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Particularly, to provide an economic incentive for businesses to invest in the development of new chemical entities as active pharmaceutical ingredients (APIs) for potential therapeutic use. 117 Conversely, originator companies argue that new formulations containing known active ingredients can and should be considered to be new and inventive and are thus correctly considered eligible for extensions of term. Bristol Myers Squibb (BMS) states: It appears that the original intention behind section 70 of the Patents Act was that it would apply to "new and inventive substances", which BMS submits may often apply to new formulations. 121 The definition of "pharmaceutical substance" provided in the Patents Act 1990 refers to "a substance (including a mixture or compound of substances) for therapeutic use".

This definition has not yet been the subject of judicial consideration. It has, however, been the subject of Patent Office decisions, where it was found that the definition encompasses not only a mixture or compound of substances, but also a compound with a controlled spatial configuration, such as a biphasic tablet or thermoplastic ring containing a diffused active ingredient. 122 However, to meet the definition a level of integration or interaction between component parts of the compound is necessary.

Analysis The current approach, allowing for extensions to patents claiming active ingredients as well as new formulations, appears reasonable on the basis that products based on these inventions are desirable, require considerable R&D and are buy hydrocodone free consultation prevented from entering the market until regulatory approval is given. This is supported by data demonstrating that the time taken to obtain regulatory approval is similar for new actives, new formulations, new compositions and biologics (see figure 6.buy hydrocodone free consultation 1 below). Figure 6.1: Average Effective Patent Life for Extended Patents by (Equivalent FDA) Pharmaceutical Classification120 Notwithstanding arguments from generic manufacturers that the scope of pharmaceutical patents eligible for an extension of term is too broad, data from IP Australia indicate that new active ingredients make up the vast majority of extended patents 6.2 below. Limiting extensions to patents on new active ingredients would therefore have little effect in reducing the overall cost of pharmaceuticals. Figure 6.2: Number of Extended Patents by (Equivalent FDA) Pharmaceutical Classification121 Some submissions argue that extensions should be available for patents claiming new methods of use or manufacture for a number of reasons: •allowing extensions for such patents would more closely match the extension buy hydrocodone free consultation of term schemes in the US, Europe and Japan123; •'[t]here is often the same public health interest in buy hydrocodone free consultation developing new therapies using known substances as there is in identifying new active ingredients ... [and] [t]he investment in developing new formulations and new therapeutic uses may be comparable to that involved in developing the original active ingredient;'124 • springboarding provisions, i.e.

provisions exempting from patent infringement those steps necessary for obtaining regulatory approval, cover a broader range of pharmaceutical patents than they did when the extension of term provisions were introduced.

IPTA argue it would seem appropriate to expand the types of patents which may be eligible for a patent term extension accordingly.'125 Novartis also suggests that the extensions of term provisions could be expanded to allow veterinary pharmaceuticals to be granted extensions on the basis of the time taken to obtain regulatory approval from the Australian Pesticides and Veterinary Medicines Authority.126 On the other hand, Alphapharm argues that the scope of patents eligible for an extension of term should be limited '...to the earliest patent to claim that substance in a pharmaceutical composition contained in a therapeutic good (the first pharmaceutical patent).'127 Given that additional clinical trials may also be required where regulatory approval is sought for a new use of a previously registered pharmaceutical, the rationale for the current scope of patents hydrocodone history eligible for extensions of term may also apply to patents for new uses.



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