Even if unenforced, gene patenting chills research and blocks cooperation

2. Legal Limitations on the Enforcement of Patents During Public Health Crises

Some might argue that pathogen patents need not be limited because patent holders are already constrained from enforcing their patents, especially during global health crises. For example, in the United States, a patent holder cannot obtain a permanent injunction preventing an infringer from practicing a patented invention unless it demonstrates that the public interest would not be disserved by the entry of the injunction.172 Likewise, the International Trade Commission, when assessing the appropriateness of an exclusion order barring the importation of infringing goods into the United States, must take into account "the effect of such exclusion upon the public health and welfare."173 These limitations have significantly reduced the number of injunctions and exclusion orders that are issued with respect to medical and health-related technologies.174 And under 28 U.S.C. §1498, injunctions may not be obtained for patent infringement against the U.S. federal government or its contractors the remedy for such infringement is limited to monetary damages as assessed by the Court of Federal Claims.175

[*572] These limitations might suggest that, at least in the United States, the existence of patents claiming pathogenic sequences might not represent a significant threat. However, the existence of patents on these basic research tools, no matter the eventual litigation outcomes, can chill research, impose delays, and provide leverage for the demand of unwarranted fees.176 Even meritless claims are costly to defend against and impose some level of risk to defendants, particularly in the United States, where fee shifting is rare. Despite the seeming assurance under §1498 that firms operating under government contracts to produce vaccines and other biomedical supplies will be shielded from actions in district court, this has not always been the case.177 Accordingly, while various litigation doctrines may tend to lessen the threat that pathogen patents will successfully be enforced in the United States, that threat is not entirely eliminated and may still impose a significant cost on firms that are engaged in research and development of pathogen-based biomedical products.