generally, CIPO considers the distinction between patentable lower life forms and unpatentable higher life forms to be whether the life form is unicellular (lower) or multicellular (higher). Higher life forms include animals, plants, seeds, mushrooms, fertilized eggs and totipotent stem cells. CIPO also considers organs and tissues to be non-statutory subject matter. Lower life forms acknowledged by CIPO to be patentable include microscopic algae, unicellular fungi (including moulds and yeasts), bacteria, protozoa, viruses, transformed cell lines, hybridomas and embryonic, pluripotent and multipotent stem cells.
CIPO explains that animals “at any stage of development” are not statutory subject matter for patents and consequently that fertilized eggs and totipotent stem cells (which CIPO defines as those that have the inherent ability to develop into animals) are included in the higher life form proscription (MOPOP, section 17.02.01a). Conversely, embryonic, multipotent and pluripotent stem cells, which do not have the inherent ability to develop into an animal, are considered by CIPO to be lower life forms. The language used by CIPO to define this exclusion echoes Article 5 of the European Biotechnology Directive and Rule 29 of the Implementing Regulations to the Convention on the Grant of European Patents, which proscribe patenting of the human body “at the various stages of its formation and development,” including germ cells. There are, however, no analogous provisions in the Canadian Patent Act or Rules.
As authority for its position, CIPO cites the Supreme Court of Canada decision in Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76, holding that a transgenic mammal is not a patentable “composition of matter.” However, both the majority and the dissent in Harvard College commented in obiter dicta that a fertilized, genetically modified egg should indeed be patentable. The Supreme Court reiterated this view in Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34, holding that a plant cell per se is eligible for patent protection. Moreover, in Schmeiser, the Court emphasized its view in Harvard College that a fertilized egg was patentable irrespective of its subsequent development into a mouse. Indeed, the patented plant cells in the Schmeiser case were without doubt totipotent, as the patent specification clearly demonstrates the regeneration of whole plants from such cells. The reasoning behind a totipotent plant cell being patentable but not a totipotent mammalian cell (assuming both plants and mammals are “higher life forms”) is not explained in chapter 17. It is therefore difficult to reconcile the position of CIPO regarding the patentability of stem cells and fertilized eggs with the views expressed by Canada’s highest court. Certainly, if the intent is to mirror the European prohibition, the necessary express exceptions to patentability are not present in the Patent Act or Patent Rules and the basis for such a prohibition does not appear to be found in the Harvard College decision.
Methods of medical treatment. There is no prohibition against patenting methods of medical treatment in the Canadian Patent Act or Patent Rules. However, methods of treatment are typically considered unpatentable in view of the 1972 decision of the Supreme Court of Canada in Tennessee Eastman Co. v. Canada (Commissioner of Patents), [1974] S.C.R. 111. In that case, the Supreme Court held that a method of using certain adhesives to close surgical incisions was unpatentable. The Court held that the otherwise broad scope of the definition of “invention” was circumscribed by section 41 of the Patent Act, which required claims directed to foods or medicines to include process-of-manufacture limitations. Permitting a claim to a method of using the adhesive per se would have circumvented the requirement in section 41 that the adhesive be claimed by reference to the method for making it. However, section 41 has since been repealed, and few subsequent Canadian court decisions have explored in any depth whether any basis still exists under the current Patent Act to exclude methods of medical treatment from patentability. One possible approach is to exclude methods of medical treatment on the ground that they are directed to professional skills rather than to trade, industry or commerce (see, e.g., Shell Oil Co. v. Canada (Commissioner of Patents), [1982] 2 S.C.R. 536 at para. 41). However, the scope of the so-called “professional skills” exclusion is not settled, and recent Patent Appeal Board decisions have confined this exclusion to methods that are not reproducible because they rely upon human intuition or judgment for their success (see, e.g., Re Diamonds.net LLC Patent Application No. 2,298,467 (2006), 55 C.P.R. (4th) 328 (P.A.B.)). Presumably, therefore, if the professional skills exclusion is the only remaining basis in Canadian law for excluding methods of medical treatment from patentability, then relatively simple, reproducible methods should not be excluded.
It appears from revised chapter 17 (section 17.02.03) that any method claim that involves at least one “step of surgery” will be rejected, regardless of the ultimate purpose of the method (e.g., an otherwise patentable diagnostic method), as will any method claim that gives a therapeutic benefit, regardless of whether a surgical step is recited. Indeed, in many instances, the issue is largely academic, as claims that recite the use of a compound for treatment of a disease are permitted, provided the use claim does not positively recite any method steps. Examples of steps that CIPO considers to be surgical are provided, and it appears that certain basic procedures, such as injections or the removal of body fluids by needle or cannula, are not considered to be surgical steps per se. However, the examples of unpatentable “medical treatment” reflect the difficulty in articulating the underlying legal basis for this exception from patentability under current Canadian patent law. Chapter 17 explains that claims to methods for curing or preventing pathological conditions or physical abnormalities are prohibited, but claims to methods for treating non-pathological natural conditions such as aging, baldness, pregnancy and wrinkles are permitted, as are cosmetic and diagnostic methods. It is unclear why this distinction would be drawn, as both types of claims seem equally related to trade, industry or commerce (assuming that is the test). This is an area of law that might benefit from clarification by Canadian courts.
Utility and sufficiency. Another addition to chapter 17 concerns the requirement of utility of the claimed invention. Utility is already the subject of chapter 12 of the MOPOP, but certain topics receive special attention in revised chapter 17. Notably, CIPO takes the position that a patent application disclosing and claiming novel and inventive compound X (i.e., a claim to the compound per se) does not comply with the requirements for sufficiency of disclosure in section 27(3) of the Patent Act if the specification states that the compound can be used to treat disorders Y, A, B and C, but the description only contains data supporting treatment of disease Y and no data or other basis for concluding that compound X would also be useful for treating disorders A, B and C. It appears that the objection is not to the claim (indeed, novel compound X is useful for treating disease Y and thus possesses utility) but rather is to the specification for failing to substantiate the additional promised utilities (MOPOP, section 17.03). This is a novel approach to examination by CIPO, which to date has always focussed on examination of the claimed invention. It is not clear how such an objection is to be overcome if the Examiner cannot be persuaded through argument. Must the applicant redact the specification to remove reference to additional, unproven utilities, even if the claim is in acceptable form? No specific citation of court authority endorsing this new approach is provided.
CIPO has also articulated a new utility requirement for priority claims: it now considers a priority claim to be effective only if the priority document satisfies the requirement of disclosing a “sound prediction” of the utility of the claimed invention (MOPOP, section 17.03.03). The requirement for a Canadian patent application to provide a sound prediction of utility is well-established, but no authority has been cited for extending this requirement to priority documents.
Correction of sequencing errors. It has historically been very difficult to correct nucleotide or amino acid sequence listings in Canadian patent applications, even if re-sequencing of a sample of biological materials would provide the correct sequence. This difficulty will persist under amended chapter 17, which indicates that if the correct sequence may only be determined by re-sequencing a sample, the correction will constitute impermissible addition of new matter (MOPOP, section 17.04.01e).
Chapter 17 does not explain whether a different standard will apply if the sample was deposited under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Protection. Section 38.1 of the Patent Act provides that such a deposit forms part of the specification, so it is arguable that a re-sequencing of a sample from such a deposit should not constitute new matter. Canadian courts have not considered this issue. The United States Patent and Trademark Office (“USPTO”) permits reliance on the deposit for this purpose (Manual of Patent Examining Procedure (“MPEP”) §2163).
Working examples. The revised chapter 17 also emphasizes the desirability of working examples in the patent specification. While CIPO correctly notes that there is no absolute requirement under section 27(3) of the Patent Act for an application to include examples, it states that exemplary support may be required in some cases to fulfill the “what is your invention” aspect of proper disclosure (MOPOP, section 17.04.03). In support of such a requirement, CIPO cites section 80(1)(f) of the Patent Rules, which provides that the description shall “set forth at least one mode contemplated by the inventor for carrying out the invention in terms of examples, where appropriate, and with reference to the drawings, if any….” Reliance on this section of the Rules is a new approach. The purpose of this provision — found in a section of the Patent Rules setting out the formal requirements for the description and also requiring a title of the invention, background section and so on — is not clear, and Canadian courts do not appear to have ever considered this provision in assessing sufficiency of description in a patent specification.
Monoclonal antibodies. Revised chapter 17 includes a section on “special topics,” which presently contains only a discussion of claims to antibodies (MOPOP, section 17.08). Based on the Commissioner’s decision in Re Institut Pasteur Application (1995), 76 C.P.R. (3d) 206 (P.A.B.), CIPO’s practice has been to permit
a claim to an antibody in an application disclosing a novel antigen but to allow a claim directed to a monoclonal antibody only if the specification includes at least one working example demonstrating the preparation of a monoclonal antibody. In Institut Pasteur, the Commissioner held that in the mid-1980s, the basic Köhler and Milstein hybridoma technique for producing monoclonal antibodies was sufficiently uncertain that a mere reference in a patent application to use of “traditional techniques” was not enabling.
The amended chapter 17 now acknowledges that the general procedures for making monoclonal antibodies are sufficiently well-known in the art that a detailed explanation of such procedures is not normally required to provide an enabling description of the invention. Nevertheless, CIPO indicates that whether a monoclonal antibody has been made remains relevant to whether the antibody has been described in sufficient detail.
In a significant departure from past practice, CIPO now indicates that a working example is not absolutely essential. However, if a working example is not provided, revised chapter 17 explains that the specification must include a structural description of the particular epitope on the antigen to which the monoclonal antibody specifically binds to sufficiently describe the monoclonal antibody. The basis for this conclusion is unclear, as no Canadian court decision has ever established such a requirement for claims to monoclonal antibodies. In contrast, the USPTO takes the view that disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties or deposit in a public depository provides an adequate written description of an antibody claimed by its binding affinity to that antigen — i.e., there is no need to characterize a particular epitope, binding pocket or the like (MPEP §2163, citing Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed.
Cir. 2004)).
From a scientific standpoint, the description of a monoclonal antibody specific to a particular antigen would not appear to require identification of the particular epitope to which the monoclonal antibody binds. If there are two or more epitopes, then the monoclonal antibody binds to one of them. This also appears to be irrelevant to making monoclonal antibodies. Presuming various antibody-producing B lymphocytes can be successfully fused with myeloma cells to produce hybridomas, serial dilution to obtain one cell per well provides monoclonal antibodies, all of the same binding specificity. The specific epitope to which such monoclonal antibodies bind would often not be known but could be determined if needed. Further, if the claim does not recite binding specificity to a particular epitope, it is unclear why the description would have to describe the particular epitope.
Provided it is possible to immortalize a B lymphocyte that produces antibodies to a particular antigen (which revised chapter 17 concedes is generally a routine matter), then it is readily possible to produce monoclonal antibodies specific to the antigen. It is not necessary to know what epitope the antibody has been raised against, nor to describe this, unless the claims are directed to an antibody specific to a particular epitope. The claimed property of being monoclonal relates to the antibodies all being derived from a single immortalized B lymphocyte (i.e., a hybridoma) and thus inherently having the same specificity, not that the B lymphocyte produces an antibody reactive with a pre-selected epitope of the antigen.
The new examination policy concerning monoclonal antibodies also appears to be internally inconsistent. It is unclear why the requirement for a structural description of a particular epitope to which a monoclonal antibody binds would be viewed as interchangeable with the alternative requirement of a statement that at least one monoclonal antibody was made. The latter description would not identify the epitope to which the antibody binds but would only demonstrate that the specification is enabling, and the MOPOP now acknowledges that methods for making monoclonal antibodies are routine. Further, the description of a single monoclonal antibody (even by structure) specific to one epitope would not describe antibodies that are specific to other epitopes on the antigen. It is unclear why the making of a single monoclonal antibody would provide a description sufficient to support a claim to a monoclonal antibody specific to an antigen but not limited to a particular epitope.
Conclusion. The field of biotechnology has evolved greatly since the inaugural version of chapter 17 was released. This updated and expanded version of chapter 17 may be welcomed by inventors and patent practitioners as an attempt by CIPO to address some of the unique challenges posed by biotechnological inventions.
Our articles and newsletters are informational only, and do not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.