Under Federal law 35 USC 287(C), US physicians and other medical practitioners have limited immunity to certain types of medical procedure patents.
US patent laws allow patents for inventive methods (such as procedures), devices (such as gadgets), and compositions of matter (such as drugs). But should we allow medical procedure patents to be used against medical practitioners?
What is a medical procedure patent? Some historical examples include 1) a new and improved method of making surgical incisions on patient corneas; 2) the first medical use of ether (first anesthetic); 3) the first use of ultrasound for fetal gender evaluation.
Public policy here is a bit uncertain. We don’t want our physicians to be afraid to try new procedures. In fact, we want them to use the best procedures possible. But if we don’t financially reward innovation (through patents), then this could stifle further medical progress. So in the US, and indeed throughout the world, almost everyone is debating this basic question: should medical procedure patents be allowed, or not?
Over about the last 100 years in the US, the pendulum has swung back and forth between “no” and “yes”. Our present 1997 era law, as described by 35 USC 287(C), is somewhere in the middle. In what is a bit of a strange compromise, the US generally allows these patents but doesn’t always let you enforce them! So unless you are aware of this unusual rule, you might accidentally end up getting a medical patent of little value because the law might not let you enforce it.
The trick to avoiding this unfortunate situation – having a patent that lacks value due to restrictions on enforcement, is to consider 35 USC 287(C) and write claims that limit the impact of this strange exception.
The good news, from the standpoint of inventors and startups, is that the enforceability carve-out aspects of this law are quite narrow. Patents for medical devices and compositions of matter are just fine and can still be enforced. Further, under the patent legal rule of “contributory infringement“, you may also still be able to enforce against manufacturers who are teaching use of their products for your patented medical procedure.
So in practice, US rules regarding medical procedure patents are not all that restrictive. The trick is that if you are trying to patent a new medical procedure, think a lot about what devices or medical supplies might be needed to implement your new procedure. Claim them, and when you get to writing the medical procedure claims, think about contributory infringement as well.