Abstract
The patent system plays an important role in stimulating the economy and advancing the quality of life in the United States. It serves as an incentive for innovation by giving inventors an exclusive right to their inventions for a limited period of time. It also increases and hastens the publication of useful knowledge by requiring inventors to disclose their invention to the public. Patents are particularly important in the pharmaceutical and biotechnology industries because they provide a mechanism by which the extremely high product development costs may be recouped. The United States Patent and Trademark Office acts as a gatekeeper in the patent system to prevent patents that do not meet the legal requirements from being thrust on the public. The legal requirements for obtaining a patent are discussed, particularly as they related to pharmaceutical and biotechnological inventions. The process of examining an application for a patent is briefly described, along with some of the burdens faced by examiners when deciding the patentability of therapy-related inventions.
Keywords: Patent, pharmaceutical, biotechnology, utility, description, obviousness, examiner
Full Text
The Full Text of this article is available as a PDF (569.3 KB).
References
- 1.Utility Examination Guidelines. 66 Federal Register 1092 (2001). Available at: http://www.uspto.gov/web/offices/com/sol/notices/ utilexmguide.pdf. Accessed July 14, 2007.
- 2.Brenner v Manson, 383 US 519, 148 USPQ 689 (1966).
- 3.In re Fisher, Court of Appeals for the Federal Circuit, 421 F3d 1365, 76 USPQ2d 1225 (Fed Cir 2005).
- 4.Graham v John Deere, 383 US 1, 148 USPQ 459 (1966).
- 5.KSR International Co v Teleflex Inc et al, 127 SCt 1727 (2007).
- 6.Bell, In re, 991 F2d 781, 26 USPQ2d 1529 (Fed Cir 1993).
- 7.Deuel, In re, 51 F3d 1552, 34 USPQ2d 1210 (Fed Cir 1995).