Molecular Biotechnology: Principles and Applications - Glick, B., Pasternak, J. 2002

Research Regulation in Molecular Biotechnology and the Patenting of Biotechnological Inventions
Patenting Biotechnological Inventions

The primary objective of biotechnology is The production of a diverse array of commercial products. However, no company will undertake long-term, high-risk projects without ensuring that the results of its R&D will be rigorously protected against exploitation by competitors. For its part, the government endeavors to foster innovation aimed at industrial growth. A strategy that reconciles the interests of both parties is for the government to grant inventors exclusive rights to new products or manufacturing processes. Such authorized privileges are known as intellectual property rights and encompass trade secrets, copyrights, trademarks, and patents. Trade secrets are confidential information regarding the specific details of a manufacturing process and product formulation that a company wishes to keep secret and shield from third-party use. Copyrights, such as published works, protect against unauthorized and unlawful use through copyright law. Trademarks are words or symbols designed to identify a specific product or process developed by a particular company. For instance, the trademark Gigapack refers to an in vitro packaging kit containing λ bacteriophage packaging extract produced by the biotechnology company Stratagene. Other firms market similar kits under their own trademarks.

The most crucial form of intellectual property for biotechnology is the invention. An invention is protected by a patent, which is a legal document granting the patent holder exclusive rights to the commercial exploitation of the invention. Furthermore, based on the patent claims, the patent holder has the right to develop other products derived from their invention, whereas competitors are compelled to license the technology to do so. On the other hand, a patent is a publicly available document that provides a detailed Description of the invention, thereby informing third parties of The Nature and Limitations of the innovation. This enables them to determine whether to pursue research in that direction or to use the patented invention as a stepping stone for potential alternative developments. Patent Procedures and laws vary across countries, despite ongoing efforts toward harmonization. For example, until recently in the U.S., exclusive patent rights lasted for 17 years from the date of issue, in Canada for 20 years, and in many European countries for 20 years from the filing date. Currently, under international agreements, the patent term in most countries, including the U.S., is 20 years from the filing date. However, unlike many other nations, the U.S. government maintains that the patent issue date takes precedence over the filing date. Typically, it takes anywhere from two to five years from the initial patent application to patent issuance. In any case, holding a patent can yield substantial dividends, yet obtaining one is far from straightforward; consequently, stringent requirements are imposed on both the patent application and the invention itself.

¹⁾ This chapter focuses on U.S. patent practice, which may differ from the regulations established in Ukraine. — Trans. note.