With the implementation of the AIA, researchers should seriously think about the possible ramifications of public disclosure of their research prior to any patent filings. Under the old patent laws, a patent was awarded to the first person to invent the subject matter, even if that person was not necessarily the first one to file a patent application for the same subject with the Patent Office. In contrast, under the new laws, the person who invents first may lose the ability to patent an invention if someone else files a patent application first. Therefore, it is very important to file a patent application as soon after conception of the invention as possible, and before public disclosure.

Under the old patent laws, inventors also had a one-year grace period after public disclosure to file a patent application for their invention. Within the one-year period, the invention remained patentable to the inventor, regardless of who made the public disclosure. Under the new system, the one-year grace period only protects disclosures made by, or derived from, the actual inventor(s).

Any other disclosures by unrelated third parties (for example, a competing research group) can destroy patentability of the invention. Research institutions and businesses, particularly universities, should pay attention to the rules involving the new “first-inventor-to-file” rules and the applicable grace period. As is common, there can be several research teams working in the same area, often with the same goals. As a result, it is not uncommon for multiple, independent research groups to develop the same inventive concept at similar times. And with the new patent laws, it does not matter which of these groups conceived of the invention first. It is basically a race to the Patent Office. Also, if one of the groups publicly discloses its work (for example, giving a lecture, submitting an abstract to a conference or publishing), and even though the group still gets a one-year grace period to file a patent application, it could very well put a competing group with the same inventive concept on notice, and it could then publicly disclose its invention and potentially prevent either party from being able to patent the invention.

The research-intensive life science industry often involves many collaborative efforts, which pose a few important considerations when it comes to the development and commercialization of inventions. For instance, it is imperative that everyone involved understands what makes someone a “co-inventor” versus a “co-owner” of an invention and also what implications each has on intellectual property rights. Furthermore, inventorship or ownership can become less and less clear as the number of collaborators increases, possibly resulting in future disputes or improper chain of title. Well drafted contractual agreements, including non-disclosure agreements, assignments and licenses, are particularly important in delineating proper rights and ownership. It is imperative that the proper individuals are the ones attempting to license and commercialize the invention, as the receiving party is likely to perform a thorough due diligence analysis.

Also, researchers must consider how the AIA’s new treatment of third-party disclosures on patentability will affect their relationships with collaborators. Since “first-to-invent” is no longer the applicable standard, researchers should carefully consider any disclosures with collaborators before they are made. If a collaborator discloses an invention that does not belong to him/her, an inventor must be able to prove the invention was derived from his or her own work. As such, it is important for inventors to keep good records of all conversations, meetings and experimentation performed with collaborators.

Historically, the research-oriented, collaborative environment of the life sciences catered to presenting one’s research to peers and publishing articles. In view of the AIA, however, researchers need to seriously think about filing a patent application before making any presentations or publishing any articles, as the subsequent acts of unrelated parties, and even collaborators, can destroy the inventor’s ability to patent the invention.