The United States Department of Justice recently announced that it does not plan to challenge proposed efforts by a handful of pharmaceutical companies to share information about manufacturing facilities and other information that could enable them to expedite the production of monoclonal antibody treatments to treat COVID-19.
Request Letter
The Requesting Parties – Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GlaxoSmithKline – submitted their business review request on July 15, 2020, requesting the ability to make “certain limited exchanges of information regarding manufacturing facilities and related issues” that would allow them to “expedite the production of COVID-19 mAb treatments once they are approved.”
In their letter, the Requesting Parties indicated that they were independently developing antibody agents that may be effective against COVID-19, but have concerns that if/when a successful treatment is identified, they may not be able to produce the volume of treatment required as quickly as need be by themselves. The information they plan to exchange is typically considered “competitively sensitive” information and would generally be considered unlawful to share among competitors without a clear procompetitive justification.
Among other competitive safeguards, the Requesting Parties have committed that they will not exchange information related to the prices of the mAb treatments or the costs of inputs for or production of those treatments, nor will they exchange information outside of the immediate COVID-19 treatment matter at hand. Additionally, the information exchange is limited to one year
DOJ Response Letter
The DOJ believes that the demand for mAb treatments targeting COVID-19 is expected to exceed what any one individual firm could produce on its own. Additionally, waiting until regulators approve specific treatments before scaling up manufacturing processes may delay access to the medicines by many months, which would negatively impact our efforts to fight COVID-19.
In its letter, the DOJ indicated that the Requesting Parties want to address both of those potential problems by sharing information about their manufacturing facilities, capacity, raw materials and supplies that could be used to produce successful COVID-19 mAb treatments (subject to important safeguards and limits), so that facilities can be ready to manufacture treatments once they are proven to be safe and effective. The DOJ believes that these efforts will expedite and expand the overall production of monoclonal antibody treatments targeting COVID-19 in a way that is unlikely to lessen competition.
“This critical collaboration will help Americans get access to potentially life-saving therapeutics sooner than otherwise would be possible,” Assistant Attorney General Makan Delrahim said. “It also will help preserve Americans’ ability to benefit from the free market competition that drives innovation and access to drugs in the biotech and pharmaceutical industry.”