The High Court of Malaysia has delivered its judgment in Winthrop Pharmaceuticals (Malaysia) Sdn Bhd v Astrazeneca UK Limited, in which Spruson & Ferguson Asia Pte Ltd successfully assisted the Plaintiff’s counsel in an invalidation and non-infringement action against Malaysian Patent No. MY-136382 entitled “Use of Cholesterol-lowering Agent.” The Plaintiff is a subsidiary of the Sanofi Group of Companies.

The claims of the patent in question relate to a particular oral dosage form of Rosuvastatin, a cholesterol-lowering agent belonging to the drug class of statins, for treatment of hypercholesterolemia. The purported invention of the patent is not Rosuvastatin per se, which already existed before the priority date of the patent, but rather the selection of a single daily dose range of Rosuvastatin from 5 mg to 10 mg which is purported to be capable of beneficially altering lipid levels to a significantly greater extent than similar or currently used statins and have a similar or improved safety profile as other known statins.

The Court found the patent to be wholly invalid on all of the grounds submitted by the Plaintiff, namely:

  • the patent was not entitled to the claimed priority dates because there was no basis for the claimed dosage regime in the priority applications;
  • pre-grant amendments to the patent extended beyond the disclosure of the initial application;
  • the alleged invention in the patent was not novel;
  • the alleged invention in the patent was obvious and did not involve an inventive step;
  • the alleged invention did not involve any inventive idea or merit;
  • the alleged invention was not supported by the disclosure in the specification;
  • the specification of the patent did not disclose the alleged invention in a manner which was sufficiently clear and complete for the invention to be carried out by a person having ordinary skill in the art; and
  • the Defendant was not entitled to the alleged invention claimed in the patent.

The Court’s decision above is based on, and is consistent with judicial precedents established in the United Kingdom and in other common law jurisdictions such as Australia. Indeed, in Apotex Pty Ltd v Astra Zeneca AB (No. 4) [2013] FCA 162, the Federal Court of Australia had also found the Defendant’s corresponding patent in Australia (Australian Patent No. 769897) to be invalid on similar grounds. The prosecution history of the Defendant’s corresponding patents and patent applications in Europe, the U.S. and China, which also found the alleged invention to lack novelty and/or inventive step, were also taken into consideration, and found to be relevant and persuasive to the above invalidity findings. Accordingly, we are of the opinion that the Malaysian Court’s decision is a well-founded decision that is in line with those of other major patent jurisdictions.

In view of the invalidity findings, the Court dismissed the Defendant’s counter-claim of infringement and awarded the Plaintiff costs.