A New JAMA Paper on Patent Law Is a Good Excuse to Detail the ‘Arnold Playbook’

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As a simple matter of data-dredging and analysis, this Public Citizen project — covered by KHN/WaPo this morning — is incredibly impressive. It maps $6 billion in industry funding to a constellation of advocacy groups, providing an illuminating look at the ties between companies and advocacy groups. 

But I don’t want to be seen as praising the project, because it is built on a dangerous assumption that ought to be called out directly: industry money is not inherently bad, and advocacy groups are not out there compromising their beliefs in return for cash. The Public Citizen work implies the opposite, and that thinking ought to be rejected. 

I wish KHN had spent some time talking to patient advocates about how they’re using industry dollars. Because they would have been flooded with stories about how the diseases around which they advocate are underdiagnosed. How patients and physicians often act according to out-of-date information or outright myths. How disease is stigmatized. How they struggle with reimbursement. And about how funding helps address those issues and improves lives. 

That’s not to say that conflicts of interest aren’t a valid topic or unworthy of exploration. But to assume that a financial relationship is compromising is unfair.

Case in point: I pulled up Public Citizen’s giant map of funders and groups this morning and clicked, at random, at a large-ish circle toward the center of the display. The Children’s Inn at NIH popped up. Turns out, that institution received $12 million from pharmaceutical companies. 

That feels like money well-spent to me, and I’m sure patients feel the same way.=

Here is the Arnold Ventures playbook* for creating policy change:

First, flood the zone with peer-reviewed articles covering as much of the nuance of the issue as possible. This creates an intellectual scaffold for the specifics of future policymaking. 

Then, begin to float policy changes in the academic press, in testimony before Congress, through model laws, in media conversations, and directly with lawmakers. 

Once those policy changes are clear, advocacy groups can join to amplify, providing a “ground game” as policymakers debate. 

I lay all of this out as content to let you know that a new JAMA article, by a team driven by West Virginia University’s legal powerhouse, Sean Tu, has dropped. The analysis looked at patents with “terminal disclaimers.” Those are apparently minor patents that are only allowed because their expiration is linked to more meaningful patents. Yet their claims still must be litigated if a company wants to bring a copycat to market. The JAMA piece said that, in biosimilar litigation, 48% of the patents involved had terminal disclaimers.

I wasn’t tracking on the background there, just as I wasn’t tracking on “inequitable conduct,” another narrow legal topic that was subject to a Tu-driven JAMA paper two weeks ago. Or “continuation patents,” the focus of a JAMA analysis by Tu and colleagues in August. All were Arnold-funded. 

The fact that there has been a spate of similar papers, all exploring small-but-important elements of the patent system, suggests that we’re in the first phases of what will blossom into a larger policy effort.** 

So if you haven’t been boning up on patent law, now is the time to start. Because we’re going to see a lot more on this stuff, I suspect. 

* I should be explicit here, lest I be accused of being conspiracy-minded, that I don’t believe Arnold Ventures is explicitly coordinating this. There is no actual playbook. The group is just pouring money into an ecosystem that is loosely (but effectively!) self-organized to accomplish this kind of policy end. 

** And I don’t want to cast this process as dark and nefarious. This is a thoughtful, reasoned, and — as evidenced by the outsized impact of Arnold grantees in making the Inflation Reduction Act happen — effective way of driving policy outcomes. Indeed, this is a model for others seeking change. It’s definitely a far more productive strategy than writing angry Real Clear op-eds. 

Objectively, the inflation penalties around Part B are small potatoes. Of the 48 medicines that violated the IRA’s “speed limit,” almost none are drugs you’ve heard of, and most of the medicines will be subject to vanishingly small supplemental rebates. (Like 0.002% small.) But the power of the presidency is a powerful thing, so when Joe Biden announced the penalties yesterday, the media took notice. Expect to see this approach — taking a small IRA-related milestone and blowing it out — a lot over the next year. 

PhRMA and BIO hosted an event yesterday to lay out the industry’s dim view of march-in rights. The main concern is if that even if this is all saber-rattling, it will harm innovation. “Even if the process takes a long time to unfold, the damage has been done today, because you’ve planted this seed of uncertainty in the ecosystem,” PhRMA CEO Stephen Ubl said. 

V-BID’s Mark Fendrick has a Health Affairs piece out pleading with CMS to take some sort of formal input from doctors before they start imposing price controls that could have all kinds of unintended impacts on access. I’m not optimistic. 

Speaking of CMS not taking input, here is Peter Pitts’ view on the CMS patient listening sessions, which further highlights what a missed opportunity that was.

Man, this is an interesting paper. It shows that Medicare generally pays a ton for prescription medicines that could be bought way cheaper if the government just bought the over-the-counter versions. (A handful of medicines are available in identical forms both as prescriptions and as OTC. Think allergy drugs and heartburn remedies.)

I’m really obsessed with the FTC objection to the Sanofi-Maze deal, and though this Endpoints piece really doesn’t get to the bottom of things because [REDACTED], it gives a worthwhile overview of the story. 

Should I care that Bernie Sanders is threatening to introduce legislation that would make international reference pricing a thing? My gut says “no,” though we’re likely to see a lot of efforts to highlight the discrepancies between international and U.S. prices for GLP-1s going forward. 

Worth tracking: bluebird bio said in a securities filing that it “has signed an outcomes-based agreement with an organization representing approximately 100 million covered lives.” But there’s no indication from any of the coverage as to which 100-million-person organization bluebird has partnered with or what the agreement covers. The company said it couldn’t say more for competitive reasons. 

For your listening pleasure: the Vivio webinar from earlier this week on “The PBM Model is Dead Is it Time to Move on?” is worth a listen, if only to hear Antonio Ciaccia talk about kayfabe and show off his Christmas Story decor. And Adam Fein’s “Outlook 2024” webinar is happening today and will likely be the best crystal ball into what’s about to hit the industry.