Drug Patents Under the Spotlight
(2003; 40 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. Four key concepts to understanding drug patents
Close this folder3. The patent system should respond to countries' public interest
View the document3.1. The subject matter of a patent must be new
View the document3.2. The subject matter of a patent must be inventive
View the document3.3. Patentability is a matter of national policy: example of new use inventions
View the document3.4. The invention should be clearly disclosed to benefit society as a whole
View the document3.5. An invalid patent may be revoked
View the document4. How to read and use the patent table
View the document5. Conclusions
View the document6. References
View the documentAnnex A - Patent Table
View the documentAnnex B - The anatomy of a patent
 

3.4. The invention should be clearly disclosed to benefit society as a whole

Tests that an invention has to pass before it can be registered as patentable are provided in TRIPS Article 27.1. However, they are not the only tests for a patent application to qualify for grant.

TRIPS Article 29, entitled "conditions on patent applicants", lists obligations for patent owners, including a mandatory requirement that an applicant for a patent "shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art". This means that the patent document must explain at least one way of putting the invention into effect, e.g. making a product or applying a process. If it turns out that the patent applicant has applied for a patent but has left out an essential piece of information so that reading the patent application will not be sufficient to make the invention work, the patent should not be valid. This is based on the patent bargain as explained earlier (see p. 5).

As discussed above regarding inventive step, it is crucial to define what is meant by a person skilled in the art[54]. Since patents are granted on a national or regional basis only, the information disclosed in the patent document must be clear and complete enough to a person (or people) in that country or region qualifying as skilled in the art to explain to them how to make the invention work. For sophisticated inventions such as many of those now encountered in the pharmaceutical field, it may be difficult to locate large numbers, or teams, of people who could be considered as skilled in the art, especially in least developed countries.

One of the justifications of the patent bargain is that the information in patent documents is published[55]. It is true to say that patent documents in Europe or the United States are published for all to see (i.e. anybody, not just European or United States citizens, can read them on the Web). If the relevant people in a developing country can read English (and/or e.g. French or German), that developing country may not gain any new information by publishing patent specifications themselves since they can read the American or European publication of what is essentially the same document. In this case, the patent bargain may not give the extra reward needed to justify granting monopoly rights. This may not be true where the patent document has to be translated into a different national language, e.g. Mandarin or Thai. However, in Africa, patent documents seem only to be published in English or French and not, for example, in Hausa or Swahili[56].

Even in countries where there is a strong concentration of scientific and technological know-how, a patent application, or a granted patent, is unlikely to provide all the necessary information for a manufacturer to begin production straight away, for instance in case a compulsory licence had been granted. The patent specification must explain how to make a new chemical entity, for instance, but the method of production may not be suitable for immediate scaling-up. Additionally, should a compulsory licence be granted, the patent holder is by no means obliged to help the compulsory licensee in any way with extra knowhow. Moving from patent specification to manufacture may still require considerable effort on the part of a generic manufacturer.

Concerns such as the above explain an optional requirement of TRIPS Article 29.1, i.e. the disclosure of the "best mode for carrying out the invention". Instead of just requiring an explanation as to at least one way of putting the invention into effect, which is the mandatory minimum requirement, WTO Members have the right to demand that applicants for patents in their country explain the best way known to them at the time of putting the invention into effect. Of course, it will be virtually impossible for a patent office to challenge what the patent applicant says, but having made the demand may prove to be important later on if the patent's validity is disputed. This is an added TRIPS safeguard intended to ensure that a country is getting the most benefit out of the patent system[57]. The UK CIPR report recommended that "developing countries should adopt the best mode provision to ensure that the patent applicant does not withhold information that would be useful to third parties"[58].

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: March 20, 2014