Sanofi-Aventis & Ors v Apotex Pty Ltd - [2015] HCATrans 300

[2015] HCATrans 300

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
Sydney No S326 of 2014

B e t w e e n -
SANOFI‑AVENTIS
First Applicant
SANOFI‑AVENTIS US LLC
Second Applicant
BRISTOL‑MYERS SQUIBB INVESTCO LLC
Third Applicant
and
APOTEX PTY LTD ACN 096 916 148
Respondent
Application for special leave to appeal

KIEFEL J
GAGELER J

TRANSCRIPT OF PROCEEDINGS

FROM SYDNEY BY VIDEO LINK TO CANBERRA

ON FRIDAY, 13 NOVEMBER 2015, AT 10.27 AM

MR B.W. WALKER, SC: May it please the Court, I appear in Canberra with my learned friends, MR S.M. NIXON and MR S. FITZPATRICK, for the applicants. (instructed by Jones Day)

MR D.C. CATTERNS, QC: May it please the Court, I appear with MS J.M. BEAUMONT for the respondent. (instructed by Ashurst Australia)

MR J.T. GLEESON, SC, Solicitor‑General of the Commonwealth: May it please the Court, I appear with MS F.T. ROUGHLEY, seeking leave to intervene on behalf of the Commonwealth of Australia. (instructed by Corrs Chambers Westgarth Lawyers)

KIEFEL J: As I understand it, there is no objection to the Commonwealth having leave to intervene in this matter. Is that correct, Mr Walker?

MR WALKER: That is correct, your Honour.

KIEFEL J: Mr Catterns?

MR CATTERNS: No, your Honour.

KIEFEL J: Yes, there will be leave to intervene.

MR WALKER: May it please the Court.

KIEFEL J: Yes, Mr Walker.

MR WALKER: Thank you, your Honour. Your Honours, this is, on any view of it, we accept – we hope you see the recognition in our written submissions - a remarkable case. It is remarkable for obviously the circumstance that this is an application by us alternatively to reopen or to be heard a second time to obtain special leave to appeal.

It is also remarkable, in our submission, for the criticism that an enlarged Full Court in the Federal Court in the AstraZeneca decision, which has since been to this Court and back, expressed in relation to the Full Court decision from which we seek special leave to appeal. I will come briefly to elaborate that in a moment.

But, finally, it is particularly remarkable because, notwithstanding the very considerable lapse of time - indeed, as your Honours have seen, the patent has expired – notwithstanding that very considerable effluxion of time, these are proceedings which in every real sense are continuing and pending, and that which is impending is itself a remarkable application. When I say remarkable, I mean it quite literally. It is a tremendously large claim, at least so far as it is mooted on behalf of the Commonwealth, approaching apparently half a billion dollars by reason of the application of the usual undertaking as to damages.

Now, of course it is true it is in the nature of the usual undertaking given in the humblest equity suit that persons not parties to the litigation may later come in order to be vindicated so as…

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 Sanofi-Aventis & Ors 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: [2015] HCATrans 300
Decision Date

CaseChat Overview and Summary

Sanofi-Aventis and others (the applicants) sought to prevent Apotex Pty Ltd (the respondent) from infringing their Australian Patent No 2004203177, which claimed a pharmaceutical product. The applicants alleged that the respondent's proposed product, a generic version of their drug Plavix (clopidogrel bisulphate), would infringe the patent. The dispute concerned the validity of the patent, specifically whether it was obvious and whether it had sufficient utility. The matter came before the Full Federal Court of Australia.

The primary legal issues before the Full Federal Court were whether the patent was invalid for obviousness under section 60(1) of the *Patents Act 1990* (Cth) and whether it lacked sufficient utility under section 40(2)(b) of the *Patents Act 1990* (Cth). The applicants contended that the patent was valid and infringed, while the respondent argued for its invalidity on these grounds.

The Court considered the established principles of patent law regarding obviousness and utility. In relation to obviousness, the Court applied the "mosaic approach," assessing whether a person skilled in the art, with the benefit of the common general knowledge, would have arrived at the claimed invention without undue burden or an inventive step. The Court examined the prior art and the evidence presented to determine if the claimed invention was a predictable or obvious development. Regarding utility, the Court considered whether the patent disclosed a practical and useful application of the invention, ensuring that the patent was not granted for a mere theoretical concept. The Court analysed the evidence concerning the therapeutic use of clopidogrel bisulphate to assess whether the patent's asserted utility was substantiated.

The Full Federal Court found that the patent was invalid for obviousness and therefore dismissed the applicants' claim for infringement.

Orders