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In Merck it was held that where an earlier ARTG registration contained the substance for which an extension was sought, even as a mere impurity, it was the earlier registration that was relevant for the first regulatory approval date.

Many submissions suggest that s.70(3) should be amended so that the relevant ARTG listing is related to the product claimed by the patent. The Law Council submits: Section 70 should be amended so that the basis for an extension is the first inclusion on the ARTG of a therapeutic good the marketing of which would otherwise infringe the claims of the relevant patent.146 6.9.3. Analysis The stated purpose of the extension of term provisions in the explanatory memorandum to the amending legislation was to compensate pharmaceutical companies for the time taken for pharmaceutical products to reach the market. It was envisaged that the provisions would provide an effective patent life that was closer to arthritis cialis inflammation medicine menstrual moderate pain tramadol viagra those available in other fields of technology, and would ensure that Australia had a patent system that was comparable with other developed nations.147 In light of the Lundbeck and Merck cases, it is arguable that the provisions are inconsistent with the original intentions of the Parliament. While the Lundbeck decision has been criticised for interpreting "contains" arthritis cialis inflammation medicine menstrual moderate pain tramadol viagra too broadly, this interpretation currently stands.

The High Court of Australia considered that the arthritis cialis inflammation medicine menstrual moderate pain tramadol viagra approach taken was not attended arthritis cialis inflammation medicine menstrual moderate pain tramadol viagra with sufficient doubt to warrant grant of an application for special leave to appeal.148 The question then arises as to whether the legislation should be amended to be more consistent with the original intentions.

The Lundbeck case can be contrasted with the position in the EU and the US, where Lundbeck has successfully obtained extensions for its enantiomer patents. In both the US and the EU, the first regulatory approval date is based on the first permitted commercial marketing or use of the product.

In the US, if the drug for which an extension is sought can be considered a separate product to that of an earlier registration, and is subject to its own regulatory approval process, then generally it will be entitled to an extension of term.149 The differences between Australian law and law in other jurisdictions have lead to an entirely different outcome despite the facts of a case being substantially similar.150 Australian law should only be amended where this is in the national interest, not simply to align with other jurisdictions. However, in the case of s.70(3), it appears that the current law has produced unintended consequences and that arthritis cialis inflammation medicine menstrual moderate pain tramadol viagra US and EU law tends to result in more appropriate outcomes. Under current Australian law the presence of impurities or enantiomers can limit the availability of extensions of term that from a policy perspective appear to be warranted.



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