Apotex Pty Ltd v AstraZeneca AB (No 4)

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FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162

Citation: Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162
Parties:

APOTEX PTY LTD v ASTRAZENECA AB and ASTRAZENECA PTY LIMITED

WATSON PHARMA PTY LTD v ASTRAZENECA AB and ASTRAZENECA PTY LIMITED

ASTRAZENECA AB and ASTRAZENECA PTY LIMITED v ASCENT PHARMA PTY LTD ACN 118 734 795

File number(s): NSD 673 of 2011
NSD 2342 of 2011
NSD 208 of 2012
Judge: JAGOT J
Date of judgment: 5 March 2013
Corrigendum:  8 March 2013
Catchwords: PATENTS – pharmaceutical patents – invalidity – priority date – novelty – inventive step – entitlement – fair basis – utility – secret use – manner of manufacture – false suggestion – infringement – authorisation  
Legislation: Patents Act 1990 (Cth)
Patents Amendment Act 2001 (Cth)
Patents Act 1952 (Cth)
Cases cited:

Advanced Building Systems Pty Ltd v Ramset Fastners (Aust) Pty Ltd (1998) 194 CLR 171; [1998] HCA 19
Allsop Inc v Bintang Pty Ltd (1989) 15 IPR 686
Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1
Aktiebolaget Hassle v Alphapharm Pty Ltd (2000) 51 IPR 375; [2000] FCA 1303
Aktiebolaget Hassle v Alphapharm Pty Ltd (2002) 212 CLR 411; [2002] HCA 59
Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416; [2009] FCAFC 134
Apotex Pty Ltd v Sanofi-Aventis (2008) 78 IPR 485 [2008] FCA 1194
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) (2012) 204 FCR 494; [2012] FCAFC 102
Apotex Pty Ltd v AstraZeneca AB (No 3) (2012) 95 IPR 581; [2012] FCA 265
Austal Ships Pty Ltd v Stena Rederi Aktiebolag (2005) 66 IPR 420; [2005] FCA 805
Australian Mud Co Pty Ltd v Coretell Pty Ltd (2011) 93 IPR 188; [2011] FCAFC 121
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524; [2000] FCA 316
Britax Childcare Pty Ltd v Infa-Secure Pty Ltd (2012) 290 ALR 47; [2012] FCA 467
British Acoustic Films Ltd v Nettlefold Productions (1935) 53 RPC 221
British United Shoe Machinery Co Ltd v A Fussell & Sons Ltd (1908) 25 RPC 631
Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183
Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254; [2006] FCA 261
Danisco A/S v Novozymes A/S (No 2) (2011) 91 IPR 209; [2011] FCA 282
Decor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385
Ethyl Corp's Patent [1972] RPC 169
Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331; [2000] FCA 890
General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457
H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151; [2009] FCAFC 70
Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd (2008) 78 IPR 20; [2008] FCAFC 139
ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc (2000) 106 FCR…

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Details
Case
[2013] FCA 162
Decision Date

CaseChat Overview and Summary

Apotex Pty Ltd brought an action against AstraZeneca AB regarding the validity and infringement of three pharmaceutical patents related to the drug rosuvastatin. The matter was heard in the Federal Court of Australia, where Justice Bromberg presided over the case. The primary legal issues revolved around the validity of the patents under sections 7 and 18 of the Patents Act 1990 (Cth), specifically considering factors such as novelty, inventive step, and utility. Additionally, the court had to determine whether the patents were infringed by the generic products proposed by Apotex.

The court's reasoning focused on the interpretation of the statutory provisions governing patent validity and infringement. It found that several claims of the patents in question were invalid due to issues of novelty and inventive step. The court concluded that the prior art, including information publicly available before the priority dates of the claims, rendered them not novel or not involving an inventive step. Furthermore, the court determined that the proposed generic products did not infringe on the valid claims of the patents. Consequently, the court dismissed AstraZeneca's applications for relief against infringement and ordered the revocation of the invalid claims. The court also directed the parties to propose orders for revocation and scheduled further proceedings to address the form of the revocation orders and to resolve any remaining matters, including costs.

Orders

Orders of the court

1. Order 2 of the orders of 14 December 2011 be dissolved.

2. The parties file agreed or competing proposed orders reflecting the reasons for judgment published today within 7 days.

3. The proceedings be listed on a date within a further 7 days thereafter, the date to be allocated in consultation with the parties.

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

1. Order 1 of the orders of 15 March 2012 be dissolved.

2. The parties file agreed or competing proposed orders reflecting the reasons for judgment published today within 7 days.

3. The proceedings be listed on a date within a further 7 days thereafter, the date to be allocated in consultation with the parties.

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

Background

Background to the litigation

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Evidence

Evidence Before The Court

Because the complete application for each patent was made before the day on which the amendments to s 7 of the Act by the Patents Amendment Act 2001 (Cth) commenced (being 1 April 2002) the version of s 7 which applies is that which existed before these amendments. Section 7, as it applies to the three patents in issue, provides as follows:(1)For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:(a)prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act;(b)prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information;(c)prior art information contained in a single specification of the kind mentioned in subparagraph (b)(ii) of the definition of prior art base in Schedule 1.(2)For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim, whether that knowledge is considered separately or together with either of the kinds of information mentioned in subsection (3), each of which must be considered separately.(3)For the purposes of subsection (2), the kinds of information are:(a)prior art information made publicly available in a single document or through doing a single act; and(b)prior art information made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information;being information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant to work in the relevant art in the patent area. 4. OVERVIEW OF WITNESS EVIDENCE4.1 AstraZeneca executives4.1.1Mike Bull Mike Bull is the Director of Primary Care at AZ in Australia. Mr Bull gave evidence on a range of topics, including the importation and sale in Australia of Crestor by AZ, the use of private prescriptions in Australia and the marketing of Crestor in Australia.4.1.2Charles Waterfield Charles Waterfield is the Director of Market Access and External Affairs at AZ. He gave evidence on the regulatory, pricing and reimbursement regimes that apply to the supply of pharmaceutical products in Australia, including the operation of the Australian Register of Therapeutic Goods and the Australian Pharmaceutical Benefits Scheme and prescriptions of Crestor in Australia including for patients with HeFH.4.2 Data providers4.2.1John Frost

Decision

Reasons for decision

On the basis of this preferred construction it is apparent that, if claim 1 and the dependent claims of the 842 or cation patent are valid, then the generic rosuvastatin products, excluding only the alternative product proposed by Apotex which does not use titanium dioxide or ferric oxide in the coating, would infringe claim 1 and the dependent claims. 14. CONCLUSIONS For the reasons given I consider that all of the claims of the 051 or low dose patent are invalid and that the patent should be revoked. The claims on which AZ relies to assert infringement of the 165 or HeFH patent (claims 1 to 10 and 21) and the 842 or cation patent (claims 1 to 5, 7 to 9 and 10 to 18) are also invalid and liable to be revoked, although there is a question whether any of the claims of these patents can be sustained given the conclusions I have reached as set out above. The generic parties should immediately be released from any undertakings and interlocutory injunctions that they have given or by which they are bound. AZ’s applications for relief against infringement should be dismissed. The invalid claims of the patents in question should be revoked but it is also appropriate that I hear the parties further on the form of orders for revocation that should be made in all of the circumstances. Costs may be resolved pursuant to other directions that can be made as required.

Ratio Decidendi

Legal Principle Established

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