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For example, in cases where prescription switching is a strategy - analysis of the patent landscape may identify a new drug as a follow-on innovation, covered by a patent that xanax bars come in yellow expires at a significantly later date xanax bars come in yellow than the patent relating to the current PBS drug.
As discussed in section 7.3.2 of this Chapter, submissions to the Panel claim that history search order tramadol venlafaxine/desvenlafaxine is an example of such prescription shifting and that the later product (desvenlafaxine) provides no improved therapeutic outcome234. Therapeutic relativity sheets, published by the PBAC in relation to these pharmaceuticals, do not refute this assertion and indicate that the listings of venlafaxine extended release and desvenlafaxine on the PBS were recommended on the basis of cost effectiveness and minimisation, rather than improved efficacy or therapeutic outcomes.235 Alphapharm estimates that the cost of the prescription shift to desvenlafaxine will amount to $257 millions by the end of the desvenlafaxine patent in 2023236. The Panel suggests that while a comparison of an existing PBS listed drug and a new derivative drug might indicate a case for cost-minimisation at single dosage level, broader considerations that take the patent landscape into account could potentially alter the cost comparison dramatically.
Due to the extended patent protection of the new derivative drug, the PBS could stand to pay substantially more in subsidies should the new drug be approved for PBS listing. The figure of $257 million, provided by Alpharpharm in relation to desvenlafaxine, suggests the scale of savings that may be achieved. This is, of course, based on the assumption that there are no improved therapeutic outcomes being provided by the new drug and where cost minimisation and provision of alternatives, for the purpose of providing choice, are the only considerations. Challenges to patent grants and validity Efficient and effective mechanisms for challenging patents are an important element in maintaining a robust and appropriately balanced intellectual property system. There are a number of processes available to parties who wish to challenge the granting or validity of a patent.
These include challenges involving the Commissioner of Patents: third party xanax bars come in yellow notifications, opposing hydrocodone phone scam the grant of the patent and requesting re-examination of the patent, or seeking revocation by the courts. Parties may also settle disputes without recourse to the Commissioner or the courts, such as through licensing agreements. Patent litigation in Australia is an expensive process. Alphapharm's submission provides an average cost of between $4.5 million and $7 million for a patent challenge, depending on the outcome.237 Novartis provides a typical range of between $750,000 to $2 million, commenting that the cost of patent litigation in Australia is disproportionately large in relation to the size of the pharmaceutical market.238 It is not clear to the Panel why these estimates differ to such a large degree.
Non-judicial third-party challenge systems aim to provide a rapid, inexpensive alternative to litigation and additional mechanisms to ensure the validity of granted patents. Opportunities to object to the grant of a patent are available during the patenting process - prior to the acceptance of a standard patent application, after acceptance and after sealing. 8.1.Third party challenge provisions 8.1.1.Third party notification Section 27 242 of the Patents Act provides for a person to submit information to the Patent Office showing that the claimed invention is not novel or does not involve an inventive step.243 This information can only be provided after publication of the application and not more than three months after the publication of a xanax bars come in yellow notice of acceptance of the application. This provision is a mechanism for ensuring examiners give due regard to the bct invisioni com buy cheap tramadol relevant prior art during the examination process.
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