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Once the five year period has no phentermine prescription prior ended, a generic manufacturer can rely on the data for approval of its own drug. A generic manufacturer seeking to rely on data previously provided to the TGA must no phentermine prescription prior provide the TGA with a certificate stating that: •the applicant, acting in good faith, believes on reasonable grounds that it is not marketing, and does not propose to market the therapeutic goods in a manner or no phentermine prescription prior circumstances that would infringe a valid claim of a patent that has been granted in relation to the therapeutic goods (s.26B(1)(a)); or •a canadian otc equilivent to hydrocodone patent has been granted in relation buy phentermine cheap buy adipex online buy ultram discount to the goods, and that the applicant proposes to market the therapeutic goods before the end of the patent, and that the applicant has notified the patentee accordingly (s.26B(1)(b)). Penalties apply for providing false information to the TGA. Providing a false or misleading s.26B certificate is an offence which incurs a fine of $170,000 and/or imprisonment for 12 months.279 The Panel is not aware of any legal actions that have been brought against an applicant for providing a false s.26B certificate. Section 26B certificates are required before the product can be included on the ARTG but are typically provided to the TGA late in the application process. The TGA does not assess the correctness of certificates280 and does not provide them to the originator. These s.26B patent certificates are unique to pharmaceutical patents. They were no phentermine prescription prior introduced in 2005 to comply with Australia's obligations under Article 17.10.4 of AUSFTA. Under AUSFTA, Australia must provide a system whereby patentees are notified of applications for regulatory approval by another party when that application seeks to rely on data previously submitted by the patentee for a product that is the subject of a patent, and the applicant seeks regulatory approval to enter the market during the term of the patent. The patentee must be notified and the identity of the applicant disclosed to the patentee.281 188.8.131.52.Submissions Submissions received about patent certificates focus primarily on the issue of notification, on the drafting of the legislation, and on whether the legislation was consistent with Australia's international obligations. 184.108.40.206.Notification A common theme among submissions received from originator companies is that generic companies rarely notify an originator of their intention to enter the market by filing a certificate pursuant to s.26B(1)(b). The Law Council of Australia submits that these certificates effectively require the applicant to certify that their product would infringe an existing patent.282 The Law Council also submits that s.26B(1)(b) certificates are not typically used because they publicise the commercial intentions of the generic manufacturer, expose the company to possible infringement proceedings and may also result in the generic manufacturer losing commercial advantage (the "first mover advantage").
A generic company is therefore much more likely to prefer to file a s.26B(1)(a) certificate, stating that it is not marketing or intending to market therapeutic goods in a manner which would infringe a valid patent claim. Consequently, the first notification received by an originator pharmaceutical company of another company's intention to enter the market is often when the other company's drug is listed on the ARTG or PBS.
The TGA publishes searchable updates of new ARTG listings on its website, although it does not actively notify patentees of generic entrants.
This is akin to the practices applying to other technologies where there is no requirement that a new entrant to a market must advise its intentions to the holder of a patent which the new entrant claims has expired or is invalid. Pfizer submits that in response, originator companies commonly seek an urgent interlocutory injunction to restrain the generic company from entering the market until the courts assess the originator's claims that its patent has been infringed.283 Bristol-Myers Squibb argues that there is a lack of appropriate notification as a result of the drafting of s.26B(1)(a).284 As indicated earlier, the provision requires an applicant to certify that, acting in good faith, it believes on reasonable grounds that it is not marketing the goods in a manner that would infringe a valid claim of a patent that has been granted in relation to the goods.
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