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The introduction of such a transparency system is discussed in detail at section 8.5.3.1 below. However, in public hearings, GMiA cautioned that the US system is a complete package unique to that country and that it involves a number of measures which may not be of benefit in this jurisdiction. Accordingly, GMiA argued that Australia should design a system to suit its own needs rather than import the US system. Dr Moir proposes that companies seeking regulatory approval for the listing of a drug should, as part of the application process, be required to submit information to the TGA about any patents in relation to the drug for which approval is being sought. This information would be published on the ARTG when approval was granted.293 Under this system, a generic manufacturer would be responsible for any infringement of the notified patents.

GMiA suggest a slightly different proposal in which a sponsor of therapeutic goods should be required to identify each patent relevant to its therapeutic good and the name of the therapeutic good should be recorded against these patents on the Register of Patents. Notification The Panel considers that, adhd medication adderall because of complex relationships between the patent, drug regulatory and pharmaceutical benefit systems, the current provisions do not appear to work well for originators or generic manufacturers and do not appear to be in the national interest. A certificate provided pursuant to s.26B(1)(a) is only required to be submitted to the TGA. There is no provision for the generic manufacturer applying for TGA approval or the TGA to notify the patentee of the application for regulatory approval. As a consequence, the patentee is unaware of the application and the identity of the applicant until the generic manufacturer obtains regulatory approval and is publicly listed on the ARTG or PBS. Without early notification an originator has no method of ascertaining whether a generic applicant adhd medication adderall is engaged in activities which could be considered infringing. There is often insufficient time to conduct proper due diligence in order to file a s.26C certificate, if court proceedings are considered necessary.294 Discovery of a generic application at regulatory approval stage often leads to the originator seeking an interlocutory injunction and the commencement of infringement proceedings.295 Court proceedings can lead to a delay to generic entry and incur substantial financial costs for both parties. They can also result in increased costs to the Commonwealth due to the use of the court system and lost savings to the PBS if the generic is found to not be infringing the patent or the patent is invalid. Generic entry to the market is reliant on data which has been established as a result of years of research, development, and financial investment by originator companies. The intent of the certificate provisions was to provide patentees with notification of applicants for regulatory approval where those applicants sought to rely on data provided by the patentee, in accordance with the terms of AUSFTA.296 Because the generic applicant is able to take advantage of the data provided by the originator company, there is an arguable case that the generic applicant should disclose to the patentee/originator the application for regulatory approval. Notification would allow patentees to better determine whether there is a risk of their patents being infringed, adhd medication adderall or whether a generic company is adhd medication adderall undertaking genuine activities to prepare for market entry when the patent expires.



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