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Wednesday, August 10, 2022

No COVID Tests At Your Drug Store? Blame The Supreme Court.

The “least dangerous branch” is a lot more ominous than that old epithet, but when it comes to COVID-19, the federal judiciary may be a lot more dangerous than people realize. And this goes beyond playing press release footsie with mask mandates or the Fifth Circuit asking lawyers to jeopardize the lives of their families for the virtue signaling of the panel, the United States Supreme Court shoulders a dose of blame for the constant shortage of COVID-19 tests.

An interesting article from former Federal Circuit Chief Judge Paul Michel in Stat News dives into the legacy of Mayo v. Prometheus, the Court’s unanimous 2012 opinion stripping diagnostic testing technology of patent eligibility.

As explained in Justice Breyer’s opinion, doctors treating patients with thiopurine compounds faced a dangerous dilemma — everyone metabolizes the drug differently, meaning the same dose of a thiopurine drug can be “too high, risking harmful side effects, or too low, and so likely ineffective.” Enter Prometheus Laboratories, the inventor of a diagnostic test that allowed doctors to determine how patients metabolized thiopurine compounds.

So far so good.

Mayo Clinic Rochester and Mayo Collaborative Services purchased the Prometheus tests before determining they didn’t need to buy the cow when they could get the thiopurine-level measuring solution for free. They developed their own test, infringing on the Prometheus patent.

At least until the Supreme Court decided Prometheus wasn’t eligible for a patent at all. Per Stat News:

The Supreme Court justices decided that the test merely clarified the optimal levels of metabolite in each patient. And since metabolization is a “natural phenomenon,” which have long been ineligible to be patented, they decided the Prometheus test was not eligible for patent protection.

And thus Prometheus was punished for bringing fire to the world.

Patent obviously should not protect a natural process, but the Prometheus patent wasn’t for the process, but for the intervention that allowed doctors to measure those processes, a distinction that had real fallout for the industry:

The deleterious real-world impact of the decision on the diagnostics industry is far worse than the flaws in the Supreme Court’s analysis. As Kimberly Moore, chief judge of the U.S. Court of Appeals for the Federal Circuit, noted, “since Mayo, [lower courts] have held every single diagnostic claim in every case before us ineligible” due to the Supreme Court’s binding, but arguably erroneous, reasoning.

And despite such complaints from lower courts, the Supreme Court has rejected dozens of requests to reconsider the precedent-reversing, patient-harming Mayo ruling over the past decade.

Stat News also points to an upcoming analysis suggesting investment in the diagnostic sector took a $9.3 billion hit in the immediate aftermath of the opinion.

Though the Mayo opinion hints at the possible flip side of ruling the other way:

On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery. On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements.

Look no further than the vaccine equity issues facing the globe as biopharma giants cling to their intellectual property. Balancing incentivization with the functional monopoly patent creates is touchy. Would a world where Mayo went the other way have given us more supply in firms researching COVID testing only to deliver a similar supply bottleneck when the first to the finish line zealously refuses to license its finding?

Charting a middle path that recognizes the “prize” system that some economists and law professors advocate, at least as a supplement to existing patent law, might help. Allowing the government to award innovation on the front-end through a significant prize without hading a single supplier control of the market could be the best of both worlds.

But for now, we’re stuck with Mayo and a closed universe of providers trying to meet demand in a pandemic.

The Supreme Court is partly to blame for the Covid-19 test kit shortage [Stat News]


HeadshotJoe Patrice is a senior editor at Above the Law and co-host of Thinking Like A Lawyer. Feel free to email any tips, questions, or comments. Follow him on Twitter if you’re interested in law, politics, and a healthy dose of college sports news. Joe also serves as a Managing Director at RPN Executive Search.

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