Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentFOREWORD
View the documentEXECUTIVE SUMMARY
View the documentINTRODUCTION
View the documentI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Open this folder and view contentsII. THE RATIONALE FOR DATA PROTECTION
Close this folderIII. CONDITIONS OF PROTECTION UNDER TRIPS
View the documentA. Protection of test data under the TRIPS Agreement
Close this folderB. The Article 39.3 conditions of protection
View the document1. Data necessary for marketing approval
View the document2. Protected data
View the document3. Undisclosed data
View the document4. New chemical entities
View the document5. Considerable effort (investment)
View the documentIV. NON-DISCLOSURE OBLIGATION
Open this folder and view contentsV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
View the documentVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
View the documentVII. THE EXCLUSIVITY APPROACH
View the documentVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
View the documentIX. CONCLUSIONS
View the documentANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
View the documentBIBLIOGRAPHY
View the documentBACK COVER
 

4. New chemical entities

Another important condition for the application of Article 39.3 is that the data must refer to a "new chemical entity". The Agreement does not define the term "new". While the term presumably does not impose a patent standard of novelty, Member countries may choose under the Agreement to apply such a standard.

It may be also held that the test for newness under Article 39.3 refers to the date of application for approval. Thus, a chemical entity may be deemed "new" if there were no prior application for approval of the same drug, or where the same drug was not previously known in commerce.

Article 39.3 does not clarify either whether newness should be absolute (universal) or relative (local), that is, whether "new" would mean the first application in the world or in the Member country where it was filed (Cook, 2000, p.6).

Occasionally, a product which is known and used in a certain field (e.g. chemical industry), may find a new application in the pharmaceutical sector. Such a new therapeutic product (generally known as "first indication") may be deemed not to constitute a "new chemical entity", since the chemical was already known. Alternatively, the newness may be assessed within a particular regulatory framework, and without regard to the fact that the same chemical may have been used in the context of another regulatory framework (Cook, 2000, p. 6).

All the above interpretations are equally permissible. The TRIPS Agreement deliberately avoids defining the concept of "new chemical entity". This is one of the clear areas in which Member countries enjoy room for manoeuvre to implement the Agreement's provisions.

Based on the ordinary meaning of the terms used, it may be also interpreted that there is no obligation to provide for protection when the test data were developed for a new use of a pharmaceutical product (generally called a "second indication"). In this case, it is the application or method of use of a known chemical entity that is new, but not the entity as such.

Similarly, Article 39.3 would not apply in cases where approval is sought for new indications, dosage forms, combinations, new forms of administration, crystalline forms, isomers, etc. of existing drugs, since there would be no novel chemical entity involved. The European Court of Justice indirectly addressed this issue in the "Squibb" case.11 The Court held that a (second) product is "essentially similar" to an earlier approved product if the second product has "the same qualitative and quantitative composition in terms of active principles", "the same pharmaceutical form" and is bio-equivalent to the first product, "unless it is apparent in the light of scientific knowledge that it differs significantly from the original product as regards safety or efficacy". In these cases, the original applicant does not receive new periods of so-called "marketing exclusivity" for each new indication, dosage form or dosage schedule (Jones and Nittenberg, 1998/1999, p. 152).

11 The ECJ decision was given in response to questions referred to it from the English High Court in relation to three cases. In all of them, the research-based pharmaceutical companies had made changes to certain aspects of their products and obtained marketing approval for each change. Subsequently, generic companies sought to rely not only on the original versions of the products but also on the products which had been approved more recently. The Medicines Control Agency acceded to certain of the generic companies requests, but not all of them (Jones and Nittenberg, 1998/1999, p. 152). See also Dodds-Smith, 2000, p. 112.

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