The use of medical samples for tender purposes – outside the scope of injunctive relief?

In the recent decision Wake Forest University Health Sciences v Smith & Nephew Pty Ltdan alleged patent infringer has been allowed to continue supplying its foam dressing kits for product evaluation purposes (such as tender processes), free of charge, notwithstanding the grant of an interlocutory injunction.  This limitation of the scope of the injunction is interesting in light of the recent trend in favour of granting injunctions to patentees, especially in circumstances where the alleged infringers knew of the existing patents. The courts have stressed that the proper course of action is to challenge the validity of the patent and not to enter the market with a potential infringing product.

Ryan J’s circumscription of the scope of the injunction aimed to provide a balance between the rights of the patent holder, the alleged infringer and the public interest. The decision potentially provides an avenue for alleged patent infringers to market their products and gain a market base pending the final proceedings.

It remains to be seen whether the decision will be strictly limited to its facts or extended to apply to different kinds of products.  It is unlikely to affect other biomedical or medical products such as generic medications.  The foam dressings were exempted from the injunction to allow hospitals to evaluate their effectiveness. Generic medications, on the other hand, are necessarily bioequivalent and have the same active ingredients to the patented product and would not need to be evaluated by medical professionals.

Overall, it appears that the decision, whilst providing an interesting limitation on the scope of injunctive relief in situations where the alleged infringer knew of the existing patent and still decided to enter the market, appears to be limited to situations where:

  • the product would need to be evaluated;
  • there is a public interest in the evaluation; and
  • the alleged infringer’s reputation would be affected and/or their ability to compete in the market would be adversely affected should they ultimately be successful at trial.

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