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N. v Organon

N. v Organon

Case [2009] APO 8 28 May 2009

Patent Law

Pharmaceutical Substances

Extension of Patent Term

Intellectual Property Law

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ABSTRACTS OF DECISIONS

DECISION OF A DEPUTY COMMISSIONER OF PATENTS

Application : Patent No. 726934 in the name of N. V. Organon.

Title:          Drug delivery system for two or more active substances
Action  :Request under s 70 of the Patents Act for an extension of term and objections of the Commissioner thereto
Decision:          Issued    28 May 2009

Abstract

The patent relates to a drug delivery system adapted to the slow release of particular steroidal mixtures such as for the purpose of contraception or hormone replacement therapy. A key aspect of the invention is that the steroidal mixture is contained in a thermoplastic polymer core over which is laid a permeable thermoplastic skin.

The patentee applied for an extension of term of the patent based on the inclusion of NUVARING^® on the Australian Register of Therapeutic Goods. If allowed and, subject to any opposition that might be filed, granted, the effect of the extension would be that the maximum term of the patent would expire on 27 June 2021 rather than 8 April 2018.

Considered whether the product NUVARING as claimed in the patent was a pharmaceutical substance within the meaning of the Act and more particularly whether it was a substance (including a mixture or compound of substances) for therapeutic use as provided in the definition given in Schedule 1.

Found that the definition of a pharmaceutical substance encompasses a compound with a controlled spatial configuration if, as a whole, it can still be considered a “pharmaceutical substance”, but the combination of such a substance with what would reasonably be considered a separate physical device, layer or structure is excluded. It may be difficult to determine whether a particular feature of a product is correctly considered part of a “substance” rather than a separate physical integer but in the present case the steroidal components are mixed with and necessarily diffuse through the thermoplastic materials in the core and skin regions and as such the product as a whole exhibits a level of integration or interaction between the component parts that was considered more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing.

Consequently the application to extend the term of the patent was allowed.

PATENTS ACT 1990

DECISION OF A DEPUTY COMMISSIONER OF PATENTS

Re:Patent No. 726934 in the name of N. V. Organon, a request under s 70 of the Patents Act for an extension of term and objections of the Commissioner thereto.

BACKGROUND

This matter concerns a request for an extension of the term of patent no. 726934 in the name of N. V. Organon (Organon). The patent relates to a "Drug delivery system for two or more active substances ". The date of the patent is 8 April 1998 and accordingly the maximum 20-year term will expire on 8 April 2018. An application for extension of the term of the patent was filed on 21 December 2006, and if an extension of the term of the…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

Continue reading N. v Organon

Details

AGLC: N. v Organon [2009] APO 8
Case: [2009] APO 8
Decision Date: 28 May 2009

CaseChat Overview and Summary

In the case of N. v Organon, the dispute centered around the extension of the term of a patent held by N. V. Organon for a drug delivery system. The patent, numbered 726934, was originally set to expire on 8 April 2018 but was eligible for an extension under Section 70 of the Patents Act if certain conditions were met, including the inclusion of the product NUVARING on the Australian Register of Therapeutic Goods. The key issue in the case was whether NUVARING qualified as a "pharmaceutical substance" under the definition provided in Schedule 1 of the Patents Act, specifically whether it could be considered a "substance (including a mixture or compound of substances)" for therapeutic use.

The Deputy Commissioner of Patents, P M Spann, reviewed the specifications of the patent and the nature of NUVARING, a vaginal drug delivery system containing a mixture of steroidal compounds in a thermoplastic polymer. The Commissioner's objection was that NUVARING was not a pharmaceutical substance, but rather a combination of a pharmaceutical substance with a physical device. The Commissioner's position was grounded in previous cases that distinguished between mixtures or compounds of substances and the inclusion of separate physical integers.

Deputy Commissioner Spann examined the legislative intent behind the term "pharmaceutical substance" and the purpose of the extension scheme, which was to reward the development of new and inventive substances for therapeutic use. The Deputy Commissioner concluded that while a compound with a controlled spatial configuration could still be considered a pharmaceutical substance, the combination of such a substance with a separate physical device, layer, or structure would not qualify. The Commissioner found that NUVARING exhibited a level of integration between its component parts that was characteristic of a pharmaceutical substance rather than a combination of a substance with a separate physical integer. Therefore, NUVARING qualified as a pharmaceutical substance under the Act.

As a result, the Deputy Commissioner allowed the application for an extension of the patent term, meaning that the patent would now expire on 27 June 2021. This decision was based on the conclusion that NUVARING met all the requirements of Sections 70 and 71 of the Patents Act, including its inclusion on the ARTG and its disclosure in the patent specification.

Orders