Gregory Stephens, RD, Windrose Partners01.02.14
The pursuit of patents in our industry has a long tradition. Since 1971, the term “nutraceutical” has been referenced in more than 10,000 U.S. patents and patent applications. In this same timeframe, “glucosamine” alone has been referenced in more than 800 issued patents. With proliferation of patent protection in the nutraceutical market, the development of new, more sophisticated products is becoming a more complex process, increasingly with greater risk.
What & Why Patents?
Simply stated, a patent is a contract with a government. It affords the right to exclude others from making, using, offering for sale, selling or importing the invention as defined by the claims of a patent. It is a limited right because it has a limit on life span, geographic area and the scope of claim coverage, all of which define the boundaries of the right to exclude others from using an invention.
The duration term afforded by a patent begins on the date of issue and lasts for a maximum period of 20 years from the filing date, provided the patent is “maintained” for the entire period by timely payment of maintenance fees. Upon expiration of a patent term, the patent is considered to be in the public domain and may be freely used by anyone.
Patents also have a limited geographic territory; specifically, they are limited to the geographic area of the country of issuance. For example, a U.S. patent is enforceable only within the U.S. and its territories. The invention is free to be used by anyone in countries in which the patent is not registered. Companies generally make strategic decisions about key markets for their technologies and select the countries in which they will seek patent protection accordingly.
A common mistake involves confusing a published international application filed as Patent Cooperation Treaty (PCT) for an international patent. There is no such thing as an international patent; publication of a patent application does not qualify as a patent either.
What Can Be Patented?
The conditions for patentability include appropriate subject matter, usefulness, novelty and non-obviousness. The appropriate subject is stated as, “Anything under the sun that is made by man,” (Diamond v. Chakrabarty, 447 U.S. 303, 308-09, 206 USPQ 193, 197 (1980)). That would include any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement of the above.
To be considered useful, the invention must provide some immediate benefit to the public. An inoperative invention is not a useful invention; however, the mere identification of the physiological activity of a compound that is relevant to an asserted nutraceutical use provides an “immediate benefit to the public” and satisfies the utility requirement.
To be novel, the invention must not previously be known or used by others. This includes items that may have been previously patented or simply described in a printed publication.
The final condition, non-obvious, means the invention must not be an obvious modification of a known item or process. This obviousness criterion is evaluated from the perspective of a hypothetical person of ordinary skill in the prior art.
Can A Natural Product Be Patented?
First, let’s consider what is not patentable. This would include the laws of nature (e.g., law of gravity), any physical phenomenon (e.g., a new plant found in the wild) and abstract ideas (e.g., E=mc2). Examples of items in our industry that may be patentable include compounds and ingredients isolated from a natural product, or a composition or mixture not found in nature. Also patentable would be a new process of making a compound or composition, or a new method of formulating or delivering it—the latter incudes a new use of a known compound or composition.
How much evidence is necessary to support a patent claim? Probably not as much as you think. Keep in mind that assertion of therapeutic utility for patent purposes is not to be confused with regulatory standards with regard to efficacy. For instance, in vitro testing may establish a practical utility for the compound of an invention and a small study with few subjects may be enough to establish a claim for a medicinal composition.
For a representative example, refer to issued U.S. Patent 6,592,896 (Rosenbloom, Jul. 15, 2003): Medicinal Composition And Method Of Using It. In this patent, claim #1 stated: “A medicinal composition comprising: a first ingredient obtainable from turmeric; a second ingredient obtainable from ginger; and a third ingredient obtainable from horseradish, and wherein the first, second and third ingredients are present in the composition in amounts effective to together provide substantial relief of one or more symptoms selected from the group consisting of symptoms of a common cold, a sore throat, congestion, laryngitis, mucositis, mucous inflammation and sialorrhea.”
A study of two patients suffering from excessive secretion of saliva, who ingested 1-2 lozenges daily for a period of three weeks, was provided as substantiation to support this claim. “It was found that the ingestion of lozenges effectively controlled excessive secretion of saliva.”
A second supportive study included seven patients suffering from sore throats, who ingested one lozenge at a time over a couple of hours, demonstrating that each lozenge provides a relief for up to 6 hours.
Licensing Patent Rights & Freedom to Operate
As mentioned, owning a patent or licensing a patent does not give you the right to practice the invention. Prior to launching a product, it is prudent to obtain a freedom to operate opinion from a patent attorney, as there may be others with a patent for a related technology that may have broader claims. Thus, launching a sale of the ingredient or product may be an infringement. A lawsuit for infringement may be avoided by in-licensing or cross-licensing.
Exploiting Your Intellectual Property
There are numerous strategies to gain the most from your intellectual property program. Many companies attempt to create a broad and diverse portfolio of various types of IP. This may include a combination of patent claims, trademarks and trade secrets. This may be accomplished internally or via in-licensing of additional patents.
Patents vs. Trade Secrets
A brief word on whether an invention may be better protected as a trade secret: When filing for a patent application, you must disclose all aspects of the invention. There are times when you may not wish to share this information openly. For instance, if the invention is difficult to reverse engineer, or if it has a short lifetime in the marketplace. In such situations, protecting the technology as a trade secret may be more appropriate. Just keep in mind that trade secrets may not be patented by their owners if in public use for more than one year—yet they may be patented by someone else (an independent discoverer).
Keep in mind, there are “proper” means of acquiring trade secret knowledge. Competing companies may discover and patent the idea by independent invention. This would preclude you from using your trade secret. One may reverse engineer the invention, discover under a license from the owner of the trade secret, or the invention may be observed when the item is on public display. The important message is: keep your trade secrets secret!
Recent Changes to U.S. Patent Law
The Leahy-Smith America Invents Act (AIA) was designed to modernize the U.S. patent system. A key provision in the AIA converted the U.S. from a first-to-invent to a first-to-file system. This provision became effective on Mar. 16, 2013. It is now imperative that a company file an application on invention at the earliest possible date or risk someone else filing first, negating the prior law that provided precedence to those with documentation of the invention.
Trademarks, service marks, trade dress and copyrights are also important elements of your IP program. These will be addressed in a future Business Insights column.
Searching, writing and filing patents can be conducted by anyone utilizing the U.S. Patent and Trademark Office (USPTO) website (www.uspto.gov). However, in most situations this skill should be conducted by a well-qualified patent attorney.
Legal assistance in development of this column was provided by Marina Volin, registered patent attorney specializing in the nutraceutical, biotechnological, pharmaceutical and medical device industries.
Save the Date: The Second Annual Health Practitioner Market Forum, April 2-4, 2014, Hotel Maya – Long Beach, CA. Position your company for success in the health practitioner channel and the market for medical foods. Contact: Greg Stephens, 215-860-5186; E-mail: gregstephens@windrosepartners.com; Website: www.HPMForum.com.
Greg Stephens, RD, is president of Windrose Partners, a company serving clients in the the dietary supplement, functional food and natural product industries. Formerly vice president of strategic consulting with The Natural Marketing Institute (NMI) and Vice President of Sales and Marketing for Nurture, Inc (OatVantage), he has 25 years of specialized expertise in the nutritional and pharmaceutical industries. His prior experience includes a progressive series of senior management positions with Abbott Nutrition (Ross Products Division of Abbott Laboratories), including development of global nutrition strategies for disease-specific growth platforms and business development for Abbott’s medical foods portfolio. He can be reached at 215-860-5186; E-mail: gregstephens@windrosepartners.com.
What & Why Patents?
Simply stated, a patent is a contract with a government. It affords the right to exclude others from making, using, offering for sale, selling or importing the invention as defined by the claims of a patent. It is a limited right because it has a limit on life span, geographic area and the scope of claim coverage, all of which define the boundaries of the right to exclude others from using an invention.
The duration term afforded by a patent begins on the date of issue and lasts for a maximum period of 20 years from the filing date, provided the patent is “maintained” for the entire period by timely payment of maintenance fees. Upon expiration of a patent term, the patent is considered to be in the public domain and may be freely used by anyone.
Patents also have a limited geographic territory; specifically, they are limited to the geographic area of the country of issuance. For example, a U.S. patent is enforceable only within the U.S. and its territories. The invention is free to be used by anyone in countries in which the patent is not registered. Companies generally make strategic decisions about key markets for their technologies and select the countries in which they will seek patent protection accordingly.
A common mistake involves confusing a published international application filed as Patent Cooperation Treaty (PCT) for an international patent. There is no such thing as an international patent; publication of a patent application does not qualify as a patent either.
What Can Be Patented?
The conditions for patentability include appropriate subject matter, usefulness, novelty and non-obviousness. The appropriate subject is stated as, “Anything under the sun that is made by man,” (Diamond v. Chakrabarty, 447 U.S. 303, 308-09, 206 USPQ 193, 197 (1980)). That would include any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement of the above.
To be considered useful, the invention must provide some immediate benefit to the public. An inoperative invention is not a useful invention; however, the mere identification of the physiological activity of a compound that is relevant to an asserted nutraceutical use provides an “immediate benefit to the public” and satisfies the utility requirement.
To be novel, the invention must not previously be known or used by others. This includes items that may have been previously patented or simply described in a printed publication.
The final condition, non-obvious, means the invention must not be an obvious modification of a known item or process. This obviousness criterion is evaluated from the perspective of a hypothetical person of ordinary skill in the prior art.
Can A Natural Product Be Patented?
First, let’s consider what is not patentable. This would include the laws of nature (e.g., law of gravity), any physical phenomenon (e.g., a new plant found in the wild) and abstract ideas (e.g., E=mc2). Examples of items in our industry that may be patentable include compounds and ingredients isolated from a natural product, or a composition or mixture not found in nature. Also patentable would be a new process of making a compound or composition, or a new method of formulating or delivering it—the latter incudes a new use of a known compound or composition.
How much evidence is necessary to support a patent claim? Probably not as much as you think. Keep in mind that assertion of therapeutic utility for patent purposes is not to be confused with regulatory standards with regard to efficacy. For instance, in vitro testing may establish a practical utility for the compound of an invention and a small study with few subjects may be enough to establish a claim for a medicinal composition.
For a representative example, refer to issued U.S. Patent 6,592,896 (Rosenbloom, Jul. 15, 2003): Medicinal Composition And Method Of Using It. In this patent, claim #1 stated: “A medicinal composition comprising: a first ingredient obtainable from turmeric; a second ingredient obtainable from ginger; and a third ingredient obtainable from horseradish, and wherein the first, second and third ingredients are present in the composition in amounts effective to together provide substantial relief of one or more symptoms selected from the group consisting of symptoms of a common cold, a sore throat, congestion, laryngitis, mucositis, mucous inflammation and sialorrhea.”
A study of two patients suffering from excessive secretion of saliva, who ingested 1-2 lozenges daily for a period of three weeks, was provided as substantiation to support this claim. “It was found that the ingestion of lozenges effectively controlled excessive secretion of saliva.”
A second supportive study included seven patients suffering from sore throats, who ingested one lozenge at a time over a couple of hours, demonstrating that each lozenge provides a relief for up to 6 hours.
Licensing Patent Rights & Freedom to Operate
As mentioned, owning a patent or licensing a patent does not give you the right to practice the invention. Prior to launching a product, it is prudent to obtain a freedom to operate opinion from a patent attorney, as there may be others with a patent for a related technology that may have broader claims. Thus, launching a sale of the ingredient or product may be an infringement. A lawsuit for infringement may be avoided by in-licensing or cross-licensing.
Exploiting Your Intellectual Property
There are numerous strategies to gain the most from your intellectual property program. Many companies attempt to create a broad and diverse portfolio of various types of IP. This may include a combination of patent claims, trademarks and trade secrets. This may be accomplished internally or via in-licensing of additional patents.
Patents vs. Trade Secrets
A brief word on whether an invention may be better protected as a trade secret: When filing for a patent application, you must disclose all aspects of the invention. There are times when you may not wish to share this information openly. For instance, if the invention is difficult to reverse engineer, or if it has a short lifetime in the marketplace. In such situations, protecting the technology as a trade secret may be more appropriate. Just keep in mind that trade secrets may not be patented by their owners if in public use for more than one year—yet they may be patented by someone else (an independent discoverer).
Keep in mind, there are “proper” means of acquiring trade secret knowledge. Competing companies may discover and patent the idea by independent invention. This would preclude you from using your trade secret. One may reverse engineer the invention, discover under a license from the owner of the trade secret, or the invention may be observed when the item is on public display. The important message is: keep your trade secrets secret!
Recent Changes to U.S. Patent Law
The Leahy-Smith America Invents Act (AIA) was designed to modernize the U.S. patent system. A key provision in the AIA converted the U.S. from a first-to-invent to a first-to-file system. This provision became effective on Mar. 16, 2013. It is now imperative that a company file an application on invention at the earliest possible date or risk someone else filing first, negating the prior law that provided precedence to those with documentation of the invention.
Trademarks, service marks, trade dress and copyrights are also important elements of your IP program. These will be addressed in a future Business Insights column.
Searching, writing and filing patents can be conducted by anyone utilizing the U.S. Patent and Trademark Office (USPTO) website (www.uspto.gov). However, in most situations this skill should be conducted by a well-qualified patent attorney.
Legal assistance in development of this column was provided by Marina Volin, registered patent attorney specializing in the nutraceutical, biotechnological, pharmaceutical and medical device industries.
Save the Date: The Second Annual Health Practitioner Market Forum, April 2-4, 2014, Hotel Maya – Long Beach, CA. Position your company for success in the health practitioner channel and the market for medical foods. Contact: Greg Stephens, 215-860-5186; E-mail: gregstephens@windrosepartners.com; Website: www.HPMForum.com.
Greg Stephens, RD, is president of Windrose Partners, a company serving clients in the the dietary supplement, functional food and natural product industries. Formerly vice president of strategic consulting with The Natural Marketing Institute (NMI) and Vice President of Sales and Marketing for Nurture, Inc (OatVantage), he has 25 years of specialized expertise in the nutritional and pharmaceutical industries. His prior experience includes a progressive series of senior management positions with Abbott Nutrition (Ross Products Division of Abbott Laboratories), including development of global nutrition strategies for disease-specific growth platforms and business development for Abbott’s medical foods portfolio. He can be reached at 215-860-5186; E-mail: gregstephens@windrosepartners.com.
