July 2021
Natural Products Consulting
By Michele C. Bosch; Erin M. Sommers, Ph.D.; Katherine T. Leonard; Zan Newkirk; Shannon M. Patrick
Whether you are a sole inventor, fledgling company, or global conglomerate, protecting innovation with patents or other types of intellectual property should factor into business considerations early and often. Patents may be valuable in any commercial endeavor, including in the natural food industry, because they can recognize valuable scientific and industry contributions, protect against market competition and may help recoup financial investment.
In the natural food industry, innovation or novelty—the newness and originality of a product—often drives the “patentability” of it. As a result, patent protection should be considered and pursued early in the development process when inventions are first discovered. But, like most things that are worthwhile, protecting innovation with patents is not always straightforward and is hard to do on your own. Requirements for securing a patent can be confusing and may be difficult to satisfy for developments in the natural food industry. These hurdles should not deter savvy natural food and food product innovators: patent protection is worth understanding and potentially harnessing its advantages. One needs to consider the pros and cons of patent protection in the natural foods industry, as well as understand what unknowing actions may negatively influence the ability to obtain a patent.
This chapter introduces patents and discusses their benefits. It also provides a brief overview of how to obtain a patent, including three requirements for patentability. The chapter wraps up with practical considerations: where to get patent-related help and how to best protect your food related invention.
Let’s say you are in your lab (or kitchen) one night, and you discover something incredible—it is a kelp-based sustainable food packaging that has a long shelf life and can endure hot and humid environments. “Wow!” you say, a month of extra freshness before rotting is enough time for packaged food to travel across oceans and deserts and reach people who are plagued with land that cannot produce their own food. No one in the industry has ever seen anything like this. You just struck gold! Not only could this exciting discovery help solve one of the greatest public health crises ever—world hunger—but it could also catapult your company into unimaginable success.
What you do right after that eureka moment could make the difference between decades of success or mere minutes of fame. The difference may come down to whether you took the right steps to protect your discovery or whether you called up the local news outlet to broadcast your achievement. Don’t let stars in your eyes blind you from taking the strategic approach and seeking patent protection—put down that phone.
Starting with the basics, a patent is a statutory (legal) property right provided by the federal Patent Act. In exchange for sharing the details of an invention with the public—to promote the progress of art and science—the Patent Act grants the patent owner, i.e., the inventor, the right to exclude others from making, using, selling, or offering to sell the invention in the United States for a limited time of up to twenty years. Importantly, and often confusing to patent novices, a patent does not give the owner the affirmative right to use their own invention. Rather, a patent identifies what has been invented and gives patent owner the right to exclude others from using the invention for the term of the patent. For example, the patent owner has the choice to grant a license to others to use the patented invention, or not to do so and effectively prevent competition. In many respects, the patent owner is the gatekeeper of who can use the patented invention, for how long and in what geographic areas or industries. A patent owner has a good amount of control over the use of the patented invention.
A patent has two main parts: a specification, or description, that details the invention including how to make and use it, and the claims. The specification needs to provide enough detail about the invention, so that others in the industry learn how to make and use the invention. The claims define the scope of legal protection for the invention similar to the way a fence identifies the boundaries of a landowner’s yard. The claims tell others what the protected invention is—everything inside of the fence. A strong patent “fence” (via the claims) allows the owner of the patent to keep others from coming into their yard, i.e., to keep others outside the fence.
Patents are granted for an invention that meets the legal requirements for patent-eligible subject matter (not everything is patentable), novelty (the subject matter is not already in the public domain in any way), and nonobviousness (generally meaning the invention would not have been obvious to others thinking about the same scientific question—this requirement is one of those murky areas of patent law). If these criteria (and a few others) are met, an inventor may be able to obtain a patent.
The main requirements to secure patent protection for an invention include that the invention must qualify as patent-eligible subject matter, must be novel, and must be nonobvious.
Section 101 of the Patent Act permits patent protection for any new and useful process, machine, article of manufacture, or composition of matter. Improvements of these categories of inventions may also be patent eligible. The usefulness requirement is rather straightforward. It asks whether the subject matter sought to be patented serves a purpose—a utility. A chemical compound used as a pharmaceutical likely meets this requirement. In the context of natural foods, the need for humans to eat would also likely easily meet this utility requirement. The eligible subject matter aspect of section 101 is trickier. The U.S. Supreme Court has said that laws of nature, abstract ideas, and natural phenomena are not patent-eligible subject matter even if they otherwise fall into one of the statutory categories of invention mentioned above. For example, one cannot patent gravity or naturally occurring, unmodified kelp. Determining what qualifies as a natural phenomenon, which includes products of nature, can also be puzzling. Dolly the Sheep, the first-ever cloned mammal, was found to be a product of nature because she did not possess “markedly different characteristics from any [farm animals] found in nature.”[i]
“But wait!” you say, what about the remarkable kelp packaging discussed above? The natural phenomena exception clarifies that kelp alone cannot be patented because it is a natural product or a product of nature, regardless of the fact that it is also a composition of matter and thus falls within one of the statutory categories mentioned above. But the kelp-based packaging that is not found in nature has a greater chance at being patent eligible.[ii] Another example might be a yogurt product that includes probiotics and other additives that are not found in a naturally occurring fermentation process. As a result, for natural foods, innovators should not automatically assume patent protection is unavailable for their products and instead should consider the possibility of obtaining a patent.
Moreover, even if a natural food product itself does not meet the patent eligibility requirement because it runs too close to a product found in nature, a patent directed to the method of making or a method of using the product may be eligible. In the case of the kelp packaging, one may be able to secure a patent for manufacturing the kelp packaging, assuming no one else has made kelp-based food packaging in the same way (remember, your way needs to be “new”).
Section 102 of the Patent Act requires that the invention be new or novel in light of any prior art. Prior art is a legal term that generally encompasses anything in the public domain, including commercial products, sales brochures, sales themselves, and research publications, that existed or occurred before the earliest filing date for a patent for the invention. Even the phone call you wanted to make to the local news outlet could potentially be prior art that prevents you from getting a patent on your invention. Understanding what is in the prior art, i.e., has been done before, and being different from—or novel over it—is vital to the likelihood of obtaining a patent.
In our example, even though kelp-based food packaging may have never been marketed and could be highly profitable, it nonetheless may be impossible to patent if someone else has already published an article about the very same kelp packaging or shared a prototype of it at a scientific convention for all to see. Inventors must understand that being first to market does not necessarily make a product new for patenting purposes.
Inventors, however, should not be deterred if a similar product is known in the prior art, as compared to the same product, because the standard for showing that something is not novel is high. Each and every element of the claimed invention must be found in a single piece of prior art (e.g., a prototype, magazine article, prior patent, or that conversation that almost happened with the local news) for the invention to fail for a lack of novelty. Returning to our example, a published research article that describes a kelp-based food packaging that prevents spoilage of the packaged food for at least 60 days would likely preclude a patent for your invention. A different result may occur if the research article described corn-based food packaging. (Be aware that the corn-based packaging could make your kelp-based packaging obvious. . . more below.) Since corn is not the same as kelp, each and every element of your claimed invention is not in the prior art.
Section 103 prohibits patenting a “new” and “subject matter eligible” invention if the differences between the claimed invention and the prior art are so minimal that the claimed invention would have been obvious to a person of ordinary skill in the relevant art. Similar to the novelty analysis, all prior art is fair game and can be relied upon for whatever it discloses. But, unlike for novelty, the teachings of multiple pieces of prior art can be combined to determine what would have been obvious to a skilled artisan in the relevant art.
Obviousness is a murky patent law concept. It relies on what a hypothetical person of ordinary skill in the art would have known, thought, and done. A person of ordinary skill in the art does not necessarily have the same scientific and experience qualifications as an inventor and may not have the same motivations or be trying to solve the same problems as an inventor. In general, for something to be obvious, a person of ordinary skill in the art must have been motivated by the prior art to develop the claimed subject matter with a reasonable expectation of successfully doing so.
In our hypothetical example, the research publication describing the corn-based food packaging, combined with a New York Times article reporting on the world’s food crisis and hypothesizing that durable plant-based food packaging may solve the food shortage, may render your kelp-based food packaging obvious. For instance, if the NYT article includes study results showing that corn-based products increase shelf-life for only about one week longer than normal, this may provide a person of ordinary skill with a motivation to make kelp-based packaging in an effort to extend shelf-life. In addition, the corn-based food packaging article may demonstrate that one could reasonably expect to successfully prepare kelp-based packaging, because a similar packaging was already successfully made. As mentioned, however, there is a lot of wiggle room in obviousness, and it makes sense for innovators to seek legal guidance regarding the patentability of newly developed natural food products.
Now that you have a better understanding of some of the requirements for obtaining a patent, you might be wondering about the process of applying for a patent. As explained above, patents are issued by the U.S. Patent and Trademark Office (“USPTO”). Getting a patent is not an automatic occurrence, even if you have an invention that meets the requirements discussed above.
Anyone who wants a patent must apply for one by filing a patent application with the USPTO that contains a specification and claims. At the USPTO, a patent Examiner is someone who has technical expertise in the subject matter of the invention. An Examiner is tasked with examining applications and their claims for compliance with the requirements of the Patent Act, including the requirements of novelty and obviousness. The Examiner provides an Office Action, which explains the reasons whether the claims should be allowed to issue as a patent or not.
Under our hypothetical, the first Office Action may reject claims to kelp-based food packaging in view of the corn-based packaging research paper and NYT article as being obvious. It is not unusual for the first Office Action to reject the claims. All hope is not lost. A patent applicant typically receives two to three Office Actions before the claims are allowed or finally rejected. And if finally rejected, appeals that challenge the Examiner’s reasons for rejection are possible.
When the claims are rejected, the patent applicant may file a response. A response provides the applicant with an opportunity to explain how the invention is different from, and not obvious in view of the prior art. An applicant can also clarify the invention by amending the claims to more precisely or distinctly claim the invention. Let’s consider this in the context of our hypothetical. If the corn-based packaging article reports that the corn packaging is capable of keeping packaged foods fresh for only one week, you may be able to amend your claims to define a kelp-based packaging capable of keeping packaged foods fresh for at least one month. You could then argue that a person of ordinary skill in the art would not have expected to successfully lengthen the time until spoilage of the packaged food given the corn packaging’s relatively limited ability to maintain freshness.
Ultimately, if the Examiner’s decision on patentability is favorable, a patent is granted. Once the requisite issue fee is paid, the USPTO issues the patent.[iii]
Patent applications can be filed on paper or online using the USPTO’s electronic filing system. The average time it takes to get a patent, according to the USPTO, is about 24-36 months from when the application is filed. However, you can expedite the process by paying an extra fee to get prioritized examination and cut the time down to six to twelve months. There are many rules governing the patent application process, so working with a patent agent or attorney that knows all the rules and regulations is strongly recommended.
Although an inventor may prepare and file a patent application without representation, the application process and examination is complex. It requires considerable knowledge of patent law and the rules of USPTO practice and procedures. It also demands an understanding of the technical or scientific subject matter involved in the invention. As a result, for any well-informed innovator, consulting with a registered patent agent or attorney throughout the process is imperative. Seeking guidance from a registered practitioner can minimize the risk of missteps and increase the likelihood of obtaining a strong and enforceable patent.
If you do not have or know a registered patent attorney, you should ask your colleagues for help to find one experienced in food, food chemistry, or the food processing/manufacturing industry. They do exist! And, if you aren’t having any luck, the USPTO maintains a directory on its website of patent attorneys or patent agents that could guide you. The USPTO also maintains legal assistance resources and programs for eligible independent inventors or small businesses with limited resources. For example, these entities may be eligible for pro bono (“for free”) attorney representation through the Law School Clinic Program or the Patent Pro Bono Program.
Patents can provide value to a successful business because they allow inventors the opportunity to recoup research and development costs and profit from their innovation. These scientific contributions that amount to patentable inventions simultaneously add to the collective scientific knowledge and are worth the patent’s right to exclude. To obtain this right, the invention must meet certain requirements including subject matter eligibility, novelty, and nonobviousness. If these are met, then an inventor can take their invention to the USPTO and start the process for obtaining a patent. Good luck as you embark on patenting the next big thing.
[i] 2106.04(c) Patent Subject Matter Eligibility, Manual of Patent Examining Procedure, https://www.uspto.gov/web/offices/pac/mpep/s2106.html#ch2100_d29a1b_13bc1_b1 (last visited Apr. 2, 2021) (citing In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337 (Fed. Cir. 2014)).
[ii] The USPTO has provided guidelines regarding subject matter eligibility. Those can be viewed at https://www.uspto.gov/web/offices/pac/mpep/index.html.
[iii] As mentioned, if the Examiner’s decision on patentability is unfavorable, an applicant can appeal the decision to the Patent Trial and Appeal Board and to the courts. By choosing this route, the applicant would incur additional expense, but might ultimately receive a patent too.
United States Patent and Trademark Office (USPTO), patent application, non-obviousness, subject matter eligibility
June 10-12, 2024
San Francisco
Lecture
Patent Protection for Software-Related Inventions in Europe and the USA Training Course
June 5, 2024
Hybrid
Workshop
Life Sciences Workshop: Updates and Key Trends in Pharmaceutical and Biotechnology IP Law
May 2, 2024
Cambridge
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.