The Medical Procedure Exemption. Episode 128

Medical Device and Procedure Patents

I’ve talked about lots of kinds of patents and what they do. And if you remember, a patent doesn’t actually give you the right to do anything — it gives you the right to prevent others from doing or making what’s in your patent.

There are many types of patents. I handle a fair number of medical device patent applications. Often, a medical device will have a method of using it, or sometimes there’s no device at all — a doctor may have come up with a new treatment method or surgical technique.

Example of a Patented Procedure

Let’s take an example. Let’s say that a doctor came up with a new way to suture a wound and got a patent on it. I’m going to make up a claim for simplicity:

A method of performing surgery, comprising the steps of:

Inserting a needle connected to a suture inside a person’s body at a first position

Pushing the needle through soft tissue of the person’s body

Pulling the needle out of the person’s body

Inserting the needle at a second position in the person’s body

Pushing the needle through the soft tissue of the person’s body

Pulling the needle out of the person’s body

This is really just a fancy way of describing two stitches. It’s not how you’d actually write the claims, but I’m just giving an example of the steps involved.

Is a Doctor Infringing a Procedure Patent?

Let’s say you got a patent on it, and you found another doctor doing these exact same steps. Is that doctor infringing your patent?

It sure sounds like it, right? But can you sue for damages? No, you can’t — because a special statute was enacted to protect doctors from being sued for performing patented medical procedures.

There are very few exceptions to patent infringement, so how did this one come about?

Background of the Exemption

The history of this exemption began in 1993. An ophthalmologist named Dr. Samuel Pallin had a patent on a cataract surgery procedure and sued Dr. Jack Singer. Dr. Pallin, the one with the patent, actually lost the case — the court found there was no infringement — but it scared other doctors who feared they could be sued for performing medical procedures.

With pressure from medical groups, Congress passed a special exemption statute.

The Statute: 35 U.S.C. § 287(c)

The statute is 35 U.S.C. § 287(c). I’ll paraphrase:

With respect to a medical practitioner’s performance of a medical activity that constitutes infringement, it shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

So let’s break that down. “Medical activity” means the performance of a medical or surgical procedure on a body. A “medical practitioner” is anyone licensed by a state to perform that procedure. This would include doctors, nurses, and probably other professionals like dentists, optometrists, and chiropractors. I’m not sure how much this has been tested in the courts regarding who exactly qualifies.

Then there’s the “related health care entity,” which means you can’t sue the hospital, medical group, nursing home, medical clinic, HMO, etc.

What about veterinarians? It seems they are not protected, because the statute refers to a “human body, organ, or cadaver,” or a nonhuman animal used in medical research or instruction relating directly to human treatment. So vets likely aren’t protected unless they’re involved in research directly tied to human health.

Is There Any Point in Patenting a Medical Procedure?

In some situations, there may be no point in getting a patent, especially if the procedure uses non-patented devices, like a basic suture that already exists.

But the exemption doesn’t apply to devices. So if your patented medical procedure requires the use of a patented device, then doctors are not protected from infringement for using that device.

Another reason why a patent may still be useful is that the exemption doesn’t cover everyone. It protects medical practitioners and related health care entities, but not third parties like biotech companies. If a biotech company sells software or training materials describing how to perform a patented procedure, they’re not exempt. You could theoretically sue them for indirect infringement.

Tools Designed to Enable Infringement

Even if the tool itself isn’t patented, you can still sue a company that makes a tool used solely to perform a patented procedure. Why? Because if there’s no other substantial non-infringing use of that tool, the company is essentially enabling doctors to infringe your patent.

Doctors can’t be sued — but the company can.

So, if you’re an inventor with a patent on a medical procedure, it might make sense to enter into a licensing agreement with a company that makes a tool for that procedure, even if the tool itself isn’t patentable.

What the Exemption Doesn’t Cover

It’s important to remember that the exemption doesn’t apply to:

• A medical device

• A drug

• The use of a drug or device

• A biotechnology process invention

The exemption is really just for pure procedural patents.

Final Thoughts

If you’re a physician, this is great news. If you’re an inventor with a new surgical procedure, maybe not so much. Whether you like this exemption or not depends on which side you’re on. I’m Adam Diament, and until next time, keep on inventing.