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The Panel, however, sees a need for an external body to audit the patent grant processes to help ensure these new standards are achieved, and the government should ask the Productivity Commission to review the effectiveness of the legislation. Another approach used to protect a product is to entangle it in a knot of patents, a so-called patent thicket, which raises costs for new entrants. Such thickets would stymie generic manufacturers or developers of new pharmaceuticals. Though opinions will differ as to whether the term 'thicket' applies, the interaction of patents, follow-on patents, and drug marketing practices may have an impact on pharmaceutical prices and the costs of the PBS. Australia's intellectual property system, like any other, works best when property rights are tightly delineated and there is an efficient adjudication system outdated pain medication hydrocodone to resolve tramadol and xanax disputes. There are three dispute mechanisms that involve the Patent Office. These non-judicial mechanisms have been affected by recent changes to the law, but they are not typically favoured by disputants as to the validity of individual patents because they lack the certainty offered by courts. As in other matters heard by Australian courts, patent challenges and patent infringement cases are expensive. Where a generic manufacturer is the potential challenger 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 price reductions for the PBS.

The Panel, however, recommends 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 to the government from improving 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 hydrocodone mental effects manufacturer wishes to enter the market. Some submissions question the adequacy of these processes and others the impetus they provide to seek tramadolas invisioni com buy tramadol injunctions against the sale of the generic.

The Panel recommends a mechanism 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 tramadolas invisioni com buy tramadol generic manufacturers plan to enter the tramadolas invisioni com buy tramadol market. It is thus inclined to tramadolas invisioni com buy tramadol 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.



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