Alphapharm Pty Ltd v H Lundbeck A/S

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FEDERAL COURT OF AUSTRALIA

Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC 138

Citation: Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC 138
Appeal from: Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185
Parties: ALPHAPHARM PTY LTD, APOTEX PTY LTD, ASPEN PHARMA PTY LTD and SANDOZ PTY LTD v H LUNDBECK A/S
File number(s): NSD 1214 of 2014
Judge(s): BENNETT, NICHOLAS AND YATES JJ
Date of judgment: 22 September 2015
Catchwords: PATENTS – construction of claim – whether claim to a (+)-enantiomer includes a further integer or limitation of isolation or purity such that it is no longer to a pharmaceutical substance per se – whether extension of term of the Patent should be granted
Legislation: Patents Act 1990 (Cth) ss 70(2)(a), 70(3)
Cases cited: Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618
Alphapharm Pty Ltd v H Lundbeck A/S (2014) 108 IPR 459
Aspen Pharma Pty Ltd v H Lundbeck A/S (2013) 216 FCR 508
Boehringer Ingelheim International v Commissioner of Patents [2000] FCA 1918
Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 52 IPR 529
D’Arcy v Myriad Genetics Inc (2014) 313 ALR 627
Emory University v Biochem Pharma Inc [1999] APO 50
Genetics Institute Inc v Kirin-Amgen (1999) 92 FCR 106
H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151
Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1
Kuligowski v Metrobus (2004) 220 CLR 363
News Limited v South Sydney District Rugby League Football Club Limited (2003) 215 CLR 563
Ortho-McNeil Pharmaceutical Inc v Mylan Laboratories Inc 348 FSupp2d 713 (ND WVa 2003)
Pfizer Corporation v Commissioner of Patents (2006) 155 FCR 578
Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2006) 69 IPR 1
Port of Melbourne Authority v Anshun Pty Ltd (1981) 147 CLR 589
Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IPR 424
Ramsay v Pigram (1968) 118 CLR 271
Re Aspen Pharma Pty Ltd and Commissioner of Patents and Anor (2012) 132 ALD 648
Tomlinson v Ramsey Food Processing Pty Limited [2015] HCA 28
Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588
Date of hearing: 23 February 2015
Place: Sydney
Division: GENERAL DIVISION
Category: Catchwords
Number of paragraphs: 105
Counsel for the Appellants: Mr DK Catterns SC with Mr C Dimitriadis SC
Solicitor for the Appellants: King & Wood Mallesons
Counsel for the Respondent: Ms K Howard SC with Mr R Niall QC
Solicitor for the Respondent: Corrs Chambers Westgarth

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

GENERAL DIVISION

NSD 1214 of 2014
ON APPEAL FROM THE FEDERAL COURT OF AUSTRALIA
BETWEEN:

ALPHAPHARM PTY LTD
First Appellant

APOTEX PTY LTD
Second Appellant

ASPEN PHARMA PTY LTD
Third Appellant

SANDOZ PTY LTD
Fourth Appellant
AND:

H LUNDBECK A/S
Respondent

JUDGES:

BENNETT, NICHOLAS AND YATES JJ

DATE OF ORDER:

22 SEPTEMBER 2015

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:

1.The application for leave to appeal be granted.

2.The appeal…

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Details
Case
[2015] FCAFC 138
Decision Date

CaseChat Overview and Summary

Alphapharm Pty Ltd sought leave to appeal against the decision of Bennett J in the Federal Court of Australia, who dismissed their application for a review of a decision of the Commissioner of Patents. The Commissioner had granted H Lundbeck A/S an extension of the term of a patent, which Alphapharm opposed. The central issue was whether the patent claim to a (+)-enantiomer of citalopram included an implicit requirement for isolation or purity, thereby excluding it from the definition of a pharmaceutical substance as per section 70 of the Patents Act 1990. Alphapharm argued that such a limitation would render the claim ineligible for the patent term extension under the Act.

The court assessed the claim's construction and whether it included additional limitations beyond the pharmaceutical substance itself. Alphapharm contended that the claim should be interpreted as requiring the enantiomer to be isolated or pure, which they argued made it ineligible for the term extension. The court found that the claim, as construed in the prior decisions, did not inherently include such a limitation. The reasoning of the previous judges, including Bennett and Middleton JJ, was that the claim was to the substance per se without any additional requirement for isolation or purity.

The court dismissed Alphapharm's argument, holding that the claim was to the substance as required by section 70 of the Act and did not include a limitation of isolation or purity. The court noted that the prior decisions correctly interpreted the claim and that the evidence showed that the skilled person would not have recognised the enantiomers without experimentation. Therefore, the extension of the patent term was appropriately granted.

The court granted the application for leave to appeal but dismissed the appeal, ordering that Alphapharm pay the respondent’s costs of and incidental to the application for leave to appeal and the appeal.

Orders

Orders of the court

1. The application for leave to appeal be granted.

2. The appeal be dismissed.

3. The appellants pay the respondent’s costs of and incidental to the application for leave to appeal and the appeal.

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

Background

Background to the litigation

There is no dispute that it is a pharmaceutical substance within the definition in Schedule 1 to the Act.BACKGROUND TECHNOLOGY It is helpful to set out some relevant aspects of the background chemistry which are not in dispute:·(+)-citalopram is the (+)-enantiomer of citalopram;·(+)-citalopram is also known as (S)-citalopram or escitalopram;·Citalopram is a racemic mixture that contains equal amounts of the (+) and (–) enantiomers of citalopram;·Citalopram and escitalopram are different chemical entities with different physical properties and different pharmacological activities. The background chemistry has been described in some detail in the Decision and does not need to be repeated. However, Alphapharm adduced evidence before the Delegate from Dr Oppenheim. We refer to some of that evidence of particular relevance, concerning a “substance” and enantiomers:Substance36.Generally speaking, a compound – whether it is the API or an excipient – will be made up of particles of that compound which are themselves made up of individual molecules of the API or the excipient. From a chemical point of view, a compound can also be described as a substance. However, in some instances the word “Compound” when it is used in pharmaceutics can also denote a mixture of two substances, that is “a compound of substances” (in the sense that two substances may be taken and “compounded” together).37.A molecule is the smallest unit, or the simplest form, of a substance. A molecule consists of two or more atoms that are arranged in a particular way and held together by chemical bonds. For example, a molecule of water consists of one atom of oxygen and two atoms of hydrogen.…50.The structure of molecules is fundamental to chemistry. The atoms contained in a molecule and the way in which they are connected will determine the properties of that molecule. Stereochemistry is the study of how the atoms of a molecule are arranged spatially. In other words, it is the study of the three-dimensional structure of molecules.…Racemic mixtures65.A racemic mixture, or racemate, is a mixture that contains equal amounts of enantiomers. Assuming that the enantiomers have only one chiral centre, a racemic mixture will not rotate plane polarised light (as the rotation of one enantiomer in this mixture is offset by the rotation of the corresponding enantiomer).66.It is possible to have an “enantiomeric excess” of one enantiomer, in which some degree of optical rotation of that mixture will exist (i.e., when there is an excess of one particular enantiomer). In this situation you do not have a racemic mixture, nor do you have an “enantiopure” system (a substance that contains only one of the enantiomers).67.While enantiomers appear very similar, they are not identical compounds. They exist in a three-dimensional form and are extremely important in biological pathways and processes. Different enantiomers can have different effects and interactions. This is most clearly seen in some medicines in which one enantiomer may have a therapeutic effect and the other may not.68.An enantiomer, or more precisely, an enantiopure system, can be obtained by resolution or asymmetric synthesis. These processes are described below.Resolution and asymmetric synthesis69.Resolution is a process in which a racemic mixture or an enantiomeric excess system is separated (i.e., resolved or isolated) into its component enantiomers. A resolution can be carried out in various ways. Most commonly, it is done by crystallisation or by chiral column chromatography.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

LINDGREN J
On appeal from that decision, Lindgren J held that the recordal of the extension of term should be removed from the Register (Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618) (the Lindgren J Decision). Lundbeck appealed the Lindgren J Decision to the Full Court (the Lundbeck Full Court) (H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151), which upheld the Lindgren J Decision (the Decision).PROCEDURAL HISTORY OF THIS PROCEEDING Following the Decision, Lundbeck applied to the Commissioner of Patents (the Commissioner) for an extension of time in which to apply for an extension of the term of the Patent, based on ARTG registration of Cipramil. This would extend the term of the Patent to 9 December 2012, to include a time in which the (+)-enantiomer of citalopram was marketed by parties other than Lundbeck. The Commissioner granted the extension of time and that decision was confirmed on appeal to the Administrative Appeals Tribunal (the Tribunal) (Re Aspen Pharma Pty Ltd and Commissioner of Patents and Anor (2012) 132 ALD 648). Alphapharm Pty Ltd, Apotex Pty Ltd, Aspen Pharma Pty Ltd and Sandoz Pty Ltd (together Alphapharm) appealed the Tribunal’s decision to the Full Court (Aspen Pharma Pty Ltd v H Lundbeck A/S (2013) 216 FCR 508), which dismissed the appeal. Alphapharm Pty Ltd appealed the Full Court’s decision to the High Court (Alphapharm Pty Ltd v H Lundbeck A/S (2014) 108 IPR 459), which dismissed the appeal. Lundbeck then applied for an extension of the term of the Patent, which was determined by a delegate of the Commissioner of Patents (the Delegate), who granted the extension. The application to extend the term of the Patent was opposed before the Delegate by Alphapharm. As recorded in the Delegate’s decision, Alphapharm argued that claim 1 is not a claim to a pharmaceutical substance per se, that is, not to the substance alone or “as such” within the meaning of that term as discussed in Boehringer Ingelheim International v Commissioner of Patents [2000] FCA 1918 per Heerey J (Boehringer) and on appeal (Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 52 IPR 529 at [37]). Alphapharm argued that claim 1 contains “other integers” in addition to the pharmaceutical substance per se. The Delegate extended the standard term of the Patent from 13 June 2009 to 9 December 2012. The primary Judge upheld the Delegate’s decision (Alphapharm Pty Ltd v H Lundbeck A/S (2014) 110 IPR 59). This is an application by Alphapharm for leave to appeal the decision of the primary Judge. The application for leave to appeal and the appeal were heard together. The determinative issue in this appeal concerns the reasoning of the Lundbeck Full Court as set out in the Decision.THE LEGISLATION Section 70 of the Patents Act 1990 (Cth) (the Act) concerns applications for an extension of patent term. Relevantly, for the purpose of this application, s 70(2)(a) provides that in order to obtain an extension of term of a patent, a relevant condition which needs to be satisfied is:One or more pharmaceutical substances per se, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.

Ratio Decidendi

Legal Principle Established

Established by: LINDGREN J

Accordingly, on the construction of the claim determined in the Decision, there is no further limitation imported into that claim. That was the clear conclusion of Bennett and Middleton JJ in the Decision. It is also consistent with their Honour’s reasoning and conclusion as to s 70 of the Act and as to whether citalopram, the racemate, contained the pharmaceutical substance per se, being the (+)-enantiomer or escitalopram disclosed and claimed in the Patent.CONSIDERATION OF ALPHAPHARM’S SUBMISSIONS Alphapharm’s submissions followed this path:·The claim has been construed in the Decision to be akin to the “pure or isolated or separated” enantiomer. This is a claim to a pharmaceutical substance limited by a requirement as to purity. Accordingly it is not a claim to a pharmaceutical substance per se.·A claim limited by the requirement, that it be separated or isolated or pure, is not a claim to the substance itself but rather to the substance defined in a particular environment as having been subjected to a particular process.·Accordingly it is not a claim to the substance itself as required by s 70(2)(a) of the Act (Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IPR 424 at [24]).·As the claim was not a claim to the pharmaceutical substance per se, it is outside the operation of s 70(2)(a) of the Act and does not entitle Lundbeck to an extension of term. Alphapharm submits that, because of the evidence accepted by Lindgren J that a skilled person looking at the structure of citalopram would have recognised the presence of two enantiomers and would have been able to depict them, a claim to the enantiomer per se would necessarily have been invalid. Alphapharm then submits that in order to find that the (+)-enantiomer citalopram was novel, Lindgren J and Bennett and Middleton JJ construed the claim as being not to the enantiomer itself but rather to the enantiomer further defined or limited by the requirement that it be separated or isolated or pure. This ignores the wording of the claim, which does not import, in terms, the limitation that it be “isolated” (cf D’Arcy v Myriad Genetics Inc (2014) 313 ALR 627 at [1]). It also ignores the reasoning of each of Lindgren J, Bennett and Middleton JJ in concluding that the racemate did not anticipate the (+)-enantiomer. This was not because the claim should be read as being to the isolated enantiomer but, as explained in the Decision at [193]–[195], the disclosure of the racemate was not a disclosure to the skilled addressee of the (+)-enantiomer. As explained at [193], the skilled addressee would have understood that (±)-citalopram (the racemate) consisted of the (+)-enantiomer and the (-)-enantiomer and would have been able to identify the formulae for the enantiomers but would not have known in the absence of experimentation which was the (+)-enantiomer and which was the (-)-enantiomer. That is, there was no prior disclosure of the enantiomer independently existing. As Bennett J explained at [194], the skilled addressee knew that the racemate could be resolved into the enantiomers but there was nothing to tell him or her to do so. It could not even be said that there were clear and unmistakable directions to obtaining the enantiomers. Accordingly, it does not follow that a claim to the enantiomer per se would necessarily have been invalid.