An overview: revised biotech patent guidelines in Canada
In March, the Canadian Intellectual Property Office (CIPO) updated its Manual of Patent Office Practice (MOPOP) to include a revised version of Chapter 17: Biotechnology and Medicinal Inventions.This is the second time this chapter has been updated since the initial release of MOPOP in 1998.
MOPOP is a guide for patent examiners, applicants, agents and the public on the operational procedures and examination practices of CIPO. MOPOP describes CIPO’s interpretation of the Canadian Patent Act, Patent Rules and Canadian jurisprudence as of the date the revisions come into effect. MOPOP reflects official CIPO practice, but it is only a guideline and is not legally binding on Canadian courts. Notably, some Canadian Courts and legal scholars have described MOPOP as “soft law” (see, for example, Bartley v Canada Commissioner of Patents, 2011 FC 873 at paragraph 45).
The MOPOP update involves a selective restructuring of information, as well as some updates and clarifications relating to subjects such as patentability of living matter, nucleic acids and proteins, and chemical combinations, as discussed below.
Patentability of living matter
Higher and lower life forms (section 17.02.01)
In general, higher life forms, such as animals, plants, mushrooms, fertilised eggs and totipotent stem cells, are not considered to be patentable subject matter in Canada. This position of CIPO is based on the landmark Supreme Court of Canada decision in Commissioner of Patents v President and Fellows of Harvard College (2002), in which it was held that a genetically modified mouse is a higher life form and is not patentable subject matter in Canada.
In particular, the court held that the genetically modified mouse is not a “manufacture” or “composition of matter” and so does not fall within the definition of “invention” under section 2 of the Patent Act.
By contrast, lower life forms, including, but not limited to, microscopic algae, unicellular fungi (including moulds and yeasts), bacteria, protozoa, viruses, and transformed cell lines, can be patentable subject matter in Canada as “compositions of matter” or “manufactures”. Lower life forms are distinguished from higher life forms since they can be mass-produced and possess uniform properties and characteristics.
The MOPOP update extends the definition of higher life forms to include plant parts such as a cutting, callus, rhizome, tuber, fruit, or seed.
Use of higher life forms (section 17.02.01)
The MOPOP update notes that claims which are not directed to a higher life form per se, but include a higher life form within their scope, could potentially be statutory subject matter in Canada.
For example, consider a claim for “an animal feed comprising X”, where X is a higher life form. If this is construed as a use claim, then MOPOP says that it would be statutory subject matter. By contrast, if the claim is construed as claiming X or a product containing X, it would be non-statutory subject matter, even if X is produced using statutory methods or processes. In cases where the higher life form has been processed by significant chemical or physical modification, the claim may be construed as a “manufacture” within the definition of “invention” provided in section 2 of the Patent Act.
Organs and tissues (section 17.02.02)
The subsection on organs and tissues was revised in the MOPOP update.
CIPO does not consider genetically-modified organs or tissues to be patentable subject matter.However, artificial organ-like or tissue-like structures that are distinct from true tissues and organs and that have been generated by human intervention through the combination of various cellular and/or inert components may be considered, on a case-by-case basis, to be manufactures or compositions of matter and thus patentable subject matter. Functional and anatomical differences may be indicators that can be used to distinguish organ-like or tissue-like structures from true organs and tissues.
Processes to produce life forms (section 17.02.03)
This subsection was revised in the MOPOP update.
MOPOP states that a process which essentially occurs according to nature with no significant human intervention, for example traditional cross-breeding techniques, is not patentable. However, plant varieties produced through traditional cross-breeding techniques may be protected under the Canadian Plant Breeders’ Rights Act, which allows plant breeders to legally protect new varieties of asexually and sexually reproduced plants for up to 18 years. All plant species except for algae, bacteria, and fungi are eligible for protection under this act.
"MOPOP is a guide for patent examiners, applicants, agents and the public on the operational procedures and examination practices of CIPO."
A process that is a result of both human intervention and the laws of nature, however, is patentable subject matter if at least one step of human intervention is an essential element of the claim.
Processes that are considered to include significant human intervention include processes to produce a lower or higher life form (if the process includes more than traditional breeding techniques); processes to produce an organ or a tissue through genetic transformation; processes for the in vitro culturing or manipulation of cells; processes to separate cells; and processes to generate mutants using a chemical or physical agent.
Nucleic acids and proteins
Defining claims to nucleic acids and proteins (section 17.05.01)
Modified genes, expression vectors, probes, modified proteins, monoclonal antibodies and receptors, cells and other chemical compounds such as small organic molecules are patentable.
Updates to this section provide clarity on how to claim a protein or nucleic acid molecule sequence so that it complies with subsection 27(4) of the Patent Act.
In particular, MOPOP states that the claim should be explicitly directed to a biomolecule by reference to the sequence, but should also include language to claim the biomolecule itself. For example, MOPOP says a claim directed to “SEQ ID NO:8” would be ambiguous, but a claim to “DNA encoding the protein comprising amino acids 1-260 of SEQ ID NO: 8” would be specific enough, assuming the reference sequence is clearly defined. Including variable symbols in the sequence may not suffice to comply with section 27(4) of the Patent Act.
Defining claims by functional limitation (section 17.05.02)
Functional language (language which describes the function of a component) is generally used to provide breadth to a claim. Language that defines specific functional or biological activity can be used to distinguish a claimed biomolecule from biomolecules within the prior art.
The MOPOP update notes that where the structure of a protein (or a nucleic acid encoding a protein) is defined in terms of its homology to a reference sequence, the claim should also specify that the protein has the same biological activity as that described in the application. For example, “a nucleic acid comprising a sequence that is at least 90% identical to SEQ ID NO:1 which encodes a protein having alpha-amylase activity” would be acceptable.
Synergistic chemical combinations (section 17.10)
This section was added in the MOPOP update.
A synergistic combination is defined as “the combined use of two or more compounds or products generates a result that is greater than the sum of its parts and provides an unexpected advantage”.
A synergistic combination of known components that leads to an unexpected advantage (the synergistic effect) may be considered to be inventive by CIPO. To ascertain whether there is an unexpected advantage, MOPOP says it is necessary to describe the point of reference of the skilled person (ie, the result that would be expected from combining the individual components), either in light of the common general knowledge of the person skilled in the art, or in light of the description in the patent.
Potentiation, defined as where a first compound is applied for its known purpose and another compound unexpectedly enhances the result of that first compound, requires similar considerations as for synergistic chemical combinations. More discussion of combinations can be found in Chapters 9 and 10 of MOPOP.
Future updates
CIPO plans to review the MOPOP chapters discussing claims and utility (Chapters 11 and 12, respectively) in the near future. These revisions may also have important implications for biotechnology patents.
Jason Markwell is a partner at Belmore Neidrauer. He can be contacted at: jmarkwell@belmorelaw.com
Stephanie Anderson is an associate at Belmore Neidrauer. She can be contacted at: stephanie.anderson@belmorelaw.com
