{ "id": "R40917", "type": "CRS Report", "typeId": "REPORTS", "number": "R40917", "active": false, "source": "EveryCRSReport.com", "versions": [ { "source": "EveryCRSReport.com", "id": 357217, "date": "2009-11-13", "retrieved": "2016-04-07T02:11:16.844356", "title": "Patent \u201cEvergreening\u201d: Issues in Innovation and Competition", "summary": "\u201cPatent evergreening\u201d is a potentially perjorative term that generally refers to the strategy of obtaining multiple patents that cover different aspects of the same product, typically by obtaining patents on improved versions of existing products. Although the patent system allows improvement patents to be obtained in any industry, evergreening is said to be most common in the pharmaceutical industry. \nSome observers believe that the availability of so-called continuation applications at the U.S. Patent and Trademark Office (USPTO) may promote evergreening practices. USPTO regulations that would have restricted the availability of continuation applications have been struck down by the courts on the grounds that the regulations exceeded the agency\u2019s statutory authority to promulgate. Others believe that the Hatch-Waxman Act, specialized legislation that governs the resolution of patent disputes between brand-name and generic drug companies, may also encourage evergreening in the pharmaceutical industry. However, 2003 amendments to the Hatch-Waxman Act may have mitigated some of these concerns.\nCritics of evergreening assert that the ability to obtain multiple patents on a product, over a period of many years, effectively extends the term of exclusivity that the patent holder obtains. They further assert that this practice is abusive, impedes the introduction of generic medications, and has a negative effect upon public health in the United States.\nOther observers believe that the term \u201cevergreening\u201d is itself inappropriate. In their view, sound intellectual property policy allows innovators to obtain patents on improvement inventions. Most technological advance occurs incrementally, they observe, and many improvement patents cover advances that are of considerable practical significance to patients and other consumers. In addition, patents on improvements may not impede the ability of competitors to market products that were covered by expired patents on original technologies. Finally, the developer of the \u201coriginal\u201d product is not always the same entity as the developer of \u201cimprovement\u201d technologies. The ability of any innovator to obtain a patent upon an improvement invention is said to promote competition.\nShould Congress conclude that the current situation is satisfactory, then no action need be taken. If Congress wishes to intervene, however, a number of options present themselves. Congress may wish to consider the regulation of continuation applications or the introduction of statutory provisions that more directly address the perceived problem of evergreening. In addition, more generalized reform of the patent system may address concerns over evergreening. Current bills before the 111th Congress would potentially introduce a broad range of reforms in an effort to improve the patent system, and would perhaps respond to criticisms of evergreening practices.", "type": "CRS Report", "typeId": "REPORTS", "active": false, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R40917", "sha1": "97e1cb3a32427d6c639ad204546f3fd7d597a72c", "filename": "files/20091113_R40917_97e1cb3a32427d6c639ad204546f3fd7d597a72c.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R40917", "sha1": "9536d486c1db2b54f1f4621cef2e664d693472f2", "filename": "files/20091113_R40917_9536d486c1db2b54f1f4621cef2e664d693472f2.pdf", "images": null } ], "topics": [] } ], "topics": [ "Health Policy" ] }