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As mentioned above, Alphapharm states that the average legal cost for patent litigation is $4-5 million, with that cost increasing to $7.5 million should the challenge prove unsuccessful. Before patent litigation is initiated, a reward to hydrocodone length of detection risk ratio of 10:1 must be demonstrated. Alphapharm further states that whilst the generic companies behind the litigation absorb most of the risk, it is the Commonwealth that stands to save hundreds of millions of hydrocodone pain medication dollars should the patent challenge prove successful. Alphapharm claims that the lack of an incentive system to encourage generic companies to mount challenges will lead to fewer patent challenges.261 Originator pharmaceutical companies submit that patentees are fully entitled to enforce and defend their IP and their concerns generally focus around issues with interlocutory injunctions and the timing of notifications. Interlocutory Injunctions Applicants in infringement actions can seek an injunction at an interlocutory hearing to restrain the defendant's allegedly infringing activities until the matter is resolved by the courts. When considering whether to grant an injunction, the court will consider whether an applicant has established that there is serious question to be tried and that the balance of convenience favours the grant of such relief.262 The respondent is often required, as a condition of the court granting an interlocutory injunction, to undertake to pay damages, which hydrocodone length of detection the court may order to be paid in the event that the applicant is unsuccessful at trial. If an interlocutory injunction is denied, the defendant may be ordered to keep an account of profits. The most recent guidance on the matters that the courts consider when granting interlocutory injunctions in patent cases is the Novartis AG v Hospira decision.263 In this case the court granted an injunction because damages would not have been an adequate remedy. This was primarily because the generic would have entered the market and triggered the 16% statutory reduction in the subsidy for the F1 (original) pharmaceutical. The statutory reduction is discussed in Chapters 2 and 5. Medicines Australia states that interlocutory injunctions are "a vital means of protecting patentees from unpredictable and irreversible effects of patent infringement while the validity of a patent is being tested in court".264 The "irreversible effects" described by Medicines Australia largely refer to the 16% statutory price reduction in the PBS subsidy. Further price reductions may also result from generic competition in the market. The original pricing is highly unlikely to be reinstated should the generic pharmaceutical hydrocodone length of detection be found to be infringing. Although the 16% price reduction may be overturned by Ministerial discretion, such discretion has never been exercised. For this reason originators argue that the status quo ought buy phentermine buy propecia cd jewel case hydrocodone length of detection computer education to be maintained until a court decision is reached.265 Medicines Australia and Bristol-Myers Squibb emphasise that interlocutory injunctions are only provided if a patentee can satisfy the Courts that the conditions outlined above exist. Furthermore, they argue that the availability of interlocutory injunctions is consistent with the presumption of validity in favour of registered patents under Australian law. GMiA submits that the balance of convenience persistently falls against generic companies. GMiA states that disproportionate interlocutory relief is being granted against generic sponsors, largely in response to claims from the originator company that it will encounter immediate adverse effects under the PBS pricing legislation.
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