Very simply, IP is something intangible that you own as a result of creativity or research. Without protection, commercialization may be difficult because you will not be able to prevent your competitors from also using your technology. A technology without intellectual property protection would be negatively viewed by future partners and investors. For all healthcare innovations, be careful not to “publicly disclose” your technology before it is protected, which means detailing your technology in a public setting such as a presentation or poster, a Ph.D., dissertation, or other publications.

Protecting your technology can be done in a variety of ways. Most commonly known is a patent, but there are other options depending on your technology. Trademark, copyright, trade secret, and contracts are also options for IP protection. The proper IP strategy varies by the type of technology, and may include more than one form of protection.

Patent: A patent is a government issued right of ownership. To get a patent, you must meet the criteria of an invention, and your rights are time-limited. A patent stops someone else from commercializing your invention.

Copyright: Automatically protects original works – most often literature, software, music, art, design, etc.

For a device or diagnostic, IP protection is usually accomplished through patents. The design and function of your technology must be useful, novel, and non-obvious to be patentable.

When you have “reduced your technology to practice,” or demonstrated that the features of your invention have a unique benefit, for example by building a prototype, your Tech Transfer Office will file a provisional patent if they determine it is a meaningful and useful method of technology protection. You then have one year after filing to make any changes to the device design, function, form factor, and method of use. One year after provisional filing, a finalized non-provisional patent is filed. In most cases, you have the opportunity to file domestically and/or internationally.

For a therapeutic innovation, patent protection is required for successful commercialization. This can be in the form of a “method of use” patent that covers a new indication for a known therapy. However, protection for a novel composition of matter AND its method of use is preferred.

For software solutions, patents are sometimes used for protected of methodologies or algorithms. Patents become public knowledge, and defending your patent would require you to be able to prove that someone is doing what you alone have a patent right to do. That is tricky because software moves very fast and the patent process, by its nature, is very slow. For this reason, patents are not always the preferred method of protection for software.

Another option is a copyright, which is your expression of that software in the form of the code that is written. Copyrights are automatic upon writing and provide absolute protection on that code, much like someone has protection on a book or a piece of artwork. However, copyrights are a relatively weak form of protection because the code isn’t what the customer is interacting with directly, unlike reading a published novel.

For software, there is also the option of “open source,” which means allowing anyone access to the code and to manipulate and adjust it for their needs. This is a viable option for IP protection because open source code attributes back to the original developers. Most open source licenses will require a new user to declare where the source code came from and who developed it. If the highest value for you is to be known as the originating source of the thought leader in your field, this is a viable and appropriate option.

Finally, a “trade secret” strategy is common in software and does not publicly disclose how the technology is produced. The protection lasts as long as the secret is kept. For example, what is the secret formula of Coca Cola? Consider the trade secret route if your technology is probably going to grow and change over time. Keep in mind, in the healthcare setting, regulations may require disclosure.

And remember to be careful not to “publicly disclose” your technology before it is protected, which means detailing your technology in a public setting such as a presentation or a poster, a Ph.D. dissertation, or other publications.

Since patents are often used to protect life science innovations, let’s start with the key elements of patentability to consider: useful, novel, and non-obvious. Think about this chronologically: Is your technology useful? If so, start with a prior art search to determine if it’s also novel. Yes? Is it also non-obvious?

“Useful” means your technology has a practical or specific purpose and does not violate scientific principles. A medical device with a specific application would most likely be considered useful. A time traveling machine would not. Claiming natural genes, enzymes, or proteins would most likely not be permitted, but a novel application, or modified use for them, could be.

“Novel” means that the technology is completely original and cannot be found in public record or through a prior art search. It has never before been described in any way, through writing, art, or verbally. In the U.S., there is a 12-month grace period, meaning if your technology is publicly disclosed through a publication, poster, etc., you have one year to apply for a patent. In Europe and most other countries, the grace period does not exist. Once the technology is in the public domain, you will no longer be eligible for protection internationally.

“Non-Obvious” means that your technology is not an obvious conclusion. For example, you have invented a sandwich made of bread and peanut butter. If someone else invented a sandwich made of bread and almond button, this would most likely be considered an obvious modification. This determination is made by the patent office.

Now that you have determined the patentability of your invention, will you be able to practice your invention without infringing on an existing patent? This is called Freedom to Operate. Freedom to Operate is the term commonly used when discussing whether a patent would infringe on claims of other patents. This may either protect or block you from moving forward with commercializing your technology. If your technology infringes on an existing patent, you may be able to license some rights from that party.

For example, let’s say a patent exists for a sandwich made with peanut butter. If you then invent a sandwich with peanut butter and jelly, you can prevent the peanut butter sandwich inventor from adding jelly, but that doesn’t mean you can sell your peanut butter and jelly sandwiches without infringing on the existing peanut butter sandwich patent. Before beginning the patent process, it is crucial to search for existing competing patents.

So who is eligible for a patent and how do. you begin the process of securing IP through a patent?

Drafting a patent application in the academic setting will involve working with your Tech Transfer Office and a patent attorney. You will be asked to complete a cover page, including your title and abstract, inventors, assignee and filing date, along with specifications and claims.

Specification: Specifications include the background of your technology, a summary, any drawing with details, and a detailed description of the invention. This defines the scope of what can be claimed. This could be considered “prior art” for future invention, but would not prevent their pratice.

Claims: The claims section details the individual aspects of your technology. This is the part of a patent that defines what is legally protected. For example, for a peanut butter and jelly sandwich:

1. A sandwich, comprising:
   1. A first bread layer consisting of a contact surface
   2. A peanut butter filling layer juxtaposed to said contact surface of the first bread layer
   3. A fruit jelly filling layer juxtaposed to said peanut butter filling layer, opposite said first bread layer
   4. A second bread layer juxtaposed to said fruit jelly filling layer, opposite of said peanut butter filling layer
      1. The sandwich of claim 1 wherein said peanut butter layer is smooth or crunchy
      2. The sandwich of claim 1 wherein said fruit jelly is grape or strawberry

Also typically included are drawings or “figures,” detailing through illustration, the specifications and embodiments of the invention.

Remember, patent rights are based on “first to file” not “first to invent.” Once you have determined that your technology would be best protected through a patent, how long does the process take? Here’s a typical overview of the patent process timeline:

1. First, file an invention disclosure with your Tech Transfer Office. Be sure this is well before your first public disclosure.
2. If a patent is the best protection for your technology, a provisional patent application will be filed by your institution. The date of this filing will be your “priority date.” This is where the clock starts – assuming your patent is awarded, you now have 20 years of protection from this date. Also, this is the date that legally allows you to prevent others from practicing your invention.
3. Within one year of filing your provisional application, your application will convert to a non-provisional application. this is when the decision to file internationally or in the U.S. only is made.
4. Typically, an application is published 18 months after first filing. It will now be publically available for search through the U.S. Patent & Trademark Office (USPTO).
5. If filing internationally, about 30 months after your earliest filing, you will decide in which specific countries to pursue protection. You will need to pay for translation and prosecution in each of these countries, so the cost of this step can add up quickly.
6. Your application will be exampled by the USPTO about 2-3 years after filing.
   1. Here, a patent examiner will review your application and respond with which claims are allowed or denied and why, known as an office action. You will likely receive multiple office actions during the prosecution process.
   2. Via your attorney, you will have an opportunity to reply to these office actions.
7. Once your patent is issued, it will expire 20 years after your priority date, so be sure to include this in your commercialization strategy.

The process is most often not straightforward.

A patent is granted by the U.S. government to prevent anyone from making, using, or selling your invention. It can reduce the risk involved with bringing a product to market and, therefore, encourage innovation. Because most research at an academic institution is at least partially federally funded, the U.S. government has the rights to the resulting IP. The Bayh-Dole Act of 1980 permits a university, small business, or non-profit institution to elect to pursue ownership of an invention in preference to the government. This incentivizes these institutions to continue to pursue new innovations and, in the health research setting, ultimately impact patient care.

You, the inventor, thought of a novel solution to a problem, but the “assignee” ultimately owns the patent rights. As faculty or staff of an academic institution, the “assignee” is the university. this may sound unfair, but consider the benefit to you by this arrangement. Filing a patent can cost tens of thousands of dollars. The research tools, lab space, technology, and equipment used to conceive of your innovation were offered to you by the university becuase of your academic appointment. The free consulting and technology protection services of the Office of Technology Transfer are offered to you, as well. You and the university are partners in bringing your technology to market with the goal of impacting patient care.

Generally, most academic institutions do not claim ownership rights for student inventions. In some cases, students might be paid for their lab research work, which means that they could function as both a student and an employee at times. In that case, the ownership would depend on the capacity in which the student made the invention. If the invention was created through the paid research work, the university may consider that as an employee invention and claim ownership of the IP rights.

If you have specific questions, it’s always a good idea to contact your institution’s Office of Tech Transfer for guidance.

In patent law, an inventor is a person who intellectually contributes to the claims of a patentable invention and does not simply assist in the reduction to practice. Authorship on primary literature is generally given to someone who designs experiments, performs experiments, provides reagents, or writes the manuscript. For this reason, someone may be an author on a manuscript, but not an inventor on a corresponding patient

Between filing costs and legal fees, a basic U.S. application will cost $10,000-$20,000 or more. More complex applications and international filing can increase this total significantly. It is not unreasonable for an international patent to cost hundreds of thousands of dollars. For this reason, some institutions do not pursue filings without a license in place.