Rising prescription drug prices are a major problem for Americans to the point where people are forced to choose between their medicines and basic necessities such as food and housing. One of the root causes of this crisis is patent abuse-when drug companies manipulate and find loopholes in our patent system to prolong their monopolies and keep prices high. Congress is considering many bills to curb these abuses. Unfortunately, one recent draft proposal would make matters worse by increasing drug costs, impeding the development of new medicines, and failing to spur new innovation.
Section 101 of the Patent Act currently prohibits the patenting of abstract ideas, laws of nature, and natural phenomena. It is the product of over 150 years of judicial interpretation, including multiple decisions by the Supreme Court, and legislative tinkering that prevents the patenting of genes and scientific discoveries. Senators Thom Tillis (R-NC) and Chris Coons (D-DE) recently introduced draft bill language that would eliminate all of this court guidance and enable patents on things previously barred. It would potentially state that human intervention to isolate an individual gene makes the gene patentable and allow drug companies to patent them. Hopefully, these expansions in patentable subject matter will be eliminated before the bill is introduced.
This proposal would have other harmful effects for consumers. To begin with, it would increase drug prices. Evergreening, in which drug companies obtain a series of patents to prolong their monopolies, is a substantial cause of high drug prices. By allowing companies to obtain even more patents, the bill will make patent evergreening easier and more common. Drug companies will build bigger patent thickets around their popular drugs to extend their monopolies and prevent price-lowering competition that is intended under current policy.
Next, the proposal would harm the development of new drugs by stifling scientific research. Scientists, along with the Department of Health and Human Services (HHS), recognize that gene patents harm research and innovation that products lifesaving tests and treatments. Scientific discovery is cumulative, and researchers have long opposed patenting of basic science discoveries, because patents on these discoveries create big roadblocks for future research. Before the Supreme Court’s 2013 decision, patents on genes prevented testing for conditions such as breast cancer, hearing loss, and Alzheimer’s, and laboratory directors frequently refrained from developing new tests or services because of these patents. The draft proposal would bring all of these problems back.
This bill would also create little value that could counteract the harm to accessible and affordable prescription drugs. In a 2010 report on gene patents, HHS concluded that “patents do not appear to be necessary to stimulate research and test development” and that scientists already have many reasons to conduct research. The draft legislation would therefore create powerful disincentives for vital research on drugs and treatments, with no corresponding gains.
Finally, the bill was developed at a series of “invitation-only” roundtables where the participants were mostly corporate representatives and patent professionals. There was no real input from the public, advocacy groups, or scientists.
The Section 101 bill would lead to great harm, and so would other bills that would allow the patenting of genes, natural laws, and products of nature. Fortunately a number of consumer and advocacy groups, led by the Coalition Against Patent Abuse, rallied against this proposal. And Senators Coons and Tillis heard their concerns and announced that the bill will be rewritten to ensure that it will not harm consumers.
This is a notable victory for consumers and everyone who wants access to affordable drugs. But Representatives and Senators should reject any expansion of patents and instead pass bills that will end patent abuse and lower prescription drug costs.