Monday, 6 January 2014

10 Points On the Ethics and Morality of Patents in Europe

These points are gleaned from a talk by Julian Cockbain at the CIPA Life Sciences Conference on 14 November 2013.

1.  Why should morality be dealt with in the EPC as part of patentability?

Morality could instead have been dealt with during infringement. However by making it part of the EPC the aim was to give uniformity of approach across Europe.  Also a patent is in a sense approval of an invention by an official body, and so it is appropriate for morality to be relevant.

2.  The unique position of a Patent Office

Unlike general law-making a Patent Office is in the unique position of being able to look at ethics on a case by case basis, providing an opportunity to consider the ethics of individual new technologies.

3.  Key questions

- do immoral acts infringe Europe patents?  This is the slightly theoretical issue of how infringement relates to claim scope when looking at morality. Can an immoral act ever infringe a patent even though on the face of it it would be within the scope of the claims?

- how do we work out whether something is contrary to morality?

- can the chain of complicity be broken, and if so, how?  The chain of complicity concerns how the invention relates to an immoral act.  For example in the case of inventions concerning cells derived from human embryos, the act of destroying a human embryo might not be mentioned in the claims, but the claims may refer to cells whose production required destruction of an embryo.

4.  Who decides?

From the travaux preparatoires of the EPC it would seem that morality is interpreted by ‘European institutions’.

5. Case Law.  Complicity and the utilitarian approach.

In the CJEU decision Brustle v Greenpeace the chain of complicity was essentially held to be unbreakable, so that if a claim required use of a technology that relied on destruction of a human embryo at any previous stage the invention was held to be unpatentable.

In the EPO decision T19/90, Harvard Onco-mouse, morality was considered by weighing up the suffering of an animal versus the usefulness to mankind, i.e. a utilitarian approach based on maximising benefit.

6.  Deontological approach

In the embryo stem cell case at the EPO, T1374/04 & G2/06 Stem cells WARF, a different approach was used; a deontological one, where the concept of ‘human dignity’ was given priority over a utilitarian analysis.

7. Human Dignity

Human dignity is an accepted concept and is defined in The Charter of Fundamental Rights of the European Union as inviolable. This has four aspects:

- the intrinsic value of human beings and life,

- the non-instrumentalisation (i.e. non-commodification of human beings),

- the non-commercialisation of human beings,

- the foundation of the duty to respect human rights.

8. Complicity

Complicity concerns how parties which are neither totally innocent nor totally guilty relate to the immoral act.  The patent concept of ‘contributory infringement’ is an example of this.  Complicity occurs by:

- direct encouragement through agency, i.e. using someone else to achieve it, or

- benefitting from the immoral act.  This can provide powerful incentive for misconduct.  An example of this would be buying stolen cars, and the chain of benefit continues as the car is sold on.

9.  How the chain of complicity is broken

The development of some vaccines can be traced back to immoral acts, and yet many people would be of the opinion that information gained from previous acts should be used to provide present benefits.  Arguably therefore the chain of complicity can be broken by using information gained from an immoral act, but not when using something material, like a stolen car.

10.  Is the chain of complicity broken in the EPO WARF decision?

The EPO decided in the WARF case that inventions that used cells from libraries were patentable, even though such cells may have been obtained by immoral means, such as destruction of a human embryo.  Therefore it would seem that an invention concerning cells derived from human embryos could become patentable simply by the patent applicant depositing the cells in a library where they would be publically available before filing a patent application.  This does not seem consistent with the usual thinking on a chain of complicity.

You may also wish to see related articles Top 10 Controversial Issues in Biotech Patents and Top 10 Debateable Aspects of Biotech and Patent Topics in the UK.

No comments:

Post a Comment