Merck Sharp & Dohme Corp v Apotex Pty Ltd - [2012] FCA 928

FEDERAL COURT OF AUSTRALIA
Merck Sharp & Dohme Corp v Apotex Pty Ltd [2012] FCA 928

Citation: Merck Sharp & Dohme Corp v Apotex Pty Ltd [2012] FCA 928

Parties: MERCK SHARP & DOHME CORP and MERCK SHARP & DOHME (AUSTRALIA) PTY LTD ACN 000 173 508 v APOTEX PTY LTD ACN 096 916 148

File number: NSD 936 of 2012

Judge: JAGOT J

Date of judgment: 31 August 2012

Catchwords: INTELLECTUAL PROPERTY – patents – application for interlocutory orders restraining patent infringement pending final hearing

Cases cited: Australian Broadcasting Corporation v O'Neill (2006) 227 CLR 57; [2006] HCA 46
Cephalon, Inc v Orchid Europe Limited [2010] All ER (D) 229; [2010] EWHC 2945
Interpharma Pty Ltd v Commissioner of Patents (2008) 79 IPR 261; [2008] FCA 1498

Date of hearing: 24 August 2012

Place: Sydney

Division: GENERAL DIVISION

Category: Catchwords

Number of paragraphs: 33

Counsel for the Applicants: Ms K Howard SC and Mr M J Darke

Solicitor for the Applicants: Spruson & Ferguson Lawyers

Counsel for the Respondent: Mr B N Caine SC with Mr A J Maryniak and Ms P Arcus

Solicitor for the Respondent: Freehills

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

GENERAL DIVISION

NSD 936 of 2012

BETWEEN:
MERCK SHARP & DOHME CORP
First Applicant

MERCK SHARP & DOHME (AUSTRALIA) PTY LTD ACN 000 173 508
Second Applicant

AND:
APOTEX PTY LTD ACN 096 916 148
Respondent

JUDGE:

JAGOT J

DATE OF ORDER:

31 AUGUST 2012

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:
Upon the applicants by their Counsel undertaking to the Court:
(a)to submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by the operation of the interlocutory order specified in para 1 below or any continuation (with or without variation) thereof; and

(b)to pay the compensation referred to in (a) to the person there referred to,

1.Order that, until further order or the final determination of these proceedings, the respondent, whether by itself, its servants, agents or otherwise howsoever, be restrained from infringing Letters Patent No. 691880, including by supplying, offering to supply, selling or offering to sell:
(a)APO-MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;
(b)APOTEX-MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;
(c)CHEMMART MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;
(d)GENRX MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;
(e)TERRY WHITE CHEMISTS MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle.

Note:Settlement and entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

GENERAL DIVISION

NSD 936 of 2012

BETWEEN:
MERCK SHARP & DOHME CORP
First Applicant

MERCK SHARP & DOHME (AUSTRALIA) PTY LTD ACN 000 173 508
Second Applicant

AND:
APOTEX PTY LTD ACN 096 916 148
Respondent

JUDGE:

JAGOT J

DATE:

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.

Keep reading for free

Create a free CaseChat account to read Merck Sharp & Dohme Corp v Apotex Pty Ltd and more:

Read every judgment in full
Ask AI and get answers linked to paragraphs
See how each paragraph was cited in later cases
Download judgments as PDF or Word

Continue with Google

One click creates your free account or signs you in.

By continuing you agree to the Terms and Privacy Policy.

Details

Case: [2012] FCA 928
Decision Date

CaseChat Overview and Summary

Merck Sharp & Dohme Corp and Merck Sharp & Dohme (Australia) Pty Ltd have brought an action against Apotex Pty Ltd for the alleged infringement of patent No. 691880, which relates to the once-daily intra-nasal use of mometasone furoate (MF), a corticosteroid, to treat allergic rhinitis. Apotex denies that it is infringing the patent and argues that the patent is invalid on the ground of lack of inventive step. Merck has applied for interlocutory orders to restrain Apotex from infringing the patent pending the final hearing of the action. The court must determine whether Merck has established a serious question to be tried, that damages will not be an adequate remedy, and that the balance of convenience favours the granting of the interlocutory relief.

The court considered the evidence of the parties on the question of inventive step. Apotex argued that the patent lacked inventive step because it was obvious to try MF as an intra-nasal once-daily treatment of allergic rhinitis with the substantial absence of systemic levels of MF in the bloodstream. Merck argued that Apotex had not established a prima facie case of invalidity because there were real arguments to counter those of Apotex as to invalidity on the basis of common general knowledge in the art. The court found that although Apotex had a real case for invalidity, it was not of sufficient strength to deny the existence of a prima facie case of infringement on Merck's part. Merck has established a prima facie case of infringement.

The court also considered the balance of convenience. Merck argued that if Apotex was not restrained it was likely that Nasonex would become a significantly less profitable product for Merck with the consequence that marketing expenditure on Nasonex would have to be reduced including the termination of the experienced sales representatives presently employed to market Nasonex. Apotex argued that damages would be an adequate remedy for Merck but not an adequate remedy for Apotex. The court found that Merck had established that it will suffer harm for which damages will not be an adequate remedy and that the balance of convenience favours protecting the status quo pending the outcome of the hearing.

Accordingly, the court made the interlocutory orders which Merck seeks. The respondent, whether by itself, its servants, agents or otherwise howsoever, is restrained from infringing Letters Patent No. 691880, including by supplying, offering to supply, selling or offering to sell: (a)APO-MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;(b)APOTEX-MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;(c)CHEMMART MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;(d)GENRX MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle;(e)TERRY WHITE CHEMISTS MOMETASONE NASAL SPRAY mometasone furoate 50 microgram/actuation suspension bottle. The applicants must undertake to the Court to submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by the operation of the interlocutory order or any continuation (with or without variation) thereof, and to pay the compensation referred to in (a) to the person there referred to.

Orders