Alphapharm Pty Ltd v H Lundbeck A/S - [2014] FCA 1185

FEDERAL COURT OF AUSTRALIA
Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185

Citation: Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185

Appeal from: Alphapharm Pty Ltd v H Lundbeck A/S [2014] APO 41

Parties: ALPHAPHARM PTY LIMITED, APOTEX PTY LTD, ASPEN PHARMA PTY LTD and SANDOZ PTY LTD v H LUNDBECK A/S

File number: NSD 706 of 2014

Judge: RARES J

Date of judgment: 6 November 2014

Catchwords:
PATENTS – whether pharmaceutical substance per se for purposes of s 70(2)(a) of the Patents Act 1990 (Cth) was isolated molecule as claimed in patent in suit or part of goods containing that molecule that had been previously included on Australian Register of Therapeutic Goods – whether earlier inclusion on Australian Register of Therapeutic Goods of pharmaceutical good before molecule isolated could form basis for extension of term of patent in suit under s 70

STATUTORY INTERPRETATION – PATENTS - where extension of term of patent in suit held invalid by Court in earlier proceedings and extension removed from Register of Patents – whether earlier invalid extension constituted a previous extension for purposes of s 70(4) of the Patents Act 1990 (Cth) – whether earlier extension no decision at all where affected by jurisdictional error – whether extension of term of patent can be granted after earlier invalid extension removed from Register

PATENTS – whether Commissioner erred in granting extension of term of patent under s 76(1) of the Patents Act 1990 (Cth) immediately after deciding the opposition and before appeal from that decision determined – where Court has plenary and express powers under ss 192 and 160 of the Act to correct Register of Patents

Legislation: Patents Act 1990 (Cth)
Patents Regulations 1991 (Cth)
Trade Marks Act 1995 (Cth)

Cases cited: Alphapharm Pty Ltd v H Lundbeck A/S (2006) 69 IPR 629 referred to
Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618 applied
Alphapharm Pty Ltd v H Lundbeck A/S (2011) 92 IPR 628 referred to
Alphapharm Pty Ltd v H Lundbeck A/S (No 2) (2008) 78 IPR 338 referred to
Alphapharm Pty Ltd v H Lundbeck A/S [2014] APO 41 referred to
Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42 referred to
Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCA 324 referred to
Aspen Pharma Pty Ltd v H Lundberg A/S (2013) 216 FCR 508 referred to
H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 applied
Minister for Immigration and Multicultural Affairs v Bhardwaj (2002) 209 CLR 597 applied
Owners of “Shin Kobe Maru” v Empire Shipping Co Inc (1994) 181 CLR 404 applied
Plaintiff S157/2002 v The Commonwealth (2013) 211 CLR 476 applied
Re Aspen Pharma Pty Ltd and Commissioner of Patents (2012) 132 ALD 648 referred to
Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd (2013) 216 FCR 344 applied
Woolworths Ltd v BP plc (2006) 150 FCR 134 distinguished

Date of hearing: 7 and 8 October 2014

Place: Sydney

Division: GENERAL DIVISION

Category:

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] FCA 1185
Decision Date: 6 November 2014

CaseChat Overview and Summary

In the matter of Alphapharm Pty Ltd versus H Lundbeck A/S, the Federal Court of Australia was tasked with resolving several issues pertaining to the interpretation and application of the Patents Act 1990. The primary dispute centred on the definition of a "pharmaceutical substance per se" as outlined in section 70(2)(a) of the Act. Specifically, the court needed to determine whether this term referred to an isolated molecule as claimed in the patent or to a part of goods containing that molecule that had already been included on the Australian Register of Therapeutic Goods. Another key issue was whether the prior inclusion of a pharmaceutical good on the Register before the isolation of the molecule could be used to extend the term of the patent in question under section 70.

The court also examined whether an earlier invalid extension of the patent term constituted a "previous extension" for the purposes of section 70(4) of the Act. Furthermore, it considered whether an extension that was affected by a jurisdictional error could be deemed not a decision at all, and whether a new extension could be granted after the removal of the earlier invalid extension from the Register. Additionally, the court assessed whether the Commissioner erred in granting an extension of the patent term immediately following the decision on an opposition and before the appeal from that decision was determined. The court recognised its plenary and express powers under sections 192 and 160 of the Act to correct the Register of Patents.

The court concluded that the Commissioner did not err in his decision-making process. It held that the earlier invalid extension did not constitute a previous extension for the purposes of section 70(4), and that an extension could be granted even after the removal of a previous invalid extension from the Register. Furthermore, the court found no error in the Commissioner's decision to grant the extension immediately after the opposition decision and before the appeal was determined. Consequently, the court dismissed the appeal and ordered the appellants to pay the respondent’s costs.

Orders

Orders of the court

1. The appeal be dismissed.

2. The appellants pay the respondent’s costs.

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

Background

Background to the litigation

Full text does not contain this section.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

For these reasons, I refuse to order any stay.Conclusion The appeal from the Commissioner must be dismissed with costs.

Ratio Decidendi

Legal Principle Established

Full text does not contain this section.

Citation:	Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185
Appeal from:	Alphapharm Pty Ltd v H Lundbeck A/S [2014] APO 41
Parties:	ALPHAPHARM PTY LIMITED, APOTEX PTY LTD, ASPEN PHARMA PTY LTD and SANDOZ PTY LTD v H LUNDBECK A/S
File number:	NSD 706 of 2014
Judge:	RARES J
Date of judgment:	6 November 2014
Catchwords:	PATENTS – whether pharmaceutical substance per se for purposes of s 70(2)(a) of the Patents Act 1990 (Cth) was isolated molecule as claimed in patent in suit or part of goods containing that molecule that had been previously included on Australian Register of Therapeutic Goods – whether earlier inclusion on Australian Register of Therapeutic Goods of pharmaceutical good before molecule isolated could form basis for extension of term of patent in suit under s 70 STATUTORY INTERPRETATION – PATENTS - where extension of term of patent in suit held invalid by Court in earlier proceedings and extension removed from Register of Patents – whether earlier invalid extension constituted a previous extension for purposes of s 70(4) of the Patents Act 1990 (Cth) – whether earlier extension no decision at all where affected by jurisdictional error – whether extension of term of patent can be granted after earlier invalid extension removed from Register PATENTS – whether Commissioner erred in granting extension of term of patent under s 76(1) of the Patents Act 1990 (Cth) immediately after deciding the opposition and before appeal from that decision determined – where Court has plenary and express powers under ss 192 and 160 of the Act to correct Register of Patents
Legislation:	Patents Act 1990 (Cth) Patents Regulations 1991 (Cth) Trade Marks Act 1995 (Cth)
Cases cited:	Alphapharm Pty Ltd v H Lundbeck A/S (2006) 69 IPR 629 referred to Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618 applied Alphapharm Pty Ltd v H Lundbeck A/S (2011) 92 IPR 628 referred to Alphapharm Pty Ltd v H Lundbeck A/S (No 2) (2008) 78 IPR 338 referred to Alphapharm Pty Ltd v H Lundbeck A/S [2014] APO 41 referred to Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42 referred to Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCA 324 referred to Aspen Pharma Pty Ltd v H Lundberg A/S (2013) 216 FCR 508 referred to H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 applied Minister for Immigration and Multicultural Affairs v Bhardwaj (2002) 209 CLR 597 applied Owners of “Shin Kobe Maru” v Empire Shipping Co Inc (1994) 181 CLR 404 applied Plaintiff S157/2002 v The Commonwealth (2013) 211 CLR 476 applied Re Aspen Pharma Pty Ltd and Commissioner of Patents (2012) 132 ALD 648 referred to Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd (2013) 216 FCR 344 applied Woolworths Ltd v BP plc (2006) 150 FCR 134 distinguished
Date of hearing:	7 and 8 October 2014
Place:	Sydney
Division:	GENERAL DIVISION
Category: