Public Order and Morality

1Inventions whose primary or intended use or commercial exploitation is contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment are not patentable. (Patents Act 1970, s 3(b). See also TRIPS Agreement, art 27(2).) The phrase ‘serious prejudice to human, animal or plant life or health or to the environment’ was introduced to accommodate and clarify the expanding meaning of the words ‘public order or morality’. (Substituted by the Patents (Amendment) Act 2002 with effect from 20 May 2003. Prior to its substitution, cl (b) read as follows: ‘(b) an invention the primary or intended use of which would be contrary to law or morality or injurious to public health’.) The jurisprudence of the EPO in interpreting the scope and meaning of the words ‘public order or morality’ will be relevant as the above provision is similar to art 53(a) of the EPC.

2In Sequenom v Controller of Patents (2025) the Delhi High Court said that “one of the embodiments in the Complete Specification of the second patent application, also deals with determination of presence of ‘Y’ chromosome nucleic acid, which would also be prohibited in terms of Section 3A of the 1994 Act” (para 104), the Pre-Conception and Pre-Natal Diagnostic Techniques Act 1994, and held that “the subject invention would also be hit by section 3(b) of the Act.” (para 105)

3An invention should not be excluded as being not patentable merely because a technology is dangerous. There is a general perception that new technologies will involve new risks. In determining the merit of new technology there must be a careful weighing up of the risks vis-à-vis the positive aspects. The issue of morality will come into play in cases of new technology involving higher life forms where not only should the risk be considered, but also the possible harm which is done to such higher life forms. (T19/90 Harvard/Onco-mouse [1991] EPOR 525, p 527 (Exam Div).) As s 3 excludes a number of inventions as being not patentable, the question of morality has to be determined for each invention before the grant. The invention has to be examined, and the possible detrimental effects and risks have to be weighed and balanced against the merits and advantages promised.

4In the Harvard Onco-mouse case, the invention involved a provision of a type of test animal useful in cancer research, which helped in a reduction in the amount of testing on animals. (T19/90 Harvard/Onco-mouse [1991] EPOR 525 (Exam Div). The case involved a patent for an oncogenic test animal. Claim 1 of the patent was directed to a method for producing a transgenic non-human mammalian animal having an increased probability of developing neoplasms by introducing an activated oncogene sequence into the animal at a stage no later than the 8-cell stage. Claim 17 was directed to the resulting animal, with claim 18 specific to the instance when the animal was a rodent. The remaining claims all referred back to one or other of these three.) The case involved conflicting issues pertaining to the basic interest of mankind to remedy widespread and dangerous diseases on one hand, and the protection of environment against the uncontrolled dissemination of unwanted genes and cruelty to animals on the other hand. The Examining Division held that the invention was useful in developing new and improved human anti-cancer treatments for the benefit of mankind, and concluded that the invention could not be considered as immoral or contrary to public order. (T19/90 Harvard/Onco-mouse [1991] EPOR 525 (Exam Div).)

5The above clause also excludes inventions that cause serious prejudice to the environment from being a subject matter of patent. Article 53(a) of the EPC contains a similar provision on the prohibition of patents, the grant of which may seriously prejudice the environment. (The concept of ‘ordre public’ contained in art 53(a) of the EPC encompasses the protection of the environment. See T356/93 Plant Genetic Systems/Glutamine synthetase inhibitors [1995] EPOR 357, p 366 (Tech Bd App).) “The scope of art 53(a) was considered by the EPO in the Harvard Onco-mouse case and in Plant Genetic Systems case. (T19/90 Harvard/Onco-mouse [1991] EPOR 525 (Exam Div).) “In the former case it was held that the ‘possible risks to the environment’ should be determined by weighing the purpose of the present invention and the risk which may be associated by practising the invention in the purpose-limited way. (T356/93 Plant Genetic Systems/Glutamine synthetase inhibitors [1995] OJ EPO 545, [1995] EPOR 357 (Tech Bd App).) In this case, the purpose of the invention was to provide animal test models which were to be used exclusively in the laboratory under controlled conditions by qualified staff. There was no scope for the release of such animals into the general environment. There could be a risk of an uncontrolled release only in cases of intentional misuse or blatant ignorance on the part of the laboratory personnel carrying out the tests. The Examining Division held that the mere fact that such uncontrollable acts are conceivable, cannot be a major determinant for deciding whether a patent should be granted. (T19/90 Harvard/Onco-mouse [1991] EPOR 525, p 528 (Exam Div).)

6In the latter case, the Technical Board of Appeal of the EPO gave a wide connotation to the term ‘ordre public (public order) or morality’ so as to cover not only protection of public security and physical integrity of individuals as part of society, but also to include the protection of environment. It further stated that inventions the exploitation of which is likely to breach public peace or social order or to seriously prejudice the environment are to be excluded from patentability as being contrary to public order. In interpreting the word ‘morality’ the Technical Board of Appeal opined that the concept of morality is founded on the totality of accepted norms which are deeply rooted in a particular culture, and inventions, the exploitation of which is not in conformity to the culture in the European society, are to be excluded from patentability as being contrary to morality. (T356/93 Plant Genetic Systems/Glutamine synthetase inhibitors [1995] EPOR 357, p 366 (Tech Bd App).)