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Comments on genetic engineering

Excerpt from the address of the President of the EPO, Mr Ingo Kober, on 27 June at the annual press conference of the Office in Munich)

"Ladies and gentlemen,

No one is seeking to deny that the patenting of biotechnological inventions raises ethically sensitive questions. Contrary to media allegations, our patent examiners are keenly aware of the ethical problems attending such applications, and take these issues into account in their dealings with applicants. Their decisions are not irresponsible and certainly have nothing to do with criminal acts, as some media reports have suggested. Their sense of responsibility is documented by numerous examples which are available for public inspection at any time. The granting of patents is a public procedure which even allows third parties to state their views - an option which is exercised frequently and vigorously.

A much-bandied accusation is that the EPO grants patents on life without any legal basis for doing so. As well as being substantively false, this ignores the long tradition of patenting in Europe in this area. Long before the EPO came into being, these matters were the subject of a number of national patents and court decisions: in Germany, for example, there was the "Red Dove" decision of 1969. The EPC, like previous legislation, does not in principle exclude living matter from patentability. The case law of the boards of appeal has consistently endorsed the criteria governing Office practice in this field.

I have already pointed to the significance of the EU Directive as applicable patent law. Its implementation by the Administrative Council is an expression of the political will of the Organisation and the Office to respect the principles laid down by the European legislator and to incorporate them in European patent law.

The Directive, together with its list of exclusions, has now been incorporated into the Implementing Regulations to the European Patent Convention.

A further frequently encountered misconception is that the Office approves technologies by granting patents for them. Patents are not licences authorising the holder to manufacture or use the protected invention, nor do they confer permission to develop a particular technology.

A patent is a purely prohibitive right, serving only to prevent third parties from exploiting the invention. The patent system cannot decide whether a technology is permissible; the responsibility for considering and resolving such questions lies with quite different branches of the law. Nor do patent offices issue safety certificates. Dangerous or ethically questionable technology cannot be held in check with the help of patent law.

It has also been alleged that the mistakes admitted by the EPO are in fact a deliberate exercise in taboo-breaking. The talk of "taboos", in this connection, strikes me as particularly symptomatic, since the claim that the EPO has broken a taboo implies, conversely, that there are taboos which the EPO has to observe. This leads us into a realm of obscurity which in my view has nothing to do with patents. What the EPO has to observe is the law governing its activities. Only the law, if anything, could have been broken - but in the present situation, even this is a highly moot point. There can be few areas of the law in which so many legal obstacles and safety precautions have been built into the system, both internally and externally. I would draw your attention, first, to the legal importance of Article 53(a) EPC; second, to the EU Directive with its list of ethical prohibitions; and third, to the internal measures for dealing with patent applications which pose ethical problems. There is, for example, a staff notice, sent in 1998 to all examiners, calling attention to the specific items in the list of ethical prohibitions in the Directive. There is also an early warning system for ethically sensitive patent applications, and there are arrangements for quality monitoring which have recently been tightened up, including use of legal experts in the patent grant procedure.

The idea that the EPO has been deliberately breaking the law is also contradicted by the extensive system of checks via opposition and appeal proceedings after grant and revocation proceedings before national courts: in Germany, for example, before the Federal Patents Court at first instance, with the possibility of appeal to the Federal Court of Justice. Despite all claims to the contrary, European patents - and the activities of the European Patent Office - are subject to numerous independent controls and checks at both national and international level.

The consistently low opposition rate of around 6% for European patents and the very small proportion of European patents leading to national revocation proceedings - a mere 0.1% before the Federal Patents Court - offer clear evidence that the patents granted by the EPO, including those in problematic areas, are fully capable of withstanding judicial scrutiny.

Finally, I should like to comment on the suggestion that the EPO has a particular economic interest in genetic patenting. Looking at the table on page 21 of the Annual Report, you will see that biotechnology is one of the Office's top ten application areas, accounting for 3.2% of filings in 1999. Its importance for research and industry in the chemical and pharmaceutical fields is therefore undeniable. Yet its share of filings is almost three times lower than that of medical technology, and is also significantly below those of telecommunications, electronics and computing.

The claim that the EPO is lining its own pockets is rebutted even more effectively by the number of genetic engineering applications as a proportion of total filings since the Office opened. Genetic patenting accounts for just under 25 000 filings, compared with a total of well over 1m published applications - which hardly indicates that the EPO is making a massive profit from this area of technology.

The idea that the EPO is seeking to maximise its income is also untenable in view of the two fee reductions, with an annual volume of nearly DEM 250m, which the Office has made over the past four years. If we were really as greedy as some people think, we would surely have dispensed with the fee reductions and saved ourselves all the trouble with genetic patents.

To get patent protection for an invention, the applicant has to disclose what he knows. Thus the patent system complies with the requirement, on which ethical theorists continually and rightly insist, for transparency in dealing with technological innovation. Patent offices are not the originators of new technological developments - this is a fallacy which will get us nowhere. One of the essential tasks of the patent system, of which patent offices are only the executive arm, is to make known the state of the art, which in many cases would never be disclosed without a patent application. People should not imagine that certain technological developments are only prevented by the non-availability of a patent. That is a serious misapprehension. (...)"