From Masnick at Techdirt. Yet another patent outrage. Though I am not sure why people are surprised by this. I doubt the Court would be wrong to permit such patents. This is a natural outcome of the entire idea of patents. (In 1997 patent law was amended to exempt certain surgical methods from patent liability,¹ but I doubt this will apply to these medical diagnostic techniques.)

See also: Cato/Reason/CEO brief opposing medical diagnostic process patents as violating freedom of speech

Supreme Court Seems Ok With Patenting Medical Diagnostics

from the bad,-bad-news dept

We’ve covered the Mayo v. Promethus Labs case for a while now. This is the lawsuit over the patentability of medical diagnostic techniques. If that sounds crazy to you, you’re not alone. Promethius got a patent on a specific way of testing for a disease, and got into a legal fight with the Mayo Clinic, because Mayo dared to diagnose without paying them. Tragically, an appeals court said this was fine. Many doctors were, quite understandably, horrified at all of this. The idea that they could violate a patent merely by understanding the science and running a test to detect an ailment? Horrifying and ridiculous. When the Supreme Court agreed to pick up the case, we had hoped it meant that some common sense might prevail.

However, that’s looking doubtful. The oral arguments were just heard in the case, and as Tim Lee points out, they don’t sound good. You can read the full transcript below, but the oral discussion was extremely narrowly focused on the patentability of this particular diagnostic test, with many comments suggesting that the patentability of a general diagnostic test is not even in question. In fact, Mayo’s own lawyer seemed to concede the point and didn’t even bother to argue the issue:

Unfortunately, the justices seemed oblivious to these arguments. And the man who should have been making them, Mayo counsel Stephen Shapiro, completely ignored them. Instead, he seemed to concede the legality of medical patents in general, and focused on nitpicking the details of Prometheus’s patent. Specifically, he noted that the patent covers a broad range of metabolite levels and applies for many different autoimmune diseases, and argued that this made the patent invalid.

Asked by Justice Kennedy if a more specific and complex diagnostic technique involving “two or three different drugs” could be eligible for patent protection, Shapiro said yes. “If it leaves room for others to have their own tests with different numbers and different procedures so that it isn’t just one test for the whole country, then yes, if it’s specific enough,” he said. “The specificity is the key.”

Justice Scalia pointed out that making patent-eligibility turn on how complex the diagnostic strategy was, or on how many diseases it claimed to address, was totally unworkable. Shapiro’s proposal, he said, was “not a patent rule that we could possibly apply.”

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.”

Except, as Lee notes, not everyone agrees with that. In fact many different groups, including the American Medical Association, argued exactly the opposite in briefs on the case.

For what’s it worth, what’s discussed in the oral hearing is not always all that relevant to how the case actually turns out. The briefs are often more important. But, either way, it’s not looking good. After a few good years in the mid-2000s, where the Supreme Court really beat back patent excesses, the more recent patent courts have been timid to the point of ridiculous. In the end, it seems like this case may turn out like the Bilski case, where the Supreme Court had the opportunity to rule broadly on software and business method patents, but chose to ignore the issue, focusing only on the specific patent in question.

This seems like a huge waste of the Supreme Court’s time and collective intellect. People look to SC rulings to set precedent and clarify points of law. Ruling extremely narrowly based on just the specifics of the patent itself doesn’t clear up any confusion. Instead, it just makes things worse.

1. See my articles Radical Patent Reform Is Not on the Way and How to Operate Within the Law: Patents on Medical Procedures, and my post Kinsella on The Medical Freedom Report: Patents on Medical Technology and Pharmaceuticals. 35 USC Sec. 287(c) reads, in part:

   (c)

   (1) With respect to a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

   (2) For the purposes of this subsection:

   (A) the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

   (B) the term “medical practitioner” means any natural person who is licensed by a State to provide the medical activity described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.

   (C) the term “related health care entity” shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.

   (D) the term “professional affiliation” shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.

   (E) the term “body” shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.

   (F) the term “patented use of a composition of matter” does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method. [↩]