Most Americans Don’t Want the Government to Go Around Breaking Patents, Bayh-Dole Survey Finds

There is so much going on in the drug-pricing world that the media can’t always track it all down, so — as much as I respect all the journalism out there — I can’t count on news coverage to highlight everything cool that’s going on. (Today’s “Arc” hits on one of those important-but-quiet topics, and I’ll hit on another one tomorrow.)

So if you see something that I should be writing about, please, please let me know.

It’s happening very quietly, but there is a largely under-the-radar effort to look at novel ways of using government power to break patents in an effort to lower drug prices. The whole deal is centered around the Bayh-Dole Act, the 1980 law that allowed commercialization of research funded, in part, with government dollars.

One of the provisions of the Bayh-Dole Act is that the government can come in and seize patents that aren’t being used. There is a theory, which has been consistently rejected by the NIH, that says that provision can be used to break IP for drugs that are inaccessible because of high prices under “march-in” rights.

It’s not a new idea, and it’s been part of the background hum of the drug pricing conversation for a long time. But, historically, the idea has been on the fringe, like returning to the gold standard or rebooting Freaks and Geeks.

That’s changing, maybe. HHS and the Department of Commerce launched a working group in March to look at the issue, pledging to “convene a workshop in 2023” and “seek input from a diverse array of stakeholders.” It’s the kind of effort that, even if it’s doomed from a regulatory and legal standpoint, could kick up a lot of dust.

There hasn’t been much heard from the working group, though, and progressives in Congress are getting worried that the group isn’t going to meet its goal. Last week, three members sent a letter to HHS asking for a “a draft framework for public comment on the criteria and guidelines for agencies to exercise their authority … without delay.”

Anyway … all that is context for an important new survey from the Bayh-Dole Coalition, which has consistently pushed to ensure that the law isn’t twisted. (Indeed, the bill’s namesakes have been explicit that it’s not designed as a cost-control tool.)

The new poll — run by Morning Consult — found that 85% of Americans think it’s important for policymakers to protect the law. (Here’s how the poll frames up the issue: “The 1980 Bayh-Dole Act helps ensure the inventions and discoveries made at universities make it to the public. The law is credited with bringing to market breakthrough medicines for HIV, cancer, and seasonal allergies as well as advanced technologies like firefighting drones and high-definition TVs.”)

The pollsters also threw tradeoffs into the mix: “Some policymakers say that weakening the patent ownership rules enabled by the Bayh-Dole Act would help lower drug prices by allowing more affordable generic drugs to be developed. Others say it would reduce medicine access and choices by discouraging government and private sector investment in new treatments and cures.”

Even with that prompt, 74% of those polls said they’d still be concerned about losing innovation.

It’s far more likely that the poll is the beginning of the debate, rather than the last word, but how this is positioned by both sides could make this the issue with the highest importance-to-awareness ratio this year.

Stay tuned.

This is an illuminating look at why CVS is getting into the manufacturing-biologics business from MedPage Today, though it feels like there are still plenty of unanswered questions.

The U.S. government will pay about $81 a dose for Moderna’s COVID-19 vaccine and about $85 for Pfizer’s, STAT reported. That’s less than the commercial price, but it’s a lot more than the government had been paying (and less, it seems, than the price Europeans will get). On the flip side, the government won’t be buying in bulk, particularly, but this is still likely to be a flashpoint.

For what it’s worth, the vaccine-reimbursement issues seem to be over.

There are more filings in the IRA lawsuits, though nothing that changes the state of play or anyone’s understanding of the arguments. But here is an AstraZeneca brief. Here is one from Boehringer. And here is an amicus brief from a handful of health policy experts, including two former CMS heads, urging the court to reject Merck’s lawsuit.

I like this Tomas Phillipson piece in the National Review. He makes an interesting point about the out-of-pocket spending on the 10 drugs subject to price controls, noting that, for 7 of the 10 medicines, consumers are paying about a dollar a day for their meds. It’s just a reminder that the medicines being targeted drive a lot of spending because they’re useful and broadly prescribed, not because they’re remotely a bad value.