Federal Court of Australia
FEDERAL COURT OF AUSTRALIA
Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647
PATENTS – Application for extension of term of patent – Patent relating to pharmaceutical substance but no claim in respect of pharmaceutical substance itself – All claims included other elements – Whether extension of term may be granted. Patents Act 1990: ss 70, 78 BOEHRINGER INGELHEIM INTERNATIONAL GMBH v COMMISSIONER OF PATENTS V 86 of 2001 WILCOX, WHITLAM and GYLES JJ 6 JUNE 2001 SYDNEY (HEARD IN MELBOURNE)
IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY V 86 of 2001
ON APPEAL FROM A JUDGE OF THE FEDERAL COURT OF AUSTRALIA
BETWEEN: BOEHRINGER INGELHEIM INTERNATIONAL GMBH
APPELLANT
AND: THE COMMISSIONER OF PATENTS
RESPONDENT
JUDGE: WILCOX, WHITLAM and GYLES JJ
DATE OF ORDER: 6 JUNE 2001
WHERE MADE: SYDNEY (HEARD IN MELBOURNE)
THE COURT ORDERS THAT: 1. The appeal be dismissed. 2. The appellant, Boehringer Ingelheim International GmbH, pay the costs incurred in connection with the appeal by the respondent, Commissioner of Patents. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY V 86 of 2001
ON APPEAL FROM A JUDGE OF THE FEDERAL COURT OF AUSTRALIA
BETWEEN: BOEHRINGER INGELHEIM INTERNATIONAL GMBH
APPELLANT
AND: THE COMMISSIONER OF PATENTS
RESPONDENT
JUDGE: WILCOX, WHITLAM and GYLES JJ
DATE: 6 JUNE 2001
PLACE: SYDNEY (HEARD IN MELBOURNE)
REASONS FOR JUDGMENT
THE COURT: 1 This appeal from a Judge of the Court (Heerey J) raises a short point about the interpretation of s 70 of the Patents Act 1990, relating to extension of the term of a standard patent; in particular, the meaning of s 70(2)(a) of the Act. 2 Section 70 provides as follows: "(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) For the purposes of this section, the first regulatory approval date,in relation to a pharmaceutical substance, is: (a) if no pre-TGA marketing approval was given in relation to the substance – the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or (b) if pre-TGA marketing approval was given in relation to the substance – the date of the first approval. (6) For the purposes of this section, pre-TGA marketing approval, in relation to a pharmaceutical substance, is an approval (however described) by a Minister, or a Secretary to a Department, to: (a) market the substance, or a product containing the substance, in Australia; or (b) import into Australia, for general marketing, the substance of a product containing the substance."
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