PATENTS, PUBLIC ORDER AND MORALITY

Most patent laws exclude some inventions from patentability on the grounds that they are contrary to public order and morality. Art. 5.1 of the Spanish Patent Law states:

“The following may not be patented: Inventions whose commercial exploitation is contrary to public order or morality, and the exploitation of an invention may not be considered as such merely because it is prohibited by a legal or regulatory provision.”

The Act then goes on to specify:

“a) processes for cloning human beings.

b) Procedures for modifying the germline genetic identity of human beings.

c) The use of human embryos for industrial or commercial purposes.

d) Procedures for modifying the genetic identity of animals which cause them suffering without substantial medical or veterinary benefit to man or animals, and animals resulting from such procedures”.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) includes this exclusion from patentability in article 27.2:

2.  Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect order 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.

This exclusion from patent rights is characterised by its dynamism. There are numerous examples of inventions that were excluded form patentability in the past for being included in this category and would now be patentable. New inventions will be regarded as contrary to public order or morality, to be later considered as patentable as morality also evolves.

The exclusion of inventions from patentability on the grounds that they are contrary to morality is deeply rooted in the patent system, with some cases already in its first years. In Spain there are some early examples of such exclusion. According to the book “Invención, patentes e innovación en la España Contemporánea” by Patricio Saiz  a patent was denied in the period 1826-1878 on the grounds of lack of morality and another one because the invention was dangerous. The “privilegio” (as patents were known at the time) was the 4860 and its subject matter a procedure for the dissection of human corpses which consisted of rapidly decomposing the flesh by means of superheated steam and calcining the bones (reducing them into ashes). The resulting ash could be used industrially. This application was declared inadmissible after the director of the Conservatory decided against its grant. The report stated that, although it was not permitted to comment on the novelty or usefulness of the privileges since in those years the system for granting patents in Spain was of the simple deposit type, there were cases in which this was desirable for public morality. The privilege 4569 referred to improvements in a procedure for the manufacture of explosive gunpowder and their saturation with blasting or percussion powder. The application was filed in 1868 and the Royal Conservatory of arts and Crafts reported that it was a very dangerous manufacturing method, which could cause explosions and fires in factories very easily.

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The U.S.A is considered an exception regarding the exclusion of inventions from patentability on the grounds that they are contrary to morality or “public order”, since this exclusion is not included in their legislation. In practice, there have been inventions excluded from patentability on these grounds. However, this has been done through the use of the utility requisite, which is considered to be the third requirement of patentability in US law. Utility is often seen as the US version of the industrial application requirement, common in the rest of the world. Utility is defined in the America Invents Act:

 “35 U.S.C. 101 Inventions patentable

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

US caselaw has traditionally identified immorality with lack of utility and several patents were revoked on these grounds in the past. That happened in 1817 in the “Lowell v Lewis” case in which the validity of a patent on a pumping system was judged:

 “The Word “useful”, therefore, is incorporated into the act in contradistinction to mischievous or immoral. For instance, a new invention to poison people, or to promote debauchery, or to facilitate private assassinations, is not a patentable invention.”

The USPTO (US Patent and Trademark Office) does not usually examine whether an invention is useful or not, neither do the US courts, although it was different in the past when some inventions like the following ones were excluded from patentability due to lack of utility:

• Gambling devices.
• Devices for deceiving the user.
• Drugs that are not safe enough.

Such inventions are no longer excluded from patentability in the USA. As far as gambling devices are concerned, one of the first court decisions allowing their patentability stated that those devices are as immoral as firearms, which are patentable. Regarding the devices for deceiving the user, their patentability was allowed because there were already government agencies protecting consumers from fraud and in the case of drugs safety that is one of the tasks of the FDA.

Morality is closely linked to religion and, therefore, in those countries that are not secular, it is possible to find an exclusion from patentability for being contrary to religion. Countries such as Saudi Arabia or Iran prohibit the granting of patents to inventions whose exploitation is against the Sharia or Muslim law.

Even in secular countries, the predominant religion throughout history has a strong influence on today’s morality. For instance, if patent laws in European countries exclude the use of human embryos for industrial and commercial purposes from patentability is undoubtedly linked to the influence of the Christian religion.

Another type of inventions that were formerly excluded from patentability as contrary to morality or public order in the Western world are those relating to sexuality and contraception. Currently, Patent Offices, at least in the Western world, receive and grant thousands of patent applications on sex toys and contraceptive devices and compositions. Likewise, one might wonder if inventions on human cloning or the use of human embryos with industrial purposes, today considered as contrary to morality, will be patentable in the future.

In 2009, a surprising case involving morality and patents appeared in the professional media. An India Patent Court, the IPAB, stated that the patent on a cancer drug, marketed by Novartis as Gleevec (Imatinib as International Nonproprietary Name) should be revoked because its high price prevented most patients from accessing it. According to the IPAB, this could trigger social unrest. Nevertheless, the Indian Supreme Court, while upholding the revocation of the patent, did not consider this ground when assessing the validity of the patent.

Under European patent law it is possible to distinguish two situations from the point of view of morality or public order: inventions where there is no need to look into possible uses in order to exclude them from patentability, such as anti-personnel mines and inventions where some uses are patentable and others are excluded from patentability for being contrary to morality or public order. Any reference to the use of the invention for a purpose considered contrary to morality or public order must be deleted in order for the patent to be granted. Several examples are included in the “examination guidelines of the European Patent Office”:

• Process for breaking open locked safes, where use by a burglar is offensive and use by a locksmith in an emergency non-offensive.
• A copying machine with features resulting in an improved precision of reproduction. It could be used for the reproduction of security strips in banknotes strikingly similar to those in genuine banknotes.

Another type of inventions explicitly excluded from patentability for being contrary to morality or public order in numerous patent laws is that of procedures for modifying the genetic identity of animals that cause them suffering without substantial medical or veterinary benefit to man or animals, and animals resulting from such procedures. This exclusion from patentability is highly controversial due to the difficulty of determining whether the suffering of animals is of substantial medical o veterinary benefit. A famous case was that of the “oncomouse” and the European Patent EP0169672 filed on 29 January 1986.

The European Patent Office Examination Division initially denied the patent because it was a patent on an animal, which is not patentable under the European Patent Convention. However, the boards of appeal of the European Patent office considered that it is “animal varieties” that are excluded from patentability and not inventions that can be applied to all animals as such, like the introduction of a gene. Once the patent on the oncomouse was granted, 17 oppositions were filed against the patent, but the patent was upheld though amended. The Board of appeals of the European Patent Office in its decision T0019/90 developed a test that made it possible to determine whether the benefit of an invention outweighed the suffering caused. The purpose was to compare the utility of the “oncomouse” in cancer research with the suffering caused. Environmental risks and social unrest can be also be taken into account in the test. In this case, the conclusion was that the benefit the invention provided for cancer research outweighed the suffering caused to the animal.

Last year, a new decision T1553/15 by one of the technical boards of appeal of the European Patent Office involving the issue of animal suffering was released. The invention referred to a pharmaceutical composition obtained from nucleic acids and amino acids that were in the skin of rabbits injected with a virus. Since  the preparation of 50ml of the pharmaceutical solution required the killing of 6-12 rabbits, a commercial exploitation of the invention would have entailed the slaughter of a staggering number of rabbits. Moreover, the analgesic effects of the drug could already be obtained by using other compounds. Therefore, the Board of appeals decided that the alleged benefits of the drug did not justify the suffering caused to the animals and thus the patent had been duly denied for being contrary to public order or morality (Art.53 – European Patent Convention).

Exclusion from patentability on the grounds of being contrary to morality or public order has recently been involved in a court case in France regarding the patent FR3002724.  The invention protected by the patent is a drug inhalation kit and the main advantage claimed was the reduction in the transmission of blood-borne diseases. In the reply to the infringement suit, the defendant argued that the patent should be revoked for being contrary to morality or public order. It was alleged that a patent on the same type of device but for inhaling opium had been denied in 1913 on the same ground. Nevertheless, this allegation was rejected by the Court because the patented kit was a tool for public health prevention, a concept unknown in 1913.

Conclusion

Albeit these two issues might seem far apart, there is a close relationship between morality and patents. What is contrary to morality or public order is continually evolving and inventions that in the past were excluded from patentability on these grounds can be now patented. For those who are fond of predicting the future, trying to foresee which inventions now excluded from patentability on these grounds will be patentable in the future is certainly an attractive challenge.

Leopoldo Belda Soriano

Proofread by Ben Rodway