Is experimenting with a patented invention patent infringement?

A patent is a set of exclusive rights granted to the inventor of an invention. A patent is an incentive granted to an inventor in exchange for the inventor teaching the public about the invention. The inventor is given a monopoly on the invention for a limited time. Anyone who uses a patented invention without authorization is liable for patent infringement under statute 35 U.S.C. § 271(a) of United States Patent Law. An inventor can sue patent infringers to stop the infringement and to get money damages. But the exclusive rights granted by a patent are not unlimited. There are some exceptions which allow other people to use an invention even when the invention is subject to a patent.

One of the exceptions to the rights granted by a patent is experimental use. Under certain circumstances, without permission from the patent owner, people can use a patented invention for the purpose of performing experiments. The experimental use exemption is very narrow and experimenters must be mindful of the conditions of the experimental use exemption if they want to use it as a defense against an accusation of patent infringement.

The experimental use exemption in the United States is derived from both the common law and statutes.

The United States Supreme Court first articulated the common law experimental use exemption in 1813. In that case the court held “It 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.” Whittemore v. Cutter, 29 F. Cas. 1120, 1121 (C.C.D. Mass. 1813). The common law experimental use exemption has transformed slightly over the years but it is extremely narrow. This is because the purpose of a patent is to grant an inventor a monopoly, to allow anyone to claim that they were experimenting to avoid liability would contradict the purpose of a patent. Essentially if the experimentation is related to any business or commercial activity, it cannot qualify for the exemption. Universities that experiment with a patented device and then use the knowledge gained from that experimentation to develop a commercial device could be held liable to patent infringement. Essentially only experimentation based purely on curiosity is eligible for the experimental use exemption and the knowledge gained from the experimentation cannot be used to develop a commercial product.

The statutory experimental use exemption was introduced in the Hatch-Waxman Act and can be found in 35 U.S.C. § 271(e). Interestingly enough this statute was introduced because of the narrowness of the judicial exemption. In Roche Products Inc. v. Bolar Pharmaceutical Co. 733 F.2d 858, 863 (Fed. Cir. 1984), Bolar was testing different molecular compounds to determine which ones acted the same way as a patented compound. To learn how the patent compound worked, it needed to be experimented on. The United States Court of Appeals for the Federal Circuit held that because the experimentation had a commercial purpose, the experimental use exception did not apply.

Congress stepped shortly after that case and passed the Hatch-Waxman Act. The key part of the statute states: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” The term drugs has been broadly interpreted to include medical devices as well.

The Hatch-Waxman Act essentially creates an exemption for drug makers because it can take an extremely long time for the Food and Drug Administration to approve new drugs, and it is in the public interest to allow experimentation on patented drugs so that new drugs can be developed.

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