A New Report on Patent Life Is a Reminder: Pharma Isn't Explaining Itself on IP

There are two ways to think about this report from I-MAK that calculated that just four medicines -- Humira, Rituxan, Avastin and Lantus -- made more than $150 billion in additional revenue after their primary patent expired.

The first is to roll your eyes.

At best, the report is incredibly low-context, with zero explanation of why the medicines received additional exclusivity and much made of the unsurprising fact that the medicines earned more money, per year, at the end of their exclusivity period than at the beginning.

It doesn’t offer much in the way of solutions or policy proposals, and it doesn’t acknowledge the existence of the Inflation Reduction Act, which is explicitly designed to restrain pricing power within 13 years (and implicitly designed to discourage barriers to generic entry), which would seem to address I-MAK’s concern.

And nothing in the report is new, per se, it’s just the same publicly available data that’s always been floating out there, rearranged to garner headlines and attention. (By that metric, the I-MAK effort was a success, grabbing a STAT story yesterday.)

But the second way to think about the report is as an example of what happens when commercial decisions go unexplained (this gets to my “unforced errors” argument from over the weekend).

I’m not sure that I’ve ever seen a company make a compelling case, outside of the context of litigation, for why the patent life of a compound is being extended. Nor have I ever seen (with the possible exception of this now-forgotten Merck piece) a celebration of a medicine’s loss of exclusivity as a natural and important part of the health care life cycle. Peter Kolchinsky’s idea of throwing a patent-burning party never caught on, although I would absolutely love to organize such an event at J.P. Morgan. (Interested? hmu.)

In short, industry doesn’t explain the way it interacts with the patent system, and it treats generic entry like a dirty secret. All of which provides a great opportunity for the I-MAKs of the world to make hay by repackaging the obvious in ways that are well-designed to poke industry right in the eye.

Are you old enough to remember when we had a national dialogue about the definition of “is”?

Well, we’re headed toward the health care version of that, only around the definition of “patient.” The 340B program is built around the idea that you’re a 340B “patient” if you’re being seen at a 340B institution and served by a 340B pharmacy.

But what if a “patient” is broader than that? What if a “patient” is anyone who has interacted with a 340B entity in the past year, even if they’re seeing a doc at a non-340B facility or getting their scrip at a non-340B pharmacy?

It’s kind of a mind-bending question, one that is the topic of a legal dispute (and legislative efforts). And it’s not an academic question, either: a new IQVIA report suggested that broadening the definition of patient to anyone who has touched a 340B facility in the past year -- a concept known as “continuum of care” -- would more than double the size of the already-giant program.

So if you’re looking for a little more light reading, add that one to the pile.

Elsewhere:

• I noted yesterday that AstraZeneca had acknowledged the obvious: they will participate in the government price-setting process. Journalists have two other companies on the record: BMS will play ball. “We have no choice other than to sign the ‘agreement.’ If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid. That is not a real choice,” the company told Endpoints. Boehringer Ingelheim, too, will enter “negotiations” though its statement was less colorful.

• Damn, this is a compelling -- if depressing -- Wall Street Journal story about antibiotic developing, hammering home a simple point: “Six startups have won Food and Drug Administration approval for new antibiotics since 2017. All have filed for bankruptcy, been acquired or are shutting down.”

• Dan Ollendorf is headed back to ICER. Dan knows his stuff when it comes to health technology assessment (and knows everyone in the field), making the hire a big deal as ICER moves from the age of Steve Pearson into the Sarah Emond era.

• Speaking of ICER, they ran the number of Merck’s sotatercept for pulmonary arterial hypertension. The group’s draft report took a dim view of the compound’s cost-effectiveness, but it’s a draft report -- patients and others now have a chance to weigh in -- so I’ll withhold judgment.