Query: I saw a cool new patented invention, and I want to make a copy to conduct experiments and perform research. I won’t sell the copy. Will I be liable for patent infringement?
Answer: Almost certainly, but maybe not.
What is ‘Experimental Use’ in Patent Law?
In certain limited circumstances, making and using a patented invention for purposes of experiment may not be a patent infringement. Pharmaceutical inventions are a special case and are discussed separately below.
The History of Experimental Use in Patent Law
Justice Story (of Amistad1 fame) first considered the matter of experimental use in 1813.
“[I]t could never have been the intention of the legislature to punish a man, who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.”
That’s what we call a ‘doctrine;’ namely, judge-made law. But what a judge giveth, a judge can taketh away. Subsequent decisions (by judges) have substantially eroded the doctrine.
How the Experimental Use Doctrine Evolved
In 1861, the doctrine became:
“…an experiment with a patented article for the sole purpose of gratifying a philosophical taste, or curiosity, or for mere amusement, is not an infringement of the rights of the patentee.”
The judges were not done. In 1984, judges decided that copying and using a patented drug for the purpose of obtaining FDA approval so the copied drug could be sold after the patent expired was for a commercial purpose and not an ‘experimental use’ and was not exempt from patent infringement. (More on that later.)
And in 2004, a court considered whether use of a patented invention by a non-profit university laboratory to conduct scientific research was an ‘experimental use‘ and exempt from infringement. No, said the judges. Why? Because the research was “…in keeping with [the university’s] legitimate business objectives… .” Namely, attracting students, faculty, grants, and providing education.
So, what would qualify as an ‘experimental use’? Pretty much nothing connected to a business or institution in any way. Perhaps a Mentos and Diet Coke experiment for the kids in the backyard would qualify, but not if you put it on YouTube and attract likes and advertisers. In short, the ‘experimental use’ exception to patent infringement liability is very skimpy and offers little protection to the modesty of the infringer.
The Special Case of Pharmaceutical Patents
Now for the special case of prescription drugs. Developing a new drug is very, very expensive and very, very time-consuming – as in $2.6 Billion and 10 to 15 years on average. As a result, patents for pharmaceuticals can be very, very valuable and are very, very jealously guarded. A lot of that cost and time is eaten up by the trials that the drug company must perform on humans and animals to demonstrate to the U.S. FDA that the new drug is safe and effective.
But, I hear you say, don’t patents have a limited life? After the patent expires, a generic drug company can freely copy the new drug, right?
Yes, but the generic drug company can’t just start making and selling a copy that it SAYS is the same drug. The generic drug company must first demonstrate to the U.S. FDA that the copy of the drug is ‘biosimilar’ to the patented drug; namely, that the copy acts the same way in the human body as the patented drug. That requires clinical studies in human beings.
FDA Approval and the Patent Infringement Exception for Generic Drugs
Clinical studies to demonstrate that the copy drug is ‘biosimilar’ take time, as in two to six years. If the generic drug company has to wait until the patent expires to conduct the studies, then the monopoly of the patent effectively extends beyond its limited life, and the public is deprived of its side of the patent bargain.
Congress to the rescue. In 1984, Congress amended the patent statute to provide that the generic drug company does not infringe the patent when it makes or uses the patented drug:
“…solely for uses reasonably related to the development and submission of information under Federal law which regulates the manufacture, use or sale of drugs.”
In other words, the generic drug company can make its copy (which would otherwise be patent infringement) and can conduct studies to support FDA approval (which also would otherwise be patent infringement ) during the life of the patent. The generic drug company does not have to wait for the patent to expire to prepare for patent expiration.
So, if the neat invention you saw is a patented drug or medical device, and if your copy and your experiments are solely for the purpose of obtaining FDA approval, then you’re protected and not liable for patent infringement.
Otherwise, not so much.
1 Justice Story is the same judge who decided that African kidnap victims who rebelled and took over the slave ship Amistad were not and had never been slaves. The kidnap victims had the right to rebel and were not the property of those who re-captured the ship.
— Robert Yarbrough, Esq.