Reforming the patent system: 5 Questions for health justice lawyer Priti Krishtel

Krishtel discusses the U.S. patent system, what reform might look like, and why that could matter for psychedelics

Priti Krishtel started her career as a lawyer in the early 2000s, when the number of global AIDS-related deaths reached its peak. After graduating from New York University’s law school, Krishtel moved to India, where she ran an office representing patients living below the poverty line in court, as well as in policy discussions about healthcare and medicine. She noticed inequities in who had access to medicines — while HIV drugs were being developed at the time, they weren’t reaching her clients or others around the world who needed treatment. 

Krishtel realized that one piece of the problem was the patent system and in 2006, she co-founded the Initiative for Medicines, Access, and Knowledge (I-MAK) with Tahir Amin to make patent offices around the world more accountable to the public. I-MAK has published research showing how U.S. drug companies file dozens of patents on popular drugs which creates monopolies and drives up prices on essential medications.  I-MAK has also advocated for patent reforms. Last week, Krishtel was awarded a 2022 MacArthur Fellowship for her work. She spoke with The Microdose about the U.S. patent system, what reform might look like, and why that could matter for psychedelics.

Where are the major issues with the U.S. patent system?

The intention behind the patent system is that a patent can incentivize or motivate people to invent something new — they could receive, say, a time-limited monopoly for 20 years. But what we’re seeing on the most profitable drugs is that when companies are facing loss of that exclusivity, they are essentially gaming the patent system. They’re filing for more and more patents, and that lengthens the period of time they stay exclusive and don’t have any competition. 

That has real consequences for people — let’s take Humira as an example. Due to patent laws, Europeans saw competition on that drug starting in 2018; in America, we’re not getting any competition on the market until 2023. [Editor’s note:Humira is a popular immunosuppressive used to treat arthritis, Crohn’s disease, ulcerative colitis, and other inflammatory conditions. Humira’s primary U.S. patents expired in 2016, but the exclusivity period of the drug has been extended by newer patent applications. According to an I-MAK report, there have been 166 Humira-related patents granted.] There are seniors who are suffering and unable to afford their co-pays. It’s costing Medicare. And these are the types of consequences that have a ripple effect. These patent practices have only started coming up in the last 30 years or so, but it’s gone off the rails; it’s a practice that has gone on for too long. 

How are we seeing those issues play out in the psychedelics industry?

People are concerned that if medicines across the board are unaffordable or inaccessible to Americans, and that patents are being used to block competition, how do we ensure that as psychedelics get approved by the FDA, they don’t get caught in the same trap? 

In our work at I-MAK, we have also spent a lot of time looking at something called prior art: that’s any patent, publication, presentation in the public domain that patent examiners use when determining whether a patent application meets the criteria for inventiveness or non-obviousness. Patent offices are often under-resourced or don’t have specialized knowledge of a specific drug that some of us in the public domain do have. With HIV, we were able to file and win cases based on pointing out prior art, and there are now individuals and organizations here in the U.S. thinking about precisely the same questions as applied to psychedelic patents, like Porta Sophia. (Editor’s note: Read The Microdose’s 5 Questions for David Casimir to learn more about Porta Sophia.) They’re asking: how do we make sure that the public library of knowledge is available to everyone, but especially to the patent office to ensure that only patents that are truly deserving get granted?

 

What would reform look like?

First and foremost, patent offices have to become more public. Historically, the patent office has thought about entities applying for patents as the people they should be serving. The biggest universities and the biggest drug companies are the entities who are applying the most, and that’s created a culture where the patent office thinks they’re supposed to be serving them. What we’ve pushed for in recent years is the recognition that the public is an equally important constituent — that has to happen before reforms.

One of the primary reforms we want is to raise the bar on what should get a patent. Right now, a big breakthrough invention gets the same amount of protection as changing the dosage form of a drug, or putting two pills into one. There’s no discernment. 

We also want to make the system for challenging patents more robust — we want to make the process easier, cheaper, and more accessible. Currently, challenging patents in the U.S. is way too expensive, and it’s not easy to penetrate, even if you’re a company. 

And additionally, we want to see more oversight and accountability — frankly, there’s not enough oversight coming from Congress. The patent office has a revolving door problem with employees, which can lead to conflicts of interest. 

Do other countries’ patent systems have the same issues?

Any country that’s part of the World Trade Organization — so, most countries — signs onto the trade agreement on intellectual property rights, and so you have a certain level of uniformity: those patents have to be new, non-obvious, and useful. Each country has the discretion to define those terms how they want. 

So in India, for instance, they defined it to say that if you’re patenting a formulation that’s essentially just making alterations to an already-known compound, the result has to be significantly more efficacious to be worthy of a patent. That’s a radically different standard than what the U.S. does, where we provide patents for just about anything. In general, most countries do not have a standard like India’s; you’ll find that a lot of countries follow precedent from the European Patent Office or from the U.S., which is why the work that happens in the West has such powerful ripple effects around the world. 

As for challenging patents, a lot of countries allow you to challenge patents for free or for very little cost, and it’s a democratic process that’s inclusive and equitable. Through that system, patients, civil society, or even generic competitors are able to meaningfully compete. But here in the U.S., you’ve got to have a team of scientists and lawyers reviewing the evidence. It’s a slog. The U.S. system de facto doesn’t allow people to participate at all, just from the cost — just the filing fee to challenge a patent costs $41,000.

As the nascent psychedelics industry grows, psychedelics-related patents — and challenges to them — are on the rise. Do you see any unique challenges the industry might face? 

The amount of public interest is unique. Usually, I’ll hear from people living with diabetes or people living with cancer, or public interest lawyers — but not like with psychedelics. There are investors, medical providers, psychiatrists, and so many kinds of people coming together who feel very passionately about medicine being developed in this space, and medicine reaching people who need it. It’s powerful, and I think it’s going to make a big difference in moving the needle on how the patent system evolves for the better.

This interview has been edited and condensed for clarity and length.