I’m not saying this would necessarily work in the case of Aderans’ patents, because the court would first have to decide whether or not they constitute “medical procedures”, aka a “medical activity”, under this law. But check this out:
What Is the Medical Procedure Exception?
Medical procedures, such as methods for performing surgery, are generally patentable. However, no remedy is available if the patent is infringed by a medical practitioner who is infringing in order to perform a medical activity.
Who Is a Medical Practitioner?
There are two types of people who are considered to be medical practitioners:
A person who is licensed to provide medical activity (for example, a licensed doctor)
A person who is performing the medical activity under the direction of a person licensed to provide medical activity (for example, a med student)
What Is a Medical Activity?
A medical activity is the performance of a medical or surgical procedure on a body. The medical procedure exception covers procedures in which the novelty is the technique, not a new drug or piece of equipment.
So Can a Doctor Infringe on any Medical Procedure Patent without Consequences?
If the medical practitioner infringes only on a patent on a medical procedure, he is safe. However, the medical procedure exception does not extend beyond patents on procedures. It does not extend to any of the machines or tools used to perform the procedure. Thus, while a doctor will not be liable for infringing on a patented procedure, if he uses a patented surgical tool or a patented article of biotechnology to do so he can be liable for patent infringement and be required to pay remedies.
My comment: The last paragraph above also explains also explains the ongoing mania among researchers filing for hair regeneration patents for including some kind of instrument or device in the procedure. A patent for a medical device would hold up in court.
That strategy goes something like this: Biotech Company wants a patent for something which is really a medical procedure. They want to prevent independent doctors from performing the medical procedure. But the law says they can’t. They file a patent application for the medical procedure. In the patent application, they refer to a medical device (like an applicator), which is really not essential to performing this medical procedure; any smart doctor could improvise without using this particular device, by using something else in its place. Biotech Company also files a separate patent application for the medical device. Biotech Company applies to the FDA for regulatory approval of the medical procedure and conducts clinical trials of the procedure, using said device. Biotech Company gets the FDA to approve its medical procedure only using said device (even though the device is, truthfully, not really essential for performing the procedure). With FDA approval, Biotech Company hopes to bar independent doctors from performing the procedure, by virtue of the patented device, arguing something like, “The FDA only approved our procedure using this device. The device is required by the FDA.” In this way, Biotech Company hopes to establish an effective functional monopoly on the medical procedure. If independent doctors want to perform the procedure, Biotech Company hopes to collect big license fees from them, or to sell the procedure and device to them in “kits”. In effect, all these “devices” we see in this field are efforts to circumvent the current law.
Also see:
The reason for this law, which came into effect in 1997, is that a lot of American doctors (and the AMA lobby) argued that the medical profession is inherently about healing and curing, so doctors shouldn’t have to worry about being sued by a patent holder for performing ANY medical procedure on their patients. In other words, that there should be an exception to the laws of patent infringement for doctors. This exception doesn’t extend to drugs or devices, however. If a doctor cooks up a drug in his lab for which some company already holds a patent, he can’t then try to sell or prescribe it to his patients. THAT would be infringing a patent. But a doctor performing ANYTHING that is defined as a medical procedure is protected.
The patent holder IS allowed to sue, but immediately upon a legal finding that what he/she did is a “medical procedure”, the lawsuit would then be thrown out of court.