The global nutraceuticals market is a growing multibillion-dollar industry with a constant flow of innovative new dietary supplements and functional foods and beverages coming to market to meet strong consumer demand. In such a competitive and varied industry, a solid understanding of the basics of intellectual property law as it relates to nutraceuticals is a critical component of business success. A variety of different types of intellectual property rights may be associated with your new nutraceutical. How you protect, secure or enforce your rights will depend upon the nature of your intellectual property, which typically includes one or more of trade secrets, copyrights, trademarks, patents and other forms of exclusivity.

Trademarks and trade secrets are the primary means of intellectual property protection for the typical nutraceutical company. Trademarks are used to indicate the source of the goods and services—in other words, they identify your company and distinguish your goods and services from those of other companies. Trademark protection may extend to a company’s brand names, logos and slogans, or any other distinctive elements associated with its products. As soon as you use your trademark in connection with marketing your goods or services, you begin to acquire common law trademark rights. Such common law rights are limited to the geographic area in which the trademark is used and any geographical areas where the trademark’s use could reasonably expand. Since most products are now advertised on the internet and in social media, however, most companies can usually establish broad common law use fairly quickly.

If another company can show that they used the same trademark outside of your geographic area for the same goods or services, however, it may be difficult for you to stop them from using their mark. To avoid this problem, and to obtain nationwide priority for your trademark, you must file a federal trademark application at the U.S. Patent and Trademark Office. A federal trademark application can be filed as soon as you decide which mark or marks you intend to use in connection with your goods or services. The minute you file the application, you establish nationwide priority for your mark. This priority is contingent upon the issuance of the trademark registration, which will not occur until the application has been examined and approved by the U.S. Patent and Trademark Office, and you have used your mark in commerce on all of the goods and services in the application.

It is important to note that trademark rights are territorial in nature, and that the only way to establish trademark rights in most foreign countries is by obtaining a trademark registration there. Even if you use your mark first, the first company to obtain a registration for the mark in a foreign country is deemed to be the owner of that mark. If you market your nutraceutical outside of the United States, you may wish to file trademark applications in all jurisdictions of interest.

In addition to registering your brand names, logos and slogans, you may also want to consider taking steps to protect the trade dress of your product and packaging. Trade dress refers to the aspects of the commercial impression, or look and feel of a product. These aspects identify the source of the product and distinguish it from the products of others. Section 43(a) of the Lanham Act provides for protection of a product’s trade dress and permits the owner to sue someone who copies the trade dress (an infringer) if certain requirements are met. Trade dress may be registered with the U.S. Patent and Trademark Office on either the Principal Register or the Supplemental Register. By registering on the Principal Register, a registrant gains nationwide constructive use and constructive notice, which prevents others from using or registering that registrant’s trade dress without contesting the registration, and after five years on the Principal Register, the registration can no longer be contested.

The good will you develop in your company’s name and nutraceutical products can be a valuable company asset as well as a critical component of your marketing plan. Once your customers come to associate your brand and trade dress with a high value/high quality product, customer retention can be improved, and cross-selling of other goods and services offered by your company can be facilitated.

Information that is economically valuable because it is not generally known, and which offers your company a competitive advantage, may be protectable as trade secrets. Trade secrets specific to nutraceuticals may include the specific formulation of a supplement (including both active ingredients and excipients), particularly effective methods of extracting an active ingredient from natural product (plant material, etc.), collections of supplier, distributor or consumer data, or other information offering a competitive edge. In order to protect a trade secret, reasonable measures must be taken to maintain its secrecy. Such measures will depend upon the nature of the information, and may include securing a nondisclosure agreement as a condition of employment or as a condition of doing business as your supplier, distributor or contractor, limiting access to the information such that it is only provided on a “need to know basis” to your employees and others in the supply chain, use of password protection and encryption of computer-stored data, and the like. Protection of the information is critical, because once the information becomes public, it is no longer a trade secret.

While trademarks and trade secrets may give you a tremendous competitive advantage over your competitors, they typically will not enable you to prevent a competitor from marketing a competing product. Patents, however, can enable you to potentially block a competitor from marketing a protected product. The owner of a United States utility patent is granted the right to exclude others from making, using, offering for sale, selling or importing the patented invention in the United States for a limited period of time—typically 20 years from the effective filing date of the application for United States utility patent. As with trademarks, patent rights are territorial, and you must pursue them through the patent offices of the countries or regions where protection is desired. In order to pursue patent protection, one must include in the application for United States patent a full description of the invention to be protected such that the public is able to practice the invention. Patent applications generally publish shortly after filing, disclosing the invention, but there is no guarantee that an application for patent will ultimately be granted. In order for an invention to be considered patentable, it must be both novel and nonobvious. An invention is novel if it is not previously known by others. Such an analysis of novelty is generally straightforward. However, a determination of nonobviousness may be nuanced and subjective. Accordingly, there is a risk in pursuing patent protection that your invention will be disclosed but no patent rights will be granted. Depending upon the nature of the invention, it may be a preferred course of action to attempt to maintain the invention as a trade secret rather than disclose the invention through the patent application process.

Utility patents protect inventions including new and useful processes, articles of manufacture, compositions of matter and any new and useful improvement thereof. Nutraceutical compositions typically fall within two categories: a known or natural substance for a new use; and combinations of known or natural substances offering enhanced performance compared to that of the individual components. Unlike many pharmaceutical compositions, the components of nutraceutical formulations are typically substances that are known (not novel), and as such are not themselves eligible for patent protection. However, if the known substance is identified for a new (novel) use, it may be possible to secure patent coverage for a new method of using the substance. It may even be possible to secure protection for known uses of a substance. An example would be using the substance in combination with an additional substance that boosts the effectiveness of the substance in a particular use, or an additional substance that masks an unpleasant flavor of the substance, or a new combination of known substances that exhibits improved stability. If the combination is new, and unexpected or synergistic results are observed for the new combination, then patent protection may be possible for the composition.

Another form of protection is the plant patent. Plant patents protect a distinct and new variety of plant that has been asexually reproduced. Such plants may exhibit desirable attributes, such as yielding a higher concentration of an active ingredient. This form of protection may be worth investigating if your nutraceutical utilizes novel plant varietals as a source of an active ingredient, e.g., cannabis extracts.

Ancillary inventions may also be amenable to patent protection. These can include new dosage forms or delivery systems (e.g., an active ingredient typically administered in liquid form is reformulated into a patch), new methods of administering or taking a supplement that unexpectedly increase effectiveness or reduce adverse effects (e.g., taking a particular dose of the supplement at certain time intervals, in combination with other substances, or in association with a special diet or medical treatment). A method of manufacturing could be new and useful, particularly if the method includes a new or more effective extraction or purification step, or the method produces the supplement at a significantly lower cost. Packaging methods may be protectable if they increase packaging efficiency or the shelf-life of the product. Functional aspects of the packaging (e.g., ease in opening, tamper-proof, child resistant) may be protectable as well.

A holistic strategy for protection of your intellectual property that incorporates trademarks, trade dress and trade secrets can be developed with the assistance of counsel. In view of the shifting legal landscape with respect to patentable inventions and the tension between trade secret protection and patent protection, it is particularly important to seek out advice of patent counsel before making the decision to pursue or forego patent protection for your nutraceutical inventions. NIE

Rose Thiessen, PhD is a partner in the San Diego, CA office of Knobbe Martens. She represents individual and business clients in patent prosecution and licensing for chemical, pharmaceutical, medical device and other life science technologies. Thiessen’s practice includes patent portfolio management and filing strategies in the U.S. and abroad, client counseling on issues related to licensing, infringement and trade secrets, and intellectual property due diligence in conjunction with financing, partnerships, acquisitions and IPOs. She can be reached at (858) 707-4000 or [email protected].