“Safe Harbor” Act May Save Pfizer From Infringement for Covid Vaccine Clinical TrialsFebruary 15, 2021

In October, 2020, Allele Biotechnology and Pharmaceuticals sued Pfizer, Inc.  for infringement of U.S. patent 10,221,221 in the U.S. District Court for the Southern District of California.  The pre-Covid ‘221 patent, entitled MONOMERIC YELLOW – GREEN FLUORESCENT PROTEIN FROM CEPHALOCHORDATE, issued on March 5, 2019, and claims priority to a provisional application filed on July 24, 2012.   Allele alleges that the clinical trials performed by Pfizer for submission to the FDA infringe the ‘221 patent by using a fluorescent protein protected by their patent.  Allele has not accused Pfizer of selling the protein or using the protein to make its Covid vaccine.

On February 8, 2021, Pfizer requested that the lawsuit be dismissed because the 1984 Hatch-Waxman Act protects their clinical trials from infringement.  The Act includes a “safe harbor” provision, which states, “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”  35 U.S.C Section 271(e)(1).

Thus, Pfizer asserts that this clause provides immunity for its acts where were undertaken to develop information required by the FDA for the manufacture, sale, or use of drugs, including Pfizers’ Covid vaccine.  Since the allegedly infringing activity was necessary to obtain regulatory approval, Pfizer asserts that there is no infringement in view of this exemption passed by Congress.

This litigation raises a host of issues regarding public policy versus patent protection. The public interest in development of a Covid vaccine arose long after the patent application was filed and a year after the patent issued.  Should the patent owner give up or ignore their rights for the benefit of the national health, despite their likely investment of substantial time, personnel, and financial resources to the development of the protein which was eventually patented?  Or should there be a mandatory license, including possible royalties from Pfizer, in view of the worldwide Covid pandemic?  These and related issues will be debated by the parties, and possibly others, and the courts will decide which policies prevail.

Kirk Hartung is Co-Chair of the Mechanical Patent Practice Group at McKee, Voorhees & Sease, PLC. For additional information please visit  www.ipmvs.com or contact Kirk directly via email at kirk.hartung@ipmvs.com.