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.