{ "id": "RL32651", "type": "CRS Report", "typeId": "REPORTS", "number": "RL32651", "active": false, "source": "EveryCRSReport.com", "versions": [ { "source": "EveryCRSReport.com", "id": 306016, "date": "2004-10-28", "retrieved": "2016-04-07T20:05:23.089812", "title": "Scientific Research and the Experimental Use Privilege in Patent Law", "summary": "Congress has identified research and development (R&D) as important contributors to\ntechnological\nprogress. The performance of R&D may have intellectual property ramifications, however. To\nthe\nextent that researchers use patented inventions without authorization, they may face infringement\nliability. Although the courts recognize an exception to patent infringement known as the\n\"experimental use privilege,\" this judicially created doctrine has been described as very narrow and\nrarely applied. In particular, the experimental use privilege applies only to uses done for amusement,\nto satisfy idle curiosity or for strictly philosophical inquiry. This doctrine does not excuse uses that\nare in keeping with the accused infringer's business objectives.\n In 2002, the U.S. Court of Appeals for the Federal Circuit applied these principles in the case\nof Madey v. Duke University . The court held that the experimental use privilege does\nnot apply to\nactivities that are \"in keeping with the alleged infringer's legitimate business\" -- even though the\nbusiness of the defendant, Duke University, was nonprofit research. This ruling has raised concerns\namong some representatives of universities and research institutions, who fear that their basic\nR&D\nactivities will subject them to patent infringement lawsuits.\n Competing views have arisen over the significance of the Madey v. Duke\n University \u00a0case.\n\u00a0Some commentators believe that a limited experimental use privilege may best encourage\ntechnological advancement by rewarding successful researchers with robust patent rights. Others\nargue that the restricted nature of the experimental use privilege may in fact limit researcher access\nto state-of-the-art technologies and thus discourage further technological development. Still others\nassert that this issue is not of great practical importance, as few patent owners will likely file costly\nand time-consuming lawsuits against researchers who are not making commercially important uses\nof patented inventions.\n The judicially created, \"common law\" experimental use privilege is complemented by a limited\nstatutory experimental use privilege for patents on pharmaceuticals, medical devices, and certain\nother products regulated by the Food and Drug Administration. This provision, enacted as part of\nthe 1984 Hatch-Waxman Act, applies to firms seeking to market generic equivalents of brand-name\nproducts. In addition, Congress has enacted other intellectual property legislation that incorporates\nprovisions shielding researchers from infringement liability. \n Should congressional interest continue in this area, a variety of options are available. If the\ncurrent scope of the common law experimental use privilege is deemed to be appropriate, then no\naction need be taken. Alternatively, Congress could enact legislation confirming the limited\nexperimental use privilege recognized in Madey v. Duke University \u00a0and\npredecessor cases. \nIntroduction of a broader form of the experimental use privilege into U.S. patent law is an additional\npossibility. The report will be updated if events warrant such action.", "type": "CRS Report", "typeId": "REPORTS", "active": false, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/RL32651", "sha1": "f38a6468ef07024703afc3aa7f670ab25bbffaa0", "filename": "files/20041028_RL32651_f38a6468ef07024703afc3aa7f670ab25bbffaa0.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/RL32651", "sha1": "39ef4594639c121f7c2afe4c4f69b048572d9978", "filename": "files/20041028_RL32651_39ef4594639c121f7c2afe4c4f69b048572d9978.pdf", "images": null } ], "topics": [] } ], "topics": [] }