Ralph Waldo Emerson said, “All great masters are chiefly distinguished by the power of adding a second, a third, and perhaps even a fourth step in a continuous line. ... With every additional step you enhance immensely the value of your first.”
Emerson, of course, was not talking about follow-on biopharmaceutical innovation, but he could have been. As University of Missouri-Kansas City Law Professor Christopher Holman has explained, follow-on (or incremental) developments are innovations that seek “to improve upon existing pharmaceuticals and their use in treating patients.”
Organizations like the Initiative for Medicines, Access, and Knowledge (I-MAK), which receives funding from billionaires John and Laura Arnold, often derisively refer to these innovations to as “secondary” patents or “evergreening.” Holman explains that the implication is that “underlying inventions are somehow lesser in nature than the subject matter claimed in ‘primary’ patents.”
That implication is wrong.
In a 2014 report, Canada’s Fraser Institute explored the benefits of incremental innovation, including the fact that follow-on drugs bring down prices. Researchers Steven Globerman and Kristina M. Lybecker cite a study that examined 20 new entrants to existing classes. That report found 80 percent of these new entrants “were launched at a discount relative to the price leader and 65 percent were launched at a discount relative to the average price for the class.” Globerman and Lyebecker conclude “one of the principal advantages of the development of follow-on drugs is the price competition that results from multiple drugs in a single therapeutic class.”
Examples of follow-own innovation include lopinavir/ritonavir, a follow-on combination HIV/AIDS drug that was safer and had a better “tolerability profile” than a previous treatment.
Globerman and Lybecker also argue incremental innovations provide “physicians with the flexibility to treat the individual needs of diverse patients with precision while improving patient compliance by eliminating adverse drug reactions and side effects.” The two conclude that “incremental innovations undertaken by drug companies provide great value for both physicians and patients.”
Secondary innovation could help address the current coronavirus pandemic. Indeed, as this article explains, “The world has taken to searching its medicine cabinets for potential cures. Some previously known substances and drugs for other ailments are now under investigation as possible treatments.” Or, as an article in the International Journal for Antimicrobial Agents says, “Repositioning drugs already approved for use in humans is a useful tool to search for new therapeutic options, particularly in the current global crisis.”
Mark Cohen, director of Asia Intellectual Property Project at the Berkeley Center for Law and Technology at University of California Berkeley Law School, agrees. He told the San Jose Mercury News that “it could be more efficacious” to use an old drug to treat COVID-19. He also said, “It could be that putting ‘this’ and ‘that’ together has a synergism that makes it more effective” and argued there “Is nothing inherently wrong with a research organization filing for a patent on an existing pharmaceutical compound for a new use.”
Particularly if that use could save millions of lives during the worst pandemic the world has seen in at least a century.