Warner-Lambert Company LLC v Apotex Pty Ltd

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FEDERAL COURT OF AUSTRALIA

Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241

Citation: Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241
Parties: WARNER-LAMBERT COMPANY LLC, PF PRISM CV, PFIZER IRELAND PHARMACEUTICALS, PFIZER ASIA PACIFIC PTE LTD and PFIZER AUSTRALIA PTY LTD ACN 008 422 348 v APOTEX PTY LTD ACN 096 916 148
File number(s): NSD 199 of 2014
Judge(s): GRIFFITHS J
Date of judgment: 18 March 2014
Catchwords:

PATENTS – application by patentee for interlocutory injunction restraining generic supplier from selling, supplying, soliciting or advertising its generic version of drug – patentee seeking interlocutory injunction pending final hearing – whether prima facie case – balance of convenience

INTERLOCUTORY INJUNCTION – whether prima facie case – balance of convenience
Legislation: National Health Act 1953 (Cth)
Patents Act1990 (Cth) s 117
Therapeutic Goods Act 1989 (Cth)
Cases cited: Apotex Pty Ltd v AstraZeneca AB (No 3) (2012) 95 IPR 581; [2012] FCA 265
Apotex Pty Ltd v AstraZeneca AB (No 4) (2013) 100 IPR 285; [2013] FCA 162
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1; [2013] HCA 50
Generic Health Pty Ltd v Otsuka Pharmaceutical Co Ltd (2013) 100 IPR 240; [2013] FCAFC 17
GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Ltd (2013) 103 IPR 487; [2013] FCAFC 102
Pharmacia Italia S.p.A v Interpharma Pty Ltd (2005) 67 IPR 397; [2005] FCA 1675
Samsung Electronics Co Ltd v Apple Inc (2011) 286 ALR 257; [2011] FCAFC 156
Date of hearing: 13 March 2014
Date of last submissions: 12 March 2014
Place: Sydney
Division: GENERAL DIVISION
Category: Catchwords
Number of paragraphs: 87
Counsel for the Applicants: Mr R C Macaw SC and Mr C Dimitriadis
Solicitor for the Applicants: Allens
Counsel for the Respondent: Mr D Catterns QC and Mr N R Murray
Solicitor for the Respondent: Ashurst Australia

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

GENERAL DIVISION

NSD 199 of 2014
BETWEEN:

WARNER-LAMBERT COMPANY LLC
First Applicant

PF PRISM CV
Second Applicant

PFIZER IRELAND PHARMACEUTICALS
Third Applicant

PFIZER ASIA PACIFIC PTE LTD
Fourth Applicant

PFIZER AUSTRALIA PTY LTD ACN 008 422 348
Fifth Applicant
AND:

APOTEX PTY LTD ACN 096 916 148
Respondent

JUDGE:

GRIFFITHS J

DATE OF ORDER:

14 MARCH 2014

WHERE MADE:

SYDNEY

UPON the applicants by their Counsel jointly and severally undertaking:

(a)to submit to such order (if any) as the Court may consider 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 the interlocutory order in paragraph 1 below and the interlocutory undertakings in sub-paragraphs (d) and (e) below or any continuation (with or without variation) thereof;

(b)to pay the compensation referred to in (a) above to the person there referred to; and

(c)to notify the respondent's solicitors promptly if Pfizer Australia Pty Ltd's accounts record a net asset position…

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Details
Case
[2014] FCA 241
Decision Date

CaseChat Overview and Summary

Warner-Lambert Company LLC brought proceedings against Apotex Pty Ltd in the Federal Court of Australia, seeking interlocutory relief in relation to the supply of pregabalin, a pharmaceutical product used for the treatment of seizures. The central issue in the case was whether Apotex could lawfully supply pregabalin under certain circumstances, specifically when the product was not listed on the Australian Register of Therapeutic Goods (ARTG) for the indication of treating seizures. This was contested on the basis that such supply might contravene Australian laws governing the marketing and distribution of pharmaceutical products, particularly those under the Therapeutic Goods Act 1989 and related regulations.

The court had to determine whether Apotex's actions were within legal bounds, particularly considering the implications of supplying a product not registered for a specific indication under the ARTG, and the interplay between Commonwealth and state legislation in regulating the supply of prescription medicines. The key legal questions revolved around the interpretation of the Therapeutic Goods Act, the Australian Register of Therapeutic Goods, and the Poisons Standard, as well as the practicalities of pharmacists substituting generic products and the regulatory frameworks governing the Pharmaceutical Benefits Scheme (PBS).

The court found that Apotex's actions were permissible under the relevant legislation. It held that while pregabalin was not listed on the ARTG for the treatment of seizures, this did not preclude Apotex from supplying the product if the prescription was in compliance with the relevant Poisons Legislation and other legal requirements. The court emphasised the distinction between the listing of a product on the ARTG for a specific indication and the broader legal framework that allows for the supply of medicines, including off-label uses, provided they are prescribed in accordance with the Poisons Legislation. The court also acknowledged the legitimate business practices of generic suppliers marketing their products to pharmacists, aiming to substitute generic products where legally permissible.

The court dismissed Warner-Lambert Company LLC's application for interlocutory relief, thereby allowing Apotex to continue supplying pregabalin under the contested conditions. The court's decision underscored the importance of understanding the interplay between various legislative frameworks and the practical realities of pharmacy practice in Australia.

Orders

Orders of the court

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Background

Background to the litigation

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Evidence

Evidence Before The Court

I will now provide a broad summary of the relevant evidence adduced by the parties, while noting that, in view of the urgency of the matter, the summary will necessarily be at a higher level of generality and less comprehensive than would otherwise be the case. Summary of the applicants’ evidence A pharmacist, Dr Shane Jackson, gave evidence for the applicants in which he outlined the marketing of generic medicines. I accept that evidence, which may be summarised as follows. Generic suppliers typically aim to persuade pharmacists to supply a generic product to patients who hold a prescription for the original brand of a particular medicine. Generic suppliers achieve this by providing pharmacists with a financial incentive, usually in the form of a discount or rebate. This means that if the pharmacist supplies a generic product instead of the original brand, the pharmacist will make a greater return. Provided there is no safety issue for the patient and relevant legal requirements are met, this is generally recognised by pharmacists as an acceptable and sensible business practice. Generic suppliers do not normally market their products to medical practitioners. Rather, they direct their marketing to pharmacists with a view to persuading them to substitute generic products at the pharmacy level. Prescribers have a discretion as to whether to prevent brand substitution under a PBS prescription by “ticking a box” on a standard PBS prescription form which appears alongside the words “brand substitution not permitted”. A pharmacist may offer a PBS listed generic substitute to a patient, and claim a PBS subsidy, if:(a)the patient agrees to the substitution;(b)the prescription does not prevent such substitution;(c)the brands are identified in the SPB as interchangeable; and (d)substitution is permitted under Poisons Legislation. If a medical practitioner writes a prescription, whether PBS or non-PBS, for a particular pharmaceutical product, whether or not a particular brand is specified, and the pharmacist is aware that there is an alternative brand of the same pharmaceutical substance registered on the ARTG and available to the pharmacist, the pharmacist is entitled to supply that alternative brand. Accordingly, irrespective of any PBS requirements, a pharmacist may legally dispense and supply a generic medicine to a patient holding a private prescription for the original prescribed brand. A pharmacist may also supply a generic non-PBS medicine to a patient with a PBS prescription after consulting with the patient. That applies even if the box is ticked alongside the brand substitution statement because that box applies only to PBS prescriptions. If, however, the pharmacist substitutes a non-PBS medicine, the pharmacist is not entitled to claim a subsidy under the PBS. As a matter of practice, supplying a substitute product in the manner described above makes practical sense where the non-PBS subsidised cost of the medicine is less than the PBS patient co-payment. Dr Jackson gave evidence that he was aware of cases where substitution of non-PBS products had occurred on a very large scale where discount pharmacies, such as warehouse pharmacies, advertise a private label at a heavily discounted price.

Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

Orders were made at 4.15 pm on 14 March 2014, which dismissed the applicants’ application for interlocutory relief in respect of the supply of products by Apotex containing pregabalin for treatment of seizures. The parties were advised then that, having regard to my commitments as duty judge, there had been insufficient time to finalise reasons for judgment and that they would be provided as soon as was practicable. Registration and listing of pharmaceutical products A pharmaceutical product may not be marketed, supplied, offered for sale, sold or distributed within Australia unless it is listed or registered on the ARTG. The registration of a pharmaceutical product must include at least one indication for the product within Australia. The PBS is maintained by the Commonwealth under the National Health Act 1953 (Cth). Under the PBS, the government subsidises the costs of medicines for many medical conditions. Medicines which are eligible for such subsidisation have to be listed on the SPB. Pharmacists are paid by the government for dispensing items which are on the SPB. If a medicine is not listed on the SPB a pharmacist cannot supply a prescription for that medicine under the PBS and the patient has to pay the full price for the medicine under a “private” or “non-PBS” prescription. This means that the prescription is not subsidised by the government. Whereas the PBS price is a fixed price (while allowing for concessions), the price charged for non-PBS medicines may differ across pharmacies. Some medications on the SPB are subsidised only for a specific patient group or indication. If a medicine is listed on the SPB for a particular indication, and the patient’s clinical condition does not match the indication, the prescription is not eligible to be supplied on the PBS, but can still be dispensed as a private prescription. An amount known as the “co-payment” is the amount which a patient pays towards the cost of their PBS medicine. From 1 January 2014, patients pay up to $36.90 for most PBS medicines or $6 if they have a concession card (that figure drops to zero once a patient’s expenditure on pharmaceutical products reaches a certain level). The supply of prescription medicines to consumers is regulated by relevant state and territory poisons legislation (Poisons Legislation). This legislation interacts with and supplements Commonwealth legislation which regulates therapeutic goods. The active chemical substances in prescription drugs are listed in Schedule 4 to the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard). While a medicine has to be registered for particular indications under the Therapeutic Goods Act 1989 (Cth) (the TGA), the Poisons Standard only lists the relevant chemical substances in a drug and does not refer to the indication or uses for such substances. Accordingly, a prescription can be given for a non-ARTG registered indication, as long as the prescription is in accordance with the considerations set out in the relevant Poisons Legislation. Such prescriptions are known in the industry as “off-label” prescriptions. They can be given by a medical practitioner or any other health professional who is capable of legally issuing a prescription.