Disclosure of origin of 'genetic resouces'

The Convention on Biological Diversity (CBD) seeks to promote:

•  Conservation of biological diversity.
•  Sustainable use of its components.
•  Equitable sharing of the benefits from the use of genetic resources.

Patent laws should forward these objectives, which are worthy of full support. Accordingly some suggest that patent applications concerned with genetic resources should be obliged to show that such resources have been accessed with Prior Informed Consent (PIC): or at a minimum to disclose the origin of such resources. This, it is said, will enable supplying countries to check that users of such resources are respecting the CBD, and encourage benefit-sharing.

This proposal is totally misconceived. It is based on false assumptions. It is unclear, impractical and disproportionate. If implemented, it will hinder the objectives of the CBD rather than promoting them, and impose burdens on innovators while benefitting no-one.

1. CBD
The Convention on Biological Diversity (CBD) came into force in December 1993.  It has about 180 members - the great majority of countries in the world, though excluding the USA.  Its objectives are set out in Article 1 as:

• Conservation of biological diversity. 
• Sustainable use of its components.
• Equitable sharing of the benefits from the use of genetic resources.

It recognises the sovereignty of each member nation to exploit its own genetic resources (Article 3). Accordingly, each nation has the right to control access to those resources (Art 15.1) but is obliged to 'facilitate' such access (Art 15.2). Access is to be granted on mutually agreed terms (Art 15.4) but subject to PIC of the party providing it (Art 15.5). Benefits arising from use are to be equitably shared with the providing party. 

Article 15 applies only to the provision of resources for which the providing country is the 'country of origin', or has received in accordance with the CBD (Art 15.3). The 'country of origin' is the country which possesses those genetic resources in in-situ conditions (Art 2).
 
Article 16 deals with access to technology, which is to be facilitated, but taking account of IP rights. Art 16.5 requires members to ensure that IP rights are 'supportive of and do not run counter to' the CBD's objectives.

2.  Objectives
The objectives of the CBD are worthy of the fullest support*. Biological diversity should be conserved: both for practical and for moral and aesthetic reasons. The components of biological diversity have many valuable existing uses (feeding the world, for example), and there are many more to be discovered. Many important drugs have been extracted from plants, or synthesised from starting materials obtained from them. It is surely unarguable that the benefits from such uses should be fairly shared - though of course there may often be disagreement about what is fair. 

However, good objectives are not sufficient. The road to Hell is paved with good intentions. Effective legislation must take account of all relevant circumstances.

3.  IP Law
Again, it is entirely proper that IP laws should support and not frustrate the CBD's objectives. But it by no means follows that changes to IP laws are good (or even acceptable) ways of achieving those objectives. Existing IP laws provide a way of extracting returns from investments in new uses. In this way they have two effects: they encourage innovators to search for such new uses, and they enable innovators to extract a financial return from the new users. This return may then be shared, equitably, with those who have contributed resources. Regulations which make it more difficult to obtain patents discourage research on new uses. Changes are worthwhile only if the benefits will outweigh the costs. 

4.  The case alleged for 'disclosure of origin and PIC'.
This runs broadly as follows:

a) Genetic resources have many valuable uses. They are concentrated in countries of high biodiversity, which are typically poor and less developed.
b) Rich developed countries have access to genetic resources provided by poor countries, with widespread disregard of the provisions of the CBD on PIC and benefit-sharing.
c) In particular, many patent applications relating to genetic resources are filed by residents of developed countries. These lead to profits which are not shared with providers. In most cases, the providers are quite unaware of this, and hence are unable to claim what is rightfully theirs.
d) If patent applicants were obliged to state the country of origin of biological materials used in their inventions, and document PIC, providing countries could see that those materials had been accessed legally, and claim their fair share of the profits. 
e) This would reduce a significant injustice and promote development of poorer nations.

5.  Basic objection
There are several weaknesses in this case, but one fundamental problem. This is the hidden assumption in b): that all access to genetic resources either takes place in accordance with the provisions of the CBD, including PIC,  or is illegal. This is simply untrue. The fact is that nearly all access to genetic resources is both legal and outside the provisions of the CBD.

The parties to the CBD are sovereign states. The provisions of the CBD, to be effective, need to be written into national laws in specific form. A few countries have done this (Philippines, India, countries of the Andean Pact) but most have not. Where no legislation exists, access to genetic resources is legal. Whether there are laws or not, in most cases local inhabitants (and indeed visitors) will have access to a wide variety of local genetic resources without formality. One sovereign state may not have access to certain genetic resources of another, and to be given such access it will appropriately follow the CBD procedure. But this is a very specific case. Most people have access to genetic resources by virtue of being in the same country as the resources. No laws inhibit them from access, any more than they require a licence to breathe the air around them (with any micro-organisms floating in it) or eat breakfast. Where (as nearly always happens) access precedes any formal or specific consent, PIC is logically impossible. Such access may happen in or outside the country of origin. When materials are exported without conditions, they pass beyond the sovereignty and control of the exporting country. The CBD recognises national sovereignty, but does not extend it extra-territorially.

There is one situation where proof of PIC might reasonably be demanded. This is Bioprospecting. Where someone sets out to collect rare or unique genetic resources in a foreign country which has suitable legislation in place, the collector is properly obliged to obtain Prior Informed Consent, and to respect conditions imposed. Such conditions might reasonably include the obligation to document PIC and mention the country of origin in any patent application filed. But Bioprospecting accounts for only a very small proportion of inventions on biological resources - probably less than 1%. A very strong case is needed to impose even minor inconvenience on the other 99% - let alone (as in some proposals) requiring them to make a statement which  (if inadvertently wrong) may render their rights invalid.

6.  Which 'Origin'?
Proposals for disclosure vary. Most developing countries believe it important that PIC be demonstrated in filing patent applications, in spite of the difficulties discussed in 5. above. Several developed countries (e.g. Switzerland; Norway; the EU) accept the difficulties in requiring evidence of PIC, but still support the disclosure in patent specifications of 'country of origin'. They believe that this will meet the concerns of developing countries and forward the objectives of the CBD. Presumably they think this will discourage breaches of CBD Article 15, and bring to light any which may occur. Also, perhaps, it will provide 'countries of origin' with the opportunity to bring pressure to bear on patentees to compensate them even though the patentee has not breached article 15.

For patent applicants who may be obliged to make such disclosure, this still raises serious questions. First, what is meant by 'country of origin'? The CBD defines 'country of origin' as 'the country which possesses those genetic resources in in-situ conditions' (Art 2). Despite the definite article, this will rarely define a unique country - mostly, similar genetic resources will be found in more than one country. If there is more than one country of origin, must the applicant name all of them, or only the one in which his sample originated? He usually will not know all the facts: for example, he may not know where his sample originated; or he may know where he got it, but not whether the country where he got it possesses it in 'in-situ conditions' (which could in some cases be very difficult to establish). 

Given the difficulties with 'country of origin', alternative proposals require the applicant to disclose 'source'; or 'origin, source or legal provenance': or to disclose 'source' if 'origin' is unknown. An applicant may be expected to know the immediate source of material he has used (or to have a good explanation why not). In most cases, probably, this source would be local (in the applicant's home country): and it is not clear how such disclosure would forward the objectives of the CBD.

7.  Other difficulties
Most discussions assume that each patent application is concerned with a single genetic resource which is essential to the invention. In fact, many patent applications disclose dozens or  even hundreds of distinct genetic resources. Some of these may be essential to the invention; others useful for carrying it out; others of minor, accidental or trivial significance. Is the 'origin' or 'source' of each such resource to be given? What is the criterion for disclosure? Verifying each case could be extremely burdensome, and would be likely to lead to a reduced disclosure, of less value to the public.

8.  Principles
In general, public policies should be promoted directly rather than indirectly. If  it is acceptable to change patent law because in a few cases genetic resources are being misappropriated, why stop there? Should the law be changed to require applicants to declare that they are obeying tax laws - or employment laws - or laws against discrimination? No - innovators need encouragement, not new obstacles put in their way. They make our lives easier: and we in return should seek to make their lives simpler, not more complicated

9.  Inefficiency
The strongest reason for not requiring disclosure of origin in patent specifications is that it will not give the advantages sought. Filing a patent application is neither a necessary nor a sufficient condition for a successful commercial venture. Of inventions on which patents are filed, less than 5% ever reach the market: perhaps less than 2% make money. Conversely, patenting is not essential to a commercial venture: many traditional medicines, for example, are sold under trade marks, without any patent protection, and equally without any direct return to countries of origin. A requirement for disclosure will be ineffective in meeting its objectives and wasteful of the resources of inventors. It will discourage use of genetic resources rather than promoting them, in direct conflict with the objectives of the CBD.

For the foregoing reasons, it is strongly recommended that no further steps be taken to require patent applicants to disclose 'country of origin'.

*The adherence of so many countries to the CBD suggests a considerable international consensus about this, though not a complete one because of the absence of USA. But the USA does not (we may suppose) dissent from the objectives: rather it has concerns about the methods of achieving them.

CIPA
September 2005