Continued IP Vigilance is Needed in a World of 'No Final Victories'
 

Mike Waring
AUTM Advocacy and Alliances Coordinator

During my career as a lobbyist, I worked for a trade association CEO who – when confronted with either a major legislative win or loss – would often remind us that “in government, there are no final victories or final defeats.” That reminder seems particularly relevant in the wake of the recent National Institutes of Health (NIH) decision regarding Bayh-Dole march-in rights.  
 
What my former CEO meant is that the political process can change in a New York minute. The ins become outs. The outs become ins. Agendas change suddenly, and so can the political will to carry out or rewrite policies. All it takes sometimes is a new Administration or a new Congress to undo the “victories” of the previous one.
 
This is why we have elections – so the will of the voters determines which party controls the Congress or the White House. And when party controls are changed, things we thought were “settled” victories may not be so settled. Even federal courts can do 180-degree turns on issues.
 
As I write this, the pro-IP community is celebrating (and rightfully so) the decision by the NIH last month to deny the latest request to “march in” on the UCLA-created prostate cancer drug Xtandi. After several attempts by outside groups to claim high prices necessitated that action, the agency made it clear that it does not see any authority under the Bayh-Dole Act to do so based on costs. This is the argument the technology transfer community and numerous others have made for years, and it was good to see that view validated in the NIH decision. Bayh-Dole Coalition Director Joe Allen said this action was “the biggest victory we’ve had in twenty years.”
 
The next day, the Department of Health and Human Services (which oversees NIH) and the Department of Commerce (which includes the National Institute of Standards and Technology [NIST]) announced they would do a joint review of the Bayh-Dole march-in rules authority. That same day, NIST also published the final version of its revisions to Bayh-Dole rules. The updates streamlined, clarified and corrected the regulations based on more than 80,000 comments in response to a 2021 request for feedback. More interesting is what the revisions did not do.
 
In the revised publication, NIST stated:
 
“NIST has not adopted in this final rule a provision in the proposed rule regarding exercising march-in rights on the sole basis of product pricing. Instead, NIST intends to engage with stakeholders and agencies with the goal of developing a comprehensive framework for agencies considering the use of march-in provisions.”
 
So, what do we take from all that? 
 
Two things, I think. First, we have gotten the government to put its foot down in a massive way against the use of march-in for drug pricing. That is a huge win. Second, there are still some who question whether march-in’s limited uses ought to be reexamined or expanded in some way.
 
In addition to the aforementioned stakeholder engagement planned by NIST, HHS has promised a workshop later this year where stakeholders will have a chance to provide input. Clearly, AUTM and its allies will need to be involved in these discussions to make sure this effort does not weaken the NIH decision victory or cause issues elsewhere in the innovation pipeline.
 
“No final victories or final defeats.” It’s worth remembering whenever we interact with government on any issue. And it’s definitely worth remembering now.