As researchers at universities and pharmaceutical companies rush to find treatments for COVID-19, new potential patent risks arise. While owners of existing patents that may be useful for COVID-19 treatments may have agreed to free up access to their patent rights through licensing or initiatives like Open COVID Pledge (U.S.) or the Open COVID-19 Declaration, the free access to these patent rights is only for the duration of the COVID-19 emergency or some specified period thereafter. Thus, COVID-19 treatments used outside those periods could result in patent infringement liability if such treatments read on claims of existing patents.
Most universities and companies have well-established procedures regarding the exchange of information and technology. These procedures often involve agreements vetted by in-house and/or outside counsel, with well-defined intellectual property rights clauses. Depending on the parties and the type of agreement, it may take time and significant resources to implement these procedures. Unfortunately, these well-established procedures may not necessarily be compatible with the aggressive timeline needed for COVID-19 treatment. Therefore, the accelerated speed of finding treatments for COVID-19 also may result in sidestepping these procedures for sharing results of research or even technology. The resulting lack of legal safeguards exposes the exchanging parties to a variety of potential legal risks.
For instance, if there is no patent ownership clause in place, one of the collaborating parties could file for a patent application without needing the other’s consent and without providing the other party any license to the technology in the patent. Without a clear definition of the scope of patent ownership, a dispute could arise in the future. Similarly, if there is no confidentiality agreement in place for a disclosure of information among parties, it is possible that such a disclosure would be considered a public disclosure, which may prevent the patenting of COVID-19 treatments.
Even if the parties are diligent about the patent rights, they still need to be cognizant of potential outside disclosures and/or patent filings. For instance, many jurisdictions require so-called foreign filing licenses for filing a patent application abroad. The penalties for failure to comply with such foreign filing licenses may be harsh. For example, in the U.S., under 35 U.S.C. § 185, failure to obtain a foreign filing license may result in a patent being invalid unless the failure to procure such license was in error and the patent does not implicate national security.
Furthermore, in the U.S. and other jurisdictions, new patent applications are publicly unavailable until 18 months from the earliest priority date (unless they grant as patents sooner). Therefore, there is always an 18-month window when it is not possible to identify patent applications that may be of concern. With the rush to find treatments for COVID-19, it is likely that a large number of patent applications are already on file that could be a concern for those trying to find treatments for COVID-19. Once these applications grant as patents, it is possible there will be a spike in infringement actions relating to COVID-19 treatments.
To minimize these risks, it would be best for universities and companies working on COVID-19 treatments to follow existing procedures, which may include consulting in-house or outside counsel. Companies working on COVID-19 treatments also may want to establish a rigorous patent publication-monitoring system to identify patents and patent publications of concern.