Ritalin wisselwerking seroxat
Sections 26C and 26D of the TGA are not required under AUSFTA. However, they were introduced at the same time as other provisions implementing AUSFTA with the intention of limiting the potential for patentees to use ritalin wisselwerking seroxat the court system to extend their patents and delay generic entry.309 18.104.22.168. Submissions A number of submissions criticise the effectiveness of sections ritalin wisselwerking seroxat 26C and 26D. As discussed in relation to s.26B certificates, submissions from originator companies argue that they usually only became aware that a generic ritalin wisselwerking seroxat product is being prepared for market entry as a result of listing on the ARTG or PBS. This leaves little time for originators to prepare and conduct due diligence to ensure the accuracy of the s.26C certificate. Bristol-Myers Squibb submits that earlier notification would enable the originator to undertake xanax release proper due diligence and determine the likelihood of infringement at an earlier stage.310 The Law Council of Australia submits that, with earlier notice, other avenues of dispute resolution can be undertaken in preference to commencing court proceedings and seeking an interlocutory injunction, and therefore a reduction in litigation would follow.311 A number of ritalin wisselwerking seroxat originators raise concerns about the substantial penalty faced by originator companies for providing a false or misleading s.26C certificate with the penalty widely considered to be disproportionate to that faced by generic manufacturers for providing a false or misleading s.26B certificate. 317,318 For example, Medicines Australia submits that: ... An originator company, the patent holder, must be afforded sufficient time, through notification in advance of generic market entry, to enable it to undertake due diligence to ensure the accuracy of the s.26C certificate. The corresponding penalty for potential infringements by generic companies for filing a false or misleading s.26B certificate is up to $550,000 or (up to) only 5.5 per cent of a patent holder's potential liability. Clearly there is a gross imbalance in the preventative deterrents for originator and generic medicine companies filing false and misleading claims in patent cases in Australia.312 The Panel agrees that patent rights are an important incentive for investment in R&D in the pharmaceutical sector. The effective enforcement of patent rights is essential to protecting that investment.313 Although the penalty faced by originator companies is much higher than that faced by generic manufacturers under s.26B, GMIA submits that penalties favour originator companies because s.26B provides for an offence, rather than a civil penalty.314 GMIA argues that s.26B should be amended to specify that filing a false or misleading certificate is a civil matter, because any harm likely to result from the filing of a certificate would be pecuniary in nature.315 22.214.171.124.
Analysis The Panel considers that the substantial penalty for providing a false or misleading s.26C certificate is an appropriate disincentive for commencing proceedings other than in genuine enforcement actions. The hydrocodone warnings Panel also expects it to be rare for a patentee to be penalised under s.26D for obtaining an interlocutory injunction inappropriately. If the patentee did not have a reasonable case or was instituting litigation vexatiously, the injunction should not have been granted in the first place.
The Panel found no evidence to suggest that patentees were commencing proceedings mtsu edu csjudy phentermine other buy hydrocodone medication online order than in circumstances where such action was genuine. It is the view of the Panel that s.26C and s.26D of the TGA are generally appropriate.
The issue to be resolved is one of notification to patentees of generic entry. As discussed above in relation to s.26B certificates, notifying patentees of applications for regulatory approval by generic applicants would lead to disputes being resolved earlier and by methods that do not involve litigation.
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