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Providing the return places a burden on patentees that is not balanced by any significant advantage to Government or the public in terms of better understanding or evaluation of the effectiveness of the extension of term scheme.

The Panel considers that s.76A is not meeting its policy objective. The usefulness of the information currently being provided is limited and does not justify the burden placed on patentees. However, the Panel is not aware of any good sources of data on R&D spending on pharmaceuticals, including Government- funded components.

The Australian Bureau of Statistics (ABS) reports that around $1 billion is spent on R&D in pharmaceuticals in Australia each year.139 The ABS provides xanax withdrawls a breakdown of this by source, including Government grants. However, the pharmaceutical development portion is not clearly identifiable.140 Figures provided to the Panel by the Department of Industry, Innovation, Climate Chance, Science, Research and Tertiary Education show that virtually all of the R&D being reported by the ABS under the industry code 'Human Pharmaceutical Products Manufacturing' is being claimed under the Department's R&D Tax Concession and new phentermine adipex R&D Tax Incentive programs. In Chapter 10 the Panel recommends that the Government establish the Pharmaceutical System Coordinating Committee (PSCC) to report annually on the effectiveness of the pharmaceutical regulatory systems. Rather than simply remove the s.76A requirements, the PSCC new phentermine adipex should assess buy diet online phentermine pill usa whether they can and should be replaced with a useful reporting mechanism.

Recommendation 6.2: Section 76A of the Patents Act should be deleted. The Pharmaceutical System Coordinating Committee recommended in Draft Recommendation 10.1 should consider whether a mechanism for reporting on the use of public and private research funds in pharmaceutical new phentermine adipex R&D, similar to that established by the PMPRB and superior to s.76A, can and should be developed. Section 70(3) and "contains or consists" 6.9.1.Current law In order to be eligible for an extension of term, a patent must claim a pharmaceutical substance per se or a pharmaceutical substance produced by a process involving the use of recombinant DNA technology.141 The period of the extension is calculated based on the 'first regulatory approval date', which is defined in the legislation as the date on which goods "containing, or consisting of, the substance" are first listed on the ARTG.142 6.9.2.Submissions A number of submissions raise concerns that goods "containing" the patented substance could include products in which the substance is present as only an impurity or minor contaminant. If this broad interpretation of the word phentermine no prescription cheapest 'containing' is adopted, there will be circumstances where the period of the extension for the patented substance is calculated from the date of listing of a product that is not covered by the patent.

IPTA and others argue that this outcome is contrary to the policy intent, which is new phentermine adipex to provide an extension based on the time taken to gain regulatory approval for a product that is hydrocodone prostate problems covered by the patent. This results in some patentees getting a foreshortened effective patent life because the first regulatory approval date will not be relevant to any substances protected by the patent.143 Australia's approach is different to the approach taken in other jurisdictions.

For example, in the US an extension is based on the first regulatory approval date of the product.144 The same approach is taken in the EU.145 Submissions refer to two court decisions, H Lundbeck A/S v Aiphaparm Pty Ltd [2009] FCAFC 70 and Merck & Co Inc v Arrow Pharmaceuticals Ltd [2003] FCA 1344 to illustrate their concerns. In Lundbeck the court found that an extension for the product Lexapro, a purified form of the enantiomer escitalopram, should have been based on the earlier listing of Cipramil: the racemate containing citalopram and escitalopram. Cipramil had been registered on the ARTG six years prior to the registration of Lexapro. Despite finding that escitalopram was novel and inventive in light of Cipramil the court found that the relevant date for the extension of new phentermine adipex term was the date of listing of Cipramil: Cipramil being a product 'containing' escitalopram.



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