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d) Export of Products Produced Under a Compulsory Licence

TRIPS Article 31(f) stipulates that the use of a compulsory license must be made predominantly for the supply of the domestic market, and the products produced under a compulsory license may not be exported to another country. But the term ?predominantly? is tantamount to ?largely? or ?mainly? (i.e., more than 50%), and the export of drugs produced under the compulsory license is not completely prohibited. This interpretation has been confirmed by the Doha Declaration on TRIPS and Public Health, in particular the decision of the TRIPS Council of 30 August 2003 on the export of drugs to WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector.15 Currently, Thai patent law does not allow for the compulsory licensing for export purposes. Since the Thai pharmaceutical sector is well-known for its ability to produce cheap medicines, and many countries have seen Thailand as the source of generic versions of branded drugs, Thailand may wish to revise her law so as to allow the export of generic drugs to those countries that have granted a compulsory licence, but lack production facilities.

4. Appraisal of the Compulsory Licensing Scheme in Thailand

The procedure for granting a compulsory licence in Thailand seem rather complex and cumbersome. As of 2004, no application for a compulsory licence has been filed and no compulsory licence has been granted since the Patent Act B.E. 2522 entered into force. Both in the legal and economic context, the ddI patent would have made a compelling case for the grant of such licence, or at least for the DPI threatening to do so should the patentee not lower the prices of its products.16

IV. The Cases for having the ddI Patent Invalidated

After attempts to secure a compulsory licence failed, the AIDS Access Foundation, an NGO, and two Thai HIV patients went to court in order to have the patent amended or invalidated.

1. Lawsuit for an Amendment of the Claims
In May 2001, the above plaintiffs filed a lawsuit before the Thai Intellectual Property and International Trade Court (CIPITC)17 against BMS and DIP. The plaintiffs alleged that the patent was wrongly granted for the ddI formulation as such and sought invalidation or an amendment of the claims.

The plaintiffs asserted that the decision to allow an amendment of the application broadened the scope of BMS? patent beyond what was initially claimed. It was also alleged that for the above reasons, the DIP was not entitled to allow the amendment.

On 2 October 2002, the CIPITC confirmed the plaintiffs' position and held the amendments unlawful. The court ordered the DIP to revoke the invalid claims and restore the original limits to the formulation. The judgment thereby permitted third parties to produce generic versions of ddI tablets containing more than 100 mg of ddI per dose without infringing BMS' patent rights.

Both BMS and DIP appealed to the Supreme Court. In addition, the DIP requested the Supreme Court to defer the enforcement of the first instance ruling. The latter request was attacked by many domestic interest groups and academics on the grounds that it protected the interests of a company rather than public interest. If approved, the request would have allowed BMS to exclude third parties from producing ddI tablets in any dosage.

2. Lawsuit for Revocation of the Patent
On 9 October 2002, days after the first ruling, a second lawsuit was filed by the Foundation for Consumer Protection of Thailand and three HIV patients against BMS and the DIP. This time, the plaintiffs sought an outright revocation of the patent. The plaintiffs asserted that the grant of a patent over the ddI formulation was unlawful due to a lack of novelty. They also argued that the idea of adding buffer (antacid) to create an improved pharmaceutical formulation in order to reduce acid in stomach and facilitate the oral dosage was obvious to a person skilled in the art. Both novelty (Sec. 5 Thai Patent Act) and non-obviousness (Sec. 54) are requirements of patentability.

Prior to the oral hearing, BMS sought a settlement with the plaintiffs. After several rounds of negotiations, an amicable agreement was reached and signed by BMS, the Foundation for Consumers and the three HIV patients. The company agreed to surrender all its exclusive marketing rights under the ddI patent in Thailand and to withdraw its appeal in the first lawsuit, while the plaintiffs agreed to withdraw the second lawsuit.

3. Legal Issues involved
a) Standing to Sue

Patents can be challenged by, either, initiating (i) invalidation proceedings, or (ii) a counterclaim in an infringement suit. The Patent Act does not provide for opposition proceedings before the DIP.

Under Sec. 54 Thai Patent Act, a patent may be challenged by (i) any interested party, and (ii) the public prosecutor. In practice, the prosecutor will file a petition to the court only when there is a request from the DIP. This means that anyone who wants to challenge the validity of the patent has to bring the case to court at his own expense. And unlike the law of some countries (for example, the UK or Japan) that provides for the revocation of patent by any person,18 Thai law requires an "interested person" typically interpreted as someone who cannot use a product or process due to the existence of the patent in question.19 This certainly includes manufacturers or competitors, while here, the plaintiffs were not affected in their commercial activities by the
existence of the patent. Still, there was no doubt that the absence of generic versions of the ddI formulation was a serious handicap to AIDS patients.

Footnotes

15. WTO Ministerial Declaration on the TRIPS Agreement and Public Health, Paragraph 6. For a detailed analysis of the Doha Declaration, see: C. TUOSTO, The TRIPs Council Decision of August 30, 2003 on the Import of Pharmaceuticals under Compulsory Licences, [2004] E.I.P.R. 542;
16. When governments issue a compulsory license, the result is often a sharp decrease in prices, similar to the introduction of other competitive forces like generic drugs. The cases of the U.S., Canada and Brazil provide good examples of the successful application of this safeguard. See C. CHIEN, ?Cheap Drugs at What Price to Innovations: Does the Compulsory Licensing of Pharmaceuticals Hurt Innovation??, 18 Berkeley Technology Law Journal 853 (2003); N.A. BASS, ?Implications of the TRIPS Agreement for Developing Countries: Pharmaceutical Patent Laws in Brazil and South Africa in the 21st Century?, 34 George Washington International Law Review 191 (2002); U.K. Commission on Intellectual Property Rights (CIPR), Final Report, Integrating Intellectual Property Rights and Development Policy 42 (2002).
17. For details on the working of this court, see V. ARIYANUNTAKA, TRIPS and the specialised Intellectual Property Court in Thailand, 30 IIC 360 [1999].
18. See UK Patent Act 1977, Section 72; Japanese Patent Act Sec. 123(2).
19. Supreme Court Decision No. 7377/2538.
 
* This article is published with the kind permission of Jakkrit Kuanpoth, Senior Lecturer, Faculty of Law, University of Wollongong, Australia. This article originally appeared in Intellectual Property Quarterly, No.2, 2006, pp.149-159.
 

 

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