In a post last week we touched on arguments made by I-MAK, a group funded in part by anti-pharmaceutical activists John and Laura Arnold that has been peddling false arguments about the U.S. patent system. We heard more about the patent issue this week at a U.S. Senate Finance Committee hearing on drug prices, so today we’ll take another look at the claim that pharmaceutical companies “game” the system.
As University of Missouri-Kansas City Law Professor Christopher Holman explained at Intellectual Property Watch, criticism of drug companies has focused on follow-on pharmaceutical innovation, or “innovation that seeks to improve upon existing pharmaceuticals and their use in treating patients.” These patents, Holman notes, often are derisively referred to as “secondary” patents, the implication being that “underlying inventions are somehow lesser in nature than the subject matter claimed in ‘primary’ patents.” Holman also explains groups like I-MAK refer to follow-on innovation as “evergreening.”
These terms are clever, but Holman says they overlook the role this type of innovation plays in “addressing compelling human health concerns.”
Take AZT, a drug used to treat AIDS. Holman explains, “AZT began its life as a failed attempt at a cancer drug, and it was only years later that its potential application in the fight against AIDS was realized.” Indeed, it was a secondary patent “that incentivized the investment necessary to bridge the gap between a promising drug candidate and a safe, effective, and FDA-approved pharmaceutical.”
AZT, of course, is part of the course of therapy that, as Washington Post’s Dylan Matthews said in 2013, “effectively turned HIV/AIDS into a chronic, manageable disease rather than a death sentence.” A 1999 article by the Food and Drug Administration also noted “AZT taken according to a strict regimen decreases by nearly 66 percent the odds of infecting the newborn.”
Holman cautions, “In a world where follow-on innovation is unpatentable, there would have been no patent incentive to invest in the development of [AZT], and without that incentive AZT might have languished on the shelf as simply one more failed drug candidate.”
Two other drugs that are a result of follow-on innovation are Evista, which is used to treat osteoporosis and to reduce the risk of invasive breast cancer, and Zyprexa, which treats schizophrenia. Follow-on innovation also often makes drugs safer, Holman says, as is the case with Lumigan, a glaucoma treatment.
“Evergreening” and “secondary patents” are fine buzzwords, but the fact is, without a strong patent system that honors follow-on innovation and protects intellectual property, fewer investors would allocate funds toward potentially life-saving discoveries and fewer innovators would be willing to work in this field. And Americans would suffer.