AIOG recently held their first virtual career seminar with special guest Andrew Levitt, an associate patent counsel at Cantor Colburn LLP. He summarized the key aspects of patent law and provided some background as to the transition from academia to law. Britt Knight, the post-doc liaison for AIOG, has written prior articles regarding these topics; for more information on patent law, please check those out (search “patent”)! A key piece of information that Levitt had to offer was that regarding the Hatch-Waxman Amendments. This is more formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984” and established the approval pathway for generic drug products. Applicants are able to submit an abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act, contained within these Amendments. Other provisions in these Amendments include patents related to new drug applications and 180-day exclusivity for certain AANDA applicants. Levitt expressed that patent lawyers who are well versed in this area are in high demand in the field.
Yet there are other channels for generic drugs being produced. For example, the current coronavirus pandemic is pushing governments to issue compulsory licenses to boost the production of generic drugs that treat COVID-19. A compulsory license is a license issued by a government to a public agency or generic drug marker allowing it to copy a patented medicine without the consent of the patent holder. In the past, countries had granted compulsory licenses to boost the production of drugs that treat HIV.
Levitt also mentioned some helpful tips to individuals interested in transitioning from academia into patent law. What he cited as helping him make the jump were the services offered by the PLI, or Practicing Law Institute. This is a nonprofit organization that aids in enhancing legal knowledge and expertise. PLI offers educational programs and a patent office exam course, among other opportunities. Additionally, what Levitt found to be helpful was networking with other legal professionals.
Cowritten by Rachel Gilmore and Yuezhe Li
Sources:
https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters
