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The Panel does not support any change to the current legislation. Scope of pharmaceutical inventions eligible for extensions 6.11.3.1.Submissions As discussed above, extensions are available for pharmaceutical substances and new formulations, but not for methods of use or processes to manufacture a pharmaceutical substance. Submissions from originator companies argue that the buy xanax online 1 scope of extensions should be broadened to include methods of use and methods of manufacture. This is because it can take significant time to develop new indications and obtain regulatory approval for them.

Originators also argue that broadening the scope of the extensions would bring Australia's legislation and practice into alignment with major trading partners such as the USA and the EU.172 In both the US and the EU an extension is available for a wider range of pharmaceutical products. For example, in buy xanax online 1 the US, an extension can be obtained for an active pharmaceutical ingredient (API), a method of using an API, or a process to manufacture an API.173 The EU also permits extensions of term for an application of the pharmaceutical substance, or a process to obtain the substance.174 Submissions from generic manufacturers oppose any broadening of extensions to methods of use or manufacture. They argue that a new treatment method has a shorter development and regulatory approval time, and therefore should not be entitled to an extension.175 Generic manufacturers also submit that it would be inconsistent with the legislative intention to allow extensions for new methods of use and manufacture.176 6.11.3.2.Analysis The Panel considers that the policy intention of the provisions is clear and that the narrow approach taken in the case law is consistent with Australia's national interest and the original policy intent. No evidence has been provided to the Panel to demonstrate that the development and marketing of new methods of use and manufacture of pharmaceuticals in Australia is adversely affected by such inventions being ineligible buy xanax online 1 for an extension of patent term. Where it is not clear that change is in the national interest, there is no merit in adopting overseas practices for the sake of aligning our policies and laws with those of other countries. Evergreening and follow-on patents The term 'evergreening' has no generally agreed definition. It is not a term originating from or commonly used in patent law. Rather, it is often used in literature to describe the utilisation of patent law and regulations, in order to maximise or extend the protection surrounding intellectual property.177 Although the concept is not limited to any particular technology, it is most commonly used in relation to the pharmaceutical industry and in reference to strategies employed by originator pharmaceutical companies to prolong patent royalties over high- earning drugs.178 It is important to note that the term 'buy xanax online 1 evergreening' is not used in this report in a pejorative way; rather it is used to describe the legitimate patenting and business strategies that pharmaceutical companies use to maintain their dominant share of a drug market. Evergreening can be used to extend both the breadth and duration of patent rights.

A common evergreening strategy is the accumulation of multiple patents surrounding a single pharmaceutical product.

These "follow-on" patents are generally directed towards various embodiments of the original active pharmaceutical ingredient (API) and may cover new formulations, derivatives, delivery systems, methods of use and methods of production.



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