Apotex Pty Ltd v Cipla Limited

Case [2017] FCA 1627

FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v Cipla Limited [2017] FCA 1627

File number: VID 1229 of 2017
Judge: BEACH J
Date of judgment: 22 December 2017
Catchwords: PRACTICE AND PROCEDURE – patents – interlocutory application – injunction – prima facie case – validity of patent – infringement of patent – balance of convenience – application granted
Legislation:

Patents Act 1990 (Cth) ss 18, 20, 40

Statute of Monopolies 1624, 21 Jac 1 c 3, s 6

Cases cited:

Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411

Apotex Pty Ltd v Sanofi-Aventis (2008) 78 IPR 485; [2008] FCA 1194

Australian Broadcasting Corporation v O’Neill (2006) 227 CLR 57

Hexal Australia Pty Ltd v Roche Therapeutics (2005) 66 IPR 325; [2005] FCA 1218

InterPharma Pty Ltd v Hospira, Inc (No 3) [2017] FCA 1536

Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1997) 137 CLR 228

Otsuka Pharmaceutical Co Limited v Generic Health Pty Ltd (2012) 291 ALR 763; [2012] FCA 239

Samsung Electronics Co Limited v Apple Inc (2011) 217 FCR 238

Smith & Nephew Pty Ltd v Wake Forest University Health Sciences (2009) 82 IPR 467; [2009] FCAFC 142

The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457

Dates of hearing: 20 and 21 December 2017
Registry: Victoria
Division: General Division
National Practice Area: Intellectual Property
Sub-area: Patents and associated Statutes
Category: Catchwords
Number of paragraphs: 159
Counsel for the Applicant and First Cross-Respondent: Mr N Murray and Mr M Fleming
Solicitor for the Applicant and First Cross-Respondent: Ashurst Australia
Counsel for the Respondent, Cross-Claimants and Second Cross-Respondent: Mr B Caine QC and Mr J Cooke
Solicitor for the Respondent, Cross-Claimants and Second Cross-Respondent: MinterEllison

ORDERS

VID 1229 of 2017
BETWEEN:

APOTEX PTY LTD (ACN 096 916 148)

Applicant
AND:

CIPLA LIMITED

Respondent
AND BETWEEN:

CIPLA LIMITED (and another named in the Schedule)

First Cross-Claimant
AND:

APOTEX PTY LTD (ACN 096 916 148) (and another named in the Schedule)

Cross-Respondents

JUDGE:

BEACH J

DATE OF ORDER:

22 DECEMBER 2017

In this order:

“Apotex Generic Products” means any product containing azelastine hydrochloride and fluticasone propionate including those having the following registrations on the Australian Register of Therapeutic Goods:

(a)ARTG ID 277526: AZELASTINE/FLUTICASONE 125/50 APOTEX azelastine (as hydrochloride)/fluticasone propionate 125 microgram/50 microgram nasal spray bottle; and

(b)ARTG ID 277525: APO-AZELASTINE/FLUTICASONE 125/50 azelastine (as hydrochloride)/fluticasone propionate 125 microgram/50 microgram nasal spray bottle.

“Patent” means Australian Patent No. 2003244799 titled “Combination of azelastine and steroids”.

UPON EACH OF THE CROSS-CLAIMANTS JOINTLY AND SEVERALLY UNDERTAKING TO THE COURT BY THEIR COUNSEL TO:

(a)submit to such order (if any) as the Court considers to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by the operation of these orders or any continuation (with or without variation) thereof; and

(b)pay the compensation referred to in (a) to the person or persons…

Continue reading Apotex Pty Ltd v Cipla Limited

Sign in free to access the full text

Details
AGLC
Apotex Pty Ltd v Cipla Limited [2017] FCA 1627
Case
[2017] FCA 1627
Decision Date

CaseChat Overview and Summary

Apotex Pty Ltd brought an application for an interlocutory injunction against Cipla Limited, alleging infringement of a patent. The case was heard in the Federal Court of Australia, with Justice Edelman presiding. The primary legal issues the court had to resolve included whether Apotex had established a prima facie case of patent infringement, the validity of the patent in question, and the balance of convenience in granting the injunction.

In determining these issues, Justice Edelman considered evidence from various sources, including expert witnesses and affidavits from the managing director of Apotex and a forensic accountant. The court examined whether the prior art, specifically Martindale, the Flonase PI, and the Astelin PI, constituted common general knowledge or statutory documents under section 7(3) of the Patents Act 1990 (Cth). The court found significant doubts about whether these documents were part of the common general knowledge or if they could be combined to arrive at the patented invention. This uncertainty supported the argument that there was a lack of inventive step.

Justice Edelman ultimately concluded that Apotex had made out a prima facie case for patent infringement and that the balance of convenience favoured granting the injunction. Consequently, the court granted the application, restraining Cipla from engaging in certain activities related to the patented product without the permission of Apotex. The court also outlined further undertakings and ordered a case management hearing for a later date.

The final orders included restraining Cipla from manufacturing, selling, or promoting the disputed product in Australia without Apotex's consent, pending the resolution of the case. Additionally, Cipla was required to provide security for their undertakings and notify Apotex of any potential infringement by third parties. The court also mandated that Cipla would prosecute their claim expeditiously and provide notice before exploiting certain pharmaceutical products.

Orders

Orders of the court

1. Subject to order 2 below, pending the determination of this proceeding or further order, the applicant/first cross-respondent (“Apotex”), whether by itself, its directors, officers, servants, agents, related bodies corporate or otherwise, be restrained from engaging in any of the following acts within Australia, without the licence or authority of the cross-claimants:

(a) making or importing any of the Apotex Generic Products;

(b) selling, supplying or otherwise disposing of any of the Apotex Generic Products;

(c) offering to sell, supply or otherwise dispose of any of the Apotex Generic Products;

(d) using or otherwise exploiting any of the Apotex Generic Products;

(e) advertising or promoting any of the Apotex Generic Products;

(f) keeping any of the Apotex Generic Products for the purpose of doing any of the acts referred to in sub-paragraphs (b) to (e) above;

(g) authorising any other person to do any act referred to in sub-paragraphs (a) to (f) above; and

(h) procuring or inducing or joining in a common design with any other person to do any act referred to in sub-paragraphs (a) to (f) above.

2. By 9.30 am on 12 February 2018, the cross-claimants provide security for their undertakings noted above in a form agreed between the parties or determined by the Court.

3. The costs of and incidental to the cross-claimants’ interlocutory application for interim injunctive relief until the making of these orders and interlocutory application for injunctive relief as provided in order 1 above, be the cross-claimants’ costs in the cause.

4. The proceeding be listed for a further case management hearing at 9.30 am on 12 February 2018.

THE COURT NOTES THE FOLLOWING FURTHER UNDERTAKINGS:

5. The cross-claimants undertake to prosecute their claim for final relief as set out in the notice of cross-claim dated 21 November 2017 (or in any subsequently amended pleading) expeditiously.

6. The cross-claimants and second cross-respondent undertake, until the final determination of the proceedings, to give 21 days’ written notice to Apotex prior to them, or either of them, or any person authorised by them exploiting a pharmaceutical containing azelastine hydrochloride and fluticasone propionate in Australia, including under ARTG 203132 DYLASTINE 125/50 azelastine (as hydrochloride) 125 microgram and fluticasone propionate 50 microgram nasal spray bottle.

7. The cross-claimants undertake, until the final determination of the proceedings, that, should they be informed or become aware of any person (“Alleged Infringer”) other than the cross-claimants or second cross-respondent seeking to exploit in Australia a pharmaceutical product which contains azelastine hydrochloride and fluticasone propionate they will notify Apotex of that fact, and if they believe the Alleged Infringer’s product infringes the Patent, they will take all reasonable steps to prevent that exploitation, including if necessary commencing proceedings seeking interim injunctive relief restraining that exploitation.

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

Background

Background to the litigation

It has also filed other evidence on the balance of convenience and other matters:(a)Mr Roger Millichamp (managing director of Apotex); (b)Mr Antony Samuel (an expert forensic accountant); and (c)Ms Kellech Smith (solicitor).BACKGROUND Before proceeding further, I should say something about the Patent and recent events.(a) The Patent The Patent relates to pharmaceutical products and formulations containing a combination of an antihistamine, in particular azelastine or a pharmaceutically acceptable salt, solvate or derivative thereof, and a corticosteroid, in particular fluticasone or a pharmaceutically acceptable ester thereof. The Patent states (p 1 lines 10 to 18): It is known to use antihistamines in nasal sprays and eye drops to treat allergy-related conditions. Thus, for example, it is known to use the antihistamine azelastine (usually as the hydrochloride salt) as a nasal spray against seasonal or perennial allergic rhinitis, or as eye drops against seasonal and perennial allergic conjunctivitis.It is also known to treat these conditions using a corticosteroid, which will suppress nasal and ocular inflammatory conditions. Among the corticosteroids known for nasal use are, for example, beclomethasone, mometasone, fluticasone, budesonide and ciclesonide. Corticosteroids known for ocular anti-inflammatory use include betamethasone sodium, dexamethasone sodium and prednisolone acetate, for example. It then states (p 1, lines 19 to 22): It would be highly desirable, however, to provide a treatment that combines the effects of anti-histamine treatments and steroid treatments, in a pharmaceutically acceptable formulation, which is tolerated in situ, without significantly disrupting the potency of the constituent pharmaceuticals. The Patent then states (p 1, lines 23 to 32) that:We have now found that, very surprisingly, azelastine (4-[(4-Chlorophenyl)methyl]-2-(hexahydro-l-methyl-lH-azepin-4-yl)-l(2H)-phthalazinone), or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, preferably in salt form and even more preferably in the form of the hydrochloride salt, can advantageously be combined with a steroid, or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, to provide a stable, very effective combination product or formulation preferably for nasal or ocular treatment. The combination can provide, in a single administration or dosing regime, the antihistaminic properties of azelastine and the anti-inflammatory (and / or other) properties of the steroid, without any significant interference between the two, or adverse reaction in situ. This passage is significant in a number of respects, particularly given Apotex’s challenge concerning manner of manufacture and inventive step. Further, on p 6 (lines 8 to 15), there is reference to an advantageous synergistic therapeutic effect referred to in the following terms: It will also be appreciated from the above, that the respective therapeutic agents of the combined preparation can be administered simultaneously, either in the same or different pharmaceutical formulations, or separately or sequentially. If there is separate or sequential administration, it will also be appreciated that the subsequently administered therapeutic agents should be administered to a patient within a time scale so as to achieve, or more particularly optimise, the above referred to advantageous synergistic therapeutic effect of a combined preparation as present in a pharmaceutical product according to the present invention.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

In summary, Dr Williams’ evidence was that the information in the Astelin and Flonase PIs and the information contained in EP 127 would have provided the skilled addressee with sufficient information to prepare a pharmaceutical formulation for an intranasal spray containing azelastine hydrochloride and fluticasone propionate falling within the asserted claims. Conclusion Accordingly, Apotex says that, on the basis of this evidence, the claims lacked an inventive step. But I consider that there are real difficulties as to whether Martindale, the Flonase PI and/or the Astelin PI formed part of the common general knowledge in Australia before the claimed priority date. Further, there are significant doubts as to whether such documents in any event could be properly characterised as s 7(3) documents. As to Martindale, Dr Williams stated that, before the claimed priority date and after that time, he regularly used a number of reference works as sources of information on drugs and pharmaceutical products marketed in Australia and overseas. But he does not attest to what others commonly practiced or knew at the time. In particular, Dr Williams does not attest that Martindale was treated as a general body of knowledge that was generally accepted and assimilated by persons skilled in the art. Furthermore, Dr Smyth gave evidence for the cross-claimants that he occasionally referred to Martindale but did not do so regularly and did not own his own copy. There are also significant doubts as to whether Martindale is a s 7(3) document. Further, there are significant doubts that the skilled addressee could reasonably have been expected to combine Martindale with any other reference. As to the Flonase PI and the Astelin PI, Dr Williams stated that during his time at Faulding and Sigma, he and his colleagues would place Freedom of Information requests (or direct others to place such requests) in order to use that information as part of drug development/optimisation projects. But the cross-claimants correctly contended that this does not necessarily establish that the information in either PI was generally accepted and assimilated by persons skilled in the art. As a consequence, it is strongly arguable that the PIs do not constitute common general knowledge. Further, the cross-claimants contend (in my view with some force) that the PIs do not constitute s 7(3) documents. Further, there is also no direct evidence of why the Astelin PI and the Flonase PI, which are two distinct s 7(3) documents, would have been combined together. It is said by the cross-claimants that in view of the common general knowledge at the claimed priority date, there was no motivation to combine them. The cross-claimants rely upon Dr Smyth who explained that there would be no motivation to combine disclosures pertaining to a solution versus a suspension due to the distinct and often conflicting nature of the two formulations. These submissions have considerable force. Further, it was contended that there would be no motivation to combine one or both of the PIs with any of the other documents that Dr Williams refers to, namely Martindale and/or EP 127. Again, it seems to me that the cross-claimants have a good point on this. Further, it is said that in relation to these documents, as well as EP 127, there is no evidence that these documents would be ascertained, understood and regarded as relevant unless an inappropriately confined hypothetical task were provided.

Ratio Decidendi

Legal Principle Established

Full text does not contain this section.