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Australia – Preliminary Discovery Of Product Information.

22 April, 2014

 

 

AstraZeneca AB v Alphapharm Pty Ltd [2014] FCA 9


What You Need To Know

 

  • Originators are increasingly seeking to use the Federal Court’s preliminary discovery procedure to obtain information about generic products and assess potential patent infringement.
  • The requirements for preliminary discovery are strict and the Court retains a discretion to refuse preliminary discovery even when the requirements are met.
  • In a recent case, AstraZeneca successfully obtained an order that Alphapharm give preliminary discovery of extracts from its regulatory dossier submitted when seeking registration of its generic products.

In AstraZeneca AB v Alphapharm Pty Ltd [2014] FCA 9, Justice Besanko ordered Alphapharm to give preliminary discovery of extracts from Alphapharm’s application to register its generic esomeprazole magnesium products on the Australian Register of Therapeutic Goods (ARTG). The case reflects the increasing trend for originator pharmaceutical companies to rely on the Federal Court’s preliminary discovery procedure to seek information about a generic product.


Aim: To Assess The Prospects Of Proving Patent Infringement


One of the challenges facing originators is how to obtain sufficient information to assess whether a generic product infringes their patents.


Pharmaceutical products in Australia are required to be registered on the ARTG. An originator will often only become aware of a new generic product when it is registered and published on the ARTG. At that time, the generic company will be free to import, market and sell the product, unless the originator obtains acceptable undertakings or commences patent infringement proceedings and obtains an interlocutory injunction.
Depending on the relevant patent, the information published on the ARTG, coupled with the fact that the generic product is bioequivalent to the originator’s own product, may not be sufficient to prove infringement. The absence of publicly available information can make it difficult for the originator to build a prima facie case of infringement for the purpose of securing an interlocutory injunction.


Method: Preliminary Discovery


In a number of recent cases, originators have sought to use the Federal Court’s preliminary discovery procedure to obtain additional information about a generic product. The purpose of the preliminary discovery procedure is to enable a party (a “prospective applicant”) to obtain information so that it can make a properly informed decision about whether to commence proceedings.


In order to obtain an order for preliminary discovery, the prospective applicant must show that:


1. it reasonably believes that it may have the right to obtain relief from a party (the “prospective respondent”);


2. it has made reasonable enquiries, but does not have sufficient information to decide whether to commence proceedings to obtain that relief; and


3. it reasonably believes that the prospective respondent has documents in its control that are directly relevant and would assist in making the decision.


The Court is strict about meeting each of these requirements due to the intrusive nature of an order for preliminary discovery. Even if the requirements for preliminary discovery are satisfied, the Court retains a discretion not to order preliminary discovery. If the information available to the prospective applicant is sufficient to enable it to make a properly informed decision about whether to commence proceedings, then preliminary discovery will not be available.

 

Results


In AstraZeneca AB v Alphapharm Pty Ltd [2014] FCA 9, AstraZeneca successfully obtained an order requiring Alphapharm to give preliminary discovery of extracts from Alphapharm’s ARTG dossier. The extracts included copies of Common Technical Document Module 3: Quality and the Drug Master File for the active pharmaceutical ingredient in Alphapharm’s products.


AstraZeneca based its preliminary discovery application on Australian Patent No. 722839, which relates to esomeprazole magnesium trihydrate and processes for preparing it. Alphapharm’s ARTG registrations describe the active pharmaceutical ingredient in Alphapharm’s products as “esomeprazole magnesium”, without specifying whether or not it is the trihydrate.


Prior to the hearing of AstraZeneca’s application, Alphapharm provided limited extracts from its ARTG dossier. These extracts were the subject of competing expert reports submitted by the parties. The dispute focused on whether the information provided by Alphapharm was sufficient to enable AstraZeneca to decide whether to commence proceedings.


Justice Besanko followed Full Court authority that preliminary discovery is not to be refused because a prospective applicant has a “bare pleadable case”. The policy underlying the rule is to enable a prospective applicant to determine if the costs and risks of litigation are worthwhile. Justice Besanko accepted the opinion of AstraZeneca’s expert that the information provided by Alphapharm was suggestive, but not determinative, of the question of infringement. His Honour considered that the documents sought would assist AstraZeneca to assess the costs and risks of litigation.

 

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For further information, please contact:

 

Grant Fisher, Partner, Ashurst
[email protected]

 

Stuart D’Aloisio, Ashurst

stuart.d’[email protected]

 

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