Protecting your natural health products

Natural health products (NHPs) represent a growing market in Canada. This has made protection and dealing with regulatory authorities more important than ever for manufacturers and sellers. Since over 70% of Canadians say they have used NHPs, according to a 2005 Ipsos Reid study, protecting advances in the field can give a substantial advantage over the competition.

Regulations relating to NHPs have been in force in Canada since January 1 2004, setting requirements for the manufacture, packaging, labelling, importation for sale and distribution of NHPs. But first, what is an NHP?

Substances falling under the definition provided by Health Canada are subjected to the regulations. Health Canada has excluded from the definition of NHPs the following:

• radiopharmaceuticals and drugs sold or represented for use in their preparation;
• biologics, (ie, a drug prepared using a biological starting or source material and using, for example, conventional manufacturing methods, recombinant DNA technology and/or another novel approach;
• substances regulated under the Tobacco Act;
• substances set out in the Controlled Drugs and Substances Act;
• substances administered by puncturing the dermis; and
• antibiotics prepared from an alga, bacterium, fungus or synthetic duplicate of that antibiotic.
• Products requiring a prescription do not qualify as NHPs.

There is a common misconception that no IP protection is available for NHPs. This is very likely due to the fact that some natural compounds have been used for a long time in traditional medicine, therefore creating a bar to novelty. However, Canadian patent law makes no distinction between inventions and NHPs. The Patent Office considers them in the same way as any other product. To be patentable, a technology must respect the following patentability criteria:

•  novelty - the subject matter to be claimed must not have been disclosed to the public before the priority date or more than one year from the disclosure by an inventor or someone having obtained the information from the inventor;
• inventiveness - the subject matter to be claimed must be inventive in view of one or more references, alone or in combination; and
• utility - the subject matter must be operative and controllable.

Moreover, the claimed subject matter must be described in a sufficient way to allow the person skilled in the art to reproduce the invention.

• an extraction or purification process - for example, “a process for preparing a fraction of a plant extract, comprising the steps of …”;
•  an extract obtained by a specific process - for example, “a formulation comprising a fraction of a plant extract obtained by …”;
• a composition of matter (if all the essential components are defined) - for example, “a herbal composition comprising X, Y and Z.”; and
•  a use - for example, “use of a herbal composition comprising X, Y and Z for reducing muscular tension in a subject.”