Disclaimer: None of the information listed below is considered legal advice and is provided for educational purposes only.
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Yesterday afternoon the Accelerator for Biosciences in Connecticut (ABCT) hosted a workshop on Intellectual Property. ABCT is a highly competitive educational program designed to teach Connecticut’s academics, inventors, and founders of start-ups how to be successful entrepreneurs. This workshop was part of their continuing education for the accepted start ups that were recently selected for the 2020 program.
Selected start-ups are chosen based on set of parameters that demonstrate the novelty of start-up’s mission and their capacity to transform the life sciences industry. Accepted participants attend sponsored workshops, informational webinars, and interactive exercises to learn necessary business skills to develop their products and services. Eligibility includes residence within the state of CT and expertise in science, medicine, and/or technology.
Yesterday’s workshop consisted of networking and a moderated panel discussion by ABCT alum Patrick O’Neill of Connecticut Innovation featuring, Craig Kenesky Ph.D. J.D., an associate at Wilson Sonsini Goodrich & Rosati, Tom Jarvie Ph.D., CMO and Co-Founder of Shoreline Biome, and Peter Cross M.S., Vice President of Intellectual Property at AON Risk Solutions. The general focus of the workshop was to discuss current topics regarding patents in the life sciences.
For background there are four major areas of intellectual property
1. Patents– protect inventions. Example: U.S. Patent No. 5,901,666 defines and protects the invention of “Wearable Pet Display” that allows you to carry a small pet (e.g. hamster) on a vest or belt. The wearable habitat consists of transparent passages and pockets for feeding.
2. Trademarks– “identifies” the source of a commercial good or service. Example: Paris Hilton was approved for the trademark “That’s Hot.” She even won a large lawsuit when Hallmark tried to use this phrase on their products.
3. Copyrights– protects the expression of works of authorship. Example: A German Chef copyrighted their carefully arranged dishes which requires that if an individual at their restaurant wants to photograph their dish before indulging, they must ask permission or be subjected to a potential lawsuit.
4. Trade Secrets– protects the know-how or technology that gives a company a “secret” competitive advantage. Examples: The Google search algorithm, the New York Times Bestseller List, Listerine, WD-40, Twinkies, McDonalds Big Mac Special Sauce, Krispy Kreme Donuts.
Majority of life science company’s deal with patents so for the scope of this article, and based on what was discussed at yesterday’s event, I will focus on patents.
A patent is a legal contract, issued by the government, that defines what the invention is, how to make it and how to use it, delineated by what are called “claims.” This contract protects the invention and gives the inventor certain rights to their invention such as excluding others from making, using, or selling the invention.
Definition: An invention is a discovery or idea that is made into a machine, product, or process.
In the life sciences this could be a reagent, an assay, or a technical process for measuring a molecule to name a few.
There are 3 requirements for obtaining a patent for an invention
-The invention must have at least one utility
-The invention must be novel
-The invention must be nonobvious (over what is already known, referred to as “prior art”)
With regards to “prior art” obtaining patents in the life sciences can be tricky. Prior art refers to publicly available knowledge of the invention such as a published abstract, journal article, or a social media post. Basically, anything searchable by the general public. This does not include a submission to the FDA or grant submission. However, once a grant is awarded and becomes available online then it becomes prior art and a patent cannot be granted (unless you applied for a provisional patent). This is especially tricky when it comes to the Freedom of Information Act (5 U.S.C. § 552) which means that unreleased information or documents controlled by the U.S. government can be disclosed/released upon a request to do so.
So, you have an idea and you want to file a patent application… before you do that you shuld be aware of 3 exceptions to patent eligibility as defined by the United States Code title 35 section 101 (35 U.S.C. § 101). This is one point of contention in the field of law as well as life science.
The law states that a patent cannot be obtained on a law of nature, natural phenomena, or abstract idea.
The subject of “patent eligibility” has been a hot topic since two instrumental cases challenged and changed the system, the Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2011-2012) and Alice Corp. v. CLS Bank International (2014) court cases. Recall the definition of invention. This classic definition defines criteria of a “thing” and the eligibility for obtaining a patent must not be a natural phenomena or abstract idea. However, this definition can revoke patent eligibility when claims describe a new process for measuring a drug effectiveness or a novel computational strategy for assessing financial risk.
An example of the first is demonstrated profoundly by the Mayo Collaborative Services v. Prometheus Laboratories court case. The Supreme Court denied eligibility to Mayo’s patent (US patent 6355623B2) because it claimed a law of nature. The claims described how to measure a metabolite of a drug based on an individual’s metabolism. In comparison, the Alice corp. court case challenged patents that comprised abstract ideas. Specifically, this patent’s claims described a computational method for mitigating settlement risk. The court determined Alice Corp.’s patent ineligible because the patent’s claims were directed towards an abstract entity: that implementing the calculation through a computer was not sufficient enough to transform the abstract entity into “something more” that could be patented.
The outcomes of both of these cases established the 2-step Mayo/Alice test process for determining patent eligibility.
Step 1- Is the patent claim in question directed towards a law of nature, a natural phenomenon, or an abstract idea? If no- pass or if yes- go to step 2
Step 2- Does the claim include additional elements that add “significantly more” or transform the invention into a patented product? If no-claim is ineligible or if yes- pass
A great example of how a patent of an abstract idea was patented because it included claims that added “significantly more”. In the case, Diamond, Commissioner of Patents and Trademarks v. Diehr et al. (1981), the court ruled in favor of Diamond for their use of the Arrhenius equation to determine an effective and accurate way to process raw uncured synthetic rubber (US patent 4,344,142). Before this invention rubber making required continuous operator self-checking of temperatures and self-determining when the rubber was finished. This technique resulted in poor rubber construction due to the loss of heat every time the rubber container was opened for a temperature reading. Using the Arrhenius equation, Diamond established a revolutionary method for making rubber that was independent of an operator and he protected this process with a patent, not the mathematical equation. His invention revolutionized the field.
As we work at the bench, we come across many specialized technologies that allow us to achieve our goals in science and our careers as a whole. One day you might come up with an idea that may help the process of scientific discovery, standardize the way we measure biological phenomena, discover a new way of targeting a disease process, or something entirely new and unexpected. If you do, great! You should protect your idea and consider forming a company to develop your product and more in the future.
If you have an idea you think could be commercialized and you want to get involved with ABCT you should sign up for their newsletter. Visit their website to learn more about their program and look for information regarding the next round of applications https://abct.co
To learn about the life Science company’s in the area, reach out or attend events hosted by the UConn Technology Incubator Program. BioCT is another great resource for connecting with start-up companies, entrepreneurs, and other professionals in the bioscience field within Connecticut.
If you are interested in intellectual property or patents refer to the US Patent and Trademark Office https://www.uspto.gov/patent
Other websites with additional information:
https://patentlyo.com
