There are various theories given by different persons to explain the claim and justification of patent system. Among these various theories “incentive” or the “reward theory” are the most common. To simplify patents are rewards in the form of monopolies granted to persons who has developed new, inventive and useful products or processes and in return it is expected that such rewards will foster inventors to come up with useful inventions at higher rate. However this is a debatable issue that whether patent system has foster a higher rate of new useful inventions.

In developing countries, patent system is not just only to increase the innovation, but is attuned to take into accounts the concerns of “access” to technology most significantly in the field of pharmaceuticals and public health. Hence it is evident that the patent regime cannot be segregated from other public policies such as moral values and health. Right from start there is conflict between the patent rights on one hand and the public policies, social values and fundamental rights on the other. The issue is to balance out between these conflicting and competing concerns and to come up with regime that would, while promoting innovation, does not erode important issues.

This article seeks to appraise the patent and public order or morality interface from the point of view of the ex-ante mechanism i.e. ways in which countries sought to limit the grant of patents to certain categories. Broadly such exclusions include public order or morality, methods of medical treatment, plants and animal varieties, discoveries, mere combinations, derivatives etc. The exclusion under public order or morality will be taken up in this article.

Public order or Morality

The exclusions of ‘public order’ or ‘morality’ from patentability vary from country to country as the scope of application of these exclusions largely depends upon local cultures and practices. What is considered as immoral in one country can be considered as normal practice and comes under public order. The terms ‘public order’ or ‘morality’ are full of ambiguity and vary according to the practices of the particular state. Looking into the issue that whether law is a reflection of morality or the same can be divorced from the former, the positivist school of law states that the law should be separated from morality and should be based on logic and reasons. However the school of natural law argues that law reflects the morals and norms of the society and it cannot be based purely on rules of reason and logic.1

Accordingly the positivist will argue that the patent shall be granted as long as the invention in novel, inventive and useful and morality should have no role to play in the grant of the patent. On the other hand school of natural law will present opposite views that an invention which offends society’s morals should not be granted patents reason being the natural schools fundamentals principle that the law is a reflection of morals of the society and something which offends morality of society cannot be given a legal character.

Article 27.2 of TRIPs

Article 27.2 of the Trade Related Intellectual Property rights (TRIPs) allow member countries to exclude form patentability such inventions which may offend the morality or public order of the its society. Nothing has been clearly defined in the TRIPs with respect as to what comes under the morality.

Article 27.2 of TRIPs states that “Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law”.

The words ordre public and morality exclusions as provided in Art. 27.2 are not easy to define. According to one interpretation ordre public means “expresses concerns about matters threatening the social structures which tie a society together i.e. matters that threaten the structure of civil society as such” and morality means “degree of conformity of an idea to moral principles”.2 Both ordre public and morality are reflective of then prevailing principles, socio-cultural and religious values of member countries thus it is not possible to provide objective definition of the same.

The latter half of the Art. 27.2 defines to some extent the aspects of such exclusions as those invention whose commercial exploitation is banned in order to protect human, animal or plant life or the environment and not merely because the existing law of the state prohibits exploitation of such inventions.

Position in United States

United States of America never had an exception of morality or ordre public in their patent laws however such requirement was fixed by the Courts but the same was used rarely. In the mid twentieth century the USPTO started banning patents on gambling machine on morality grounds however the same came to end in 1980’s when the Court held that inventions for gambling machines are no more or less immoral than invention such as gun which may used for killing people.

The USPTO in late nineties invoked moral utility doctrine in order to check the controversial applications related to biotechnology inventions.

But the same was criticized by the Courts because according to them it is the legislature not the executive which can define the boundaries of the law. Hence there are very few examples where the morality exception was raised by the USPTO.

Position in European Union

The European Union adopted a different approach by inserting the morality and public ordre clause in the patent laws since very beginning. Unlike TRIPs the European Patent Convention mandatorily requires its members to provide for morality exclusions. Further the EPO later on issued Biotech Directive – 98/44/EC which bars certain biotechnological invention derived from the destruction of human embryos or manipulation of genetic structures. EPO is very stringent on this morality and public ordre exclusion and unlike US first asks the question before deciding for the grant of the controversial patents.

Article 53(a) of the European Patent Convention 2000 provides that European patents ‘shall not be granted in respect of inventions the commercial exploitation of which would be contrary to “ordre public” or morality’ and that ‘such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting states’.

Rule 28 Exceptions to patentability: Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:

  1. processes for cloning human beings;
  2. processes for modifying the germ line genetic identity of human beings;
  3. uses of human embryos for industrial or commercial purposes;
  4. processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

In the case of Onco-Mouse the exclusion under Article 53(a) of the EPC was argued for the first time. In this case the subject matter of patent application was a mouse which has been genetically modified to carry an oncogene in order to make them more vulnerable to cancer. The object of the invention is to use these modified mice in cancer research. Upon examination of the application the EPO rejected the application stating that the animal varieties are not patentable. However on appeal the Technical Board of Appeal applies the morality clause under Article 53(a). The technical board is of view that genetically modifying a mammal and that to ensure that it will develop cancer was very problematic as the same cause suffering to the animal. However the Board of Appeal forwarded the application back to the examination division stating that while considering morality, the Office should balance inventions utility to the mankind with the suffering caused to the animals. The Board accordingly held the genetically modified mouse to be patentable on the grounds that the same was for the benefit of the humanity.

Since then there are several cases like The Plant Genetic Systems Case,3 The Transgenic Animals decision,4 The Wisconsin Alumni Research Foundation (WARF) case5 etc. where exclusion under Art. 53(a) has been discussed in detail.

Position in India

The Indian Patents Act, 1970 provides a statutory provision regarding the public order or morality exclusion.

Section 3(b) states that “an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment”.

Further the draft manual of Patents also provides some examples which come under exclusion on the grounds of public order or morality. However the exclusion as provided under the law is yet to be scrutinized by the Indian Courts. In the case of Novartis AG v. UoI & Ors.6 the IPAB denied patent on the ground that the prices of the drug Gleevec is excessively high and was out of reach of common man. The IPAB held that “in our view [the drug] is too unaffordable to the poor cancer patients in India. Thus, we also observe that a grant of product patent on this application can create havoc to the lives of poor people and their families affected with the cancer for which this drug is effective. This will have disastrous effect on the society as well. Considering all the circumstances of the appeals before us, we observe that the Appellant’s alleged invention won’t be worthy of a reward of any product patent on the basis of its impugned application for not only for not satisfying the requirement of section 3(d) of the Act, but also for its possible disastrous consequences on such grant as stated above, which also is being attracted by the provisions of section 3(b) of the Act which prohibits grant of patent on inventions, exploitation of which could create public disorder among other things.”

It is interested to note that the IPAB has rejected the above case on the ground of public order and not on the grounds of morality. At present the case is pending before the Supreme Court of India.