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GMiA claims that in the last 8 years, 22 interlocutory injunctions concerning pharmaceuticals and medical devices have been sought and that injunctions were granted in 18 of these cases. Medicines Australia's submission also discusses the number of recent cases involving interlocutory injunctions. It states that since 2007, at least 20 interlocutory injunctions have been granted by the Federal Court in view of the 16% price reduction in PBS subsidy. Medicines Australia makes the following point: That two of these 20 injunctions were granted in cases where patents were subsequently revoked does not in any way undermine the necessity of interlocutory injunctions as a means of preventing third parties from causing irreparable harm to patent owners in the vast majority of cases where patents are in fact upheld.266 The Panel notes that in recent years the US courts have raised the thresholds to be met before granting an injunction from what appears to have been a low base.267 Also, the US Patent and Trademark Office and US Department of Justice have proposed that, for patents relating to industry standards, injunctions should be discouraged and voluntary licensing on fair, reasonable and non- discriminatory terms should be encouraged.268 8.3.1.

Timing issues A number of submissions raise concerns regarding timing issues in regard to interlocutory injunction applications. Bristol-Myers Squibb states that due to a lack of ingrediants of tramadol any early notification process, interlocutory injunctions are required to be pursued urgently in order to prevent generic PBS listing. It is submitted that a preferable system would be to provide earlier notification to the patentee to allow early adjudication of disputes, potentially avoiding interlocutory rulings.269 The issue of early notification is considered in more detail in the discussion of patent certificates below. Costs to PBS of invalid patents Where a patentee has undertaken to pay damages as a condition of obtaining an interlocutory injunction and the patent has been found invalid, the patentee may be liable to pay damages to the Government. These would involve the foregone savings to the PBS budget resulting from delay in generic entry into the market and reduction ingrediants of tramadol in the Government subsidy.

Damages could how long oxycontin stay in system total in the millions of dollars, depending on the value of the product and the period of the injunction. As discussed by Medicines Australia above, in recent years there have been two cases of injunctions being granted for PBS-listed products and the patents subsequently being revoked - Sanofi-Aventis' patent for clopidogrel (Plavix)270 and Wyeth's patent for venlafaxine (EFEXOR XR).271 In both cases the Department of Health and Ageing is currently seeking compensation from the patentees. GMiA supports the Government seeking such damages, as this may deter originators from seeking interlocutory injunctions.272 Conversely, Medicines Australia submits the following: The Australian Government ought not be seeking to recover its damages under an undertaking as to damages in cases to which it was ingrediants of tramadol not a party. Putting aside legal arguments about the ability of the Australian Government to claim damages pursuant to the usual undertaking as to damages, on one view, such recovery is bad public yellow xanax bar time released ingrediants of tramadol policy. To the extent that the Australian Government is able to recover damages pursuant to the usual undertaking as to damages, the quantum of such claims will act as a significant deterrent to patentees enforcing their rights in Australia and will, therefore, result in fewer pharmaceutical products coming to market in Australia.273 The issue of originator companies deciding not to bring products to the Australian market due to insufficient IP protection is discussed in Chapter 2 and 9. Analysis The Panel notes that litigation in general is slow and expensive in Australia.



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