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Injunction Granted to Prevent Sale of Generic Pharmaceutical Drug

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Wyeth is an innovator pharmaceutical company incorporated in the United States and owns an Australian granted patent for the formulation of its leading anti-depressant drug Efexor-XR® (Wyeth patent).  The Wyeth patent provides for a method of treating patients using an extended release, single dose formulation of venlafaxine hydrochloride.

Sigma Pharmaceuticals (Australia) Pty Ltd (Sigma) is the leading provider of generic pharmaceutical products in Australia.  Sigma launched a generic equivalent to Efexor-XR® – namely Evelexa-XR® – with the intention of having Evelexa-XR® delivered to pharmacists for sale by 1 June 2009.  Sigma obtained registration for Evelexa-XR® with the Australian Register of Therapeutic Goods, and subsequently became aware of the Wyeth patent which had not previously been identified by patent searches undertaken on its behalf by a third party.

Sigma sued Wyeth claiming the Wyeth patent was invalid and should be revoked.  Wyeth cross-claimed and sought an interlocutory injunction restraining Sigma from exploiting Evelexa-XR® pending determination by the court of the validity of the Wyeth patent.

In considering the injunction Sundberg J reviewed the legal principles for injunctions as they apply to patent actions, and held:

    1. Wyeth established that there was a serious question to be tried in respect of infringement of the Wyeth patent. However, Sigma had also established that there was a serious question to be tried as to the validity of the Wyeth patent. The court noted that the strength of each party’s case needed to be considered in light of the balance of convenience for granting the injunction (see point 3 below).

 

    1. Wyeth would suffer irreparable harm which would be difficult to quantify. For example, Wyeth was likely to lose its share of the anti-depressant market as a result of Sigma’s potential discounted sales of Evelexa-XR®. In addition, if Sigma was successful in opposing the injunction, it was likely that other generic companies would release competing products into the marketplace, and Wyeth was likely to further suffer as a result of this.

 

  1. The balance of convenience favoured an injunction being granted. For example, Sigma was a new entrant into the market. There was no evidence of a supply contract for Evelexa-XR®, and Sigma had arguably entered into the market with ‘its eyes open to the risk’. Wyeth, on the other hand, had an established trade in Efexor-XR® and would be subject to intense competition from other generic companies with similar products if Sigma was successful in opposing the injunction.

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Consequently, his Honour granted the injunction thereby restraining Sigma from exploiting Evelexa-XR® until the validity of the Wyeth patent had been determined at trial.

Mason Sier Turnbull is able to assist you with applying for and opposing applications for injunctions pertaining to your business activities, particularly as they relate to intellectual property matters.

Author: Noelene Treloar