By Seán Finan

Last week, a patent application in India was refused, apparently on the basis that the invention under review could have been used to counterfeit money. This practice of denying patents on the basis of public policy or morality is almost as old as the practice of granting patents. For example, the State of Monopolies was enacted in England in 1624 to prohibit monopolies where they would be “mischievous to the State”. In many other jurisdictions, patents on food and medicines were prohibited, on the basis that the public good served by these products outweighed any claims of monopoly rights by the inventor. The other approach is preferred in the US. Cases like Diamond v Chakrabarty removed much of the normative question from American patent law and it has been strongly argued that a patent application “is not an ethical event.”

Whether a patent can be refused on the basis of morality is a difficult enough question, but the problem is compounded once the “morality” in question is not confined to a single jurisdiction. The harmonization of patent law across Europe in the last fifty years has forced the European Patent Office (EPO) to consider how to make a moral judgement on behalf of all the contracting states to the European Patent Convention. Its approach has been neither consistent between cases nor consistent with the underlying treaties. I would like to give a quick sketch of the contrast between the European legal framework and its manifestation in the decisions of the EPO.

The Strasbourg Convention 1963

The Convention on the Unification of Certain Points of Substantive Law on Patents for Invention 1963 (the Strasbourg Convention) was the first major modern harmonization of European patent law and lived up to its name. It harmonized substantive patent requirements among EEC members, particularly the ubiquitous tripartite substantive test for patentability (industrial application, novelty and inventive step). It did not ignore the moral question. Article 2 provides that

[t]he Contracting States shall not be bound to provide for the grant of patents in respect of:

(a) inventions the publication or exploitation of which would be contrary to ordre public or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by a law or regulation

Where most of the final Strasbourg Convention is mandatory, Article 2 is not. States were free to choose to exclude or not to exclude certain inventions where domestic policy required. This permissive exception is quite contrary to the Strasbourg Convention’s goal of harmonization and suggests that the morality test was seen as a dispensable part of the patent examination. Furthermore, Armitage and Davies note that there was no morality provision in early drafts of the Strasbourg Convention. Mills suggests that the late addition of a margin of appreciation was not born of a sudden recognition of principle but of political necessity as states began to worry about ceding sovereignty over substantive patent law. On the whole, the parties to the Strasbourg Convention seemed to think that a morality test was not a key feature of patent law and any injection of morality into the field of invention was best left to the governments of individual states.

The European Patent Convention

The project of European patent harmonization continued with the establishment of the European Patent Convention (EPC) and the European Patent Office (EPO). Mills notes that during the drafting of the EPC, a Working Group on Patents was established and was tasked, among other things, with examining potential exceptions to patentability under the new regime. They agreed that there was no discernible “European morality” on which to base exceptions. It was enough “to mention the concept of morality… without giving further details”. They concluded that any definition of morality should be left to European institutions. The finished product was Article 53(a), which provides

European patents shall not be granted in respect of:

(a) inventions the commercial exploitation of which would be contrary to “ordre public” or morality; 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

There is a tension here. The first thing to note is the mandatory language. Even though Article 53(a) was expressly based on Article 2 of the Strasbourg Convention, the EPC does not afford any choice to its contracting parties. This might immediately indicate a general consensus on the importance of a moral element to the patent examination. However, the cursory nature of the Working Group’s discussion suggests exactly the opposite. It seems strange to first conclude that no European morality exists and then continue to create a moral hurdle for patent applications. It also seems strange to leave the definition of ordre public and morality to “European institutions”. The enacted EPC was not a creature of the European Economic Community: it was a multilateral treaty creating an autonomous legal system. It not immediately clear who these competent “European institutions” are or how they might go about defining and securing a moral consensus. The 1973 Guidelines for Examination failed to provide any more clarity. They suggest that the provision “is likely to be invoked only in rare and extreme cases”. So again, despite the mandatory nature of the provision, the importance of the morality test was downplayed to a “just in case” provision, likely to be invoked only as a last resort.

Whatever the intentions of the drafters, the provision has been invoked before the EPO a number of times since 1973. The decisions indicate that the EPO considers the question of morality to be more important than the underlying treaties would suggest.

Plant Genetics Systems

The Plant Genetics Systems decision (T 0356/93) is a clear example. Contrary to the approach of narrowly construing exclusions in the absence of official guidance or international consensus, the Board of Appeals of the EPO found that the question of morality was one that required careful examination. They held that morality was to be defined by “deeply rooted norms” and conventionally accepted standards of right and wrong in the “European society and civilisation”. They went on to hold that neither the existence of national regulation prohibiting an invention nor the existence of surveys or opinion polls indicating disapproval of an invention were enough to support an argument that an invention was contrary to ordre public or morality. They considered both potential indicators to be too transient and not representative of a true European morality. They found that it was up to the EPO to assess every invention on its merits. The invention was found to be acceptable under Article 53(a). The European public was left with the knowledge that an invention could be subject to strict moral scrutiny but little wiser as to when or why it might fail.

The Effect of the 1998 Biotech Directive: The Harvard Oncomouse

In 1998, EU Directive 98/44/EC created four categorical exclusions to patentability across EU member states, including processes for genetically modifying animals that is likely to cause them suffering [Article 6(d)]. The European Courts of Justice have shown a strong commitment to this mandated categorical approach in cases like Brustle.

The EPO seized the chance to implement a European morality as confirmed by a European institution. The revised EPC (2000) incorporated EU Directive’s exclusions word-for-word. However, the Harvard Oncomouse (T 315/03) decision saw the EPO eschew the categorical exclusion of a process for genetically modifying animals and instead opt for a “balancing test” which pitted the potential of the invention to benefit mankind against the suffering of the animal. Again, they brought the moral merits of an individual case within the purview of the patent office. Again, they did so without providing a basis on which the success or failure of patent applications might be predicted.

Conclusion

All of the foregoing raises serious concerns for inventors in Europe. It seems clear that the EPO will insist on undertaking a moral examination of inventions. However, its ad hoc balancing approach leaves it very difficult to predict how they will assess any particular invention (contrast the success of the Harvard Oncomouse to the failure of the Upjohn Mouse). It also raises broader questions. Should a patent be subject to moral examination? If so, how is the “common morality” of a group of countries to be assessed? Now is the time to answer these questions. Though Brexit may have torpedoed the current scheme of the European Unitary Patent, a revision may well be proposed. In the meantime, the rate of controversial inventions is only increasing, especially in the biotech sphere and the European system is looking increasingly ill-equipped to deal with it.