From Inaugural Guest Blogger Brian Gray, setting a high bar:
On January 14 CIPO issued the revised version of chapter 17 of its Manual of Patent Operating Procedures (MOPOP) re biotechnology (pdf). Obviously a lot of work has gone into this. Interestingly enough, while the previous chapter 17 (pdf) dealt mainly with the formalities of filing sequence listings and other technical issues relating to biotechnology, this chapter attacks the more meaty issues of subject matter, utility, sufficiency and novelty as they relate to biotechnology, matters that had previously been and still are covered by chapter 12, a chapter that is still waiting for revision and is probably hung up on policy issues relating to business method patents and other abstract methods and elsewhere in MOPOP.
Thus the revised chapter 17 contains the following:
“As a matter of administrative economy, certain principles of general applicability are, however, discussed in the present chapter. Inclusion of these sections (e.g. on utility, sufficiency, selection patents, etc.) is intended to clarify practice in these areas of particular importance to biotechnology prior to formal amendment of the relevant chapters to which they more appropriately belong.”
Perhaps these amendments portend something about the general amendments to come in chapter 12.
I have not had the time to review this lengthy chapter in detail but I note that:
- In general unicellular material is statutory subject matter while multicellular life forms are not statutory, BUT any cell that has the ability to grow into an animal (i.e., fertilized eggs and totipotent stem cells) are also non-statutory.
- Embryonic, multipotent and pluripotent stem cells that do not have the inherent ability to develop into animals are therefore statutory.
On the method of medical treatment side:
- Treatments that cure, prevent or ameliorate an ailment or pathological condition are not patentable. However I note with some personal relief that methods that prevent ageing, baldness or wrinkles are not considered “pathological” and are therefore patentable.
- Diagnostic methods and research methods which are not methods of medical treatment are also patentable.
There is a long discussion of utility and sound prediction and if it was not clear before it is clear now that the examiners will look closely at what was promised in the specification. For example:
“Although an invention need only have one use in order to be patentable, where several uses are promised each must be properly established. For example, if a composition is promised to be useful as a drug in treating a specific disease, it must be established that it is useful in the therapy of that disease. If, however, it is promised to be useful as a drug for treating many diseases, its utility in treating all the diseases must be established in order for the specification to comply with subsection 27(3) of the Patent Act [see 17.04].”
This new chapter is 55 pages long and has lengthy discussions on sufficiency, novelty (including an interesting discussion of the ever-confusing concept of inherency), inventiveness of selections, and much more. It should be bed-time reading for every Canadian patent attorney.