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Merck v. Integra Lifesciences I, Ltd.

In a straightforward, 9-0 decision issued late in its term, the U.S. Supreme Court held that Congress had intended a much broader "safe harbor" provision under U.S. patent law than that found by the Federal Circuit Court of Appeals. Merck v. Integra Lifesciences I, Ltd. No. 03-1237, 545 U.S. __ (2005). In so holding, the Court left untouched the scope of the common law "experimental use" exemption from patent infringement as well.

The so-called safe harbor provision of the patent statute [35 U.S.C. 271(e)(1)] was added in 1984 to protect from charges of infringement certain inventions and/or research that are "reasonably related to the development and submission of information under a Federal law which regulates the…use…of drugs [the FDA]." Under FDA regulations, a drug maker must submit research data in an "investigational new drug application" (IND) when seeking authorization to conduct human clinical trials, or in a "new drug application" (NDA) when seeking authorization to market a new drug. The question before the Court in Merck was whether the use of patented inventions in preclinical research, the results of which may not ultimately be included in a submission to the FDA, were nonetheless exempted from infringement under Section 271(e)(1).

Integra Lifesciences, Ltd. owned five medical/pharmaceutical patents involving RGD peptides, which promote cell adhesion. Since 1988, Merck had funded research for angiogenesis (blood vessel regrowth) that ultimately (1995) incorporated the use of a cyclic RGD peptide developed and promoted by Merck, but fully within the purview of Integra's patents.

In 1996, Integra filed suit for patent infringement against Merck, charging, among other things, that Merck willfully supplied Integra's RGD peptides to other defendants for use in preclinical research. Merck responded that its actions were exempted under the common law research exemption, as well as Section 271(e)(1). The federal district court ruled on the pre-1995 claims, dismissing them as protected by the common law research exemption. But the court found that a question of fact remained as to whether the use of the RGD peptides after 1995 fell within the safe harbor provisions of Section 271(e)(1). Under the court's directed jury instruction, the jury found that Merck, et al, failed to show that its actions were protected under the statute, and awarded $15 million to plaintiff Integra.

A divided Federal Circuit Court of Appeals upheld denial of Merck's motion for judgment as a matter of law, but reversed the district court's refusal to modify the damages award. Another appeal followed.

Justice Scalia, writing for the unanimous Supreme Court which vacated the appellate decision and remanded, concluded,

We thus agree with the Government that the use of patented compounds in preclinical studies is protected under Section 271(e)(1) as long as there is reasonable basis for believing that the experiments will produce "the types of information that are relevant to an IND or NDA.

The Court found the statutory text clear in providing a wide berth for the use of patented drugs in activities related to the federal regulatory process, including uses reasonably related to the development and submission of any information under the FDAC. This necessarily would include preclinical studies. The Supreme Court quoted another district court's observation that "[I]t will not always be clear to parties setting out to seek FDA approval for their new product exactly which kinds of information, and in what quantities, it will take to win that agency's approval." [quoting Intermedics, Inc. v. Ventritex, Inc., 775 F.Supp. 1269 (1991)]. Noted the Supreme Court, "This is particularly true at the preclinical stage of drug approval."

As the United States had argued in its amicus brief on behalf of the FDA, even when "hundreds or even thousands [of compounds] must be tested" while screening to identify the ultimate drug target, that screening is exempt from infringement. "As long as a scientist is working on developing a particular drug…the number of compounds screened has nothing to do with whether the screening was reasonably related to the development and submission of information to the FDA. Instead, it reflects the luck (or intuition) of the scientist, or the difficulty of the task." (Government brief, citations omitted.) The high court agreed.

The Court noted that basic scientific research on a particular compound is often performed without the express intent to develop a particular drug, or even without a reasonable belief that the compound will cause the necessary effect the researcher intended to produce. Surely, this would not be "reasonably related to the development and submission of information" to the FDA. Nonetheless, said the Court, "It does not follow from this, however, that Section 271(e)(1)'s exemption from infringement categorically excludes either (1) experimentation on drugs that are not ultimately the subject of an FDA submission or (2) use of patented compounds in experiments that are not ultimately submitted to the FDA."

The Court remanded the case for review of trial evidence under the Court's more developed and detailed standard under which Merck now needed to show that its activities were covered by Section 271(e)(1).

NTP v. Research in Motion, Ltd

In December 2004, the U.S. Court of Appeals for the Federal Circuit returned a mixed ruling in a highly watched patent case crossing international borders. The important aspect of the decision was its potential to serve as precedent on the issue of the territorial reach of U.S. patents under 35 U.S.C. §271(a). In NTP, Inc. v. Research in Motion, Ltd., 392 F.3d 1336 (Fed. Cir. 2004), the Virginia-based NTP filed suit for patent infringement in the U.S. District Court for the Eastern District of Virginia against the Ontario-based Research in Motion, Ltd. (RIM), the maker of the popular BlackBerry wireless e-mail device.

In summary, NTP's patents were directed toward an "electronic mail system with RF communications to mobile processors". The technology at issue related to systems for integrating existing e-mail systems ("wireline" systems) with radio frequency (RF) wireless communication networks. This integration enables mobile users to receive e-mail over a wireless network.

A jury found that RIM had infringed on 14 claims in five NTP patents. It also found that the infringement willful. In August 2003, the district court awarded $57.3 million in damages to NTP and entered a permanent injunction against RIM from further manufacture, sale, use, or importation of all accused BlackBerry systems in the United States. RIM appealed, and the injunction was stayed pending the appeal.

The appellate court affirmed the district court's rulings on all but one point, relating to the construction of the term "originating processor." The Federal Circuit found that the originating processor, as asserted by NTP, referred to only one processor and not to three separate processors. On all else, it upheld the district court's finding of infringement under 35 U.S.C. §271, the exclusion of RIM's expert and demonstrative testimony, and the denial of RIM's motion for judgment as a matter of law. The key issue on appeal, however, was the decision that RIM's Canadian server location did not prevent the application of U.S. patent law to the e-mail system.

Specifically, 35 U.S.C. §271(a) reads as follows:

Except as otherwise provided in this title, whoever without authority makes, sells, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefore, infringes the patent.

RIM had argued on appeal that under §271(a), the territorial reach of a patent right was limited to patent infringement that occurred completely "within the United States." In this case, BlackBerry's relay component was physically located in Canada. The appellate court considered this argument but reasoned, "Even though one of the accused components in RIM's BlackBerry system may not be physically located in the United States, it is beyond dispute that the location of the beneficial use and function of the whole operable system assembly is in the United States."

The import of this case was the Federal Circuit's stance on the inclusion of foreign components in the infringement analysis. According to the appellate decision, the test is not whether the infringement took place within the United States but whether "control and beneficial use" of the infringing system was within the United States. Traditionally, patent rights were generally understood to be geographically territorial in nature. However, with the advance of information and communication technologies and the establishment of multijurisdictional operations, the jurisdictional boundaries could be delineated more by commerce than geography.

The appellate court only addressed the infringement decision on five of the 14 verdict counts. The verdict of infringement on the other 11 claims was upheld. The ultimate decision affirmed in part, vacated in part, and remanded.

Following remand, the parties announced in early 2005 that a settlement had been reached for $450 million U.S. However, and contrary to the permanent injunction earlier ordered, the settlement confirmed that RIM would receive a perpetual, fully paid license under NTP's patents.

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Article I grants to Congress the power to "promote the Progress of Science and useful Arts, by securing for limited times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." This clause confers on the federal government authority to provide for both patents and copyrights.

United States patent law derives from the English experience. During Tudor times, English monarchs granted various monopolies (such as ones over salt) to royal favorites. The populace arose against the high prices charged by such monopolies. In 1623, Parliament enacted the germinal Statute of Monopolies. The statute declared monopolies void but as an exception allowed letters patent for fourteen years to the "true and first inventors" of "new manufactures."

In America, some states prior to adoption of the Constitution granted patents to inventors. But in listing the limited and specific powers of the federal legislature, the drafters of the Constitution agreed that patents and copyrights should be among those powers. As james madison argued in the federalist #43, "the States cannot separately make effectual provision for either." The drafters perceived that the interests of both a unified national economy and a strong system of incentives for invention required that a patent power lie in the federal government.

The constitutional power specifies both the end of the patent system (progress of the useful arts) and the means for achieving it (secure for a limited time to inventors the exclusive right to their discoveries). The power is only an enablement and does not of its own force create any patent rights. Nevertheless, the first Congress in 1790 enacted a patent statute. An 1836 statute revised the patent laws and created the Patent Office. A 1952 statute restated the patent laws in their current form. An inventor of a new and useful product or process may obtain from the Patent Office a patent granting for a number of years (currently seventeen) the right to exclude others from making, selling, or using the invention defined by the claims in the patent.

Although most questions concerning patentability are defined by statute, the Constitution limits Congress's power to authorize patent monopolies. In Graham v. John Deere Co. of Kansas City (1966), the Supreme Court stressed that Congress may not authorize patents that "remove existent knowledge from the public domain." Rejecting a natural rights theory of patents for inventions, the Court emphasized the utilitarian function of patents: they stimulate innovation and the disclosure of new knowledge. Patents may issue only for inventions that advance the state of technology. This constitutional standard of innovation finds expression in the patent law doctrine of "nonobviousness," which bars a patent for any discovery that would have been obvious at the time of invention to a person with ordinary skill in the pertinent art who had knowledge of all the prior art.

A patent may issue for virtually any type of useful product or process. In Diamond v. Chakrabarty (1980), the Supreme Court upheld the potential patentability of a live, genetically altered strain of microorganism.

Donald S. Chisum


Chisum, Donald S. 1978 Patents: A Treatise on the Law of Patentability, Validity and Infringement. New York: Matthew Bender.

Machlup, Fritz 1958 An Economic Review of the Patent System. Study No. 15, Subcommittee on Patents, Trademarks & Copyrights, Judiciary Committee, 85th Congress, 2d Session.

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patent, in law, governmental grant of some privilege, property, or authority. Today patent refers to the granting to the inventor of a useful product or process the privilege to exclude others from making that invention. Patent is also the term for the conveyance of public lands to an individual. Patents developed out of the medieval institution of allowing monopolistic control over useful goods in order to encourage their sale and distribution; the authority was contained in letters patent (meaning open, i.e., public). The corrupt sale of such privileges and the consequent increase in the price of necessities led in England to the Statute of Monopolies (1623), which abolished all monopolies except those of inventors in their inventions.

The U.S. Constitution (Article 1, Section 8) authorizes Congress to enact patent legislation; the first such law was enacted Apr. 10, 1790. In 1836, Congress created the U.S. Patent Office (now the U.S. Patent and Trademark Office) and established the basic principles of American patent law. Comprehensive revision of that law occurred in 1870 and in 1952. In the United States any process or device may be patented if it is novel and useful and if plans and a working model are supplied. In all countries patents are valid for a limited term only (17 years in the United States); this limit ordinarily secures a profit to the inventor for a reasonable period yet will not permanently deprive the public of the free use of the invention.

The American law was designed to encourage the maximum inventiveness. Unlike many European countries where the rights to patents are limited so as to make innovations in industry easier, the United States does not require the patentee to permit the use of the invention on pain of losing the patent. Although there have been many independent inventors in the United States, most important patents today are the property of large corporations capable of exploiting them.

Injurious practices, such as withholding beneficial patents that might make obsolete some widely used product or process, have developed. Other practices, such as acquiring all patents in a given field and granting manufacturing licenses only to firms that promise to refrain from effective competition, have been repeatedly attacked by the federal government under the antitrust laws (see trust). Difficulties have also developed in the effective and equitable regulation of patents taken out by foreigners.

See F. L. Vaughan, The United States Patent System: Legal and Economic Conflicts in American Patent History (1956); B. W. Bugbee, Genesis of American Patent and Copyright Law (1967); C. MacLeod, Inventing the Industrial Revolution (1989).

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A patent is a legal document issued by a government granting exclusive authority to an inventor for making, using, and selling an invention. The invention must have a sufficient degree of newness, usefulness, or novelty to distinguish it from items with existing patents. To qualify for a patent, an invention may not merely be a substitution, change, or combination of items. In the United States inventions may include products, machines, methods, new uses, and even new forms of life as genetically engineered bacteria.

The exclusive authority granted is considered a barrier to entry, that is, something that prevents anyone else from copying or producing the invention without permission. By doing so, government hopes to encourage creative innovations by providing sufficient time for the innovator to recoup his research costs and realize profits. The inventor may manufacture, use, or sell his invention in a monopolistic atmosphere.

Each country has its own system of patents. In the United States, applications are made to the U.S. Patent and Trademark Office (PTO), and it takes up to two years to process. The patent is granted to the first inventor rather than the first person to make application, so inventors must document when they first came up with the idea. The PTO exhaustively checks previous patents to make sure of no duplications. If none exist, PTO sends a notice of allowance to the inventor. Upon paying fees, the patent is issued. The patent protects the invention for 17 years. A design patent, which covers only the appearance of an item, is issued for 14 years. A patent owner may sue on grounds of infringement to stop any copying of the invention.

The U.S. Constitution first empowered Congress to secure exclusive rights for inventors. At the beginning of the twentieth century, 82 percent of patents issued in the United States went to individuals and 17 percent to U.S. corporations. By 1962 about 28 percent of the patents went to individuals while 59 percent went to U.S. corporations, 12 percent to foreign entities, and two percent to the U.S. government. The sharp decline in individual patents could partially be explained by large increases in corporate research and development expenditures funded by both the federal government and private industry.

In 1992 the North American Free Trade Agreement (NAFTA) highlighted the continued importance of patents by requiring each member country to provide both product and process patents for all kinds of inventions.

See also: North American Free Trade Agreement

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pat·ent • n. / ˈpatnt/ 1. a government authority to an individual or organization conferring a right or title, esp. the sole right to make, use, or sell some invention: he took out a patent for an improved steam hammer. 2. short for patent leather. • adj. 1. / ˈpātnt; ˈpat-/ easily recognizable; obvious: she was smiling with patent insincerity. 2. Med. / ˈpātnt; ˈpat-/ (of a vessel, duct, or aperture) open and unobstructed; failing to close. ∎  (of a parasitic infection) showing detectable parasites in the tissues or feces. 3. / ˈpatnt/ made and marketed under a patent; proprietary: patent milk powder. • v. / ˈpatnt/ [tr.] obtain a patent for (an invention): an invention is not your own until it is patented. DERIVATIVES: pat·ent·a·ble adj. pat·ent·ly / ˈpatntlē; ˈpā-/ adv. (in sense 1 of the adjective).

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patent A government grant to an inventor assuring him/her the exclusive right to exploit or sell the invention for a limited period (usually 20 years). Under the 1985 Guidelines for Examination in the European Patent Office, patent protection is available to inventive computer programs in Europe if the invention is expressed in terms of a programmed machine. Programs can be patented in the USA if they comply with the originality and other requirements of the US Patent Act. Inventive hardware is patentable in Europe and this leads to a serious flaw in the law; the same task can be performed by both software and hardware but the former is expressly excluded from protection by a clause in the European Patent Convention. The question of whether a program that performs the same task as a piece of patented hardware infringes the patent in the hardware has not yet been decided in Europe, nor has it been decided whether a PROM is a piece of software or hardware. Many of these inventions are now given a special type of copyright protection under new laws protecting chip masks. See also trade secrets.

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patent a government authority or licence to an individual or organization conferring a right or title for a set period, especially the sole right to make, use, or sell some invention. Recorded from late Middle English, the word comes via Old French from Latin patent- ‘lying open’.
patent roll a parchment roll containing the letters patent issued in Britain (or formerly in England) in any one year.

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A. in letters p., formerly also letters p—s, open letter from an authority recording, enjoining, or conferring something XIV; conferred by these XVI; protected by letters patent, as an invention XVIII;

B. (gen.) open, manifest XVI. In A — (O)F. patent, -ente (in lettres patentes) — L. patēns, -ent-, prp. of patēre lie open; in B, directly — L.
Hence as sb., by ellipsis of letters XIV.

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patent (letters patent) Privilege granted to the inventor of a new product or process. A patent excludes others from producing or making use of an invention for a limited period, unless under license from the holder of the patent. See also copyright

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