Widespread access to a safe and effective COVID-19 vaccine is the key to getting back to normal, according to health experts. However, some are questioning whether patent rights could serve as a "barrier" to access to COVID-19 vaccines and treatments.
Pharmaceutical companies are generally entitled to protect their intellectual property by obtaining patents for vaccines and treatments they develop. However, the need to quickly respond to the COVID-19 pandemic has raised questions over the proper balance between IP rights and serving the public good.
The Bayh-Dole Act is being touted by some as the answer to access concerns involving COVID-19 vaccines and treatment. The law applies to inventions springing from government-funded research, and its stated goal is to “ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions.”
Under the Bayh-Dole Act, a nonprofit organization or small business may elect to retain title to any “subject invention” generated with federal financial assistance. However, they must comply with certain requirements, including the obligation to disclose U.S. federal government support in patent applications. The disclosure requirements are also set forth in regulations issued by the U.S. Patent and Trademark Office (USPTO).
One of the most controversial provisions of the Bayh-Dohl Act involves the federal government’s march-in rights, which provide a Federal agency with the authority, in certain very limited and specified circumstances, to make sure that a federally funded invention is made available to the public. The march-in provisions are set out in 35 U.S. Code § 203, which states that:
With respect to any subject invention in which a small business firm or nonprofit organization has acquired title under this chapter, the Federal agency under whose funding agreement the subject invention was made shall have the right, in accordance with such procedures as are provided in regulations promulgated hereunder to require the contractor, an assignee or exclusive licensee of a subject invention to grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the contractor, assignee, or exclusive licensee refuses such request, to grant such a license itself (under certain enumerated rights).
Investigation into COVID-19 Treatment Development
In August, 34 state attorneys general sent a letter requesting the federal government to exercise march-in drug rights for Gilead Sciences’ COVID-19 treatment remdesivir. “Here, we think it is clear that Gilead has not established a reasonable price, nor has it met the health and safety needs of the public given the COVID-19 pandemic,” the letter states. “We urge the federal government to use its march-in rights to help increase the supply of this drug and lower the price so it is accessible to our state residents.”
USPTO Response to Access Concerns
To date, the USPTO has downplayed concerns about barriers to access. In remarks at IP Week on August 27, 2020, USPTO Director Andrei Iancu said that the public should be concerned by statements like “IP is a barrier to innovation” or that drastic measures like compulsory licenses should be imposed in light of the COVID-19 pandemic. Director Iancu emphasized that evidence of need must be shown before any such measure is taken, stating:
As it turns out, the evidence to date shows that IP is a catalyst for, and not a barrier to, the development of vital technologies needed for the current pandemic. The evidence also shows that voluntary actions are being undertaken by many rights holders during this crisis, including: innovative licensing arrangements, the publication of scientific data on a free-to-use basis, the publication of technical specifications that enable others to manufacture, and the voluntary renouncement of enforcement of patents in certain jurisdictions during the crisis.
Director Iancu’s confidence in companies “doing the right thing” was recently validated. On October 8, Moderna clarified its position on COVID-19-related IP. In a statement, the company committed to making its IP available to other vaccine manufacturers in an effort to prevent barriers to access. The company wrote:
Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post-pandemic period.
The COVID-19 pandemic has the potential to spur innovation that may continue to benefit the world once the emergency has passed. How companies and the federal government balance IP rights and public access going forward will continue to be a closely watched issue.
If you have questions, please contact us
If you have any questions or if you would like to discuss the matter further, please contact me, David Einhorn, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.