Who Owns Federally Funded Research Products?

Many important medications available today have been developed with public dollars and yet are costly to patients. The government, especially through the National Institutes of Health (NIH)  has funded many seminal research directly contributing to the discovery of transformative medicines. Congress enacted the Bayh-Dole Act in 1980 which allowed universities to patent the results of federally funded research and then license these patents to commercial entities. In 2013, Senator Patrick Leahy asked the NIH to expand the availability of Myriad’s genetic tests to identify BRCA 1 and BRCA 2 which predict high risk of breast and ovarian cancer. The essential discoveries that made the test possible were developed with government funding and that the cost of the test ($3000) is unaffordable for millions of women; the request was denied.

Undifferentiated stem cell separation technology used in bone marrow transplants was heavily supported by NIH funding, however, the procedure is extremely costly to the patient and unaffordable for patients without insurance.

The retroviral drug, ritonavir- a human immunodeficiency virus (HIV) protease inhibitor was developed with government funding to Abbott Laboratories and Columbia University. This is a major medicine for the treatment of HIV, but its pharmaceutical cost in America is 4 to 5 times higher than the same drug in other countries.

Recently, patients with Fabry disease requested an open license for an enzyme replacement therapy developed with government funding at Mount Sinai School of Medicine and licensed to Genzyme. The NIH rejected the petition.