Merrel Dow Pharmaceuticals Inc. (Petition under part IX of Patents Act) - [1991] FCA 6

Re: MERRELL DOW PHARMACEUTICALS INC. (PETITION UNDER PART IX OF THE PATENTS
ACT
No. V G210 of 1988
FED No. 6
(1991) AIPC 90-779
20 IPR 347

COURT

IN THE FEDERAL COURT OF AUSTRALIA

VICTORIAN DISTRICT REGISTRY
GENERAL DIVISION
Jenkinson J.(1)

HEARING

MELBOURNE

#DATE 5:2:1991

Counsel for the Applicant: Dr J. McL. Emmerson QC and Mr C.A. Spence

Counsel for the Commissioner Mr R.M. Downing of Patents
of Patents:

Solicitors for the Applicant : Minter Ellison

Solicitor for the Commissioner Australian Government Solicitor
of Patents:

JUDGE1

Petition for extension, by way of grant of a new patent, of a standard patent, pursuant to s.90(1) of the Patents Act 1952 as in force before the commencement of the Patents Amendment Act 1989.

Australian Patent No. 467,361, which was sealed on 16 March 1976, was dated as of the date on which the complete specification was lodged, 11 December 1972, and expired on 11 December 1988. The petitioner's intention to take action in accordance with s.90(1) as in force before the commencement of the Patents Amendment Act 1989 having been advertised in the Official Journal published on 12 May 1988, and the petition having been filed in this Court on 14 June 1988, Part IX of the Patents Act 1952 as in force before that commencement applies to the proceeding instituted by the petition : Patents Amendment Act 1989, ss. 8(1), 10(1); Patents Regulations reg. 37.
The grantee named in the patent was Richardson-Merrell Inc., a corporation by the law of the State of Delaware. On 10 March 1981 the name of the corporation was changed by the law of that State to that of the applicant, according to a certificate of the Secretary of State for that State, in effectuation of what is described by a deponent expert in the laws of the United States of America as "a transaction referred to as a reverse subsidiary merger", being one of what is described by the same deponent as "a complex series of transactions .... as a result of which" the applicant was sworn to have become a wholly owned subsidiary of another United States corporation, The Dow Chemical Company. A certified copy of the entries in the Register of Patents in respect of the patent discloses an entry of "Merrell Dow Pharmaceuticals Inc." as the proprietor of the patent by "Assignment of the whole interest in these Letters Patent" to that corporation "by virtue of Merger Agreement effective as at 10 March 1981". If there be an unresolved question, raised by the evidence to which I have referred, as to whether the grantee of the patent remained the proprietor thereof throughout the term of the patent, it seems unnecessary that I resolve the question, having regard to the reasoning of Fullagar J. in Re Sanofi's Patent Extension Petition (1983) VR 25 at 27-30. (Cf. Sanofi v. Parke Davis Pty. Ltd. (1983) 152 CLR 1)
The claims of the complete specification comprehend inter alia claims for a chemical compound, for…

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.

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Details

AGLC: Merrel Dow Pharmaceuticals Inc. (Petition under part IX of Patents Act) [1991] FCA 6 ((1991) AIPC 90-779; 20 IPR 347)
Case: [1991] FCA 6
Decision Date: 05 FEBRUARY 1991

CaseChat Overview and Summary

Merrell Dow Pharmaceuticals Inc. sought an extension of its expired Australian patent for terfenadine, an antihistamine drug, under section 90 of the Patents Act 1952. The patent, originally granted in 1976, expired in 1988. The company argued that the drug's unique properties and the extensive time required for regulatory approvals and market entry justified an extension. The Commissioner of Patents opposed the petition, arguing that the company had not acted with sufficient diligence in obtaining market approval. The court had to determine whether the invention was of exceptional benefit to the public, whether exceptional inventive ingenuity was exercised, and whether the inadequate remuneration was due to the company's default.

The court found that terfenadine was of exceptional benefit to the public, as it provided an effective antihistamine without the sedative effects of other drugs, significantly improving patients' quality of life. The invention involved substantial inventive ingenuity, resolving a long-standing problem in the field through sophisticated reasoning and extensive testing. The inadequate remuneration was not due to any default by the company; the lengthy process of obtaining regulatory approvals and bringing the drug to market was inherent to the invention's characteristics. The court granted a 10-year extension, considering the exceptional benefit to the public and the inherent difficulties in bringing terfenadine to market.

Orders