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 line of separation was very distinct, and the Indian immediately remarked, “I guess you and I go there,—I guess there’s room for my canoe there.” This was his common expression instead of saying “we.” He never addressed us by our names, though curious to know how they were spelled and what they meant, while we called him Polis. He had already guessed very accurately at our ages, and said that he was forty-eight.”
—Henry David Thoreau (1817–1862)
“There are no fixtures in nature. The universe is fluid and volatile. Permanence is but a word of degrees. Our globe seen by God is a transparent law, not a mass of facts. The law dissolves the fact and holds it fluid.”
—Ralph Waldo Emerson (1803–1882)
“The great question that has never been answered, and which I have not yet been able to answer, despite my thirty years of research into the feminine soul, is “What does a woman want?” [Was will das Weib?]”
—Sigmund Freud (1856–1939)
“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)