Policy Forecast: Partly Sunny-- with a Chance of Typhoons
These days we should never say that things can’t get any stranger. They can and often do. We just endured an election that left Congress divided with slim majorities in both houses, along with presidential approval ratings in the dumps and the public in a sour mood.
What does this mean for us? The odds of passing any sweeping legislation are remote, so opponents of the Bayh-Dole Act will press hard for the current administration to undermine our system through executive actions. Several targets are already lined up.
The first is an attempt to extend the current TRIPS (Trade Related aspects of Intellectual Property Rights) waiver on COVID-19 vaccines to any COVID therapy. The original waiver was made under the pretext that patents were preventing the manufacturing of vaccines needed to fight the pandemic. The Biden Administration agreed, even though it was apparent that the real problem was the difficulty in safely making mRNA vaccines, and even more importantly, getting them distributed. The waiver was aimed squarely at the U.S. (no one wants to copy Chinese or Russian vaccines, for good reason). Ironically, other countries are pushing back against this extension, while the Administration remains silent.
The next target involves the march-in rights provision of Bayh-Dole which critics have long sought to misuse so the government can set prices on products based on federally funded R&D. Because this authority is illusory, every Democratic and Republican administration in the past 20 years has denied these petitions. Nevertheless, the Biden Administration is under considerable pressure to march in on Xtandi, a prostate cancer drug, even though previous petitions on the drug were rejected under the Obama-Biden Administration.
The critics also claim the government can use its authorities under 28 U.S.C.1498 (a) to seize any patent so products could be copied to lower their price. As explained by the retired Chief Judge of the U.S. Court of Claims, Susan G. Braden, this is a gross misrepresentation of the law.
If the Administration caves on march-in rights or Section 1498, the courts are likely to intervene. But confidence in government funded institutions as reliable research partners could collapse if it appears that long established policies can be turned on their heads according to political whim.
Lastly, there are rumors the Administration is going to make it harder for universities to get waivers from Bayh-Dole’s domestic manufacturing preference even when products can’t be made here competitively.
Despite all the political uncertainties, one thing is constant: Growing the American economy is the top issue for any leader who wants to remain in office.
We can prove that our system works and that it’s driven by small companies which can only take the substantial risks required when they can protect their investments with patents. We can show that academic institutions are good stewards of public trust as proven by their tremendous impact on state, regional and national economic development.
Finally, we must stand up to the claim that the way to improve public health and welfare is to steal intellectual property.
We’ve won this battle before. We have a good story to tell. Now’s the time to tell it.