The court found that since a patent confers exclusive rights on the holder, particular care should be taken for patent rights over pharmaceuticals which are basic necessities for people. Patents enable pharmaceutical manufacturers to charge prices above marginal costs and the exercise of patent rights by the owner may lead to higher prices and restricted supply of essential products.
The court noted that the WTO Doha Ministerial Declaration on TRIPS and Public Health adopted on 14 November 2001 expresses concern of Members over ?the gravity of the public health problems afflicting many developing and least-developed countries?, and specifically recognises concerns about the effects of patents on pharmaceutical prices.

The court reaffirmed the conditions under which Thai patent law should apply to protect the right of the public regarding access to medicines, and ruled that "interested persons" should not be confined to manufacturers or competitors that are excluded from using the patented invention. In the case of pharmaceuticals, those who are in need of the patented medicines must also be regarded as interested persons allowed to request the revocation of a patent on the grounds set out below.

b) Grounds for invalidation

The validity of a patent may be challenged at any time after grant by raising a nullity action before the CIPITC based on the following grounds:

(i) the invention under the patent was not patentable (Secs. 5 and 9), or
(ii) the patent was granted to a person not entitled to apply for a patent, Secs. 10, 11, 14.
Limiting the grounds of invalidity to these two circumstances is clearly a defect in the Thai patent law. In particular, the law does not mention:

- insufficient disclosure (different from, e.g., Arts. 100 b), 83 EPC);
- subsequent amendments broadening the scope of the original filing (different from, e.g., Arts. 100c), 123 (2) EPC);
- fraud or misrepresentation in obtaining the patent²⁰.
In the first ddI lawsuit, the plaintiffs nonetheless challenged the validity of the patent on the grounds that a subsequent amendment had broadened the original claim. The court was willing to hear this ground that was argued in two steps.

First, whether or not such amendment should have been allowed by the DPI. As a general rule, amendments should be allowable when made within time limit and without extending the ambit of the right. As mentioned above, amendments after publication required approval by the Director-General of DIP under Clause 16 of the Ministerial Regulation, and such approval was
obtained.

Second, while the Director-General can authorise amendments after publication, he has no authority to approve amendments extending the scope of the invention. It was disputed whether BMS's request for removing the dosage range of 5-100 mg amounted to an extension of scope. BMS asserted that the deletion of subject-matter did not add anything to the essential features of the invention. The court disagreed, since the amendment would allow BMS to prohibit anyone from producing ddI tablets of any dosage range, rather than only between 5-100 mg.

c) Remedies

The plaintiffs in the first case did not petition for the revocation of the ddI patent, but for reverting the application to its unamended form. While the court acknowledged that the Patent Act B.E. 2522 contained no special provisions for correcting the claims, it ruled that there was no reason to bar the court from ordering such correction, the more so since the alternative, the revocation of the patent, was less favourable to the patentee. The ruling has established a new precedent that when the court finds a patent invalid, the court may allow the claims to be amended instead of revoking the patent.

d) Evaluation

This ruling was a landmark judgment in that it took cognisance of the Doha Declaration and showed that the Declaration, while perhaps not legally binding carries weight in the interpretation of the law.²¹ The judgment was also significant in that it has manifestly increased the awareness that access to treatment is a human rights issue. The suit against BMS and the court verdict were not least the result of a public display of strength and solidarity. The ruling also sets a precedent in Thailand about the legal rights of civil society to challenge the validity of patents. It could equally provide the basis for challenging patents on essential drugs in other countries and strengthen the ability of civil society to gain access to treatment for those infected with HIV/AIDS.

V. Appraisal of the ddl Cases - Patents and Innovation in Developing Countries

The effectiveness of the patent system primarily depends on the quality of the technical examination. While the number of patent applications in developing countries is increasing, it is worrying that the limited resources of developing countries' do not permit an efficient patent examination and thus a promotion of inventive activities among local inventors. The patent office?s laxity in issuing patents often results in invalid patents being granted. In developed countries, it is not uncommon to find a number of invalid patents being issued each year.²² In view of the weaker patent examination system, it is thus logical to assume that the number of invalid patents granted in the developing countries like Thailand is even hi gher.²³

No doubt, the costs resulted from the improper granting of patents are high²⁴, especially when life-saving drugs are concerned. It is perhaps fair to say that the lack of governmental competence is the biggest obstacle for Thailand to maximise the benefits of her intellectual property system and to minimise the costs to consumers and local manufacturers. Thailand may wish to increase the capability of the patent office, including subsidising the patent application and examination, and increasing the salaries of examiners. Proceedings for the invalidation or amendment of patents before the patent office should be introduced. A straightforward administrative procedure is necessary because it would allow the patentee?s competitors to challenge the validity of the patent at relatively low cost prior to an infringement action. The system would also reduce the excessive burden on the courts and contribute to speedy proceedings of patent invalidation. In addition thereto, a developing country like Thailand may incorporate a disgorgement remedy into its national patent law which would require the patent holder to return excess profits earned from an invalid patent.

VI. Conclusion

The development of new anti-retroviral drugs has made HIV/AIDS a manageable disease. But those life-saving medicines are beyond the reach of most patients in Thailand due to their high cost. The problem of inaccessibility can be exacerbated by the patent office?s inability to accurately examine patent applications, thereby granting patents that should not have been granted at all, or should have been granted in a more restricted form only. The social costs of improvidently granted patents are substantial, the more so in the case of life-saving medicines like ddI. It is necessary that less complex invalidation proceedings are introduced in order to overcome the inadequacies of patent examination practice. Attempts should also be made to simplify the procedure for obtaining a compulsory license in order to make essential drugs available for all, as is prevised by the Doha Declaration.

Footnotes

20. Which has been developed in the US based on common law since the case Hazel-Atlas Glass Co. v. Hartford Empire Co., 322 U.S. 238 (1944) and may particularly translate into a duty to prosecute patent applications before the patent office in good faith, candour and honesty: Molins plc v. Textron Inc, 48 F.3rd 1172, 1178.
21. The Doha Declaration is a Ministerial Declaration within the WTO that generates no legally binding force for governments or courts in the Member States. See A.O. SYKES, ?TRIPS, Pharmaceuticals, Developing Countries, and the Doha Resolution?, 2002 Chicago Journal of International Law 1.
22. R.M. SHERWOOD ET AL., ?Promotion of Inventiveness in Developing Countries through a More Advanced Patent Administration?, 39 IDEA 473 (1999).
23. See for example L. TANASUGARN, ?When Patent Rights may not be Enforceable: The Case of the Kwao Krua Patent? 105 (The Intellectual Property and International Trade Law Forum: Special Issue 1999, Bangkok 1999).
24. As is argued by J. FARRELL/R. MERGES, Incentives to challenge and defend patents: Why litigation won't reliably fix patent office errors and why administrative patent review might help, 19 Berkeley Technology Law Journal 943 [2004]. The authors argue that "Since litigation cannot fix all errors, we urge better USPTO funding and higher standards of initial review, better incentives (not limited to formal duties) for applicants to find and disclose prior art information, and the creation of a cheap and workable administrative ex-post review" (943). Also A. JAFFE & J. LERNER, Innovation and its Discontents, Princeton 2005, argue that the grant of invalid patents is one of the biggest obstacles to innovation.