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After regulatory approval has been granted, the applicant has thirty days in which to file information about the patent. Only patents related to the drug itself, or a method of use of the drug, are published in the Orange Book.

Patents which claim a process to produce a substance or a method of manufacture are excluded. A generic company seeking to rely on data provided for regulatory approval by an originator must provide a certificate to the FDA that marketing the goods will not constitute infringement of the listed patents. The certificate must contain a detailed statement about the factual and legal phentermine put viagra xanax basis that the patent is invalid or will not be infringed.303 The notice must also be supplied to the patentee and phentermine put viagra xanax the originator.

If the originator decides to institute proceedings then an automatic stay of 30 months will apply to the generic application while the matter is resolved.304 However, where a generic company successfully challenges a patent which has been listed in the Orange Book, it will be entitled to a period of six months market exclusivity.305 Several submissions received by the panel advocate the introduction of a similar system phentermine put viagra xanax in Australia. Such a system would provide greater transparency and certainty in relation to freedom to operate. The Panel also notes that the US government has pushed for elements of the Orange Book system to form part of the new Trans-Pacific Partnership Agreement (discussed in Chapter 3 of this report). The Panel does not recommend the adoption of the Orange Book system in its entirety, but takes the view that the following limited elements of the system would be beneficial for Australia: •a company that has obtained regulatory approval for a pharmaceutical product (the drug owner) would be required phentermine put viagra xanax to identify on a public register the details of all patent applications and granted patents owned, or licensed by that company and its subsidiaries that relate to that product within a certain period of the product being included on the ARTG or of the patent application being published, whichever is the later; •patents that are directly related to the listed product would be required to be listed by the sponsor/patentee. Patents which are relevant to the product but not directly related to it, for example, a new method of use, would not be listed; •the patentee would be precluded from commencing infringement action against generic manufacturers seeking TGA listing in regards to a patent which phentermine put viagra xanax is not listed on that register; •generic manufacturers would provide s.26B certificates to the TGA and to the relevant patentee within a certain period of filing an application for inclusion on the painpharmacy tramadol ARTG. To meet the requirements of the patent certificate, generic manufacturers would need to conduct their own search for relevant patents owned by other parties; and •incentives would be provided for the first generic manufacturer to successfully challenge a patent, such as a period of marketing exclusivity or a share of the savings to the PBS from the entry of generics to the market.

Key advantages of such a system include: •greater transparency and certainty for both originator and generic pharmaceutical manufacturers, increasing efficiency; •linkage of information about patents and therapeutic goods, reducing the difficulty of searching, and increasing certainty of freedom to operate.



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