Risk of patent thickets in genetic research is very low

Congress could decide whether to make all uses of the genetic association protected by patent law, such that those who later invent gene therapies or biologic products to treat a condition would have to first license the right to make use of the genetic association from the genetic association patent holder. This approach would greatly increase the incentive to make genetic association discoveries, because genetic association patent holders would share in the profits from follow-on treatments. This raises the specter of impeding downstream innovation because of the need to obtain a license from the genetic association patent holder, potentially causing patent thickets. But there is reason to think that impairment of downstream research would be rare since only a single gene association patent would have to be licensed, rather than hundreds or thousands of upstream patents that must be licensed in some high-tech products like smart phones. In addition, not only would genetic association patent holders be incentivized to license so as to share in the profits from downstream treatments, but the availability of downstream treatments would also encourage more people to get tested for genetic associations, further increasing profits. This is because before a treatment is available, some people would prefer not to know if they are more likely to suffer from a disease such as Alzheimer’s. But after a treatment is available, people would have incentives to get genetic testing so that they could treat the condition if they find out they are susceptible to it because of their genes. On the other hand, if Congress is concerned about patent thickets, it could amend the patent statute in various ways to restrict the assertion of genetic association patents only to the use of those genetic associations for diagnostic testing. For example, Congress could do this by creating a statutory patentability exception for genetic association patents while leaving unaltered the current statutory language for “new” and “utility.”