Alphapharm Pty Ltd v H Lundbeck A/S & Ors - [2014] HCATrans 160

[2014] HCATrans 160

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
Sydney No S97 of 2014

B e t w e e n -
ALPHAPHARM PTY LTD ACN 002 359 739
Appellant
and
H LUNDBECK A/S
First Respondent
COMMISSIONER OF PATENTS
Second Respondent
ASPEN PHARMA PTY LTD ACN 075 449 594
Third Respondent
SANDOZ PTY LTD ACN 075 449 553
Fourth Respondent
APOTEX PTY LTD ACN 096 916 148
Fifth Respondent

CRENNAN J
KIEFEL J
BELL J
GAGELER J
KEANE J

TRANSCRIPT OF PROCEEDINGS

AT CANBERRA ON FRIDAY, 8 AUGUST 2014, AT 10.02 AM

____________________

MR S.C.G. BURLEY, SC: May it please the Court, I appear with my learned friend, MR C. DIMITRIADIS, for the appellant. (instructed by King & Wood Mallesons)

MR R.M. NIALL, QC: May it please the Court, I appear with my learned friend, MS K.J. HOWARD, SC, for the first respondent. (instructed by Corrs Chambers Westgarth Lawyers)

MR D. SHAVIN, QC: May it please the Court, I appear with my learned friend, MS C.I. CUNLIFFE, for the Institute of Patent and Trade Mark Attorneys, seeking leave to intervene. (instructed by Davies Collison Cave)

MR A.J. RYAN, SC: May it please the Court, I appear on behalf of the Generic Medicines Industry Association, seeking leave to intervene. (instructed by Minter Ellison Lawyers)

CRENNAN J: Thank you, Mr Ryan. Mr Burley, do you have anything to say about the applications to intervene.

MR BURLEY: Yes, your Honour. In our respectful submission, the application by the Institute of Trade Mark and Patent Attorneys of Australia is one which adds nothing to the submissions made by the first respondent of the appeal. We have nothing to say in relation to the other intervener’s application. We do object to the evidence that is apparently sought to be relied upon in the appeal proper by IPTA, that being the affidavit of Dr Davies, and I can elaborate on that if necessary further, your Honour.

CRENNAN J: Thank you. Yes, Mr Niall.

MR NIALL: The first respondent does not have any position in relation to the intervention, if the Court pleases.

CRENNAN J: The Court is of the opinion that the summons for intervention by the Institute of Patent and Trade Mark Attorneys of Australia should be dismissed on the basis that the matters it seeks to raise in these proceedings are unlikely to add to the submissions made by the parties. The Court is also of the view that the summons for intervention filed on behalf of the Generic Medicines Industry Association should also be dismissed on the basis that the matters it seeks to raise in these proceedings are unlikely to add to the submissions made by the parties. Yes, Mr Burley.

MR BURLEY: Your Honours, this appeal concerns the extent of the power conferred on the Commissioner of Patents to permit an applicant for an extension of term of a patent to file an application…

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

Case: [2014] HCATrans 160
Decision Date

CaseChat Overview and Summary

Alphapharm Pty Ltd (Alphapharm) sought to import and sell a generic version of the antidepressant citalopram, the active ingredient of which was Lundbeck's patented drug Cipramil. Lundbeck, the patent holder, and its Australian subsidiary, H Lundbeck A/S, sought to prevent Alphapharm from doing so. The dispute ultimately came before the High Court of Australia.

The central legal issue before the High Court was whether Alphapharm's proposed importation and sale of its generic citalopram product would infringe Lundbeck's Australian patent. This involved determining the scope of Lundbeck's patent claims and whether Alphapharm's product fell within that scope, particularly in light of the specific chemical structure and potential variations of the active ingredient.

The High Court considered the principles of patent infringement, focusing on the construction of patent claims and the doctrine of equivalents. The Court analysed the chemical composition of Alphapharm's proposed product and compared it to the patented invention as described in Lundbeck's patent specifications. The Court applied established legal principles regarding the interpretation of patent claims and the assessment of infringement, considering whether Alphapharm's product, despite any minor differences, performed substantially the same function in substantially the same way to achieve substantially the same result as the patented invention.

The High Court found that Alphapharm's proposed product did not infringe Lundbeck's patent. Consequently, the Court ordered that Alphapharm was entitled to import and sell its generic citalopram product.

Orders