Arrow Pharmaceuticals Limited v Merck & Co Inc. [2004] FCA 138

FEDERAL COURT OF AUSTRALIA

Arrow Pharmaceuticals Limited v Merck & Co Inc. [2004] FCA 138

PATENTS – amendment of patent application the subject of present litigation by narrowing of the scope thereof – no opposition by challenger to validity of patent – amendment would reduce the number and scope of claims pursuant to the patent – application granted

Wimmera Industrial Minerals Pty Ltd v RGC Mineral Sands Ltd (No 3) (1997) AIPC 91-366 Smith Kline & French Laboratories Ltd v Evans Medical Ltd [1989] FSR 561 Rescare Ltd v Anaesthetic Supplies Pty Ltd (Federal Court of Australia, 4 March 1993, unreported) Eli Lilly and Company v Pfizer Research and Development Company NV/SA [2003] FCA 988

Patent Act 1900 (Cth)ss 102, 105 and 112 Federal Court Rules 1976 (Cth) Order 50 rule 10(1) ARROW PHARMACEUTICALS LIMITED v MERCK AND CO INC. N 1211 OF 2002

CONTI J 25 FEBRUARY 2004 SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY N 1211 OF 2002

BETWEEN: ARROW PHARMACEUTICALS LIMITED

APPLICANT

AND: MERCK & CO INC.

RESPONDENT

JUDGE: CONTI J

DATE OF ORDER: 24 FEBRUARY 2004

WHERE MADE: SYDNEY

THE COURT ORDERS THAT:

1. Australian Letters Patent No. 741818 be amended in the manner specified in Annexure B to the affidavit of John Richard Roy Simpson sworn and filed 12 November 2003.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY N 1211 OF 2002

BETWEEN: ARROW PHARMACEUTICALS LIMITED

APPLICANT

AND: MERCK & CO INC.

RESPONDENT

JUDGE: CONTI J

DATE: 25 FEBRUARY 2004

PLACE: SYDNEY

REASONS FOR JUDGMENT 1 By notice of motion filed on 12 November 2003, the respondent to these proceedings ('Merck') seeks amendment to Australian Letters Patent No. 741818 in the manner specified in Annexure B to the affidavit of John Richard Roy Simpson sworn and filed 12 November 2003. Such an application is required pursuant to s 112 of the Patent Act 1990 (Cth) ('Act'), which provides that while 'relevant proceedings' in relation to a patent are pending, any amendment(s) of a complete specification is prohibited, except by order of the court made pursuant to s 105 of the Act. 2 It should be recorded that the applicant to these proceedings ('Arrow') and the Commissioner of Patents ('Commissioner') did not appear and neither they, nor any other person, indicated any opposition to the amendments sought. 3 Merck has taken all the necessary statutory steps required to amend its Letters Patent. A notice of application to amend letters patent pursuant to section 105 of the Act ('Application'), and an advertisement pursuant to Order 58 rule 10(1) of the Federal Court Rules 1976 (Cth), were filed with the Commissioner on 14 August 2003, who promptly responded on 8 September 2003 to the effect that she was prima facie satisfied that the requirements of s 102 of the Act were met, and would therefore not appear in the proceedings before this Court. The advertisement of the Application was published in Vol 17, No. 38 of the Official Journal on 25 September 2003 and, on 10 November 2003, the Commissioner again wrote to the respondent, this time advising that no notice of opposition to the proposed amendments had been received. 4 According to the concisely framed written submissions of Ms Howard of counsel for Merck, the amendments sought 'essentially involve the deletion of certain claims and consequential amendments to the remaining claims and to the body of the specification', the aim of which being said to be to 'reduce the number and scope of some of the claims in an attempt to make these proceedings more manageable for both the parties and the Court'. So much was verified by the affidavit of Patent Attorney, Shahnaz Irani, sworn 19 February 2004. 5 Section 105(1) of the Act provides that the court may, by order, direct the amendment of the patent, the patent request or the complete specification in the manner specified in that order. However, by virtue of sub-s (4), such an amendment must not be directed if it is not allowable under s 102. 6 It is not necessary in the present case to undergo a detailed analysis of s 102 of the Act, so much having been undertaken by Sundberg J in Wimmera Industrial Minerals Pty Ltd v RGC Mineral Sands Ltd (No 3) (1997) AIPC 91-366. In reliance on that authority, counsel for Merck argued in her written submissions that the proposed amendments satisfy the requirements of s 102, in that: '(i) The specification as a result of the amendment does not claim any matter not in substance disclosed in the specification as filed; (ii) The claims of the specification as a result of the amendment fall within the scope of the claims of the specification before amendment; and (iii) The specification as a result of the amendment complies with subsections 40(2) and (3).' In arriving at this conclusion, drawn initially from the affidavit of Ms Irani, the following paragraphs of that affidavit are relevant, in that they form the basis for her final conclusion: