Common Law Research Exemption
The common law research exemption is an affirmative defense to infringement where the alleged infringer is using a patented invention for research purposes. The doctrine originated in the 1813 decision by Justice Joseph Story appellate decision Whittemore v. Cutter, 29 Fed. Cas. 1120 (C.C.D. Mass. 1813). Story famously wrote that the intent of the legislature could not have been to punish someone who infringes "merely for experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects." Subsequent decisions later distinguished between commercial and non-commercial research.
In 2002, the Court of Appeals for the Federal Circuit dramatically limited the scope of the research exemption in Madey v. Duke University, 307 F.3d 1351, 1362 (Fed. Cir. 2002). The court did not reject the defense, but left only a "very narrow and strictly limited experimental use defense" for "amusement, to satisfy idle curiosity, or for strictly philosophical inquiry." The court also precludes the defense where, regardless of profit motive, the research was done "in furtherance of the alleged infringer’s legitimate business." In the case of a research university like Duke University, the court held that the alleged use was in furtherance of its legitimate business, and thus the defense was inapplicable.
In Merck KGaA v. Integra Lifesciences I, Ltd. 545 U.S. 193 (2005), the United States Supreme Court held that the use of patented compounds in preclinical studies is protected under 35 U.S.C §271(e)(1) if there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and if the experiments will produce the types of information relevant to an Investigational New Drug or New Drug Application.
Read more about this topic: Research Exemption
Famous quotes containing the words common, law, research and/or exemption:
“The moment the very name of Ireland is mentioned, the English seem to bid adieu to common feeling, common prudence, and common sense, and to act with the barbarity of tyrants, and the fatuity of idiots.”
—Sydney Smith (1771–1845)
“Will mankind never learn that policy is not morality,—that it never secures any moral right, but considers merely what is expedient? chooses the available candidate,—who is invariably the devil,—and what right have his constituents to be surprised, because the devil does not behave like an angel of light? What is wanted is men, not of policy, but of probity,—who recognize a higher law than the Constitution, or the decision of the majority.”
—Henry David Thoreau (1817–1862)
“Our science has become terrible, our research dangerous, our findings deadly. We physicists have to make peace with reality. Reality is not as strong as we are. We will ruin reality.”
—Friedrich Dürrenmatt (1921–1990)
“Extemporaneous speaking should be practised and cultivated. It is the lawyer’s avenue to the public.... And yet there is not a more fatal error to young lawyers than relying too much on speechmaking. If any one, upon his rare powers of speaking, shall claim an exemption from the drudgery of the law, his case is a failure in advance.”
—Abraham Lincoln (1809–1865)