Huge Ruling: Court Rejects Medical Diagnostic Patent

from the a-step-forward dept

We've been covering the Prometheus Laboratories v. Mayo Labs case for a few years now, as it was a key case involving whether or not you could patent basic medial diagnostics -- i.e., can you patent basic science and limit doctors from doing such science without paying up. Tragically, in a series of decisions, the appeals court (CAFC) twice ruled that diagnostics are patentable, and we were particularly concerned that the oral hearings in the Supreme Court on this case seemed very narrowly focused. Of course, as we noted at the time, the oral hearings can be a red herring, as rulings often have little (if anything) to do with what is said during the oral hearings. This appears to be one such case.

Instead, it looks like we got a reasonably good (not great, but definitely pretty good) ruling from the Court effectively rejecting the concept of patenting basic medical diagnostics as laws of nature that are not patentable. It's always a good sign when Supreme Court IP case rulings are written by Justice Stephen Breyer -- as he remains the one Supreme Court Justice who seems to consistently, and instinctively, understand how excessive intellectual monopolies can cause much more harm than good. In this case, Breyer wrote the decision which, thankfully, was actually a unanimous decision, rejecting Prometheus' patents, and reiterating that laws of nature are not patentable.

In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.

Breyer's opinion is pretty clear and easy to read and makes some important points:

If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.” Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.

One nice aside: the ruling also rejects the US government's own brief in the case, which effectively suggested that we get rid of the rule that laws of nature can't be patented, and instead just focus on whether or not the claims are new and non-obvious. As Breyer wrote, this "risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do."

Finally, at the end, Breyer highlights the costs and benefits of patents and how the arguments that more patents automatically lead to greater innovation is simply not the case:

Patent protection is, after all, a two-edged sword. 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. At the same time, patent law’s general rules must govern inventive activity in many different fields of human endeavor, with the result that the practical effects of rules that reflect a general effort to balance these considerations may differ from one field to another....

In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another. And we must recognize the role of Congress in crafting more finely tailored rules where necessary.

All in all this is a good ruling. It's a little limited in suggesting that you could patent diagnostics that go further rather than just "drafting" on a natural law, but this is definitely a big step in the right direction. And as Patently-O notes, it's likely that this ruling will mean that the appeals court will now also be told to go back and re-evaluate its awful decision saying genes are patentable in the Myriad Genetics case. Hopefully, this ruling is a clear statement that not only are diagnostics not patentable, but genes aren't patentable either. If that's true it will be a huge boost to research in the biotech field, which won't be held back by expensive restrictions and tollbooths.

Of course, that's not the story you hear from the patent maximalists, who are arguing that this is horrible for the biotech community because it will mean fewer patents. But that ignores all of the good this does in making it easier to do research, to share results and lead to more real innovations built on basic laws of nature and facts, rather than locking up that knowledge.

Filed Under: biotech, diagnostics, gene patents, laws of nature, medical, patents
Companies: mayo clinic, myriad genetics, prometheus