The USPTO has launched a new Cancer Moonshot Expedited Examination Pilot Program. The program — which began on February 1, 2023 — expedites the examination of patent applications pertaining to a host of technologies that prevent cancer and cancer mortality.
This is a promising measure taken by the Biden administration to encourage IP-based investments in innovation and make headway on the president’s goal of slashing cancer death rates by 50% over the next 25 years.
Unfortunately, for every step forward on this front, some policymakers would take us two steps back. Right now, members of Congress are calling for the Department of Health and Human services to misuse the Bayh-Dole Act’s march-in provision to seize a developer’s patent rights — undercutting the investment incentives behind the USPTO’s new program.
If successful, patent rights would be subject to the whim of lawmakers, who would have the government relicense them to generic manufacturers on the basis of price — which is not a valid criterion to “march-in” under the Bayh-Dole Act. The law’s principal authors, Senators Birch Bayh (D-IN) and Bob Dole (R-KS), never intended for march-in rights to be used as de-facto price controls. That’s precisely why no Republican or Democratic administration has ever approved a petition on those grounds.
Veering from this well-established precedent would spell disaster for American innovation. Revoking intellectual property safeguards — via government march-in — would cast a dark cloud of uncertainty over biotech companies and the likelihood of recouping their investments. They wouldn’t be able to dedicate billions of dollars towards the risky R&D endeavors required to deliver a bona fide cure for cancer patients.
As lawmakers weigh these policy decisions, they should bear in mind that the success of the cancer moonshot is inextricably linked to a strong IP system. Undermine patents and this sky-high ambition will never leave the launch pad.