What: In the United States, a patent gives the inventor an exclusive right to exclude others from making, using, selling, offering for sale, or importing the claimed invention.

Many people unfamiliar with the patenting process mistakenly believe that patents protect ideas when in reality it is the invention that is protected. Think of an invention as a tangible form or application of an idea. Example:

Thomas Edison’s big idea was to use electricity as a source of light. His invention was the lightbulb.

It wouldn’t make sense or seem fair to give Mr. Edison a patent on electricity as a source of light without providing more than just his mere idea—now would it? So it is the lightbulb, the application/tangible form of his idea that is protected by a patent.

Another common misconception is that a patent provides the holder (the patentee) with the right to use the invention. While, in the vast majority of cases, the patentee will end up exploiting the invention in some form or another((One common form of exploitation is Licensing. The patentee will confer a license to another individual or company who is better suited to develop and commercialize the invention in exchange for a share of the profits.)), the mere fact that the invention is patented does not allow the patentee to bypass other applicable laws or regulations. If the patent is directed to a pharmaceutical composition, the pharmaceutical composition must undergo clinical trials and be approved by the FDA before it can be sold in the US. If the patent is to a new low-emissions airplane, FAA regulations would be in play before the patentee could operate and sell their new plane. Thus, a patent is not an exclusive right to use, but rather, the exclusive right to exclude others from making, using, selling, offering for sale, or importing the claimed invention and the performance of any of these aforementioned activities without authorization from the patentee may constitute patent infringement depending on the circumstances. The exclusive right provided by the patent is actually rooted in the US Constitution, which authorizes Congress to allow inventors to secure exclusive rights in their inventions in exchange for the inventors disclosing and teaching the invention to the public; thereby promoting the progress of science and useful arts.((Article 1, Section 8, Clause 8, of the United States Constitution which means patents are regulated exclusively by the federal government. Disputes concerning the scope and validity of patent rights can only be adjudicated in federal court or before the Patent Trial and Appeal Board (PTAB) at the United States Patent and Trademark Office (USPTO).))

Where: Issuance and enforcement of patent rights are jurisdictional matters; meaning that if you have a patent in the US, your right to exclude others does not extend beyond US Borders. Foreign patent rights must be sought in jurisdictions where the ability to enforce is desirable. However, it is important to note that a US patent would allow the patentee to prevent infringing products/processes from being imported into the US via the appropriate judicial and administrative procedures.

Who: In the United States, only persons (not entities) can be inventors and it is therefore the inventors (or joint inventors) who are the original owners of the invention absent any contractual agreement stating otherwise. With this ownership comes the right to file a patent application claiming the invention. It is very important to distinguish between “inventorship” and “ownership.” In the scenario where an employee creates an invention within the scope of their employment, and there is a contractual agreement to assign such inventions to the employer, the employer is the owner of the invention and therefore has the right to file a patent application as “the applicant” while designating the employee as the “inventor.” If the employer subsequently decides to sell the issued patent rights or gets acquired by another company, the ownership of the patent will change accordingly but the inventorship will always remain the same.

When: Two things are required to have an invention; conception and reduction-to-practice (RTP). Conception is just that, it’s the idea-stage. Think back to our Thomas Edison example but now picture that he literally has a lightbulb envisioned in that cloud above his head and he begins to sketch it out on paper; this is conception. RTP occurs when you successfully practice the invention. Think of this as the prototype or “proof-of-concept((For the life science and biotech folks, proof-of-concept (POC) can be the basis for RTP. If the invention is a small molecule that is capable of treating cancer, the inventor can establish RTP by demonstrating the small molecule’s efficacy as a cancer treatment via animal/in-vitro experiments.))” stage. While working prototypes are probably the best way to establish RTP, US Patent Law provides that RTP can be “shown” by filing a patent application. If Thomas Edison can take his sketch of the lightbulb and provide a blueprint or recipe that enables others to make and use the lightbulb, he has sufficiently established that he has an invention (conception + RTP) ready for patenting.((This does not mean his invention is ready to receive a patent. Rather, it means that Tom has “enough” to begin the patenting process (file a patent application) which will require him to satisfy other legal standards before he can be entitled to a patent for his invention.)) In the US, the term of a patent is twenty (20) years from the effective filing date.((The clock starts to run on the date you file your patent application. Because it typically takes 3-4 years to receive a patent, the patentee is often left with 16-17 years of patent term to exploit the patented invention. Patent terms can be adjusted (extended) by the USPTO in certain circumstances. A patent applicant can also pay additional money to speed up the 3-4-year patent application process thereby preserving more of their 20-year patent term.))

How/Why: The patenting process begins with filing of a patent application. Once filed, a negotiation between the patent examiner and patent attorney/agent will commence wherein the patent examiner will advise the patent attorney/agent as to what can be patented when applying the law in light of the examiner’s prior art((Prior Art is anything under the sun that is public, that can render an invention “not-novel” or “obvious.” It can be a printed publication, a video clip, a picture, or a public presentation given orally at a conference with no corresponding visual presentation. Prior art searches can also be performed by the patent applicant prior to filing the application as the results may help inform the patent applicant’s strategy.)) search. If successful, the negotiation will cease when the patent attorney/agent and patent examiner agree on the allowable subject matter to be patented and the patent application is granted; the patent “issues.” This process typically takes 3-4 years due to the volume of required correspondence between the applicant and the patent office in addition to administrative backlog within the patent office.

Due to their exclusive nature, patents are highly desirable business assets that provide competitive market advantages. Patents are also useful in raising capital for newly formed businesses as they help reassure investors that their investments will be maximized while simultaneously minimizing the threat from market competitors.((It would be disingenuous for me to tell you that this is a commonly-held belief. It is in fact, not uncommon for some more seasoned business executives and venture capitalists to see patents as more of hindrance to getting a business off the ground as pursuing a patent brings with it added costs and liability. Costs with respect to the acquisition and defense of the patent right(s) and added liability stemming from patent infringement and validity actions going both ways. Let’s not forget those attorney’s fees!)) Last but most importantly, patents provide an incentive to innovate by giving the inventor the exclusive but limited (in time and territory) right to exploit (and exclude others) their invention in exchange for sharing the knowledge of how to make/use the invention with the general public.((You might be asking “how is the inventor sharing the invention with public if only they get to use it for 20 years?” After the 20-year period the invention becomes part of the public domain and is free to be exploited (subject to applicable laws and regulations) by members of the public. It is the disclosure of information written in the patent application that is the benefit to the public prior to the end of the 20-year period. This information informs the public about a new technology and may inspire others to invent similar inventions or improvements prior to the expiration the 20-year term. It is also not uncommon to license patent rights solely for the purpose of further developing the underlying technology which inevitably leads to more patents. If there were no incentive (20-year exclusivity) for inventors to share their inventions with the public, then it would be in the inventor’s best (commercial) interests to keep the invention a Trade Secret and exploit the invention indefinitely or for as long they can keep it a secret. It is easy to see how such a secretive system would have a chilling effect on innovation.)) It is this “quid pro quo” dynamic of the patent system that is the bedrock of many key pieces of legislation such as the Bayh-Dole Act (1980), the Drug Price Competition and Patent Term Restoration Act (1984), and the Biologics Price Competition and Innovation Act (2010); all of which are collectively aimed at providing patent-based incentives and regulations that promote innovation from both the private and public sectors alike.

Final Thoughts: It is my hope that this article provides you with a general foundation of knowledge with respect patents and the critical role they play in the advancement of science and technology. As illustrated above, patents and the patenting process can be very esoteric and we could spend days getting into the details of any one of the subtopics covered above; but that’s what textbooks are for. Luckily, the Partners Healthcare Office of Innovation is here to serve as a primary resource of information and guidance for navigating all intellectual property (IP)((Intellectual Property is primarily made up of patents, copyrights, trademarks, and trade secrets. There are some that consider “name and likeness,” trade-dress, and “know-how” to be distinct forms of IP but that really depends on who you ask and within what industry you or are operating.)) related issues that arise from the research performed by or on behalf of the institutions within the Partners Healthcare System. Please feel free to contact your designated Licensing Manager or Associate should you have any questions regarding this article or general IP matters.