Globalization and Access to Drugs. Perspectives on the WTO/TRIPS Agreement - Health Economics and Drugs Series, No. 007 (Revised)
(1998; 97 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentAbbreviations and acronyms
View the documentExecutive summary
View the documentIntroduction
Open this folder and view contents1. Brief historical background to the international trading system
Close this folder2. Reading the TRIPS Agreement from the perspective of access to drugs
View the document2.1 General presentation of the Agreement
View the document2.2 Fundamental principles and objectives of the Agreement: the necessary balance between intellectual property and accessibility
View the document2.3 Patents for pharmaceutical products and processes available all over the world
View the document2.4 Non-patentable inventions: biotechnology inventions
Close this folder2.5 Effects of protection: a monopoly of working for 20 years
View the documentAttenuation of the monopoly through exhaustion of rights
View the documentStrengthening the monopoly through the patenting of processes
View the documentExtension of the duration of the monopoly
Open this folder and view contents2.6 Application of the TRIPS Agreement
Open this folder and view contents2.7 During the transitional period
Open this folder and view contents2.8 How can the monopoly be limited?
Open this folder and view contents3. Conclusions: issues at stake and constraints on access to drugs
View the documentDefinitions and terminology4
Open this folder and view contentsSelected bibliography5
View the documentOther documents in the DAP - Health Economics and Drugs Series
View the documentBack cover
Strengthening the monopoly through the patenting of processes

Compared to pre-existing conventions, the TRIPS Agreement strengthens the rights conferred by a process patent.

• In the first place, the Agreement imposes protection of the product obtained by the patented process as though there was also a patent for the product itself.

Article 28.1(b): “where the subject matter of a patent is a process, to prevent third parties not having the owner’s consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process (authors’ emphasis).

This extension of the protection of the manufacturing process to the resulting product increases the protection conferred upon the holders of know-how. The issue has been raised as to whether, in practice, the inventor of a new manufacturing process for a product already known and not protected by a patent could be granted exclusive rights to that product under the Agreement. This would only happen if the patented process used to manufacture the product was totally or partially unique and irreplaceable.

The fundamental question that then arises is whether or not it would be possible, based on this reasoning, to obtain an exclusive right to exploitation for a drug not covered by a patent, (for example, a drug included in the WHO Model List of Essential Drugs), through a new process for the manufacture of that drug. The answer would appear to be negative, since only the product directly obtained by the new process enjoys the protection attaching to the new process. This implies that a manufacturer using the old manufacturing process could not be accused of infringement of the process patent. However, the extension of process protection to a product may lead to an increase in lawsuits, which may be a deterrent to small local companies.

It is clear that developing countries will need to monitor the interpretation and application of this provision very closely.

• Secondly, Article 34 reverses the burden of proof in certain circumstances regarding process patents in infringement proceedings.

Article 34
Process patents: burden of proof


For the purposes of civil proceedings in respect of the infringement of the rights of the owner referred to in paragraph 1(b) of Article 28, if the subject matter of a patent is a process for obtaining a product,

If (civil) proceedings for infringement of a process patent are initiated,

the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process.

the judge may decide to reverse the burden of proof (which in principle falls upon the plaintiff) and require the person suspected of infringement to prove that an identical product has been obtained using a manufacturing process different from the patented process.

Therefore, Members shall provide, in at least one of the following circumstances, that any identical product when produced without the consent of the patent owner shall, in the absence of proof to the contrary, be deemed to have been obtained by the patented process:

This is not in fact a matter left to the judge’s discretion since Member States must make this reversal of the burden of proof a legal presumption, which the judge will be obliged to respect.

Country Members must then provide for the reversal of the burden of proof in one of the following cases or both:

(a) if the product obtained by the patented process is new;

1st case: only if the product made with the patented process is a new product. Therefore, Members may have to define the newness of such a product.

(b) if there is a substantial likelihood that the identical product was made by the process and the owner of the patent has been unable through reasonable efforts to determine the process actually used.

2nd case: whether or not the product (obtained by the patented process) is new, the defendant is required to prove that he has not used the patented process to obtain an identical product.

By virtue of Article 34, Member States must therefore provide for reversal of the burden of proof in their legislation. In other words, if the owner of a process patent suspects somebody of having used his patented process to obtain an identical product, it will be the person suspected of infringement who must prove his innocence. The Agreement calls upon Member States to provide for the application of this legal mechanism either when the product (obtained by the patented process) is new, or independently of the novelty of the product, in any case when the patent owner cannot determine that the patented process has not been used. It would seem that the first case, more restrictive since it only applies to new products, is the one best suited to the situation of developing countries.

Finally, the principal innovation of the TRIPS Agreement lies in the obligation imposed on all Member States to grant patents for drug manufacturing processes and for actual drugs. Since patents are a monopoly of the exploitation of an invention, the Agreement amounts to a limitation of supply and thus directly affects accessibility to products, including drugs.

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