The ethics of biotech patenting: a dialogue about monopolies, human dignity and the cost of medicines

Further to last week’s introductory Katpost on biotech, this post will discuss the impact of ethics on the ‘patentability’ of biotech inventions and the ‘enforcement’ of biotech patents. At the onset this Kat would like to say that he believes patents are necessary in our current free-market system to bring investment to research that needs to be funded, and does not see any real alternatives. This Kat also believes that a key question to ask when looking at any given ethical problem in biotech patenting is whether the solution requires a change to the patent system or lies elsewhere. It must be borne in mind that reducing patent rights is not the only mechanism available to deal with the issues discussed below.

Fundamental principles

Where do ethics come from?

The ethics of biotech patenting can be looked at using the concept of ‘human dignity’, the theory of the ‘commons’ and the effect of patent monopolies on the cost of medicines.
‘Human dignity’ is an accepted concept and is defined in Article 1 of the The Charter of Fundamental Rights of the European Union as inviolable. It requires recognition of the intrinsic value of human beings and that they are not to be commercialised. In practice this concept has only come into play when assessing the patentability of inventions relating to human embryos.

The theory of the commons is about what we all share and is used to help define the limits of what can be the subject of private ownership. Nature clearly belongs to everyone, though it is not straightforward to see how that should impact patent rights. It could also be argued that our genetic material, and in fact the genetic material of any naturally occurring organism, is part of the commons (see Katpost here about the Nagoya Protocol and ownership of genetic resources). Such considerations do not directly impact on patentability in Europe, but they do in the US as mentioned below.

Patent monopolies are part of the reason why medicines are increasingly expensive in the developed world and are unaffordable for many in the developing world. This raises the issue of the extent to which national patent laws should take into account public health matters.

It is not the purpose of this article to consider the general moral principles that apply to all patents, as only issues related to biotech will be discussed. However those principles consider the balance between giving a monopoly right and society as a whole deriving consequent benefits. Clearly the benefits derived from biotech patents need to be borne in mind when discussing ethical issues.

How ethics influences the patent rights that are granted

In Europe the patentability of biotech inventions on moral grounds is substantially determined by the EU Biotech Directive which was adopted in 1998. The Directive only lists four specific types of invention as being unpatentable on moral grounds:

(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

It also confirms that elements of the human body, such as genes, can be patentable when isolated from the human body.

The Directive basically settled a lot of the ethical debates about patentability of biotech inventions in Europe. Complicated issues such ‘human dignity’ and the ‘commons’ have not really had much impact since, probably to the relief of the biotech industry.

The patentability of human embryo stem cells was referred to the Court of Justice of the European Union (CJEU) in Brüstle (see Katposts here and here). The decision essentially took a strict view and held that inventions concerning embryo stem cells where unpatentable if an embryo had been destroyed at any stage, including prior to the steps referred to in the claim.

This Kat believes that in Europe the extent to which ethics influences ‘patentability’ has now been mostly defined. providing certainty for the biotech industry.

Do we need to redefine the commons for biotech?

Thickets are not always
a bad thing

The nature of biotech inventions means that often there are overlapping patent rights for any given technology. The ‘tragedy of the anticommons’ is a term that is used to describe this situation where it is believed that patent thickets inhibit biomedical research and prevent medical products reaching the marketplace. However it is unclear to this Kat to what extent this is a real problem for the biotech industry, and if it is, what the solution would be. It must also be remembered that there are research exemptions which provide some assistance to the problem of patent thickets (see Katpost here about the exemption for clinical trials).

Having said that, in the US it seems that the ‘commons’ for biotech has been substantially enlarged by the Mayo and Myriad decisions (see Katpost here). The US biotech industry has mostly reacted with dismay to this, and so they do not seem to perceive advantages in increasing the size of the commons.

Patents and the price of drugs

Medicines are becoming ever more expensive (see Katpost here on the economics of IP in the pharmaceutical industry). In the US the cost of the newly released drug Sovaldi has caused much debate on the issue. Sovaldi is used to treat hepatitis C and will cost $94,500 for a 12-week treatment. In the UK the National Institute for Health and Care Excellence (NICE) has been assessing the benefits of new drugs to determine whether they are worth the cost. That assessment can lead to negotiations with drug companies about prices. Generally the cost of drugs in the developed world has not led to calls to reform the patent system.

Being ill is never fun

However in the developing world the situation is more severe (see Katpost here about the ‘access to medicines’ debate). Patents lead to medicines being unaffordable for many people and so part of a major public health issue. This has led to calls for patent rights to be restricted in way that allows cheaper generic medicines to be made available as quickly as possible.

Should developing countries limit patent rights for medicines?

Presently the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires countries to provide patents rights for medicines. As noted in a Declaration by the Max Planck Institute, TRIPS does provide some flexibility in the scope of patent rights that are granted, but developing countries have not taken advantage of these to make it more difficult to obtain patent protection for medicines. Certain countries have limited the protection available for subsequent new uses of a known drug, such as India, countries in the Andean region and the members of the Gulf Cooperation Council.

Some countries have taken steps to stop ‘evergreening’. This is where subsequent to an initial patent filing on a drug further patent applications are filed to specific formulations of the drug. It has been argued this is a way to extend the monopoly on the drug beyond the term of the first patent. India has tackled this by making the patentability requirement higher for known drugs, requiring them to have an ‘enhancement of the known efficacy’.

Without taking sides, this Kat wonders whether the ‘access to medicines’ problem is best solved by cutting back on patent rights. In the developed world governments have instead chosen to negotiate prices with drug makers. This would seem a preferable solution for the developing world also, and would mean that the development of domestic biotech industries would not be hindered by weaker patent protection being available.