Can you protect herbal & food supplements as products or formulations under the current ip legal provisions, to make any investment in research & development worthwhile?
The answer is ‘certainly yes‘ – provided, however, the product or formulation is new, inventive and has a technical character.
Intellectual property (IP), such as a patent, is critical in protecting such products or formulations. Patents are the “holy grail” for herbal & food supplements products or formulations. If a company owns a strong patent it benefits from a monopoly in the marketplace that allows the company to exclude competitors from practicing the patented invention for the life of the patent.
Consequently, patent-protected herbal & food supplements allow a company a valuable ‘lead time’ in the marketplace during which to recoup R&D investment, provide a powerful competitive advantage, and allow greater profitability through premium pricing for its patented products or formulations that cannot be obtained elsewhere. For this reason, for example, some dietary-supplement companies are plunging into the pharmaceutical strategy playbook, forsaking public-domain recipes from herbal manuals that cannot be protected, and starting to develop patent-protected products or formulations. The test of what is patentable and what can freely be copied by competitors, is largely dependent on whether the product, formulation or the use thereof is “novel” and ‘inventive’.
In order to meet the requirements of being “novel” the product, formulation or the use thereof must not have been disclosed to the public as such. The assessment of novelty is an objective assessment i.e. it was either disclosed or it was not. Remember, a leaf in the forest is still public disclosure, “… even if the wise man hid the leaf there…”!
To meet the requirements of being “inventive’ the product, formulation or the use thereof must be assessed from the point of view of the skilled person’s perception. The test for “inventiveness” is therefore a subjective assessment. In other words, ‘inventive’ is looked upon from the point of view of the skilled person who for example in herbal folklore would understand—based upon appreciation of the common general knowledge—why the various ingredients were put together. Thus, if for example dandelion and rosehip were combined into a recipe as detox, the rationale for the formulation would be obvious to anyone who had read an herbal manual. Such a recipe could be used or copied legally by anyone, but it couldn’t be patented because the knowledge it is based upon is ‘folklore’ which is already, and by definition, in the public domain or available for all to use.
However, if it isn’t obvious, for example, that herb ‘X’ is combined with herb ‘Y’ in a certain species which delivers enhanced efficacy in a way previously unrealised (or because either herb was harvested at a particular time point e.g. early morning), it may be considered to be inventive, and it could then be patented!
Consider the pharmaceutical model that, takes the basic elements of carbon, hydrogen, fluorine, nitrogen, and oxygen and forms them into a new combination (a ‘molecule’) known, in this case, as Atorvastatin, or more popularly as Lipitor, to reduce triglycerides (e.g. cholesterol). That molecule is what the pharmaceutical company patents. With herbal & food supplements, the as yet largely unexploited but patentable model is identical — a herbalist takes individual herbs and imaginatively combines them, not into a single organic molecule but into a new product or formulation that delivers a certain effect on the human body, which effect is technical in nature and thereby certainly patentable.