Alphapharm Pty Ltd v H Lundbeck A/S - [2008] FCA 559

FEDERAL COURT OF AUSTRALIA
Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559
PATENTS – validity – patent for (+)-enantiomer of the racemate, citalopram, and for method of obtaining that enantiomer – patentee also held previous patent for the racemate – both the racemate and the enantiomer, drugs for the treatment of depression – (+)-citalopram claimed to be therapeutically more effective than citalopram – challenge to validity of claim for (+)-citalopram – construction of claim – whether for (+)-enantiomer as an independently existing molecule or whether also for (+)-enantiomer when part of racemate – whether claim for (+)-enantiomer anticipated by patent for citalopram – whether (+)-enantiomer as an independent molecule was obvious – Australian test for obviousness – application of that test to product claims for the (+)-enantiomer, and to method claim for the method of obtaining it – lack of utility – product claim for a dosage that, inter alia, was less than and more than a useful dosage range.
Held: (1) upon its proper construction, product claimed was the independently existing enantiomer; (2) the invention of the independently existing enantiomer was not anticipated by the patent for the racemate; (3) the Australian “matter of routine” test for obviousness, when applied to the invention of the product, equated to the question whether those skilled in the art, as a matter of routine, would have had the goal of obtaining separate enantiomers in the expectation that one would be a desirable drug for the treatment of depression; (4) one of the product claims relating to dosage failed test of utility; (5) on the evidence, neither the (+)-enantiomer nor the method for obtaining it was obvious at the priority date.
PATENTS – extension of term – patent for (+)-enantiomer of the racemate, citalopram, and for method of obtaining that enantiomer – patentee also held previous patent for the racemate – both the racemate and the enantiomer, drugs for the treatment of depression – (+)-citalopram claimed to be therapeutically more effective than citalopram – both Cipramil (goods based on racemic citalopram) and Lexapro (goods based on (+)-citalopram) entered in Australian Register of Therapeutic Goods (ARTG) – application for extension of term of patent for (+)-citalopram – Commissioner of Patents initially granted extension sought – subsequently, following hearing before her delegate, decided to reduce term of extension on ground that “first regulatory approval date” was date when goods Cipramil based on racemate had been entered in ARTG – appeal by patentee – opponent pharmaceutical company contending that no extension at all should have been granted because application for extension had been made outside six month period following date of first inclusion in ARTG of goods containing the (+)-enantiomer, namely, Cipramil, of which the active pharmaceutical substance was the racemate – questions of proper construction of Patents Act 1990 (Cth) ss 70, 71, 77 – whether goods based on racemate “contain” individual enantiomer – meaning of “first regulatory approval date” in s 70(5) of Act.
Held: (1) Cipramil contained pharmaceutical substance (+)-citalopram; (2) application for extension of term of patent had not been made within six months of first inclusion in ARTG of Cipramil; (3) in circumstances, Commissioner had lacked power to grant any extension to term of patent; (4) Register of Patents to be rectified by removal of particulars of extension.
PATENTS – infringement – patent for (+)-enantiomer of the racemate, citalopram, and for method of obtaining that enantiomer – generic company applying to Therapeutic Goods Administration (TGA) for registration of generic drug based on (+)-enantiomer of citalopram – whether doctrine of “mechanical equivalents” or “non-essential integers” applicable to method of obtaining pharmaceutical compound – generic pharmaceutical company producing generic drug only for purpose of applying for regulatory approval – s 78(2) of Patents Act 1990 (Cth).
Held: (1) doctrine of mechanical equivalents applied so that certain different steps in method did not prevent generic company’s method from infringing method the subject of patent; (2) no infringement by reason of s 78(2).
PATENTS – Therapeutic Goods Act 1989 (Cth) (TG Act), s 25A – protected information – patentee held earlier patent for racemate (citalopram) and under later patent for one of its enantiomers ((+)-citalopram) – registration in Australian Register of Therapeutic Goods (ARTG) of therapeutic goods (Cipramil) of which racemate was active component – later registration in ARTG of therapeutic goods (Lexapro) of which (+)-citalopram was active component – generic company applying for registration in ARTG of goods of which (+)-citalopram was active component – question whether information that patentee had supplied to Therapeutic Goods Administration (TGA) in connection with its application to register Lexapro could be used by TGA in connection with generic company’s application to register generic drug – s 25A of TG Act had effect that certain information about other therapeutic goods not to be used in evaluation of therapeutic goods for registration in ARTG – whether information supplied by patentee on its application for registration of Lexapro was such “protected information” in respect of generic company’s application to register generic drug – question whether Cipramil was goods “containing” (+)-citalopram for purposes of s 25A(2)(c) of TG Act.
Held: (1) Cipramil contained (+)-citalopram; (2) information given by patentee in relation to registration of Lexapro was therefore not protected information and could be used by TGA in evaluation of generic company’s application to register generic drug.
EVIDENCE – expert opinion evidence – professor of psychiatry citing carrying out of clinical studies and their results for purpose of showing that patented enantiomer had far greater therapeutic effects than those of previously patented racemate – clinical studies carried out after priority date – whether surprisingly favourable results relevant – whether citation of clinical studies and their results admissible – whether order should be made under s 136 of Evidence Act 1995 (Cth) limiting use to be made of psychiatrist’s evidence.
Held: (1) carrying out of clinical studies after priority date of patent and the results of those studies irrelevant to state of common general knowledge as at priority date, and therefore not probative on issue of obviousness; (2) citation of clinical studies and their results not rendered inadmissible for failure to prove them otherwise than by psychiatrist’s hearsay evidence; (3) s 60 of Evidence Act 1995 (Cth) applied to the clinical studies and their results, cited by psychiatrist; (4) no order made under s 136 of that Act.
Patents Act 1990 (Cth) ss 13(3), 18, 40, 70, 71, 77, 78, 119A
Therapeutic Goods Act 1989 (Cth) ss 25A, 26B
Evidence Act 1995 (Cth) ss 59, 60, 136
Patents Regulations 1991 (Cth) reg 10.7
Therapeutic Goods Regulations 1990 (Cth) Sch 9
Acme Bedstead Co Ltd v Newlands Bros Ltd (1937) 58 CLR 689 cited
Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171 cited
Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411 applied
Angiotech Pharmaceuticals v Conor [2007] RPC 20 cited
Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29 distinguished
Beecham Group Ltd v Bristol Laboratories Ltd (1977) 1B IPR 665 referred to
Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595 discussed
Borowski v Quayle [1966] VR 382 cited
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524 cited
Burroughs Corporation (Perkins’s Application) [1974] RPC 147 cited
Cadbury Schweppes Pty Ltd v Darrell Lee Chocolate Shops Pty Ltd (2006) 228 ALR 719 cited
CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 cited
Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 cited
Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 cited
EI Dupont De Nemours & Co v Imperial Chemicals Industries plc (2002) 54 IPR 304 cited
F Hoffman-La Roche & Co AG v Commissioner of Patents (1971) 123 CLR 529 cited
F Hoffmann-La Roche AG v Chiron Corporation (2000) 47 IPR 516 cited
Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331 cited
Flour Oxidising Co Ltd v Carr & Co Ltd (1908) 25 RPC 428 cited
General Tire & Rubber Co v Firestone Tyre & Rubber Co Limited [1972] RPC 457 cited
Generics (UK) Ltd v H Lundbeck A/S [2007] RPC 32 referred to
Glaxo Group Ltd’s Patent [2004] RPC 43 cited
H Lundbeck A/S v Generics (UK) Ltd [2008] EWCA 311 referred to
Harrington-Smith v State of Western Australia (No 2) (2003) 130 FCR 424 referred to
HG v The Queen (1999) 197 CLR 414 cited
Hill v Evans (1862) 1A IPR 1 cited
Imperial Chemical Industries Pty Ltd v Commissioner of Patents (2005) 213 ALR 399 cited
In re Adamson (1960) 275 F 2d 952 not followed
In re O’Farrell (1988) 853 F 2d 894 at 903) cited
Jango v Northern Territory (No 4) (2004) 214 ALR 608 cited
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274 cited
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 ALR 202 referred to
Lubrizol Corporation Inc v Imperial Chemical Industries plc (2000) 50 IPR 526 cited
Makita (Australia) Pty Ltd v Sprowles (2001) 52 NSWLR 705 referred to
Merck & Co Inc v Arrow Pharmaceuticals Ltd (2003) 59 IPR 226 discussed
Merck Frosst Canada Inc v Canada (Minister of National Health and Welfare) (2000) 8 CPR (4^th) 48 referred to
Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 cited
Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 applied
Minnesota Mining and Manufacturing Co v Tyco Electronics Pty Ltd (2002) 56 IPR 248 cited
National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 cited
Neolab Ltd and others v H Lundbeck AS 3 Ni 9/05 (EU) cited
Neowarra v Western Australia (No 1) (2003) 134 FCR 208 cited
Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56 cited
Nicaro Holdings Pty Ltd v Marlin Engineering Co (1990) 91 ALR 513 cited
NutraSweet Australia Pty Ltd v Ajinomoto Co Inc (2005) 67 IPR 381 cited
Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 cited
Olin Mathieson Chemical Corporation v Biorex Laboratories Limited [1970] RPC 157 cited
Ortho-McNeil Pharmaceutical Inc v Mylan LaboratoriesInc 348 F Supp 2d 713 approved
Pfizer Canada Inc v Apotex Inc (1998) 78 CPR (3d) 3 referred to
Pfizer Overseas Pharmaceuticals v Ely Lilly & Co (2005) 225 ALR 416 cited
Pharmacia Corporation v Merck & Co Inc [2002] RPC 775 cited
Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2006) 69 IPR 1 discussed
PhotoCure ASA v Queen’s University at Kingston (2005) 216 ALR 41 cited
Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IPR 424 discussed
Ranbaxy Australia Pty Ltd v Warner-Lambert Company LLC (No 2) (2006) 71 IPR 46 referred to
Re Application of Eli Lilly & Co [1982] 1 NSWLR 526 referred to
Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 11 IPR 289 cited
Richardson-Vicks Inc’s Patent [1995] RPC 568 cited
Root Quality Pty Ltd v Root Control Technologies Pty Ltd (2000) 177 ALR 231 cited
Saccharin Corporation Ltd v Anglo-Continental Chemical Works Ltd (1900) 17 RPC 307 referred to
Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 65 IPR 605 cited
Seyfang v G D Searle & Co [1973] QB 148 cited
Société Des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 cited
Sydneywide Distributors Pty Ltd v Red Bull Australia Pty Ltd (2002) 55 IPR 354 cited
Wellcome Foundation Ltd v V.R. Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 cited
Wm Wrigley Jr Company v Cadbury Schweppes Pty Ltd (2006) 66 IPR 298 followed
Blanco White TA, Patents for Inventions and the Protection of Industrial Design (5^th ed, Stephens, London, 1983)
Bodkin C, Patent Law in Australia (Thomson Lawbook Co, 2008)
Chadbourn JH (ed), Wigmore on Evidence (Little, Brown & Co, Boston, 1979)
ALPHAPHARM PTY LTD (ACN 002 359 739) v
H LUNDBECK A/S AND LUNDBECK AUSTRALIA PTY LTD (ACN 070 094 290)
NSD 1120 OF 2005
LUNDBECK AUSTRALIA PTY LTD (ACN 070 094 290) v
SECRETARY OF THE DEPARTMENT OF HEALTH & AGEING OF THE COMMONWEALTH OF AUSTRALIA AND ALPHAPHARM PTY LTD
NSD 1870 OF 2005
ARROW PHARMACEUTICALS PTY LTD (ACN 003 144 170) v
H LUNDBECK A/S
NSD 954 OF 2006
H LUNDBECK A/S v COMMISSIONER OF PATENTS AND
ALPHAPHARM PTY LTD
NSD 1078 OF 2006
LINDGREN J
24 APRIL 2008
SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY
NSD 1120 OF 2005

BETWEEN:

ALPHAPHARM PTY LTD (ACN 002 359 739)
Applicant/Cross-respondent

AND:

H LUNDBECK A/S
Respondent/First Cross-claimant

LUNDBECK AUSTRALIA PTY LTD (ACN 070 094 290)
Second Cross-claimant

JUDGE:

LINDGREN J

DATE OF ORDER:

24 APRIL 2008

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:
1.The proceeding be stood over to Friday 9 May 2008 at 9:30am for the making of orders, including orders as to costs.
2.The parties attempt to agree on the orders to be made.
3.If the parties agree on the orders to be made, they supply a copy of those orders to the Associate to Lindgren J by Monday 5 May 2008.
4.If the parties fail to agree on the orders to be made, they serve (with a copy to the Associate to Lindgren J), by Monday 5 May 2008, the forms of the orders they respectively propose and submissions in support.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

NSD 1870 OF 2005

NEW SOUTH WALES DISTRICT REGISTRY

BETWEEN:

LUNDBECK AUSTRALIA PTY LTD (ACN 070 094 290)
Applicant

AND:

SECRETARY OF THE DEPARTMENT OF HEALTH AND AGEING OF THE COMMONWEALTH OF AUSTRALIA
First Respondent

ALPHAPHARM PTY LTD (ACN 002 359 739)
Second Respondent

JUDGE:

LINDGREN J

DATE OF ORDER:

24 APRIL 2008

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:
1.The proceeding be stood over to Friday 9 May 2008 at 9:30am for the making of orders, including orders as to costs.
2.The parties attempt to agree on the orders to be made.
3.If the parties agree on the orders to be made, they supply a copy of those orders to the Associate to Lindgren J by Monday 5 May 2008.
4.If the parties fail to agree on the orders to be made, they serve (with a copy to the Associate to Lindgren J), by Monday 5 May 2008, the forms of the orders they respectively propose and submissions in support.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY
NSD 954 OF 2006

BETWEEN:

ARROW PHARMACEUTICALS PTY LTD
(ACN 003 144 170)
Applicant

AND:

H LUNDBECK A/S
Respondent

JUDGE:

LINDGREN J

DATE OF ORDER:

24 APRIL 2008

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:
1.The proceeding be stood over to Friday 9 May 2008 at 9:30am for the making of orders, including orders as to costs.
2.The parties attempt to agree on the orders to be made.
3.If the parties agree on the orders to be made, they supply a copy of those orders to the Associate to Lindgren J by Monday 5 May 2008.
4.If the parties fail to agree on the orders to be made, they serve (with a copy to the Associate to Lindgren J), by Monday 5 May 2008, the forms of the orders they respectively propose and submissions in support.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY
NSD 1078 OF 2006

BETWEEN:

H LUNDBECK A/S
Applicant

AND:

COMMISSIONER OF PATENTS
First Respondent

ALPHAPHARM PTY LTD (ACN 002 359 739)
Second Respondent

DATE OF ORDER:

24 APRIL 2008

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:
1.The proceeding be stood over to Friday 9 May 2008 at 9:30am for the making of orders, including orders as to costs.
2.The parties attempt to agree on the orders to be made.
3.If the parties agree on the orders to be made, they supply a copy of those orders to the Associate to Lindgren J by Monday 5 May 2008.
4.If the parties fail to agree on the orders to be made, they serve (with a copy to the Associate to Lindgren J), by Monday 5 May 2008, the forms of the orders they respectively propose and submissions in support.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

NSD 1120 OF 2005

BETWEEN:

ALPHAPHARM PTY LTD (ACN 002 359 739)
Applicant/Cross-respondent

AND:

H LUNDBECK A/S
Respondent/First Cross-claimant

LUNDBECK AUSTRALIA PTY LTD (ACN 070 094 290)
Second Cross-claimant

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

NSD 1870 OF 2005

BETWEEN:

LUNDBECK AUSTRALIA PTY LTD (ACN 070 094 290)
Applicant

AND:

SECRETARY OF THE DEPARTMENT OF HEALTH AND AGEING OF THE COMMONWEALTH OF AUSTRALIA
First Respondent

ALPHAPHARM PTY LTD (ACN 002 359 739)
Second Respondent

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

NSD 954 OF 2006

BETWEEN:

ARROW PHARMACEUTICALS PTY LTD
(ACN 003 144 170)
Applicant

AND:

H LUNDBECK A/S
Respondent

IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
NSD 1078 OF 2006

ON APPEAL FROM THE COMMISSIONER OF PATENTS

BETWEEN:

H LUNDBECK A/S
Applicant

AND:

COMMISSIONER OF PATENTS
First Respondent

ALPHAPHARM PTY LTD (ACN 002 359 739)
Second Respondent

JUDGE:

LINDGREN J

DATE:

24 APRIL 2008

PLACE:

SYDNEY

REASONS FOR JUDGMENT
TABLE OF CONTENTS

Section
Para No.

A INTRODUCTION AND BACKGROUND
[1] – [78]

B THE PATENT
[79] – [113]

C CONSTRUCTION OF THE PATENT
[114] – [153]

D NOVELTY
[154] – [174]

E OBVIOUSNESS
[175] – [426]

F MANNER OF MANUFACTURE – s 18(1)(a) OF THE ACT
[427] – [441]

G LACK OF DEFINITION – s 40(2)(b) OF THE ACT
[442] – [447]

H LACK OF FAIR BASING – s 40(3) OF THE ACT
[448] – [460]

I LACK OF CLARITY – s 40(3) OF THE ACT
[461] – [465]

J INUTILITY – s 18(1)(c) OF THE ACT
[466] – [474]

K
THE LUNDBECK APPEAL (EXTENSION OF TERM)
PROCEEDING – ALPHAPHARM’S AND ARROW’S CLAIMS
FOR RECTIFICATION UNDER s 192 OF THE ACT

[475] – [544]

L THE TGA (PROTECTED INFORMATION) PROCEEDING
[545] – [633]

M INFRINGEMENT BY ALPHAPHARM
[634] – [697]

N ADMISSIBILITY OF CERTAIN EVIDENCE
[698] – [783]

O CONCLUSION
[784] – [785]

SECTION A – INTRODUCTION AND BACKGROUND
General

These four proceedings, which were heard together, relate to Australian patent No 623144 (the Patent or the Australian Escitalopram Patent) held by H Lundbeck A/S (Lundbeck), a Danish pharmaceutical company.
Lundbeck applied for the Patent on 13 June 1989. The application was a Convention application and was said in the application to be based on application No 8814057 for a patent made in the United Kingdom on 14 June 1988 (the UK Escitalopram Patent – see [79] below). The title of the invention in the Patent is: “(+)-Enantiomer of citalopram and process for the preparation thereof”.
Citalopram is a molecule patented by Lundbeck which is used for the treatment of depression. Citalopram is a chiral molecule, a racemic mixture (or racemate) comprising in equal measure two enantiomers. Enantiomers are non-superimposable mirror images of each other. They are designated “(+)” or “(–)” based on a particular physical property referred to below, and “R” or “S” based on their three-dimensional structure. The correlation between the (+) or (–) and the R or S designations can only be determined, however, through experimentation.

In the case of citalopram, experimentation subsequent to the priority date has shown that the (+)-enantiomer is in fact the S-enantiomer. It is commonly referred to as “S-citalopram”, and has the International Nonproprietary Name “escitalopram”.
The Patent discloses processes for obtaining escitalopram, and data showing that (+)-citalopram is therapeutically more active than citalopram itself, and more than 100 fold more active than (-)-citalopram.
The 20 year term of the Patent was due to expire on 13 June 2009. The term has, however, been extended as discussed at [28] ff below.
Citalopram is an invention claimed in Australian patent No 509,445 (the Australian Citalopram Patent) dated 5 January 1977, the term of which was sixteen years commencing on that date. The Australian Citalopram Patent was, in turn, said in the application to be based on the application No 1486/76 for a patent filed in Great Britain on 14 January 1976 (the UK Citalopram Patent). The title of the invention in the Australian Citalopram Patent is “phthalanes”, a class of compounds that includes citalopram.
In various ways, the proceedings before the Court raise issues concerning the relationship between citalopram and escitalopram. Broadly, the issues can be separated into those that relate to patentability (raised in the proceedings brought by Alphapharm Pty Ltd (Alphapharm) and Arrow Pharmaceuticals Pty Ltd (Arrow) for revocation of the Patent), infringement (a cross-claim in Alphapharm’s revocation proceeding) and regulatory aspects (all four proceedings).
Proceeding NSD 1120 of 2005 (the Revocation Proceeding)
Alphapharm’s claim for revocation
The Patent comprises six claims. In proceeding NSD 1120 of 2005 (“the Revocation Proceeding”), Alphapharm seeks a declaration that all six claims are invalid, and an order pursuant to s 138(3) of the Patents Act 1990 (Cth) (the Act) revoking them all, or, in the alternative, an order pursuant to s 192 of the Act that the Register be rectified to remove an extension of the term of the Patent from the Register of Patents (the Register).
The six claims are as follows:
1. (+)-1-(3-dimethylaminopropyl)-1-(4’-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof.
2. The pamoic acid salt of (+)-1-(3-dimethylaminopropyl)-1-(4’-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile.
3. A pharmaceutical composition in unit dosage form comprising as an active ingredient, a compound as defined in claim 1, together with a pharmaceutically accepta[ble] carrier or excipient.
4. A pharmaceutical composition in unit dosage form comprising, as an active ingredient, the compound of claim 2, together with a pharmaceutically acceptable carrier or excipient.
5. A pharmaceutical composition in unit dosage form, according to claim 3 or 4, wherein the active ingredient is present in an amount from 0.1 to 100 milligram per unit dose, together with a pharmaceutically acceptable carrier or excipient.
6. A method for the preparation of the compound of claim 1, which comprises:
(a) reacting a compound of the formula
with an enantiomerically pure acid derivative as an acid chloride, anhydride or labile ester, subsequently separating the resolved intermediate enantiomer for (+)-citalopram having the formula

wherein R is a labile ester group; by HPLC or fractional crystallization, and then treating said intermediate enantiomer with strong base: or
(b) reacting a compound of formula II with the enantiomer of an optically active acid affording the pure enantiomer salt of the compound of formula II for (+)-citalopram, and subsequently performing ringclosure via a labile ester by reacting the pure enantiomer of formula II as a base with an activated acid with simultaneous addition of a base and, if desired, transferring the (+)-citalopram obtained to a pharmaceutically acceptable salt thereof.
Claims 1–5 are product claims. Claim 6 is a method claim.
According to Alphapharm’s further amended particulars of invalidity filed in Court on the hearing:
·claims 3, 4 and 5 of the Patent are not entitled to a priority date earlier than 13 June 1989, being the date of the filing of the application for the Patent, because those claims are not fairly based on United Kingdom Patent Application 8814057, the application for which was made on 14 June 1988;
·the alleged invention as claimed in claims 1–5 and 6(b) of the Patent is not a patentable invention, because it was not novel when compared with the prior art base as it existed in Australia prior to the priority date (in the event, Alphapharm relied on two publications: the first, the publication of an article by Dr Donald F Smith which became publicly available in Australia on or about 8 October 1986; the second, the publication of the Australian Citalopram Patent on or about 13 July 1978);
·the alleged invention as claimed in each claim of the Patent is not a patentable invention because it was obvious and did not involve an inventive step having regard to what was known or used in Australia before the priority date;
·the alleged invention as claimed in each claim of the Patent is not a patentable invention within the meaning of s 18(1)(a) of the Act, because it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies;
·the complete specification of the Patent does not comply with s 40(2)(b) of the Act, because it does not define the alleged invention as claimed in each of claims 1-5 of the Patent;
·the specification of the Patent does not comply with s 40(3) of the Act in that the alleged invention as claimed in each of claims 3, 4, 5 and 6 of the Patent is not fairly based on the matter described in the specification, and each claim of the Patent is not clear and succinct; and
·the alleged invention as claimed in claims 1–5 of the Patent is not a patentable invention within s 18(1)(c) of the Act because it is not useful.
At the hearing, senior counsel for Alphapharm indicated that Alphapharm was content to proceed on the basis of a priority date of 14 June 1988. I proceed on the basis of that priority date of 14 June 1988.
I will discuss the case that Alphapharm seeks to make in respect of these grounds of invalidity in due course.
Alphapharm’s alternative claim for rectification of the Register
Alphapharm’s alternative claim for rectification of the Register concerns the interaction between the Act and the Therapeutic Goods Act 1989 (Cth) (the TG Act). Under the TG Act, a pharmaceutical substance may not be marketed in Australia unless it is, or is contained within, a therapeutic good that is registered on the Australian Register of Therapeutic Goods (ARTG).
Alphapharm’s application for rectification of the Register raises the same issues as are raised in the Lundbeck Appeal (Extension of Term) Proceeding (discussed at [45] ff below).
An appropriate starting point for an understanding of Alphapharm’s alternative claim for rectification of the Register is the Act’s provisions relating to the extension of the terms of patents in Pt 3 of Ch 6 of the Act.
Section 67 of the Act provides that the term of a standard patent is 20 years from the date of the patent. Section 65 provides, relevantly, that the date of a patent is the date of filing of the complete specification, being 13 June 1989 in the present case.
Part 3 (ss 70–79A) of the Act is headed “EXTENSION OF TERM OF STANDARD PATENTS RELATING TO PHARMACEUTICAL SUBSTANCES”. Section 70 of the Act provides, relevantly, as follows:
(1) The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.
(2) Either or both of the following conditions must be satisfied:
(a) 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;
(b) …
(3) Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:
(a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;
(b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.
(4) …
(5) For the purposes of this section, the first regulatory approval date, in relation to a pharmaceutical substance, is:
(a) if no pre‑TGA marketing approval was given in relation to the substance [none was given in the present case] — the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or
(b) …
(6) …
Section 71(2) of the Act provides a time limit for applications for an extension of the term of a standard patent. It provides:
An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:
(a) the date the patent was granted;
(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3);
(c) the date of commencement of this section.
Sections 74–76 of the Act provide:
74(1) If a patentee of a standard patent makes an application for an extension of the term of the patent, the Commissioner must accept the application if the Commissioner is satisfied that the requirements of sections 70 and 71 are satisfied in relation to the application.
(2) If the Commissioner accepts the application, the Commissioner must:
(a) notify the applicant in writing of the acceptance; and
(b) publish a notice of the acceptance in the Official Journal.
(3) The Commissioner must refuse to accept the application if the Commissioner is not satisfied that the requirements of sections 70 and 71 are satisfied in relation to the application.
(4) If the Commissioner refuses to accept the application, the Commissioner must:
(a) notify the applicant in writing of the reasons for the refusal; and
(b) publish a notice of the refusal in the Official Journal.
75(1) The Minister or any other person may, in accordance with the regulations, oppose the grant of an extension of the term of a standard patent on the ground that one or more of the requirements of sections 70 and 71 are not satisfied in relation to the application for the extension. The Minister or other person may not oppose the grant of the extension on any other ground.
(2) If the grant of an extension of the term of a standard patent is opposed, the Commissioner must decide the case in accordance with the regulations.
(3) The Commissioner must give the applicant and the opponent a reasonable opportunity to be heard before deciding a case.
(4) The applicant, and any opponent, may appeal to the Federal Court against a decision of the Commissioner under this section.
76(1) The Commissioner must grant an extension of the term of a standard patent if:
(a) there is no opposition to the grant; or
(b) in spite of opposition, the Commissioner’s decision, or the decision on appeal, is that the extension should be granted.
(2) If the Commissioner grants an extension, the Commissioner must notify the applicant in writing of the grant and publish a notice of the grant in the Official Journal.
Finally, s 77 provides for the calculation of the term of an extension as follows:
(1) If the Commissioner grants an extension of the term of a standard patent, the term of the extension is equal to:
(a) the period beginning on the date of the patent and ending on the earliest first regulatory approval date (as defined by section 70) in relation to any of the pharmaceutical substances referred to in subsection 70(2);
reduced (but not below zero) by:
(b) 5 years.
(2) However, the term of the extension cannot be longer than 5 years.
Underlying these provisions are certain assumptions. One is that it may be unreasonable to expect a patentee to derive a sufficient return from a pharmaceutical patent within 20 years because of the necessity, under the TG Act, of first having the relevant goods listed on the ARTG, and of the time that it may take to obtain that listing. Another assumption, however, is that the patentee should not be permitted to “sit on its hands” once the patent has been issued and once the relevant goods have been listed on the ARTG.
Two timing aspects of the provisions are noteworthy. Section 71(2) relevantly requires an application for an extension to be made within six months after the date of the “first inclusion” in the ARTG of “goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3)”. This provision reflects a view that, ordinarily, ARTG registration should mark the beginning of exploitation. If there is some difficulty in the patentee’s exploiting its patent promptly following ARTG registration, it is expected to bring this to light and to apply for an extension without delay.
The second timing aspect is found in ss 70(3)(b) and 77. These provisions reflect a policy that extensions are intended for circumstances in which the patentee has not been in a position to exploit the invention adequately. Thus, if the period beginning on the date of the patent and ending on the first regulatory approval date does not exceed five years, the period of the extension is zero, because, after all, the patentee will still have had the benefit of at least 15 years’ exploitation of the patent. On the other hand, if the first regulatory approval date occurs say 15 years into the term of the patent, the period remaining available for exploitation of the patent is only some five years, and the period of the extension for which s 77 provides would be some ten years if s 77(1) stood alone. However, subs (2) reduces this period to five years because it provides for a maximum extension of five years in all cases.
Since 3 January 1998, Lundbeck Australia Pty Ltd (Lundbeck Australia), a subsidiary of Lundbeck, has marketed an anti-depressant medicine in Australia under the trade mark “CIPRAMIL” (Cipramil). Cipramil was included in the ARTG on 9 December 1997, as citalopram hydrobromide, an acid addition salt of citalopram.
Since 1 October 2003, Lundbeck Australia has marketed an anti-depressant medicine in Australia under the trade mark “LEXAPRO” (Lexapro). Lexapro was included in the ARTG on 16 September 2003 as escitalopram oxalate. It will be recalled that the (+)-enantiomer of citalopram, which experimentation shows is S-citalopram or escitalopram, is the subject of the Patent.
I turn now to the extension of the term of the Patent.
Lundbeck applied for the extension on 22 December 2003. The Commissioner of Patents (Commissioner) granted the extension on 27 May 2004. The extension granted was from and including 14 June 2009 to 13 June 2014. Particulars of the extension granted were entered on the Register.
The date of Lundbeck’s filing of its application for the extension, 22 December 2003, was well within six months of the inclusion of Lexapro in the ARTG on 16 September 2003. However, Alphapharm’s contention is that the relevant first inclusion in the ARTG was the inclusion of Cipramil in the ARTG on 9 December 1997. If Alphapharm is correct, Lundbeck had only until 9 June 1998 to apply for an extension and the application it made on 22 December 2003 was well out of time, and it was not open to the Commissioner to grant an extension. (I note that Alphapharm’s amended statement of claim uses the date 20 November 1997. However, the trial seemed to have proceeded on the basis that the 9 December 1997 date is correct.) The question raised is whether, for the purpose of the statutory provisions mentioned, the pharmaceutical substance, the (+)-enantiomer of citalopram, was “contained in” the pharmaceutical good, Cipramil. This question is related to other issues in the case, such as the issue of novelty (was the (+)-enantiomer the subject of the Patent not novel by reason of the earlier Australian Citalopram Patent?) and the issues in the TGA (Protected Information) Proceeding discussed at [36] ff below.
Alphapharm pleads in para 7 of its amended statement of claim that Cipramil “contains” a substance which is a mixture of the (+)-enantiomer of citalopram and the (–)-enantiomer of citalopram. In its further amended defence, Lundbeck replies that S-citalopram and R-citalopram are the appropriate descriptors of (+)-citalopram and (-)-citalopram when in a racemic mixture, but otherwise it denies the allegations in the paragraph. Thus, Lundbeck denies that Cipramil “contains” (+)-citalopram.
The period from the date of the Patent (13 June 1989) to 9 December 1997, when Cipramil was included in the ARTG, is 8 years, 5 months and 26 days. The period from the date of the Patent (13 June 1989) to 16 September 2003, when Lexapro was included in the ARTG, is 14 years, 3 months and 3 days. Accordingly, whichever of the competing contentions as to the “first regulatory approval date” is correct, Lundbeck’s application for the extension of term satisfied s 70(3)(b) of the Act, because each of the periods was a period of “at least five years”.
If the correct first regulatory approval date is 9 December 1997, s 77(1) makes the term of the extension 8 years, 5 months and 26 days minus five years, which is 3 years, 5 months and 26 days. This period, added on to the original 20 year term of the Patent expiring on 13 June 2009, would extend the term of the Patent to 9 December 2012. The Commissioner contends that the Register should reflect this period if Alphapharm’s contention as to the first regulatory approval date is correct (see the Lundbeck Appeal (Extension of Term) Proceeding discussed at [45] ff below).
If, on the other hand, the correct first regulatory approval date is 16 September 2003, s 77(1) would make the term of the extension 14 years, 3 months and 3 days minus 5 years, which is 9 years, 3 months and 3 days. But s 77(2) provides that the term of an extension cannot be longer than five years, and so the term of the extension would be reduced to five years. This extension of five years, added on to the 20 year term of the Patent expiring on 13 June 2009, would extend that term to 13 June 2014. This was the extension, particulars of which the Commissioner entered in the Register, that Lundbeck supports (again see the Lundbeck Appeal (Extension of Term) Proceeding discussed at [45] ff below).
Lundbeck’s cross-claim against Alphapharm for infringement
In the Revocation Proceeding, Lundbeck and the exclusive licensee of the Patent in Australia, Lundbeck Australia (together, the Lundbecks) cross-claim against Alphapharm for infringement of the Patent. A claim was made that certain particulars of the alleged infringement were confidential, but any difficulty on the hearing in this respect was overcome by the co-operation and common sense of the parties (which was a characteristic of the hearing throughout). The alleged infringement is of product claims 1, 3, and 5 and of method claim 6(b). The Lundbecks allege that Alphapharm has used, whether for the purpose of obtaining regulatory approval to market a pharmaceutical substance in Australia or in other countries or otherwise, manufactured, imported, sold or otherwise disposed of, or offered to import, sell (whether in Australia or elsewhere) or otherwise dispose of, or kept for the purpose of sale, use or other disposition:
(i) (+)-citalopram or a salt thereof as claimed in claim 1 of the Patent; or
(ii) a pharmaceutical composition as claimed in claim 3 or claim 5 of the Patent;
or has done any of those acts in respect of a product resulting from the use of the method claimed in claim 6(b) of the Patent, or authorised, procured or induced a person to do any of the acts mentioned above.

In particular, the Lundbecks rely on Alphapharm’s threat to manufacture and sell goods containing (+)-citalopram in Australia if Alphapharm obtains the necessary regulatory approvals and listings. The Lundbecks also rely on steps already taken by Alphapharm in connection with its application to the Therapeutic Goods Administration (TGA) to that end.
Proceeding NSD 1870 of 2005 (the TGA (Protected Information) Proceeding)
In proceeding NSD 1870 of 2005 (the TGA (Protected Information) Proceeding), Lundbeck Australia seeks a declaration that the information it provided to the Secretary of the Department of Health and Ageing of the Commonwealth of Australia (the Secretary) in respect of its applications for the registration of various therapeutic goods on the ARTG containing the active substance escitalopram oxalate, is “protected information” within the meaning of s 25A(2) of TG Act. Section 25A provides:
(1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information.
(2) Information is protected information if:
(a) the information was given to the Secretary in relation to an application to register therapeutic goods (the new goods):
           (i) not being therapeutic devices; and
           (ii) consisting of, or containing, an active component; and
(b) the information is about the active component and is not available to the public; and
(c) when the application to register the new goods was lodged:
           (i) no other therapeutic goods consisting of, or containing, that active         component were included in the Register; and
           (ii) no such therapeutic goods had been included in the Register at any      time before then; and
(d) the new goods became registered on or after the commencement of this subsection; and
(e) 5 years have not passed since the day the new goods became registered; and
(f) the person in relation to whom the new goods are registered has not given the Secretary permission in writing for the Secretary to use the information.
(3) For the purposes of subsection (2), an active component, in relation to therapeutic goods, is a substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods.
(4) The use of protected information contrary to subsection (1) does not render the Commonwealth, the Secretary or a delegate of the Secretary liable to a person in respect of loss, damage or injury of any kind suffered by the person as a result of, or arising out of, the use of that information.
In its statement of claim, Lundbeck Australia “particularises” the information it alleges it gave to the Secretary in relation to the registration of Lexapro, which it contends is “protected information” within s 25A of the TG Act (the Information), as follows:
The Information included information in each of the following categories:
(a) Chemical, Pharmaceutical and biological information;
(b) Pharmaco-toxicological information; and
(c) Clinical information.
Lundbeck Australia seeks, inter alia, prohibition or an injunction prohibiting the Secretary, an officer of the Commonwealth (see s 39B(1) of the Judiciary Act 1903 (Cth)), from using the Information or permitting it to be used when evaluating any application by a person other than Lundbeck Australia, notably Alphapharm, for the registration of therapeutic goods pursuant to s 25(1) of the TG Act, for so long as the Information remains protected information within the meaning of s 25A(2).
In pleading that the Secretary threatens and intends to use the Information in evaluating other therapeutic goods for inclusion in the ARTG, Lundbeck Australia is referring to the fact that in the Revocation Proceeding, Alphapharm alleges that if marketing approval is granted, it wishes to manufacture and sell in Australia goods containing (+)-citalopram, and that goods cannot be marketed in Australia unless they are first registered on the ARTG. Lundbeck Australia complains that it will suffer loss and damage if the Information is not treated by the Secretary as protected, and is used by the Secretary in the evaluation of the therapeutic goods of Alphapharm for registration on the ARTG. In support, it also refers to the fact that by s 25A(4) of the TG Act, Lundbeck Australia is precluded from recovering any of that loss or damage from the Secretary.
In the course of the proceeding, I ordered that Alphapharm be added as second respondent. The Secretary and Alphapharm have filed defences. In substance, they put in issue Lundbeck Australia’s allegation that the Information constitutes “protected information” within s 25A(2). The defences are not identical. One defence raised by both the Secretary and Alphapharm is that the Information was not protected information as defined in s 25A(2) of the TG Act because para (c) of that subsection was not satisfied because, when the application to register Lexapro was lodged, other therapeutic goods containing the same active component that the Information was about (escitalopram), were already included in the ARTG. Of course, the other therapeutic goods to which the Secretary and Alphapharm are referring are Cipramil (citalopram hydrobromide), an acid addition salt of the racemate citalopram.
Proceeding NSD 954 of 2006 (the Arrow Proceeding)
In proceeding NSD 954 of 2006 (“the Arrow Proceeding”), Arrow Pharmaceuticals Pty Ltd (“Arrow”), like Alphapharm, seeks a declaration that claims 1 to 6 of the Patent are invalid, an order that they be revoked and that the Register be rectified pursuant to s 192 of the Act by removing the particulars of the Patent from the Register. In the alternative, Arrow seeks an order that the Register be rectified by removing all record of the extension of the Patent and of the period of the extension, and recording, instead, that the term of the Patent will expire on 13 June 2009, or in the alternative, 9 December 2012.
Arrow also complains that claims 2 to 5 of the Patent are not entitled to a priority date earlier than 13 June 1989, being the date of the filing of the application on which the Patent was granted. It asserts that those claims are not fairly based on the alleged priority document, namely, the UK Escitalopram Patent. (However, like Alphapharm, Arrow was content to proceed on the basis of a priority date of 14 June 1988 - see [12] above.) Arrow asserts that the alleged invention, so far as claimed in claims 1 to 6 of the Patent, is not a patentable invention because it is:
·not an “invention” or, further or alternatively, not a “manner of manufacture” within s 6 of the Statute of Monopolies (s 18(1)(a) of the Act);
·not novel (s 18(1)(b)(i) of the Act);
·obvious (s 18(1)(b)(ii) of the Act); and
·not useful (s 18(1)(c) of the Act).
Arrow also asserts that the complete specification does not comply with s 40(3) of the Act in that claims 1 to 5 are not clear and succinct and claims 3 to 6 are not fairly based on the matter described in the specification. Accordingly, Arrow seeks revocation of the Patent under s 138(3) of the Act and removal of the particulars of the Patent from the Register.
In relation to the alternative application for rectification of the Register, like Alphapharm, Arrow alleges that the first regulatory approval date was 9 December 1997, because that was the date when Cipramil was first included in the ARTG, and Cipramil contains citalopram which is a racemic mixture of (+)-citalopram and (-)-citalopram. Accordingly, like Alphapharm, Arrow complains that it was a misrepresentation for Lundbeck to represent to the Commissioner, as it did when it applied for and obtained the extension, that 16 September 2003 was the relevant first regulatory approval date.
Given the overlap of Arrow Proceeding with the Revocation Proceeding, I find it convenient in these reasons, generally speaking, to refer only to Alphapharm when addressing various issues. However, it should be understood that my reasoning applies equally to Arrow’s submissions on the same issues.
Proceeding NSD 1078 of 2006 (the Lundbeck Appeal (Extension of Term) Proceeding)
I turn last to proceeding NSD 1078 of 2006 (the Lundbeck Appeal (Extension of Term) Proceeding). This proceeding is an appeal by Lundbeck from part of a decision of the Commissioner, by her delegate, Dr SD Barker, issued on 19 May 2006. That decision was a decision to direct that the entry in the Register in respect of the Patent be amended by alteration of the expiry of the extension on the ground that the extended term was not calculated from the “first regulatory approval date” referred to in s 77 of the Act, with the consequence that reg 10.7(7) of the Patents Regulations 1991 (Cth) (the Regulations) required the Commissioner to amend the Register by bringing forward the expiry of the Patent.
(In H Lundbeck A/S v Commissioner of Patents [2006] FCA 163, I held that reg 10.7(7) was intra vires s 228 of the Act. Bennett J followed me in Pfizer Corporation v Commissioner of Patents (No 2) (2006) 69 IPR 525, and on appeal from her Honour, the Full Court agreed with us: see Pfizer Corporation v Commissioner of Patents (2006) 155 FCR 578. An application by Pfizer Corporation for special leave to appeal to the High Court was refused: see [2007] HCA Trans 93.)
As noted earlier, on 27 May 2004 the Commissioner granted the extension. No opposition was entered to the grant of it in the time provided by the Regulations. However, Alphapharm later wrote to the Commissioner asserting that the Commissioner had been misled by Lundbeck as to the true first regulatory approval date. On 13 July 2005, the Acting Deputy Commissioner of Patents copied Lundbeck into correspondence stating that the Commissioner considered that she was obliged to amend the entry in the Register of the expiry of the term of the Patent from 13 June 2014 to 9 December 2012 under reg 10.7(7) of the Regulations. This was on the footing that the correct first regulatory approval date was 9 December 1997, the date of the registration of Cipramil in the ARTG.
The Commissioner’s letter requested Lundbeck either to provide reasons why the Commissioner should not make the amendment or to accede to the amendment. Lundbeck did not accede to the amendment and there was a hearing before Dr Barker at which Lundbeck and Alphapharm made submissions. This led to the decision of 19 May 2006 from which Lundbeck now appeals, as it is entitled to do under s 154 of the Act and reg 10.7(9) of the Regulations.
Regulations 10.7(7), (8) and (9) provide:
(7) If:
(a) an extension of the term of a standard patent for a pharmaceutical substance has been granted under section 76 of the Act; and
(b) the Commissioner becomes aware that the first regulatory approval date in relation to the pharmaceutical substance is earlier than:
           (i) the date of commencement of the first inclusion in the Australian          Register of Therapeutic Goods that was supplied, under subregulation 6.9(2), with the application for the extension of the term; or
           (ii) the date of the first approval that was supplied, under subregulation      6.10(2), with the application for the extension of the term;
           the Commissioner must amend the relevant entry in the Register to            insert the correct extension of the term of the patent.
(8) If the Commissioner proposes to amend an entry in the Register under subregulation (7), the Commissioner must:
(a) give notice to that effect to the patentee; and
(b) act in accordance with regulations 22.22 to 22.24 as if those regulations applied to a decision to amend an entry.
(9) An appeal lies to the Federal Court against a decision of the Commissioner to amend the Register under subregulation (7).
Regulations 22.22 to 22.24, referred to in para (8)(b), provide for the giving of notice and of an opportunity to be heard, before the Commissioner exercises a discretionary power adversely to a person.
Dr Barker decided that the decision of Wilcox J in Merck & Co Inc v Arrow Pharmaceuticals Ltd (2003) 59 IPR 226 (Merck) governed the issue before him. As Dr Barker understood the position, Merck produced the result that it did not matter that escitalopram was a new chemical entity having properties different from those of the racemate, citalopram, or that the registration of citalopram under its brand name Cipramil on the ARTG did not give the right to market escitalopram except as part of the racemate. All that mattered was that Cipramil did in fact “contain” escitalopram, or put another way, that escitalopram was present (to some extent) in Cipramil, and that Cipramil was included in the ARTG. It was also immaterial, according to Dr Barker, that escitalopram was not responsible for all of the activity of Cipramil.
Dr Barker concluded that since citalopram hydrobromide, marketed under the brand name Cipramil and containing escitalopram, was first registered on the ARTG on 9 December 1997, the Commissioner was required by reg 10.7(7) to amend the relevant entry in the Register to reflect the correct extension of the term of the Patent as expiring on 9 December 2012 (see [32] above).
Lundbeck complains that the Dr Barker erred in finding that the first regulatory approval date was the date on which Cipramil was registered on the ARTG, and that Dr Barker ought to have found that it was the date on which Lexapro was so registered (see [33] above).
Which legislative régime applies?
The Revocation Proceeding (including the cross-claim for infringement) falls to be decided under the Act. However, the application for the Patent was filed on 13 June 1989 under the Patents Act 1952 (Cth) (the 1952 Act). The application for the Patent was advertised and accepted on 7 May 1992. That was well after the commencement of the Act (being the first day after the end of the period of 6 months beginning on 30 October 1990). The Patent was therefore granted under the Act on an application lodged under the 1952 Act. In these circumstances, s 234(2) of the Act is applicable. That subsection and s 234(5) of the Act relevantly provide:
(2) Where, before the commencing day:
(a) a patent application had been lodged under the 1952 Act; and
(b) a complete specification...had been lodged under that Act in respect of the application; and
(c) the application had not been withdrawn or finally dealt with;
then, subject to this Chapter and the regulations, this Act applies on and after that day:
(d) in relation to the application as if it were a complete application made under this Act; ...
(5) Objection cannot be taken to:
(a) an application mentioned in subsection (2); or
(b) a patent granted on such an application;
and such a patent is not invalid, so far as the invention is claimed in any claim, on any ground that would not have been available against the application or patent, as the case may be, under the 1952 Act.
The effect of these provisions is that the Patent can be revoked under the Act only on a ground of invalidity that would have been available under the 1952 Act. In any case where a relevant ground of invalidity under the 1952 Act is narrower than the corresponding ground under the Act, the patentee has the benefit of the narrower ground and is not to be worse off than if the 1952 Act had continued to operate: NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1993) 44 FCR 239 at 250 ff per Lockhart J, with whom Northrop J agreed and with whom Burchett J agreed on this point; ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc (2000) 106 FCR 214 (Lubrizol) at [22]–[24]; Aktiebolaget Hässle v Alphapharm Pty Ltd (2000) 51 IPR 375 at [8]–[10].
Professors Banwell and Davies
Lundbeck and Alphapharm led evidence from a number of experts, not all of whom were cross-examined. Two of the experts, Professor Martin Banwell called by Alphapharm, and Professor Stephen G Davies called by Lundbeck, conferred and produced a joint report (the Joint Report) in which they responded to six issues that had been formulated by the legal representatives of Alphapharm and Lundbeck. In response to each issue, they stated matters on which they were agreed, and, where they disagreed, their respective positions. The legal representatives of Alphapharm and Lundbeck played no part in the Professors’ conference or in their formulation of their responses to the six questions.
The Joint Report of Professors Banwell and Davies was admitted in part as Exhibit A9 and, as to the remainder, as Exhibit A10.
Professors Banwell and Davies were sworn in in immediate succession, and in addition to being cross-examined in the conventional manner, they had the opportunity, in a “concurrent evidence” session, to elaborate on their positions and to respond to questions asked by me, as well as to questions asked by each other.
Both Professors Banwell and Davies are highly qualified in the area of organic chemistry. I discuss their qualifications and experience further at Section E [207] ff.
General chemical background
In order to understand the issues in these proceedings, it is necessary to have some understanding of organic chemistry. The following outline is based on the affidavit evidence of Professors Banwell and Davies and on the text, Morrison and Boyd, Organic Chemistry, published by Allyn and Bacon (Morrison and Boyd), to which they referred. At the priority date of 14 June 1988, the 5^th edition of this text, published in 1987, was a standard text for students and organic chemists. It would be tedious for every phrase or sentence that I quote to be placed within quotation marks and for distinctions to be made between quotation and paraphrase. I acknowledge, however, my quotation from, and otherwise my reliance on, paras 16 to 56 of Professor Banwell’s affidavit sworn 11 August 2006, Annexure 1 to Professor Davies’s affidavit sworn 4 April 2007, and Chapters 1 and 4 of Morrison and Boyd.
Atoms and molecules
Organic chemistry is a specialised branch of chemistry dedicated to the study of molecules that contain carbon atoms. Atoms are the building blocks of all matter. They are composed of three types of particles: protons, which carry a positive (+1) charge; neutrons, which carry no charge; and electrons, which carry a negative (–1) charge. Protons and neutrons are held together by very strong forces and constitute the “nucleus” of an atom. Electrons orbit the nucleus at different levels.
The chemical elements, such as carbon, hydrogen and oxygen, are particular types of atoms. Each element has a unique number of protons, which, if the element is uncharged, is equal to its number of electrons. Some elements have a more stable number of electrons than other elements. Stability is achieved by filling orbitals known as electron shells. The first electron shell requires two electrons. The second and third each require eight electrons. The greatest stability is reached when the outermost electron shell for the particular element is full. Elements interact with each other in order to achieve a stable number of electrons either by gaining, losing or sharing electrons.
Molecules are combinations of atoms. They are described by molecular formulae which utilise chemical symbols for each element followed by numeric subscripts for the number of atoms of that element in the molecule. For example, a molecule of water is shown as H₂O to signify that the molecule comprises two atoms of hydrogen (H) and one of oxygen (O). Citalopram comprises the elements hydrogen, oxygen, carbon (C), fluorine (F) and nitrogen (N). In complicated molecules, groups of atoms with a specific function are called functional groups. An example in this case is the hydroxyl group (OH).
Atoms are held together in molecules by electron sharing, in a process called covalent bonding. A covalent bond refers to the sharing of two electrons between two atoms, so that both electrons fall within the outer shell of each atom. Most elements need to share a certain number of electrons to be stable. For example, in order to achieve stability, hydrogen, which has one electron and needs to fill the first electron shell (which has a capacity of two electrons), forms one covalent bond; carbon, which has six electrons and needs to fill both the first electron shell and the second electron shell (which has a capacity of eight electrons), forms four covalent bonds; and chlorine (Cl), which has seventeen electrons and needs to fill the first, second and third electron shells, forms one covalent bond. When an atom of hydrogen reacts with an atom of chlorine, they share one electron with each other to make a covalent bond. Once this happens, both atoms have a stable number of electrons and a molecule of hydrogen chloride is the result. Pictorially, a hydrogen chloride molecule (HCl) is represented by a line joining the two atoms to indicate a covalent bond (H–Cl).

Stereochemistry is the study of the three-dimensional structure of molecules. A molecular formula generally conveys little about how the constituent atoms are physically arranged with respect to each other. Structural formulae have been developed to convey two-dimensional (2D) and, where appropriate, three-dimensional (3D) arrangements of atoms within a given molecule.
Diagram I below shows several ways of representing the molecule methane. Within that diagram, Drawing 1 is the molecular formula. Drawing 2 is a 2D structural formula that shows the connectivity of the atoms, but not their orientation in space. Drawing 3 is a projection drawing showing the 3D spatial arrangement of the atoms. The solid wedge indicates that the hydrogen atom at the lower right is coming directly out of the plane of the paper, whereas the broken or hashed wedge shows that the hydrogen atom to the right lies behind the plane of the paper. Straight lines show bonds in the plane of the paper.
Diagram I – Various formulaic representations of methane

Isomers and enantiomers

Molecules with the same molecular formulae but different connections or different spatial arrangements between atoms are called isomers. Structural isomers differ in the way in which the atoms are connected together. In the case of stereoisomers, the atoms are connected in the same way, but the atoms are arranged differently in space. Stereoisomers behave similarly in many chemical reactions. However, in some chemical reactions they behave quite differently. This is particularly the case when stereoisomers interact with molecules within living organisms, such as enzymes within the human central nervous system.
There are two types of stereoisomers: enantiomers and diastereomers. Enantiomers are non-superimposable mirror images of each other, much like a person’s left hand and right hand. Diastereomers are not mirror images of each other and have different physical and chemical properties. Objects that have a non-superimposable mirror image, such as human hands, are chiral. A chiral molecule can exist in two isomeric forms, each of which is the mirror image of the other, that it to say, is not superimposable on the other. An achiral molecule lacks that feature: its isomeric forms are superimposable on one another. In organic chemistry, a molecule that contains a carbon atom bonded to four different atoms or functional groups is chiral. For example, the molecule bromochlorofluoromethane is chiral because it has bromine (Br), chlorine, fluorine and hydrogen atoms attached to the central carbon atom. In Diagram II below, Drawing 4 shows the 2D structure of bromochlorofluoromethane and Drawings 5 and 6 show the 3D structures of the two enantiomers.
Diagram II – 2D structure (4) and two enantiomers (5 and 6)
of bromochlorofluoromethane

4 5
Mirror
6

It is common ground that in 1988, an ordinary skilled but non-inventive chemist, being given a 2D structural formula with a single chiral centre (such as Drawing 4) would recognise the presence of two enantiomers (Drawings 5 and 6). The 2D structural formula would represent either a single enantiomer or, if the molecule was part of a mixture, the two enantiomers in either equal or unequal parts. It is also common ground that if that chemist was also given some background to the origin of the molecule or mixture, the chemist would be able to determine which of those situations applied. This is because of what was known about how enantiomers are produced.
Generally speaking, chiral molecules exist in nature only as one enantiomer. However, when chiral molecules are synthesised in a laboratory, there is a 50% probability that either enantiomer will be produced, so the two enantiomers are produced in equal parts. The resultant mixture is known as a racemate or racemic mixture. It may be a solid, liquid or gas. To obtain an unequal mixture of the enantiomers, or a single enantiomer, some specific step must be taken in the synthesis (enantio-selective synthesis).
Labelling enantiomers as (+) or (-) and as R or S
. There are two conventions for describing enantiomers. The first depends on the physical property of the rotation of plane-polarised light (optical activity). Enantiomers rotate plane-polarised light in opposite directions. Enantiomers are designated (+) (dextrorotatory) or (-) (levorotatory) on the basis of whether, in solution, they rotate plane-polarised light clockwise (to the right) or anti-clockwise (to the left), respectively. Because enantiomers rotate plane-polarised light in opposite directions to equal extents, a racemate has no net rotation of plane-polarised light. It is optically inactive.
The second way of describing enantiomers is an abstract theoretical description (as distinct from requiring physical testing) and provides an absolute configuration. Enantiomers are designated R or S on the basis of the direction of rotation when the molecule is abstractly positioned according to certain standard rules (the Cahn Ingold Prelog (CIP) rules). The rules are based on the atomic number (number of protons) of each atom or functional group connected to the chiral centre. First, each atom or functional group is labelled 1 to 4, with 1 indicating the highest atomic number and 4 indicating the lowest atomic number. Second, the molecule is visualised so that the atom or group labelled 1 (and so having the lowest atomic number) is directed into the page. Third, a curved arrow is drawn from the 1 position to the 2 position and then to the 3 position, and from the 3 position to the 4 position. If the arrow points clockwise, the configuration is designated R (Latin: rectus, right); if it points anticlockwise, the configuration is designated S (Latin: sinister, left). Diagram III below shows the two enantiomers of bromochlorofluoromethane, reoriented so that the atom with the lowest atomic number (H) is facing away from the page. The enantiomers are designated R and S based on the descending priority of the other three elements.
Diagram III – 3D structure and R and S designations of two enantiomers (7 and 8)
of bromochlorofluoromethane

7 8

It is common ground that in 1988, an ordinary skilled but non-inventive chemist, being given a 2D structural formula with a single chiral centre, could, by applying the CIP rules, have drawn the absolute configuration of each of the two enantiomers, R and S.
Application to citalopram
The following is the 2D structural formula of citalopram:
Diagram IV – 2D structural formula of citalopram
This formula uses a convention for organic molecules where carbon and hydrogen molecules are not identified by symbols. For example, each of the lines surrounding the N (nitrogen) on the right side of the structure represents a bond to a carbon atom, which is itself bonded to two or three hydrogen atoms. The hydrogen atoms never appear in such formulae. Because each carbon atom must have four covalent bonds, bonds to hydrogen atoms are inferred if a junction has less than four bonds emanating from it. The hexagon ‘rings’ contain carbon atoms at each junction. Double bonds between carbon atoms are indicated by double lines and single bonds by single lines. The carbon atoms at each junction are also bonded either to another carbon atom (indicated by a bond ending in a junction), a fluorine atom (indicated by – F) or a hydrogen (not represented by symbol).
It is not in dispute that, based on the principles referred to above, including the CIP rules, a chemist could, at the priority date, identify from the formula in Diagram IV:
·four different chemical groups attached to a common carbon (the carbon being, by definition, a centre of chirality); and
·the R and S enantiomers of the compound.
Furthermore, a chemist could, at the priority date, depict the R and S enantiomers of citalopram, but not which of them would be the (+)-enantiomer and (-)-enantiomer. There is no fixed relationship between the R and S dichotomy and the (+) and (-) dichotomy. It is only as a result of testing with plane-polarised light that one can know which of the R and S enantiomers is the (+)-enantiomer and which is the (-)-enantiomer.
Major Depressive Disorder and selective serotonin reuptake inhibitors
Depression, and in particular, Major Depressive Disorder (MDD) is a common psychiatric disorder. Its basis is thought to be a disruption of normal neural transmission. Serotonin (5-HT) is a neurotransmitter which allows messages to be transmitted between nerves. By the priority date of the Patent, it was understood that neurotransmission by, relevantly, serotonin was comparatively deficient in MDD sufferers. It was thought that if the reuptake of 5-HT by nerve cells could be inhibited, there would be more free 5-HT in the synapses between the nerve cells, and that this additional 5-HT would improve neurotransmission and therefore give relief from MDD.
Citalopram and escitalopram is a selective serotonin reuptake inhibitor (SSRIs). The term “selective” implies the avoidance of undesirable side effects. Citalopram and escitalopram are compounds that selectively block only the uptake of 5-HT. In 1988, there were no SSRIs on the market, although some had been launched previously and withdrawn due to toxicity, while others were being developed. Fluoxetine (sold under the brand name “Prozac”), paroxetine (sold under the brand name “Seroxat”), and citalopram were early SSRIs. Fluoxetine and citalopram were racemates and paroxetine was a single enantiomer. Citalopram was considered to be the most selective of these SSRIs.
Since 1988, other SSRIs have been introduced, including escitalopram.
SECTION B – THE PATENT
The various earlier patents
I find it convenient to list here the various patents which were referred to in the evidence. They fall into three groups:
·the patents for the racemic mixture citalopram having both the (+) and (-) enantiomers in equal portions (the Citalopram Patents);
·the patents for the intermediate diol (the Diol Patents); and
·the patents for the (+)-enantiomer of citalopram, which is in fact the S-enantiomer or escitalopram (the Escitalopram Patents).
The Citalopram Patents
1.The UK Citalopram Patent based on Convention application No 1486/76, filed in Great Britain on 14 January 1976.
2.The Australian Citalopram Patent, being Australian patent No 509,445 dated 5 January 1977, for an invention entitled “phthalanes” of a given general chemical formula, and based on the Convention application for the UK Citalopram Patent.
3.The US Citalopram Patent, being United States patent No 4,136,193 dated 23 January 1979, for the same invention and based on the application for the UK Citalopram Patent.
The Diol Patents
4.The UK Diol Patent, being application No 8419963, filed the United Kingdom on 6 August 1984.
5.The Australian Diol Patent, being Australian patent No 574819 dated 2 August 1985 for a “novel intermediate and method for its preparation” and based on the application for the UK Diol Patent.
6.The US Diol Patent, being United States patent No 4,650,884 dated 17 March 1987 for the same invention and based on the application for the UK Diol Patent (the US Diol Patent).
The Escitalopram Patents
7.The UK Escitalopram Patent, being patent application No 8814057 filed in Great Britain on 1 June 1989 with a priority date of 14 June 1988.
8.The EU Escitalopram Patent, being European patent No 0 347 066, based on the application for the UK Escitalopram Patent being for “New enantiomers and their isolation”. (The validity of the EU Escitalopram Patent has been the subject of three decisions:
·the decision of Justice Kitchin given on 4 May 2007 in Generics (UK) Ltd v H Lundbeck A/S (Generics v Lundbeck) in the Patents Court, Chancery Division, High Court of Justice and reported at [2007] RPC 32 ;
·the decision on appeal from that decision of the English Court of Appeal given on 10 April 2008 in H Lundbeck A/S v Generics (UK) Ltd [2008] EWCA 311; and
·the decision of the German Federal Patent Court given on 27 August 2007 in proceeding number 3 Ni 9/05 (EU), Neolab Ltd v H Lundbeck AS.)
9.The Australian Escitalopram Patent, being Australian patent No 623144 dated 9 June 1989 (application filed on 13 June 1989), based on the application for the UK Escitalopram Patent, being for “(+) Enantiomer of Citalopram and process for the preparation thereof” – the Patent.
10.The US Escitalopram Patent, being United States patent No 4,943,590 dated 24 July 1990, based on the application for the UK Escitalopram Patent, being for “pharmaceutically useful (+)-1-(3-dimethylaminopropyl)-1-(4’-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof”.
11.The US Re-issued Escitalopram Patent, being United States patent No 34,712 dated 30 August 1994 (a re-issue of the US Escitalopram Patent) based on the application for the UK Escitalopram Patent and being for “pharmaceutically useful (+)-1-(3-dimethylaminopropyl)-1-(4’-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof”. (The validity of this US Re-issued Escitalopram Patent was the subject of a decision of the United States District Court for the District of Delaware given on 13 July 2006 in Forest Laboratories Inc v Ivax Pharmaceuticals Inc 438 F Supp 2d 479 (2006) and of the decision on appeal from that decision, given on 5 September 2007 by the United States Court of Appeals for the Federal Circuit in Forest Laboratories Inc v Ivax Pharmaceuticals Inc 501 F 3d 1263 (2007).)
The complete specification of the Patent
I will now summarise the content of the complete specification of the Patent.
I set out the claims of the Patent at [10] above. The specification states that “the present invention relates to the two novel enantiomers of the antidepressant drug 1-(3-dimethylaminopropyl)-1-(4'-fluorophenyl)-1,3,-dihydroisobenzofuran-5-carbonitrile (citalopram) of the following formula I:
and to the use of these enantiomers as antidepressant compounds as well as the possible use as geriatrics [sic – their possible use with geriatrics] or in the cure of obesity or alcoholism”.
The specification states that the invention includes pharmaceutically acceptable salts of the enantiomers of compound I (being a compound of the formula I set out above), and gives examples of such pharmaceutically acceptable organic salts and inorganic salts.
The specification states that the invention is also concerned with the method to resolve the racemate of I into the individual isomers. In this context, “the individual isomers” means the individual enantiomers.
According to the specification, citalopram, the racemate, was disclosed in the US Citalopram Patent. The US Citalopram Patent is the US equivalent of the Australian Citalopram Patent, on which Alphapharm relies as an anticipation of the Patent. Both the US Citalopram Patent and the Australian Citalopram Patent were based on the UK Citalopram Patent (see [79] above).
The specification states that citalopram has proved to be an efficient antidepressant compound in man, and has been shown pharmacologically to be a very selective inhibitor of 5-HT reuptake.
The specification states that previous attempts to crystallise diastereomeric salts of citalopram enantiomers have failed. This calls for some explanation.
A conventional approach to the resolution of a racemate is to attempt to react it with a chiral organic acid (resolving agent) prepared as a single enantiomer. The theory is that the two enantiomers of the racemate will form two different diastereomeric salts with the single enantiomer of the acid. Diastereomers were discussed at [68] above. Diastereomers can have different physical and chemical properties. One of the properties which may differ between the diastereomeric salts is the propensity to crystallise, and it is possible by means of this difference to isolate one of the diastereomeric salts. As Dr Bøgesø of Lundbeck explained in his affidavit: “….if suitable conditions can be found to exploit [the propensity to crystallise], it is possible to crystallize out of solution only one of the diastereomeric salts…the isolated salt may then be recrystallized and then transformed into the free base which again may be transformed to a salt and crystallized, thereby isolating a single pure enantiomer of the originally racemic material”. This technique is called fractional crystallisation.
There are two prerequisites for success in using fractional crystallisation. First, it is necessary that crystals be obtained, and this is not assured. Second, it is necessary that the diastereomers have different degrees of solubility for preferential crystallisation of one enantiomer to occur. As will be noted below, Dr Bøgesø gave evidence that his attempts to separate the enantiomers of citalopram in this way had been unsuccessful, principally because he could not obtain crystallisation, and on the one occasion when he did obtain it (with (+)-camphorsulfonic acid), separation was not obtained.
The specification states, however, that “[s]urprisingly, it has now proven possible to resolve the intermediate 4-(4-dimethylamino)-1-(4’-fluorophenyl)-1-(hydroxy-1-butyl)-3-hydroxymethyl) benzonitrile, II, into its enantiomers and finally in a stereoselective way to convert these enantiomers to the corresponding citalopram enantiomers.” The process just described (and described in more detail below) was referred to as “Reaction Scheme II” before me.
Formula II, referred to above, is as follows:
This formula II is of the intermediate diol of citalopram. Reaction Scheme II thus consists of a resolution of this diol into its own enantiomers and then, in a stereoselective way, a conversion of those enantiomers to the enantiomers of citalopram.
The intermediate racemic diol (II) was disclosed in, for example, the US Diol Patent. The US Diol Patent is the equivalent of the Australian Diol Patent, and both the US and the Australian Diol Patents were based on the UK Diol Patent (see [79] above).
A “Reaction Scheme I” (described in more detail below) is also referred to in the specification. Reaction Scheme I reads: “Likewise, monoesters of II formed by optically active carboxylic acids could be separated into the corresponding diastereomers and subsequently converted directly into citalopram enantiomers in a stereoselective ringclosure reaction”. The “optically active carboxylic acid” that featured in the case was “Mosher’s Reagent” or “Mosher’s acid chloride”.
The “intermediate” or “precursor” diol was the essence of both Reaction Schemes I and II. The reference to “stereoselective” in both Reaction Schemes signifies the importance of stereoselectivity in the step from the enantiomer of the diol (in Reaction Scheme II) or monoesters of the diol (in Reaction Scheme I) to the enantiomer of citalopram. The ringclosure reaction had to be, in general terms, one that enabled optical activity to be retained, and racemisation (or “re-racemisation”) to be avoided.
According to the specification it was shown, surprisingly, that almost the entire 5-HT uptake inhibition resided in the (+)-enantiomer of citalopram.
Reaction Scheme I is depicted in the specification as follows (I have taken the liberty of indicating with square brackets and arrows on the diagram certain features of the reaction):
The racemic diol (which is compound II – see [90] above) is depicted at the top of the diagram. It includes at the top left a benzonitrile ring. Attached to the right of this ring is hydroxyl methyl (CH₂OH), which is a primary alcohol (the carbon in the alcohol being bonded to one other carbon). Below that is a further alcohol comprised of the hydroxyl group (OH) and the carbon (C), which is a tertiary alcohol (the carbon being bonded to three other carbons). The bottom ring is a flourophenyl ring.

Accordingly, Alphapharm submits that Professor Montgomery’s evidence of the kind mentioned is not relevant in any of the three proceedings mentioned. Arrow supports Alphapharm’s objection made in the Revocation Proceeding for the purposes of the Arrow Proceeding.
Lundbeck countered the General Relevance Objection in the Revocation Proceeding and the Arrow Proceeding on the basis that the evidence was relevant to the issue of obviousness. Lundbeck submits that Professor Montgomery’s evidence goes to, for example:
(i) there having been little motivation to separate and test the enantiomers of citalopram when the racemate was safe and effective
(ii) the unexpected superior clinical properties of escitalopram, including its superior efficacy, earlier onset of action, it being more effective in the more severely depressed patients, and it being effective in a greater number of patients than citalopram and other SSRIs; ...
Lundbeck also submitted that Professor Montgomery’s evidence is relevant to showing that escitalopram has different pharmacological and clinical effects, which, it says, is relevant, in relation to TGA (Protected Information) Proceeding, to the issue whether citalopram consists of or contains the same active component as escitalopram, and, in relation to the Lundbeck Appeal (Extension of Term) Proceeding, to the issue whether escitalopram is a different pharmaceutical substance per se from citalopram.
Consideration of Alphapharm’s General Relevance Objection
In relation to inventive step, it is the common general knowledge, understandings and expectations of the hypothetical skilled non-inventive addressee or team as at the priority date that matter. As noted in Section E at [224], I accept Professor Montgomery’s evidence and that of other witnesses:
·that it was common general knowledge at the priority date that it was possible that at most all of the beneficial effects of citalopram might reside in one enantiomer, the other being mere “ballast”; and, if so,
·that by means of using a single enantiomer, all the benefits of citalopram might be obtained from half the dosage.
I do not accept, however, that it was part of common general knowledge at that time that it was possible that one enantiomer might be many times more therapeutically effective than the racemate.
The Patent specification accords with the position as I have described it in the preceding paragraph. It states:
Furthermore, it was shown to our surprise that almost the entire 5 H-T uptake inhibition resided in the (+)-citalopram enantiomer.
If it surprised the inventors that “almost the entire 5 H-T uptake inhibition resided in the (+)-enantiomer” [my emphasis] it must have also been very surprising to them to learn after the priority date that the (+)-enantiomer gave many times the therapeutic benefits given by citalopram.
There is a series of decisions of the various courts of the United States in which it has been accepted that unexpected superiority in effectiveness is probative of non-obviousness: see, for example, Sterling Drug Inc v Watson 135 F Supp 173 (1955) at 175-176; In re Gershon, 372 F 2d 535 (1967) at 537; In re Skoner, 517 F 2d 947 (1975) at 950; Ex parte Sohda 2002 WL 519757 at 2-3; In re Chupp, 816 F 2d 643 (1987) at 646-647; Ortho-McNeil Pharmaceutical Inc v Mylan Laboratories Inc 348 F Supp 2d 713 at 755-756.
In some of these cases it has been said that the evidence of unexpected superior clinical benefits has been admitted to counter prima facie obviousness arising from other evidence. I do not find other evidence in the present case raising a prima facie case of obviousness. In any event, this was not a basis of admissibility relied upon by Lundbeck.
In Canada, it has been suggested that in relation to obviousness, little weight should be given to “subsequently recognised advantages”: see Janssen-Ortho Inc v Novapharm Ltd [2006] Carswell Nat 3249 at [113](8), [114](8).
In oral submissions, senior counsel for Lundbeck stated:
In terms of obviousness, the opinion as to how predictable this material was is relevant. It’s not advanced for the proposition that because there was this unexpected benefit, that somehow makes it inventive. That’s not what we’re saying. We’re simply not advancing that argument. But we are advancing the argument on motivation. If you didn’t expect this unexpected benefit, then the fact that you have this massive benefit doesn’t mean that you were motivated to move mountains to get there.
The problem with this basis of admissibility is that Alphapharm does not rely upon escitalopram’s having far superior therapeutic benefits to those of citalopram as establishing motivation. In fact, by its objection, Alphapharm is seeking to keep out Professor Montgomery’s evidence that escitalopram was later found to have therapeutic benefits far superior to those of citalopram.
In Wellcome, Aickin J, with whom the other members of the High Court agreed, stated (at 287):
... not all inventions are to be classified as fulfilling a long-felt want. Those which reveal an “unfelt want” are as likely, or sometimes more likely, to involve an inventive step.
In Astra at [38], Gleeson CJ, Gaudron, Gummow and Hayne JJ approved of this passage. However, neither Aickin J in Wellcome nor their Honours in Astra were saying that evidence of unexpected benefits is admissible. Rather, the point they were making was that evidence of previous unsuccessful attempts to satisfy a long-felt want, while admissible, might not be entitled to much weight since inventive step can be present, not only in the presence of a long-felt want and associated motivation, but also in their absence.
It seems to me that Lundbeck has set up a “straw man” to knock down. In the light of the nature of the case that Lundbeck had to counter, it was only evidence of what was commonly known and expected at the priority date that it was entitled to seek to prove. Evidence of post-priority date surprises did not fall within that description.
Since arriving at the conclusion expressed in the last paragraph, I have read what Kitchin J has said on the present issue in Generics v Lundbeck at [231]–[237] and the passages from the authorities to which his Lordship refers, namely, Richardson-Vicks Inc’s Patent [1995] RPC 568 at 581 and Glaxo Group Ltd’s Patent [2004] RPC 43 at [113]. I note that my conclusion is generally in line with those three authorities.
In summary, while I would admit any parts of Professor Montgomery’s affidavit that go to the pre-priority date common general knowledge and expectations of the hypothetical skilled but non-inventive addressee or team as to the benefits to be found in a separate enantiomer, I do not admit the passages tendered to prove that the post-priority date clinical studies and data established that in fact the therapeutic benefits of escitalopram far exceeded those expectations.
In relation to the Lundbeck Appeal (Extension of Term) Proceeding, Professor Montgomery’s evidence showing that escitalopram has different pharmacological and clinical effects was initially potentially relevant to the question of whether Cipramil consisted of or contained the pharmaceutical substance (+)-citalopram because of submissions made by Lundbeck as to the meaning and application of provisions of the TG Act. However, I have now rejected Lundbeck’s submissions in that respect (see Section K above), and the evidence is therefore shown to be irrelevant.
Finally, in relation to the TGA (Protected Information) Proceeding, Lundbeck Australia contended that Professor Montgomery’s evidence showing that citalopram and escitalopram have different pharmacological properties and effects was relevant to the question whether Cipramil can be said to consist of or contain (+)-citalopram. According to the submission, his evidence was relevant to that question because of Lundbeck Australia’s submission as to the meaning and application of the expression “active component”. However, again, I have now rejected Lundbeck’s submission in that respect too (see Section L above), and so the evidence is shown to be irrelevant.
In sum, the General Relevance Objection is sustained in the Lundbeck Appeal (Extension of Term) Proceeding and the TGA Proceeding and, to the extent mentioned, in the Revocation Proceeding and the Arrow Proceeding.
The nature of Alphapharm’s Factual Basis Objection
Alphapharm submits:
415. ... Professor Montgomery articulates a series of opinions regarding the efficacy of citalopram vs (+) citalopram on the basis of his interpretation of reports or articles, which in turn report the results of certain clinical studies (most of which were conducted by or on behalf of Lundbeck).
416. No person has given evidence regarding the conduct of those studies, the underlying data concerning the studies has not been provided and there has been no disclosure of primary documents that might reveal (for instance) the aims, objectives or methodology of those studies. The authors of the Journal Articles relied upon have not given evidence. As submitted above, Alphapharm was able to call the pooled studies seriously into question, on the basis of limited material.
417. The Journal Articles themselves constitute reports of selected information taken from and summarized as the results from clinical studies. Further, there is no evidence as to the existence of other unpublished studies the results of which may be unhelpful to the Lundbeck arguments. Professor Montgomery does not refer to the underlying data, but relies on the results as reported in the Articles.
418. The Journal Articles themselves are at times opaque as to the studies upon which their conclusions are based ... Further, not all of the studies upon which the Montgomery expert evidence is based were published.
419. Accordingly, the basis upon which Professor Montgomery has expressed his opinions is hearsay evidence which cannot be admitted as evidence of the truth of its contents.
420. Alphapharm submits that, in the absence of proof of that factual basis, the evidence of Professor Montgomery in this regard is inadmissible.
Alphapharm relies on a passage from the well-known judgment of Heydon JA (as his Honour then was) in Makita (Australia) Pty Limited v Sprowles (2001) 52 NSWLR 705 (Makita) at [85]:
In short, if evidence tendered as expert opinion evidence is to be admissible, it must be agreed or demonstrated that there is a field of “specialised knowledge”; there must be an identified aspect of that field in which the witness demonstrates that by reason of specified training, study or experience, the witness has become an expert; the opinion proffered must be “wholly or substantially based on the witness’s expert knowledge”; so far as the opinion is based on facts “observed” by the expert; they must be identified and admissibly proved by the expert, and so far as the opinion is based on “assumed” or “accepted” facts, they must be identified and proved in some other way; it must be established that the facts on which the opinion is based form a proper foundation for it; and the opinion of an expert requires demonstration or examination of the scientific or other intellectual basis of the conclusions reached: that is, the expert’s evidence must explain how the field of “specialised knowledge” in which the witness is expert by reason of “training, study or experience”, and on which the opinion is “wholly or substantially based”, applies to the facts assumed or observed so as to produce the opinion propounded. If all these matters are not made explicit, it is not possible to be sure whether the opinion is based wholly or substantially on the expert’s specialised knowledge. If the court cannot be sure of that, the evidence is strictly speaking not admissible, and, so far as it is admissible, of diminished weight.
Lundbeck submits that it has not been accepted in this Court that an expert’s opinion is inadmissible if it is based on assumed or accepted facts that are not identified and proved, citing: Sydneywide Distributors Pty Ltd v Red Bull Australia Pty Ltd (2002) 55 IPR 354 (Sydneywide) at [16] per Branson J and [87] per Weinberg and Dowsett JJ); Neowarra v Western Australia (No 1) (2003) 134 FCR 208 at [16], [21]–[27] per Sundberg J; Jango v Northern Territory (No 4) (2004) 214 ALR 608 at [19] per Sackville J; NutraSweet Australia Pty Ltd v Ajinomoto Co Inc (2005) 67 IPR 381 at [33] per Finkelstein J; Cadbury Schweppes Pty Ltd v Darrell Lee Chocolate Shops Pty Ltd (2006) 228 ALR 719 at [7] per Heerey J.
I do not think it necessary to review all of these cases.
It is necessary to distinguish between two potential meanings of the notion of a “basis rule”. The expression may be used to refer to a supposed rule that evidence of expert opinion is not admissible unless the expert identifies the assumed factual basis for his or her opinion, thereby distinguishing between what is opinion and what is not. This goes to the form taken by the expert’s evidence. The provisions of s 79 of the Evidence Act tend to have the practical effect of requiring attention to the form that expert evidence takes: HG v The Queen (1999) 197 CLR 414 at [39] per Gleeson CJ. As I noted in Harrington-Smith v State of Western Australia (No 2) (2003) 130 FCR 424 at [25], in the absence of a distinction between opinion and assumed factual basis, the Court may not be able to be satisfied:
·as to what is the opinion proffered;
·that the facts assumed by the expert are sufficiently like the actual facts to make the opinion relevant for the purposes of s 56 of the Evidence Act (see Quick v Stoland Pty Ltd (1998) 87 FCR 371 (Quick v Stoland) at 374 per Branson J; Sydneywide at [14] per Branson J); or
·that the opinion is one substantially based on the expert’s specialised knowledge, for the purposes of s 79 of the Evidence Act (see Makita at [85] per Heydon JA).
On the other hand, the expression “basis rule” may be used to refer to a supposed rule that evidence of expert opinion is not admissible unless the factual basis of the opinion is proved by admissible evidence.
Generally speaking, Professor Montgomery’s evidence is not criticised for not identifying the basis of his opinions: he identifies precisely enough the journal articles on which he relies, and where he does not attribute a statement to a particular article, he is making only an introductory statement (for example, para 77 of his affidavit which was set out at [732] above) or giving an overall summary of the effect of all of the articles. What is put by Alphapharm is that Professor Montgomery’s opinions are not admissible because the factual basis for them, being the actual carrying out and recording of the results of the clinical studies reported in the journal articles, were not proved by admissible evidence (see para 416 of Alphapharm’s submissions set out at [754] above).
Consideration of Alphapharm’s Factual Basis Objection
The starting point for resolution of Alphapharm’s General Relevance Objection is a particular group of exceptions to the hearsay rule that were recognised under the general law as being dictated by necessity. In the Law Reform Commission’s Interim Report on Evidence (ALRC No 26, 1985), the Commission described these exceptions as (a) the expert’s accumulated knowledge, (b) the reported data of fellow scientists, and (c) information commonly relied upon in an industry, trade or calling (ALRC No 26 vol 1 at [131], vol 2 at [91]). The Commission cited in support: English Exporters (London) Ltd v Eldonwall Ltd [1973] 1 Ch 415; R v Abadom [1983] 1 WLR 126; Borowski v Quayle [1966] VR 382 (Borowski); H v Schering Chemicals Ltd [1983] 1 All ER 849 (Schering Chemicals); Reid v Kerr [1974] 9 SASR 367; Rowley v London and North Western Railway Co (1873) LR 8 Exch 221; Dickins v Randerson [1901] 1 KB 437; R v Perryman (1907) 147 CCC Sess Pap 109 (Lawrence J). There is some overlap between the three categories.
The Commission referred, as an illustration of (b), to Borowski, in which the following passage from Wigmore on Evidence, Chadbourn JH (ed) (Little, Brown & Co, Boston, 1979) vol 2 at [665b], was cited with approval:
The data of every science are enormous in scope and variety. No one professional man can know from personal observation more than a minute fraction of the data which he must every day treat as working truths. Hence a reliance on the reported data of fellow scientists, learned by perusing their reports in books and journals. The law must and does accept this kind of knowledge from scientific men…[T]o reject a professional physician or mathematician because the fact or some facts to which he testifies are known to him only upon the authority of others would be to ignore the accepted methods of professional work and to insist on finical and impossible standards…..In general, the considerations which define the (professional) are (a) a proper source of information, (b) an extent of personal observation in the general subject, enabling him to estimate the general plausibility, or probability of soundness, of the views expressed, and (c) the impossibility of obtaining information on the particular technical detail except through reported data in part or entirely. The true solution must be to trust the discretion of the trial judge, exercised in the light of the nature of the subject and the witness’ equipments. The decisions show in general a liberal attitude in receiving technical testimony based on professional reading.
In Borowski, his Honour found (at 386) that evidence given by the expert in that case:
…would have been directed to matter travelling outside opinion and dependent to a degree upon knowledge based upon hearsay. But this is an area where the hearsay rule does not apply and the matter dealt with in the evidence would clearly have been admissible.
This passage was cited with approval in Reid v Kerr [1974] 9 SASR 367, 370, and the necessity of the approach reflected in it was noted in Schering Chemicals at 854.
The same judge-made exception to the hearsay rule was recognised in the standard texts on evidence at that time: see, for example, D Byrne QC and JD Heydon, Cross on Evidence (3^rd Australian Edition, Butterworths, 1986) at [15.31], [17.161], citing, in addition to Borowski and Schering Chemicals, See v Milner (1980) 2A Crim R 210 (FCA); Holt v Auckland City Council [1980] 2 NZLR 124; Cuthill v State Electricity Commissioner of Victoria [1981] VR 908 at 915 (FC); Baker v Australian Asbestos Insulations Pty Ltd [1984] 3 NSWLR 595 at 607.
The Law Reform Commission dealt with the present issue under the heading “Evidence Admissible for a Non-hearsay Purpose” (ALRC No 26 Vol 1 at [685]) stating (footnotes omitted):
Under existing law hearsay evidence that is admissible for a non-hearsay purpose is not excluded, but may not be used by the court as evidence of the facts stated. This involves the drawing of unrealistic distinctions. The issue is resolved by defining the hearsay rule as preventing the admissibility of hearsay evidence where it is relevant by reason only that it would affect the court’s assessment of the facts intended to be asserted. This would have the effect that evidence relevant for a non-hearsay purpose – eg to prove a prior consistent or inconsistent statement, or to prove the basis of the expert’s opinion – will be admissible also of evidence of the facts stated:
Tender of Prior Consistent and Inconsistent Statements
........ .......
Expert’s evidence of Basis of Opinion
Reference has been made above to the uncertainties that exist as to the admissibility of such evidence and to the unclear exceptions which have had to be created to meet the problems created by the hearsay rule. Under the proposal, evidence by an expert of the facts on which his opinion is based will be admissible as evidence of those facts. Potential dangers have been raised. First, there is the danger that false evidence may be placed before the court. However, the expert will usually form a judgment about the accuracy of what he is told. In addition the tactical pressure on the parties to verify the facts relied upon by the expert should ensure that problems of assessment of the evidence will not arise. They will either call more direct evidence or have to face adverse comment. When assessment problems do arise, the exclusionary discretions may be used. This is similar to the present approach. Another danger suggested is that it could result in an increase in evidence adduced – particularly that which is adduced in the Family Court and is of marginal relevance. As at present, the expert will do no more than adduce evidence of the basis of his opinion – what he was told will be relevant to that opinion and the assessment of it. However, the relevance proposal and relevance discretion will apply and give the courts express control where now that control and its extent is unclear. It has also been suggested that parties will want to answer the allegations of marginal relevance and this will give rise to an increase in the evidence given. However, this should not occur. First the party against whom the evidence is led can object to the relevance of the facts related by the expert – only those affecting his opinion will be relevant. As to such facts, that party will have to decide, as at present, whether he accepts those facts or wishes to challenge them. He would have to do this whether the evidence was admitted as the basis of the expert’s opinion or to prove the facts asserted – it would be a foolish party who relied on that distinction in relation to key factual elements and did not call rebutting evidence. The proposal in fact has the potential to save time and costs. At present, the party leading the expert evidence should lead non-hearsay evidence to confirm all the statements made to and relied upon by the court. If he does not, it will be open to the opposing party to argue that the opinion should be rejected – the hearsay rile will lie in wait. Under the proposal he can call witnesses to confirm the key material, and leave it up to the opposing party to cross-examine the witness to raise the matters in issue. If he does not and leads evidence in rebuttal, it will be possible for the first party to call further evidence.

The result of the Commission’s deliberations was s 60 of the Evidence Act. The hearsay rule itself is set out in s 59 of that Act. Section 59(1) provides:
Evidence of a previous representation made by a person is not admissible to prove the existence of a fact that the person intended to assert by the representation.
Section 60 provides for an exception to the hearsay rule as follows:
The hearsay rule does not apply to evidence of a previous representation that is admitted because it is relevant for a purpose other than proof of the fact intended to be asserted by the representation.
A “previous representation” is defined in the Dictionary to the Evidence Act to be a representation made otherwise than in the course of the giving of evidence in the proceeding in which evidence of the representation is sought to be adduced.
The representations made by the authors of the articles cited by Professor Montgomery are “previous representations” as to the carrying out of the clinical studies and the results of them.
Sections 59 and 60 are perhaps an odd way of grappling with the present issue. It seems clear, however, that it was intended that in a case like the present one, statements of the bases for expert opinions like those made by Professor Montgomery were to be characterised as being relevant for a purpose other than proof of the facts intended to be asserted by the representations by the authors of the articles. Prior to the enactment of s 60, the summaries given by Professor Montgomery of the effect of the journal articles would have been ruled admissible as falling within the exceptions dictated by necessity referred to at [761]-[765] above.
In their joint report, Uniform Evidence Law: Report of December 2005, the Australian, New South Wales and Victorian Law Reform Commissions have recognised that s 60 had the effect of excluding from the hearsay rule an expert’s statement of the factual basis of his or her opinion (see [7.74] ff). The Commissions recognised (at [7.74]) that an expert relies on “statements made to him or her by others about their observations of events which are facts in issue, together with a wide range of factual information from more remote sources”. The Commissions gave as illustrations:
·knowledge acquired by experts from reading the work of other experts and from discussion with them;
·the reported data of fellow experts relied upon by such persons as scientists and technical experts in giving expert opinion evidence;
·factual material commonly relied upon in a particular industry or trade or calling.
The Commissions also recognised that, through necessity, there existed those judge-made exceptions to the hearsay rule referred to at [761] above. In addition to Borowski, they cited PQ v Australian Red Cross Society [1992] 1 VR 19; R v Vivona (Unreported, Victorian Court of Criminal Appeal, Crockett, Tadgell and Teague JJ, 12 September 1994); R v Fazio (1997) 93 A Crim R 522. The Commissions then stated at [7.77], [7.78] (footnotes omitted):
7.77 The proposal that became s 60 was formulated with these exceptions in mind, with the intention that s 60 would perform the role the miscellaneous common law exceptions had performed and the complication of specific exceptions for these kinds of evidence avoided.
7.78 Section 60 also applies to representations of fact unique to the particular case upon which the expert bases his or her opinion. Such evidence is hearsay at common law, but s 60 lifts the statutory hearsay rule in that situation.
It will be recalled that the Law Reform Commission noted at [685] of ALRC No 26 Vol 1 (set out at [765] above) that “[p]otential dangers [of the application of s 60] have been raised”, including that false evidence may be placed before the Court. However, it stated that “the expert will usually form a judgment about the accuracy of what he is told”. It also stated that when “assessment problems [in relation to the evidence] do arise, the exclusionary discretions [a reference to Part 3.11 of that Evidence Act] may be used”. Such a use of s 136 of the Evidence Act (which falls within Part 3.11 of the Evidence Act) was referred to by Finkelstein J in Quick v Stoland at 382 and by Nicholson J in Daniel v State of Western Australia (2000) 178 ALR 542 at [30]-[34].
Section 136 of the Evidence Act is entitled “General discretion to limit use of evidence” and provides:
The court may limit the use to be made of evidence if there is a danger that a particular use of the evidence might:
(a) be unfairly prejudicial to a party; or
(b) be misleading or confusing.
As noted earlier, Alphapharm and Arrow ask the Court to exercise its discretion under s 136 in relation to the evidence constituting the factual basis of Professor Montgomery’s opinion.
In a sense, it is true, as Alphapharm submits, that the relevant parts of Professor Montgomery’s evidence consist of a review of scientific literature. This characterisation, however, does not adequately reflect the significance of his testimony. A person lacking his “specialised knowledge based on [his] training, study or experience” (see s 79 of the Evidence Act) would not know how to go about locating relevant articles, would not be able to distinguish between relevant and the irrelevant ones, would not be able to interpret the articles, and would not be able to assess their overall effect in the light of the questions on which his opinion evidence is required. Part of Professor Montgomery’s specialist knowledge is precisely knowledge of the identity of the scientific journals that publish research carried out within his area of expertise, knowledge of the clinicians who have been working and publishing in the area, and knowledge of the relevance and reliability of their published work in relation to the questions raised.
Professor Montgomery gave evidence of the peer-review process that is followed in the case of the two journals of which he has been the editor for approximately the last 16 years. Three or four reviewers are approached, with the possibility of substitutes if any of those approached initially prove to be too slow in providing their comments as reviewers. The article will be accepted for publication if the reviewers so recommend. The reviewers may suggest amendments which, in Professor Montgomery’s experience, only rarely have authors declined to adopt. If, for any reason, reviewers cannot be found for an article, it will not be accepted for publication. Professor Montgomery said that, in the case of both of the journals of which he is editor, approximately 75% of the articles submitted are rejected, some of them out of hand.
While Professor Montgomery did not give evidence of the peer-review process that is followed in the case of the other journals in which the articles he cited were published, I infer that all of those journals in which they were published were peer reviewed and that their editors followed a generally similar peer review process to that followed by Professor Montgomery himself.
It is true that when the Parliament enacted s 60, it was considered that Part 3.11 of the Evidence Act, which contains s 136, would act as a safeguard to limit the operation of s 60 in appropriate circumstances (see [765], [772] above). However, I will not make an order under s 136. The evidence with which I am concerned is the evidence of Professor Montgomery’s opinions. If the opinions were otherwise admissible, I would not think it appropriate to limit the use to be made of them pursuant s 136.
Ultimately, if the scientific community, represented here by Professor Montgomery, accepts as a sufficient basis for the forming of opinions, the reportings of clinical studies published in peer-reviewed articles in scientific journals of high repute, I do not see why the Court should interfere by limiting the use to be made of the opinions.
The weight to be accorded to Professor Montgomery’s opinions remains a matter for the Court. Criticisms made by Alphapharm of particular opinions expressed by him are to be taken into account as going to the weight to be given to those opinions (see Quick v Stoland at 378 per Branson J; Welsh v The Queen (1996) 90 A Crim R 364 at 369, 371). Indeed, as Lundbeck itself states in its submissions:
If Alphapharm doubts the validity of the reports or articles to which Lundbeck’s expert witnesses have referred, it is entitled to question the credibility of these reports or articles (as has been done by Dr Mitchell in his affidavit). His Honour is then invited to make a determination of the validity of these arguments based upon the cross-examination of Dr Mitchell and of Professor Montgomery and use this determination as one of the factors in deciding the weight to be afforded to a particular expert’s evidence.
In fact, Alphapharm adduced evidence from Professor Mitchell countering that of Professor Montgomery and addressing the post-priority date studies mentioned by him. Because Alphapharm’s General Relevance Objection has succeeded, that evidence of Professor Mitchell was rendered irrelevant.
This seems to me to reflect the only practicable way in which opinion evidence of the kind given by Professor Montgomery can be dealt with. In this respect, I note the statement made by Cooke J in Seyfang v G D Searle & Co [1973] QB 148 at 151:
It does appear to me with the greatest respect that a system which does not permit experts to refer in their expert evidence to the publications of other experts in the same field is a system which puts peculiar difficulties in the way of proof of matters which depend on expert opinion.
I have not overlooked the decision of the High Court in Lee v The Queen (1998) 195 CLR 594 or Cadbury Schweppes Pty Ltd v Darrell Lea Chocolate Shops Pty Ltd (No 3) (2006) 229 ALR 179. I do not think, however, that they stand against the approach that I have taken above.
In my opinion, for the reasons given above, s 60 of the Evidence Act defeats the Factual Basis Objection. I would have declined to make an order under s 136 of that Act if the passages objected to had not succumbed to the General Relevance Objection.
SECTION O – CONCLUSION
As the parties requested, I will publish these reasons and give them an opportunity to make submissions as to the orders (including orders as to costs) to be made. The four proceedings will be fixed for a date for the making of such orders. Directions will be made for the filing and service of submissions as necessary.
While the reasons set out above were being proofread in preparation for delivery of judgment, the English Court of Appeal on 10 April 2008 gave judgment in H Lundbeck A/S v Generics (UK) Ltd [2008] EWCA Civ 311, the appeal from the judgment of Kitchin J in Generics v Lundbeck previously noted. With respect, I do not think it necessary to incorporate references to their Lordships’ reasons, which are, generally speaking, consistent with what I have written above.

I certify that the preceding seven hundred and eighty-five (785) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Lindgren.
Associate:
Dated: 24 April 2008
Proceeding NSD 1120 of 2005

Counsel for the Applicant/Cross Respondent (Alphapharm Pty Ltd):
Mr DK Catterns QC, Mr S Burley SC and Mr JS Cooke

Solicitor for the Applicant/Cross Respondent (Alphapharm Pty Ltd): Mallesons Stephen Jaques

Counsel for the Respondent/First Cross Claimant
(H Lundbeck A/S) and for the Second Cross Claimant (Lundbeck Australia Pty Ltd):
Mr D Shavin QC and Ms KJ Howard SC

Solicitor for the Respondent/First Cross Claimant
(H Lundbeck A/S) and for the Second Cross Claimant (Lundbeck Australia Pty Ltd):
Corrs Chambers Westgarth
Proceeding NSD 1870 of 2005

Counsel for the Applicant (Lundbeck Aust Pty Ltd):

Mr D Shavin QC and Ms KJ Howard SC

Solicitor for the Applicant (Lundbeck Aust Pty Ltd): Corrs Chambers Westgarth

Counsel for the First Respondent (the Secretary of the Department of Health & Ageing of the Commonwealth of Australia):
Mr G Kennett

Solicitor for the First Respondent (the Secretary
of the Department of Health & Ageing of the Commonwealth of Australia):
Australian Government Solicitor

Counsel for the Second Respondent
(Alphapharm Pty Ltd): Mr DK Catterns QC, Mr S Burley SC
and Mr JS Cooke

Solicitor for the Second Respondent
(Alphapharm Pty Ltd): Mallesons Stephen Jaques
Proceeding NSD 954 of 2006

Counsel for the Applicant
(Arrow Pharmaceuticals Pty Ltd): Mr C Dimitriadis

Solicitor for the Applicant
(Arrow Pharmaceuticals Pty Ltd): Blake Dawson Waldron

Counsel for the Respondent (H Lundbeck A/S):

Mr D Shavin QC and Ms KJ Howard SC

Solicitor for the Respondent (H Lundbeck A/S): Corrs Chambers Westgarth
Proceeding NSD 1078 of 2006

Counsel for the Applicant (H Lundbeck A/S): Mr D Shavin QC and Ms KJ Howard SC

Solicitor for the Applicant (H Lundbeck A/S): Corrs Chambers Westgarth

The First Respondent (Commissioner of Patents) did not appear, having filed a submitting appearance.

Counsel for the Second Respondent
(Alphapharm Pty Ltd): Mr DK Catterns QC, Mr S Burley SC
and Mr JS Cooke

Solicitor for the Second Respondent
(Alphapharm Pty Ltd):
Mallesons Stephen Jaques

Dates of Hearing: 11, 12, 13, 16, 17, 18, 19, 23, 24, 26 April 2007; 1, 7, 8, 9, 10, 11 May 2007

Date Last Written Submission Received: 21 November 2007

Date of Judgment: 24 April 2008

BETWEEN:		ALPHAPHARM PTY LTD (ACN 002 359 739) Applicant/Cross-respondent
AND:		H LUNDBECK A/S Respondent/First Cross-claimant LUNDBECK AUSTRALIA PTY LTD (ACN 070 094 290) Second Cross-claimant
JUDGE:	LINDGREN J
DATE OF ORDER:	24 APRIL 2008
WHERE MADE:	SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA	NSD 1870 OF 2005
NEW SOUTH WALES DISTRICT REGISTRY

BETWEEN:		LUNDBECK AUSTRALIA PTY LTD (ACN 070 094 290) Applicant
AND:		SECRETARY OF THE DEPARTMENT OF HEALTH AND AGEING OF THE COMMONWEALTH OF AUSTRALIA First Respondent ALPHAPHARM PTY LTD (ACN 002 359 739) Second Respondent
JUDGE:		LINDGREN J
DATE OF ORDER:	24 APRIL 2008
WHERE MADE:	SYDNEY

BETWEEN:		ARROW PHARMACEUTICALS PTY LTD (ACN 003 144 170) Applicant
AND:		H LUNDBECK A/S Respondent
JUDGE:	LINDGREN J
DATE OF ORDER:	24 APRIL 2008
WHERE MADE:	SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY			NSD 1078 OF 2006
BETWEEN:		H LUNDBECK A/S Applicant
AND:		COMMISSIONER OF PATENTS First Respondent ALPHAPHARM PTY LTD (ACN 002 359 739) Second Respondent
DATE OF ORDER:	24 APRIL 2008
WHERE MADE:	SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY		NSD 1078 OF 2006
ON APPEAL FROM THE COMMISSIONER OF PATENTS
BETWEEN:	H LUNDBECK A/S Applicant
AND:	COMMISSIONER OF PATENTS First Respondent ALPHAPHARM PTY LTD (ACN 002 359 739) Second Respondent

JUDGE:	LINDGREN J
DATE:	24 APRIL 2008
PLACE:	SYDNEY

Section	Para No.
A	INTRODUCTION AND BACKGROUND	[1] – [78]
B	THE PATENT	[79] – [113]
C	CONSTRUCTION OF THE PATENT	[114] – [153]
D	NOVELTY	[154] – [174]
E	OBVIOUSNESS	[175] – [426]
F	MANNER OF MANUFACTURE – s 18(1)(a) OF THE ACT	[427] – [441]
G	LACK OF DEFINITION – s 40(2)(b) OF THE ACT	[442] – [447]
H	LACK OF FAIR BASING – s 40(3) OF THE ACT	[448] – [460]
I	LACK OF CLARITY – s 40(3) OF THE ACT	[461] – [465]
J	INUTILITY – s 18(1)(c) OF THE ACT	[466] – [474]
K	THE LUNDBECK APPEAL (EXTENSION OF TERM) PROCEEDING – ALPHAPHARM’S AND ARROW’S CLAIMS FOR RECTIFICATION UNDER s 192 OF THE ACT	[475] – [544]
L	THE TGA (PROTECTED INFORMATION) PROCEEDING	[545] – [633]
M	INFRINGEMENT BY ALPHAPHARM	[634] – [697]
N	ADMISSIBILITY OF CERTAIN EVIDENCE	[698] – [783]
O	CONCLUSION	[784] – [785]

Counsel for the Applicant/Cross Respondent (Alphapharm Pty Ltd):	Mr DK Catterns QC, Mr S Burley SC and Mr JS Cooke
Solicitor for the Applicant/Cross Respondent (Alphapharm Pty Ltd):	Mallesons Stephen Jaques
Counsel for the Respondent/First Cross Claimant (H Lundbeck A/S) and for the Second Cross Claimant (Lundbeck Australia Pty Ltd):	Mr D Shavin QC and Ms KJ Howard SC
Solicitor for the Respondent/First Cross Claimant (H Lundbeck A/S) and for the Second Cross Claimant (Lundbeck Australia Pty Ltd):	Corrs Chambers Westgarth

Counsel for the Applicant (Lundbeck Aust Pty Ltd):	Mr D Shavin QC and Ms KJ Howard SC
Solicitor for the Applicant (Lundbeck Aust Pty Ltd):	Corrs Chambers Westgarth
Counsel for the First Respondent (the Secretary of the Department of Health & Ageing of the Commonwealth of Australia):	Mr G Kennett
Solicitor for the First Respondent (the Secretary of the Department of Health & Ageing of the Commonwealth of Australia):	Australian Government Solicitor
Counsel for the Second Respondent (Alphapharm Pty Ltd):	Mr DK Catterns QC, Mr S Burley SC and Mr JS Cooke
Solicitor for the Second Respondent (Alphapharm Pty Ltd):	Mallesons Stephen Jaques

Counsel for the Applicant (Arrow Pharmaceuticals Pty Ltd):	Mr C Dimitriadis
Solicitor for the Applicant (Arrow Pharmaceuticals Pty Ltd):	Blake Dawson Waldron
Counsel for the Respondent (H Lundbeck A/S):	Mr D Shavin QC and Ms KJ Howard SC
Solicitor for the Respondent (H Lundbeck A/S):	Corrs Chambers Westgarth

Counsel for the Applicant (H Lundbeck A/S):	Mr D Shavin QC and Ms KJ Howard SC
Solicitor for the Applicant (H Lundbeck A/S):	Corrs Chambers Westgarth
The First Respondent (Commissioner of Patents) did not appear, having filed a submitting appearance.
Counsel for the Second Respondent (Alphapharm Pty Ltd):	Mr DK Catterns QC, Mr S Burley SC and Mr JS Cooke
Solicitor for the Second Respondent (Alphapharm Pty Ltd):	Mallesons Stephen Jaques
Dates of Hearing:	11, 12, 13, 16, 17, 18, 19, 23, 24, 26 April 2007; 1, 7, 8, 9, 10, 11 May 2007
Date Last Written Submission Received:	21 November 2007
Date of Judgment:	24 April 2008