Prejay Holdings Ltd v Commissioner of Patents

REASONS FOR JUDGMENT 1 The applicants seek an order under the Administrative Decisions (Judicial Review) Act 1977 (Cth) for review of a decision of Dr Gillian Jenkins, a delegate of the Commissioner of Patents, refusing to accept an application under s 70 of the Patents Act 1990 (Cth) (the Act) for an extension of the term of a standard patent, Australian Patent no 520834 (the Patent). 2 Relevantly for present purposes s 70 provides (emphasis added) : "70 Applications for extension of patent (1) The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied. (2) Either or both of the following conditions must be satisfied: (a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification; (b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
(3) Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances: (a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods; (b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years. (4) The term of the patent must not have been previously extended under this Division. (5) … (6) …" 3 The delegate found that all requirements were satisfied except for the one emphasised which is the second limb of s 70(2)(a). 4 The Patent was granted on 28 July 1989 and its twenty year term expires on 1 August 2004. 5 The Patent is for an invention comprising a method of treating menopausal or post-menopausal disorders in women by administering a combination of progestogen and estrogen hormones. The Patent has 24 claims, all of which are method claims. The claim with which the present proceeding is concerned is claim 14 which is as follows: "A method of hormonally treating menopausal or post-menopausal disorders in a womAn, comprising administering to said woman continuously and uninterruptedly both progestogen and estrogen in daily dosage units of progestogen equivalent to laevo-norgestrel dosages of from about 0.025mg to 0.05mg and of estrogen equivalent to estradiol dosages of about 0.5mg to 1.0mg." 6 "Pharmaceutical substance" is defined in sch 1 of the Act to mean "… a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves: (a) a chemical interaction, or physio-chemical interaction, with a human physiological system; or (b) action on an infectious agent, or on a toxin or other poison, in a human body; but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing." "Therapeutic use" is defined in sch 1 to mean "… use for the purpose: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or (b) influencing, inhibiting or modifying a physiological process n persons; or (c) testing the susceptibilityo if persons to a disease or ailment." Delegate's decision 7 The delegate identified as the relevant pharmaceutical substance the product marketed as PREMIA 2.5 CONTINUOUS (Premia) which is a combination of 2.5 mg medroxyprogesterone acetate and 0.625 mg oestrogen-conjugate. This product is listed on the Australian Register of Therapeutic Goods (ARTG) and is a tablet comprising a combined dosage of the two hormones. It was accepted by the delegate that this product is disclosed in the specification of the Patent. The delegate was further satisfied that Premia per se was in substance disclosed in the specification. Although the invention was directed to the use of Premia, the delegate accepted that there was disclosure in the specification of that pharmaceutical substance by itself. 8 However the delegate, applying my decision in Boehringer Ingelheim International GmbH v Commissioner of Patents [2000] FCA 1918, held that Premia in substance did not fall within the scope of the claim. The delegate considered that the effect of Boehringer was that s 70(2)(a) is only available to extend the term of a patent when there is at least one claim to a pharmaceutical substance by itself, and unqualified by process or method components. The intent of the legislation was only to provide an extension of term for a patent in certain circumstances and such an extension was not available in relation to method claims.