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This is commonly referred to as a "carve out".155 The use of a carve out is currently sufficient to avoid liability for patent infringement in the hydrocodone papain urea topical hydralazine fosfomycin EU156 and the US.157 This was recently confirmed in the case of AstraZeneca Pharm LP v Apotex Corp.158 The result of a carve out is that a generic manufacturer can supply a drug for a treatment indication which is not covered by a patent without being liable for infringement of a patent covering another indication for the drug. Submissions from originator companies also support the use of carve outs. Novartis submits that where a supplier has taken reasonable steps to ensure a product is hydrocodone papain urea topical hydralazine fosfomycin not put to an infringing use, such as carving out a particular indication, then this should be prima facie evidence that a supplier is not engaged in infringing conduct. This would not, however, preclude the patentee from arguing hydrocodone papain urea topical hydralazine fosfomycin buy xanax alprazolam that there was in fact an infringing use of the product, irrespective of any carve out.159 Additional concerns have been raised about the drafting of the legislation and the meaning of "staple commercial product". Both generic manufacturers and originators seek clarification of this term and are concerned about the judicial interpretation of it in the recent decision of Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) [2012] FCAFC 102. According to the courts' interpretation, most pharmaceuticals would not be considered to be staple commercial products because they would only have a small number of uses.

Contributory infringement will therefore net order tramadol often be a question of whether a generic manufacturer had reason to believe that the end user would use the product in an infringing way, even where the product information does not include that use. It should be noted that this matter is currently on appeal before the High Court of Australia. Analysis The current contributory infringement provisions are unclear and lead to uncertainty for both patentees and generic manufacturers. Patentees should be able to continue to take action against suppliers who have hydrocodone without apap clearly directed a user to use a patented hydrocodone papain urea topical hydralazine fosfomycin product in an infringing manner. However, where a product has patented and unpatented indications, a supplier should be able to supply the product for the unpatented indications without fear of infringing. Without this, originators may be able to prevent generics from supplying products for treatments that are off patent by obtaining patents for new treatments using the same drug. The Panel supports the use of carve outs to provide greater certainty for originators and generic manufacturers. The legislation should be amended to provide that, in the absence of clear directions from a supplier to use a product in an infringing manner, the supply of the product with instructions that only direct a person to use it in non-infringing ways will not amount to infringement.



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