Tuesday, December 13, 2011

Supreme Court Takes a Look at Medical Patents-USA

What if your doctor couldn’t use scientific research about the drugs she was prescribing to you in order to ensure that you received the proper dosage of medication? What if a doctor had to navigate a complex thicket of procedural patents simply to treat her patients?
Well, according to Tim Lee, the Supreme Court is on the verge of making medical patents a reality, allowing drug companies to not only patent their drugs, but also the way doctors prescribe them to patients:
This should make the nation’s doctors extremely nervous. For two decades, the software industry hasstruggled with the harmful effects of patents on software. In contrast, doctors have traditionally been free to practice medicine without worrying about whether their treatment decisions run afoul of someone’s patent. Now the Supreme Court seems poised to expand patent law into the medical profession, where it’s unlikely to work any better than it has in software.
The case focuses on a patent that covers the concept of adjusting the dosage of a drug, thiopurine, based on the concentration of a particular chemical (called a metabolite) in the patient’s blood. The patent does not cover the drug itself—that patent expired years ago—nor does it cover any specific machine or procedure for measuring the metabolite level. Rather, it covers the idea that particular levels of the chemical “indicate a need” to raise or lower the drug dosage.
The patent holder, Prometheus Labs, offers a thiopurine testing product. It sued the Mayo Clinic when the latter announced it would offer its own, competing thiopurine test. But Prometheus claims much more than its specific testing process. It claims a physician administering thiopurine to a patient can infringe its patent merely by being aware of the scientific correlation disclosed in the patent—even if the doctor doesn’t act on the patent’s recommendations.
The American Medical Association’s brief on the matter argues that ”If claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.”
“Conscientious physicians will be unwilling and unable to avoid considering all relevant scientific information when reviewing test results. Thus, as medical knowledge accumulates, patent licenses increasingly will be required for physicians to conduct even well established diagnostic tests.”

Sounds a bit like the patent trolling we’ve been encountering in the software universe in recent years, as an increasingly bizarre and burgeoning patent system weighs down innovation and stymies growth.
Of course, in medicine the stakes are somewhat higher. Already drug patents give the prescription industry far too much cushioning from competition. Add this to the mix and you create all sorts of bad incentives, lawsuits, and other obstacles to good patient care.
Now obviously this is totally insane, but the Supreme Court doesn’t seem to realize just how insane:
Justices Scalia and Breyer showed some skepticism that patents could cover the use of scientific correlations in medical practice. But the other justices expressed no such skepticism. At one point, Justice Kagan offered some advice to Prometheus’s lawyer. “What you haven’t done is say at a certain number you should use a certain treatment, at another number you should use another treatment,” she said. “I guess the first question is why didn’t you file a patent like that? Because that clearly would have been patentable. Everybody agrees with that.”
Of course “everyone” does not agree with that. In particular, the American Medical Association (and, presumably, many of the nation’s doctors) doesn’t. Neither does the ACLU, the AARP, or the Cato Institute. Yet if any members of the high court disagreed with Kagan, they didn’t speak up.

We’ve long argued that the Supreme Court should overturn the lower courts’ de facto legalization of software patents. Instead, the Supreme Court appears poised to take a step in the opposite direction and expand patent law to cover the medical profession. And they seemed oblivious to how dramatic a step that would be.
The world, it appears, is determined to turn me into a full-fledged libertarian. What with SOPA, PIPA, the NDAA, software patent trolling, police violence, and now patents on how doctors provide treatment to their patients, it’s becoming more and more clear how pernicious the law can be when it’s designed for powerful special interests, national security hawks, and big corporations.
There may indeed be a place for patents, but the way they’ve been used to stifle competition and innovation in software shows how limited their utility really is – at least for the majority of people. A small handful of patent-entrepreneurs make loads of money. They just don’t produce anything in order to make that money. It’s a sort of legal banditry. Loophole highwaymen waiting to waylay the unfortunate software engineer or doctor.

No comments:

Post a Comment