Single Market, creating more opportunities for people and business. Thus, while the courts are an evaluation of Patents PDF frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, evergreening is rarely mentioned explicitly by judges in patent protection cases.
Författare: Alexander Wurzer.
The evergreening process has caused some controversy in the pharmaceutical industry. In this context, evergreening may be used by manufacturers of a particular drug to restrict or prevent competition from manufacturers of generic equivalents to that drug. The process of evergreening may involve specific aspects of patent law and international trade law. Linkage evergreening is the process whereby pharmaceutical safety, quality and efficacy regulators are required to ‚link‘ their normal evaluation with an assessment of whether an impending generic product may infringe an existing patent. Health Canada were prevented from issuing an authorization for market entry, until all of the relevant patents on a brand name product had been proven to have expired.
A requirement for the AUSFTA to come into force was fulfilment of the article 17. The amendments inserted a new section 26B which required applicants for marketing approval to certify their product would not infringe a valid patent claim, or that the patent holder had been notified of the application. We are not importing the Hatch-Waxman legislation into Australian law as a result of the free trade agreement will not extend the time of the marketing approval process, and it does not add or provide any additional rights to the patent holders in that processthere is no injunction that can be applied under this articleit will be clear in the legislation tomorrow. In November 2004, the US expressly signalled their disapproval of Australia’s implementation of article 17. If Australia’s law is not sufficient to prevent the marketing of a product, or a product for an approved use, where the produce or use is covered by a patent, Australia will have acted inconsistently with the Agreement. We will be monitoring the matter closely, and reserve all rights and remedies as discussed below. The capacity of the US to make such threats is arguably facilitated by the linkage of article 17.