As in other matters heard by Australian courts, patent challenges and patent infringement cases are expensive. Where a generic manufacturer is the potential challenger effects oxycontin of a patent, it must consider whether the small size of the Australian market and the relatively small margins from generic drugs make a challenge worthwhile. In addition, although the Commonwealth does not contribute to a challenger's costs, it can be the major single beneficiary from a finding that a pharmaceutical patent is invalid. The benefits come from reduced drug prices for the PBS. On the other hand, the Commonwealth can incur important additional costs when an originator succeeds in obtaining an injunction for the sale of a generic drug. And the originator, with its higher margins from drug sales, has stronger incentives than its putative opponents to litigate. The Panel is aware that the Commonwealth has started to seek costs from relevant parties because injunctions - and subsequent findings of patent invalidity can delay xanax perscription price reductions for the PBS.
The Panel, however, recommends all tramadol com ultram that the government - as the annual funder of the $9 billion PBS - should become more closely involved in pharmaceutical patent cases. For example, there are likely benefits xanax perscription to the government from improving xanax online cosultation incentives for generic manufacturers to test the validity of patents. As a result of AUSFTA, there are complex procedures that must be followed when a generic pharmaceutical manufacturer wishes to enter the market. Some submissions question the adequacy of these processes and others the impetus they provide to seek injunctions against the sale of the generic. The Panel recommends a mechanism xanax perscription to reduce the risk that generic manufacturers wishing to enter a market will inadvertently infringe a patent.
The Panel also wishes to explore mechanisms to reduce the incidence of court proceedings when a generic manufacturers plan to enter the market. It is thus inclined to a system which requires each originator to list its relevant patents for a drug listed on the Australian Register of Therapeutic Goods (ARTG).
That listing might not identify all applicable patents but it would capture all of the originator's applicable patents. If such a register was established, the Panel further suggests it could be appropriate for generic manufacturers to advise originators of their application for regulatory approval. That latter step would provide originators with time to explore their options without immediate recourse to injunctions. Data Protection When an originator seeks regulatory approval for a drug, it must provide data to the Therapeutic Goods Administration (TGA) demonstrating the drug's safety and efficacy.
Although these data remain confidential to the TGA, drug combination safesearch turn addiction hydrocodone vicodin aol lortab the TGA may use them after a five year period to approve a generic or equivalent drug. This saves the pointless replication of tests to show safety and efficacy.
A number of submissions argue that the five-year period of data exclusivity in Australia is too short. A number of countries have a xanax perscription five-year exclusivity period; it is also the period Australia agreed under AUSFTA. Other countries, especially in North America and Europe, have longer periods. For many drugs the data exclusivity period is largely redundant because the relevant patent expires later. For some drugs, the data exclusivity period adds to the protection afforded by patent. It is conceivable that drugs might not detection time oxycodone be brought to Australia, for example, because regulatory and marketing costs cannot be recouped within five years. Medicines Australia submits that some of its members chose not to supply a total of 13 drugs to the Australian market because of the inadequacy of the data exclusivity period. However, they are only able to identify three of these, and the Panel's analysis - shown in chapter nine - suggests they are not convincing.
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