Can They Really Do That? The Specter of Government-Authorized Infringement of Pharmaceutical Patents
The perception that pharmaceuticals in the United States are overpriced, and that patent rights are why, has been a recurrent political theme over the last several years. This view, along with the ongoing novel coronavirus pandemic, has caused some to consider whether the U.S. government should act to ensure affordable access to potentially life-saving medicines.
But under what authority could the U.S. government take action on patents in an attempt to lower drug prices or make a lifesaving product more widely accessible? A team of Ropes & Gray intellectual property litigators, led by partners Matt Rizzolo, Filko Prugo, and Charlotte Jacobsen, has authored a white paper exploring the topic in depth. The paper – titled Can They Really Do That? The Specter of Government-Authorized Infringement of Pharmaceutical Patents – offers a detailed look into two possible statutory levers that the federal government could pull. The authors also discuss the important roles that the Food, Drug, & Cosmetic Act and the fragmented nature of the U.S. health care system may play in any government-authorized infringement or compulsory licensing efforts. Finally, they discuss a variety of legal and policy avenues that patent holders may employ if their patent rights are threatened by the government, up to and including constitutional claims.