This article was first published by Natural Products Canada (NPC) on June 23, 2020.
For many companies, a strong IP portfolio that covers key markets is their most valuable asset. Noel Courage and Don Bocchinfuso from Bereskin & Parr LLP, explain how different forms of IP can be combined to protect innovations based on natural products.
A patent grants an exclusive right to manufacture, use, or sell an invention. There can be issues in some countries about patentability of natural products. These issues tend to be less as products are processed by human intervention. Our natural product example below shows how a single product may be covered by multiple patents.
Starch is typically extracted from natural sources like wheat, rice, and potatoes and is a commonly used product in a variety of industries including food and beverage, pharmaceuticals, and industrial applications. There may be inventions in reagents, extraction processes, or for novel, engineered starches not found in nature. In some jurisdictions, plant breeders' rights or plant patents may cover modified plants with increased starch production capabilities. For example, there are dozens of potato varieties protected by plant breeders' rights, including "Elmo", "Lady Liberty", and "True Blue". Inventive methods of using starches in food production may also be patentable. For example, in 2014 Nihon Shokuhin Kako Co. was granted a patent for swelling-resistant starch used to improve the texture of food.
In situations where a company decides not to file a patent, keeping an innovation as a trade secret may provide an advantage.
Trademark protection grants the exclusive right to use a brand. Using the starch example, products bear the name or logo of their manufacturer. This mark serves as a clear indication of the source of the product, and is a tool used by companies to build and protect goodwill (ie. distinguish their goods or services). "Fleischmann's", "Red Mill" and "Roquette" are examples of registered trademarks.
Copyright grants the exclusive right to reproduce a protected work. Unlike other forms of IP, copyright need not be registered; it exists automatically as soon as a work is created (registration does provide additional advantages). In our example, starch itself is not eligible for copyright protection. However, processing instructions, product images, and laboratory notes are all protected by copyright and extend IP protection beyond starch itself.
The IP and regulatory strategies need to be aligned. The IP must cover the approved product that will be commercialized, as well as variants. For example, the Food and Drug Regulations create labelling and compositional rules for starch-containing products. Products labelled as "corn starch" for example must be made from maize and contain not less than 84% starch. Advertisement claims, such as those based on performance (eg. "fastest thickening of soups"), must also be supported by adequate and proper tests before the claim is made.
It is important to determine your regulatory pathway early on, whether marketing a product as a food, cosmetic, nutraceutical or even a drug. A starch that is used in food and beverage products may also be used in pharmaceutical products (eg. as an excipient). While chemically identical, different uses each bring their own regulatory challenges.
Some companies may choose to enter license agreements to allow others permission to use the IP rights. Licences are particularly attractive for companies that do not have the interest or means to profitably exploit an IP right themselves. Getting back to our example, patents covering starch innovations have been licensed by significant industry players for novel formulations and extraction methods.
IP litigation enforces IP rights against an infringer. You don't want to be the infringer, so you'll want to do a 'freedom-to-operate' analysis to identify competitor patents. You can design around or license patents where necessary. It is better to be the IP owner, so protect your own IP. In Canada, a patent owner may seek a permanent injunction preventing an infringer from selling infringing products. A court may also award compensatory damages, or an accounting of profits.
Companies should use a wide range of IP tools to protect their innovations, as shown by the example above. IP supports your own company's growth and products, but can also commercially exploited by licensing or enforcement.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.