Patenting life

Our European patent system is self-financing, self-sufficient and almost self-legislating. It works on two, intertwined levels. It is complex, has its own courts, and perhaps, some may say, the very last thing we need is further legislative interest by a body that, until recently, has had little to do with patenting in Europe. Yet this is what the European Council and Parliament did when trying to legislate for patents and morality in 1998 via Directive 98/44/EC on the legal protection of biotechnological inventions—the Biotech Directive.

It says much, but principal amongst its objects is to somehow enforce morality; patents must not be immoral, so the Biotech Directive tells us. Oh yes, and you cannot actually patent the human body “at the various stages of its formation and development”. That, for most of us, is what it took eight pages of directive to tell us. Morality includes not being able to patent uses of human embryos for industrial or commercial purposes.

This human body objection is not really an objection at all. You never could patent a discovery, so it seems that patent law, in this respect at least, is being restated. It is the latter prohibition—patents shall not monopolise uses of human embryos—that causes more comment.

There is undoubtedly a case for saying that science should not do certain things. Two questions arise: what should science not do and who should decide? These questions are of supreme importance and a few observations may be made about them. The first is that where monopolies are conferred, it is generally a bad thing; though when thought about and talked about as part of some democratic process, it can be a good thing.

The second is that whatever science is or is not allowed to do, it is related, but only in part, to the question of what scientists are allowed to patent. It follows that scientists will not necessarily be put off from research simply because they cannot (or in some cases, will not) obtain patents at the end. This is not an uncommon situation. Third, questions of morality are not for lawyers, judges, politicians, churchmen or anybody else to decide.

When people speak of things being moral or immoral, they are really trying to tell you that your thinking is being done for you. Any sort of examination, even if by the most accidental philosopher, will reveal that morality is easy to define—it is concerned with the notion of what is right and wrong—and almost impossible to apply. Instead of morality, why don’t we have a set of predefined rules that everybody understands—the law?

The Biotech Directive, a piece of Eurolegislation, can be the subject of consideration of what used to be called the European Court of Justice (now called the Court of Justice of the European Union) that is what has happened recently.

Human embryonic stem cells are not new. They have been around for pretty much as long as humans have trod the earth. Stem cells are precursor cells. Specific cells start off as general or stem cells and then become adapted or fashioned by their host body with all of its chemistry into cells that perform specific functions. Embryonic stem cells are the same except that they come from embryos; human embryonic stem cells come from human embryos and are easy to harvest and turn into other cells (pluripotent is the word that ‘they’ use).

Human embryos are unborn humans or (so as to be as neutral as possible) are precursors to unborn humans—the distinction is unimportant.

There is not time or space here to debate when an embryo becomes a human being—the views are varied, many and complex. Human embryos have no voice; they cannot consent or refuse; they have to be looked after carefully—and generally we humans and our bodies (but mainly our bodies) do quite a good job at that.

However, it might be possible to make or grow things from stem cells that are truly ghastly or it might be necessary in the harvesting process to take something from an embryo that affects the future viability of that embryo. One can also envisage humans being specially bred so that such harvesting can take place. In the view of this author, this is distasteful to say the least.

Conversely, it might also be possible to make real and painless advances in disease treatment and cure, if such things were allowed. Some might call such things (which are potentially perfectly lawful, though licences may be required) immoral and some not. Scientists want to research this and want to reap any commercial reward available to them. They have one small problem—the laws of patents say that you cannot do this even when you are not trying to do so in the first place.

In Oliver Brüstle v Greenpeace eV, the Court of Justice was asked to decide whether Brüstle’s patent was bad because it amounted to an attempt to patent the use of a human embryo for industrial or commercial purposes. Brüstle’s patent was a patent concerning a means of using a human embryonic stem cell to create nerve cells that could then be used to treat nervetype disorders.

Greenpeace sought to have the patent or parts of it revoked. Advocate General Bot, having considered submissions, came to the view that where the process in question “necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos”, then any related patent would be invalid.

He seemed to find as fact that this is the case even though it does not appear to have been found, yet. The Court of Justice has yet to decide the matter. However the Advocate General’s reasoning was curious.

It was accepted that an embryonic stem cell originating from an embryo was no longer an embryo. It was also accepted that the patent was concerned with what to do with that embryonic stem cell, once removed. In other words, nothing was being patented concerning the actual use of the embryo, but only parts of it once removed.

However, the Advocate General then voiced his disgust by saying that where the patent entailed doing something that would, if any attempt had been made to patent it, be objectionable, then the result was objectionable even if there was no legal reason to stop the intermediate process from being done anyway. Indeed, a specific set of licensing rules exists to regulate (but not prohibit) such things.

This seems like an awful mess. It may indeed be immoral—and perhaps an objection might be tenable on such a ground—but the basis of objection was not to do with morals generally; it was to do with patenting the use of human embryonic cells. The result is, again, that the Biotech Directive means something other than its words suggest.

The Brüstle case has got the Biotech Directive off to a bad start. Legislation by extensive judicial colouring in, or even redrawing, does nothing but give our legislators a bad name and, importantly for patents and their backers, can scare away much-needed investment and encouragement.

Ashley Roughton is a barrister with Hogarth Chambers in London. He can be contacted at: barristers@hogarthchambers.com