Merck & Co Inc v Arrow Pharmaceuticals Ltd [2003] FCA 1344

Merck & Co Inc v Arrow Pharmaceuticals Ltd [2003] FCA 1344

The requirements of s 70(3)(a) are satisfied if a good (MEVACOR) included in the ARTG contains the claimed pharmaceutical substance (LHA), regardless of the quantity present. Therefore, the applicant is entitled to an extension of the patent term on this basis. It is unnecessary to decide whether the listing of the prodrug alone would suffice.

Parties
Applicant: Merck & Co Inc; Respondent: Arrow Pharmaceuticals Limited
Jurisdiction
Australia
Judgment Date
25 November 2003
Procedural Posture
Appeal / Judgment
Outcome
appeal allowed
Legal Topics
Extension of Patent Term, Pharmaceutical Patents, Interpretation of Patents Act S 70, Therapeutic Goods Register
Intellectual Property Patents Extension of Patent Term Pharmaceutical Patents Interpretation of Patents Act S 70 Therapeutic Goods Register

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Parties

Merck & Co Inc

Applicant

Arrow Pharmaceuticals Limited

Respondent

Procedural Posture

Appeal / Judgment

Legal Issues

  1. 1 Whether the applicant is entitled to an extension of the patent term for the metabolite on the basis that the prodrug is listed on the ARTG and its only known use is the production of the metabolite
  2. 2 Whether the presence of small quantities of the metabolite in a product listed on the ARTG entitles the applicant to a patent extension

Ratio Decidendi

The requirements of s 70(3)(a) are satisfied if a good (MEVACOR) included in the ARTG contains the claimed pharmaceutical substance (LHA), regardless of the quantity present. Therefore, the applicant is entitled to an extension of the patent term on this basis. It is unnecessary to decide whether the listing of the prodrug alone would suffice.

Court Disposition

appeal allowed

Orders

  • The appeal is allowed.
  • The decision of the delegate of the Commissioner of Patents to refuse the application for extension of the term of Australian Patent 535944 is set aside.