In patent law, the research exemption or safe harbor exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA in the United States, does not constitute infringement for a limited term before the end of patent term. [1] This exemption allows generic manufacturers to prepare generic drugs in advance of the patent expiration.
In the United States, this exemption is also technically called § 271(e)(1) exemption or Hatch-Waxman exemption. In 2005, the U.S. Supreme Court considered the scope of the Hatch-Waxman exemption in Merck v. Integra . The Supreme Court held that the statute exempts from infringement all uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs.
In Canada, this exemption is known as the Bolar provision or Roche-Bolar provision, named after the case Roche Products v. Bolar Pharmaceutical .
In the European Union, equivalent exemptions are allowed under the terms of EC Directives 2001/82/EC (as amended by Directive 2004/28/EC) and 2001/83/EC (as amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC).
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 [scientific] 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 - namely "increas[ing] the status of the institution and lur[ing] lucrative research grants", and thus the defense was inapplicable. [2]
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.
In cases where the Supreme Court has ruled narrowly (e.g., pharmaceutical drugs only) and a lower court has ruled more broadly, further litigation in the lower courts will often be necessary before a subsequent case will resolve the issue more generally as a matter of settled case law. [3]
Fair use is a doctrine in the law of the United States that permits limited use of copyrighted material without having to first acquire permission from the copyright holder. Fair use is one of the limitations to copyright intended to balance the interests of copyright holders with the public interest in the wider distribution and use of creative works by allowing as a defense to copyright infringement claims certain limited uses that might otherwise be considered infringement. Unlike "fair dealing" rights that exist in most countries with a British legal history, the fair use right is a general exception that applies to all different kinds of uses with all types of works and turns on a flexible proportionality test that examines the purpose of the use, the amount used, and the impact on the market of the original work.
The idea–expression distinction or idea–expression dichotomy is a legal doctrine in the United States that limits the scope of copyright protection by differentiating an idea from the expression or manifestation of that idea.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), is a United States Supreme Court case with ramifications for patent law. The dispute dates to approximately 1996 and centers on a federal law known as the "FDA safe harbor".
Triamterene is a potassium-sparing diuretic often used in combination with thiazide diuretics for the treatment of high blood pressure or swelling. The combination with hydrochlorothiazide, is known as hydrochlorothiazide/triamterene.
The Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.
Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858, was a court case in the United States related to the manufacturing of generic pharmaceuticals.
Evergreening is any of various legal, business and technological strategies by which producers extend the lifetime of their patents that are about to expire, in order to retain royalties from them, by either taking out new patents, or by buying out, or frustrating competitors, for longer periods of time than would normally be permissible under the law.
In the United States, a valid patent provides its proprietor with the right to exclude others from practicing the invention claimed in that patent. A person who practices that invention without the permission of the patent holder infringes that patent.
John M. J. Madey was a professor of Physics at the University of Hawaii at Manoa, a former director of the Free Electron Laser Laboratory at Duke University, and formerly a professor (research) at Stanford University. He is best known for his development of the free-electron laser (FEL) at Stanford University in the 1970s.
Inwood Laboratories Inc. v. Ives Laboratories, Inc., 456 U.S. 844 (1982), is a United States Supreme Court case, in which the Court confirmed the application of and set out a test for contributory trademark liability under § 32 of the Lanham Act.
A patent holder in Canada has the exclusive right, privilege and liberty to making, constructing, using and selling the invention for the term of the patent, from the time the patent is granted. Any person who does any of these acts in relation to an invention without permission of the patent owner is liable for patent infringement.
Reverse payment patent settlements, also known as "pay-for-delay" agreements, are a type of agreement that has been used to settle pharmaceutical patent infringement litigation, in which the company that has brought the suit agrees to pay the company it sued. That is, the patent holder pays the alleged infringer to stop its alleged infringing activity for some period of time and to stop disputing the validity of the patent. These agreements are distinct from most patent settlements, which usually involve the alleged infringer paying the patent holder.
FTC v. Actavis, Inc., 570 U.S. 136 (2013), was a United States Supreme Court decision in which the Court held that the FTC could make an antitrust challenge under the rule of reason against a so-called pay-for-delay agreement, also referred to as a reverse payment patent settlement. Such an agreement is one in which a drug patentee pays another company, ordinarily a generic drug manufacturer, to stay out of the market, thus avoiding generic competition and a challenge to patent validity. The FTC sought to establish a rule that such agreements were presumptively illegal, but the Court ruled only that the FTC could bring a case under more general antitrust principles permitting a defendant to assert justifications for its actions under the rule of reason.
Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), is a decision by the Supreme Court of the United States holding that generic drug manufactures cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.
The Plant Variety Protection Act of 1970 (PVPA), 7 U.S.C. §§ 2321-2582, is an intellectual property statute in the United States. The PVPA gives breeders up to 25 years of exclusive control over new, distinct, uniform, and stable sexually reproduced or tuber propagated plant varieties. A major expression of plant breeders' rights in the United States, the PVPA grants protection similar to that available through patents, but these legal schemes differ in critical respects. The PVPA should not be confused with plant patents, which are limited to asexually reproduced plants.
J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001), was a decision of the United States Supreme Court holding for the first time that utility patents may be issued for crops and other flowering plants under 35 U.S.C. § 101. The Supreme Court rejected the argument that the exclusive ways to protect these plants are under the Plant Variety Protection Act (PVPA), 7 U.S.C. § 2321, and the Plant Patent Act of 1930 (PPA), 35 U.S.C. §§ 161-164.
Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020, is a 2015 en banc decision of the United States Court of Appeals for the Federal Circuit, on remand from a 2014 decision of the U.S. Supreme Court reversing a previous Federal Circuit decision in the case. This is the most recent in a string of decisions in the case that concern the proper legal standard for determining patent infringement liability when multiple actors are involved in carrying out the claimed infringement of a method patent and no single accused infringer has performed all of the steps. In the 2015 remand decision, the Federal Circuit expanded the scope of vicarious liability in such cases, holding that one actor could be held liable for the acts of another actor "when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance." In addition, the court held that where multiple "actors form a joint enterprise, all can be charged with the acts of the other[s], rendering each liable for the steps performed by the other[s] as if each is a single actor."
Saint Regis Mohawk Tribe v. Mylan Pharms. Inc., 896 F.3d 1322 is a United States Patent case, decided by the CAFC, deciding whether or not indigenous tribes' sovereign immunity extended to patent lawsuits. In September 2017, the American pharmaceutical company Allergan agreed to transfer six pharmaceutical patents for the ophthalmic form of the drug Restasis to the St. Regis tribe of the Mohawk people. At the time, the St. Regis tribe viewed this blockbuster deal as a new, viable supply of income outside of their primary source, the gambling industry. Following the deal, Allergan received an onslaught of criticism from outside companies and politicians such as Rep. Trey Gowdy, chairman of the Committee on Oversight and Government Reform, who said that the deal, "'impair[s] competition across the pharmaceutical industry.'"
