- Keywords > compulsory licences
- Keywords > intellectual property laws
- Keywords > intellectual property protection (IPP)
- Keywords > parallel importation
- Keywords > patentability criteria - policy options
- Keywords > patents
- Keywords > pharmaceutical legislation
- Keywords > public health
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
(2000; 140 pages) [French] [Spanish]
V.4 Analogy processes
Some countries have permitted patenting of non-novel processes (sometimes called “analogy processes”) if the resulting chemical is novel and displays unexpected properties.
The United States has held “analogy process” claims to be unpatentable unless they are inventive in themselves103, but has carved out an exception for biotechnology. The products and processes of biotechnology have posed hard problems for applying the inventive step standard, since many biotechnology “inventions” repeat previously invented processes in slightly different contexts. This problem led to a statutory amendment of U.S. law in 1995, which lowered the nonobviousness standard by deeming a biotech process claim nonobvious if it involves new and nonobvious starting materials or produces a new and nonobvious result104. While this solution, targeted only to biotechnology, may be deemed discriminatory - and hence inconsistent with article 27.1 of the TRIPs Agreement - it has been extended by case law to other fields of technology105.
103 See, e.g., Grubb, 1999, p. 206.
104 See, e.g., Dratler, §2.03.
105 See, e.g., Grubb, 1999, p. 207.
While the protection of “analogy processes” has been accepted in many jurisdictions as a logical means of protecting new developments, no country is obliged under the TRIPs Agreement to follow this approach of expanding the realm of patentable subject matter.