The Research Use Exception to Patent Infringement Earlier cases Whittemore v. Cutter 29 F. Cas (C.C.D. Mass. 1813) “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.” (raised by defendant in exception to jury instructions, new trial granted on other grounds) Dugan v. Lear Avia 61 U.S.P.Q. 404 (S.D.N.Y. 1944), aff’d 156 F.2d 29 (2d Cir. 1946) One of the accused devices was eliminated from consideration because “it affirmatively appeared, without contradiction by plaintiff, that defendant built that device only experimentally” and that it wasn’t manufactured for sale or sold. Chestervield v. U.S. 159 F.Supp. 371 (Ct. Cl. 1958) “Experimental use does not infringe” However, this is dicta because the court found the claims in suit to be invalid.

The Research Use Exception to Patent Infringement More recent cases Pitcairn v. U.S. 547 F.2d, 192 U.S.P.Q. 612 (Ct. Cl. 1976) “Tests, demonstrations, and experiments of such nature are intended uses... and are in keeping with the legitimate business” of the accused infringer. (finding no experimental use defense in the instant litigation) Embrex v. Service Eng’g 216 F.3d 1343, 55 U.S.P.Q.2d 1161 (Fed. Cir. 2000) The defendant’s “chief commercial purpose was to demonstrate to customers the usefulness of the methods performed by its... machines.” (finding infringment by testing for commercial purposes).

The Research Use Exception to Patent Infringement Madey v. Duke Univ. 307 F.3d 1351, 64 U.S.P.Q.2d 1737 (Fed. Cir. 2002) cert. denied, 123 S.Ct (2003) The experimental use defense to infringement is “very narrow and strictly limited” The Ruth case (D. Colo. 1935), finding an experimental use defense, is bad law.

The Research Use Exception to Patent Infringement Madey v. Duke Univ. (cont’d) FACTS: Madey was sole owner of certain patents used in his lab at Duke University. Madey left Duke, which continued to operate some of the equipment in the lab. Madey sued for infringement Duke asserted the defense of experimental use.

The Research Use Exception to Patent Infringement Madey v. Duke Univ. (cont’d) HOLDING: The burden is on the defendant to establish the experimental use defense. The defense is very narrow: Acts in “in furtherance of the alleged infringer’s legitimate business” and “not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry” do not qualify. Non-profit status carries little weight.

The Research Use Exception: 35 U.S.C. § 271(e)(1) (e)(1) It shall not be an act of infringement to make, use, offer to sell, or sell … or import into the United States a patented invention (other than a new animal drug or veterinary biological product … which is primarily manufactured using … processes involving site specific genetic manipulation techniques) 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. Purpose: To ensure that a patentee’s rights did not de facto extend beyond the patent term because of the time for a competitor to obtain regulatory approval. Question: How to define “reasonably related” ?

The Research Use Exception: 35 U.S.C. § 271(e)(1) Integra Lifesciences v. Merck KgaA 331 F.3d 860, 66 U.S.P.Q.2d 1865 (Fed. Cir. 2003) reh’g & reh’g en banc denied, (Dec. 3, 2003) Use of a patented peptide in pre-clinical experiments did not come within statutory safe harbor of 35 U.S.C. § 271(e)(1) protecting uses “reasonably related to the development & submission of information” to the FDA.

The Research Use Exception: 35 U.S.C. § 271(e)(1) Integra Lifesciences v. Merck KgaA (cont’d) FACTS: Integra owned patents covering the “RGD peptide” (glycine-arginine-aspartic acid) which binds integrin receptors. Scripps scientist discovered a potential therapeutic application of RGD peptides, and was hired by Merck to conduct research. Integra’s offer of a license was rejected, and Integra sued for infringement.

The Research Use Exception: 35 U.S.C. § 271(e)(1) Integra Lifesciences v. Merck KgaA (cont’d) HOLDING: The pre-clinical research conducted was not to supply information to the FDA, but to identify new pharmaceutical compounds, therefor outside the scope of “solely... reasonably related.”