Medical procedure patents

tux surgeon
Patents on surgical methods?

Under Federal law 35 USC 287(C), US physicians and other medical practitioners have a 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 medical procedure 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 medical procedure 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 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.

35 USC 287: Marking inventions

Remember to mark your products!

To avoid damaging your patent rights, mark your products with patent numbers. The law covers devices but not methods, so marking software is a bit tricky.

You probably have noticed that some products are marked with the word “patent” and a list of patent numbers. These are usually written in small type somewhere on the product or on its packaging. If you (as a patent holder) are planning to start producing your own patented products, what happens if you don’t include this marking?

Because it is hard to tell what is and isn’t patented, Congress passed the 35 USC 287 statute (Federal law) to protect the public from accidental patent infringement. The law holds that absent such marking, your ability to recover past damages from an infringer can be very limited.  For example, past damages may only extend back to the time that you first sent a notice letter to the infringer. This law also covers your patent licensees (who often forget such markings) as well, so remember this for license negotiations.  Otherwise, your licensee could end up damaging your rights.

Although traditionally actual patent numbers had to be marked on the product, a few years ago it became OK to just use “virtual marking”. Here, just marking “patent or pat”, followed by a publically accessible web page address, is enough.  Virtual marking has advantages, but make sure the web page is actually “up”.

To prevent inadvertent loss of rights, it may seem safer to always err on the side of marking, but don’t overdo it.  There is a different law, 35 USC 292, designed to protect the public against false patent marking. So the general rule of thumb is to try to provide adequate patent notice, but avoid being deceptive.

35 USC 287 has some “bugs” and “features”

Bugs: Untended consequence — the law somewhat favors patent trolls. A patent holder who doesn’t produce anything (and hence has nothing to mark) can still recover past damages from up to six years earlier.

Features: Because it is hard to affix a mark to a method, 35 USC 287 generally doesn’t apply to methods patents.

But what about software and software implemented inventions? Software patents often contain a mixture of methods claims and device claims. However, software typically runs on (or is stored in) some sort of physical object. So is software covered by 35 USC 287 or not?  If so, what to mark, and how to mark it? What about websites and apps?

The courts have not been consistent here, and the law is still evolving. However, a fair number of court cases have required marking. It is safest to assume that patent marking is likely required, and then examine legal aspects as they apply to the specifics of your situation.