The court affirmed the validity of Claims 7 and 8 of the 414 Patent under the Patents Act 1983, rejecting claims of insufficient disclosure and confirming infringement by the Plaintiff's products.

JUDGMENT

The dispute in this action revolves around Malaysian Patent MY-110414-A entitled "Angiotensin 11 Receptor Blocking Imidazoles and Combinations thereof with Diuretics and Nsaids ("the 414 Patent"). The 414 Patent has 29 claims. For the purpose of this suit, only two claims are in issue, that is, Claims 7 and 8. These two claims concern the substituted imidazole called losartan potassium in crystalline form. These chemical compounds have activity for treating hypertension and congestive heart failure.

RANBAXY (MALAYSIA) SDN BHD (the Plaintiff) is a company incorporated under the laws of Malaysia and is involved in the business of manufacturing and distributing pharmaceutical products in particular the manufacturing and distribution of pills commercially known as "COVANCE" containing the active pharmaceutical ingredient losartan potassium. The Plaintiff has obtained regulatory approval from the National Pharmaceutical Control Bureau (NPCB) for "COVANCE" tablet 25mg, 50mg, 100mg in Malaysia.

E.I. DU PONT DE NEMOURS AND COMPANY (the Defendant) is a company incorporated in the United States of America. The Defendant is the proprietor of the 414 Patent. The Defendant carries on business as, inter alia , a manufacturer, distributor and exporter of a wide range of chemical and other products.

The Plaintiff's case against the Defendant is that Claims 7 and 8 of the 414 Patent, are invalid and hence, is unenforceable against any third party. The Plaintiff is also seeking for a declaration that its COVANCE products with the active pharmaceutical ingredient losartan potassium, do not infringe Claims 7 and 8 of the 414 Patent.

The Defendant has counterclaimed that the Plaintiff has infringed Claim 7 of the 414 Patent wherein the Plaintiff's products COVANCE contain losartan potassium in crystalline form.

Before dealing with the issues which arise for decision, it is important to have an understanding of what the rival contentions of the parties are.

The Plaintiff's case

A summary of the Plaintiff's case is given here. The Plaintiff has given due consideration of the existence of the 414 Patent before the manufacturing of the Plaintiff's COVANCE products. The Plaintiff has obtained regulatory approval for the sale of the Plaintiff's COVANCE products and, therefore, the manufacturing and sale of the Plaintiff's COVANCE products do not constitute an infringement of the 414 Patent.

The following are the Particulars of Objection (see: Annexure 2 of the Statement of Claim) to the validity of the 414 Patent relied upon by the Plaintiff:

A. Insufficient Description

The said 414 Patent specification does not sufficiently and fairly describe Claims 7 and 8 of the 414 Patent and the method by which it is to be performed. Claims 7 and 8 of the 414 Patent are not supported by the 414 Patent specification as although the said 414 Patent specification discloses the preparation of substituted imidazoles with potassium salt in page 201, Part D, the method as disclosed in the 414 Patent specification does not teach the formation of substituted imidazoles in crystalline form. By following this method the person skilled in the art when repeating this method would not be able to obtain the crystalline form of the substituted imidazoles with potassium salt.

B. Non-compliance with the Patents Act 1983 and the Patents Regulation 1986 .

Claims 7 and 8 of the 414 Patent did not comply with s 23 of the Patents Act 1983 (the Act) . The said 414 Patent was granted based on modified substantive examination which requires the 414 Patent to conform to a corresponding patent granted in one of the prescribed countries or convention being (at the material time when the said 414 Patent was filed on 6.1.1981) Australia, The United Kingdom, The United States of America and the European Patent Convention, The corresponding patents in the prescribed countries or convention do not contain the equivalent of claims 7 and 8 of the said 414 Patent and thereby the said 414 Patent does no