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LAW CHANGES


Venezuelan authorities recognise that a new IP law is needed since the 1955 law is not TRIPS- compliant and, although workable, is outdated. Compulsory licensing could be an alternative in the new law.


In Tailand, applicants have also been experiencing delays in the examination and grant of patents for drug-related inventions. Te patent office is moving to redress the problem by increasing the number of examiners and reducing their workloads, but it is not clear whether this will make a difference.


In Japan, the effect of a recent Supreme Court ruling dismissing an appeal by the Japan Patent Office is to liberalise the rules regarding extensions of pharmaceutical patents. It means that a five- year patent extension should be allowed if the application meets the usual requirements and if there is no relevant overlap between medicines that have the same active ingredients and granted patent claims.


Amendments to the People’s Republic of China (PRC) Patent Law have brought a mix of changes. Many innovators are pleased that an absolute novelty standard has been introduced,


meaning that prior disclosures or uses anywhere in the world can be cited to pre-empt a patent application in China. Also, the option to request evaluation reports to test the robustness of utility model and design patents should stem the flow of junk patents onto the register. On the other hand, the introduction of a security examination for inventions in the PRC prior to patent filings being made overseas, and of a patent infringement exemption to apply to the regulatory approval process, are less welcome to innovators.


Moving from patents, the use of confidential innovator information by third parties to accelerate their market entry is a vexed question that is handled differently around the world. Australia has plans to amend its copyright laws to stop innovators using copyright to delay market entry by generic competitors. If enacted, the Terapeutic Goods Legislation Amendment (Copyright) Bill 2011 would mean that the manufacturer of a generic version of a registered medicine would not infringe copyright if it reproduced an innovator’s Terapeutic


Goods Administration-approved


product information document in order to apply to register a medicine or for purposes related to the safe and effective use of the medicine.


Poland, on the other hand, is finally implementing the European directive regarding data exclusivity for drugs for human use. Despite the delay since October 2005, the rule will apply to drugs for which marketing authorisation applications were filed aſter November 1, 2005, with the result that, in practice, there will be no adverse consequences for those wanting to preserve data exclusivity. Tis is because the data exclusivity periods referred to in the directive and the law currently in force have yet to expire.


Canada has published guidelines that streamline the process


for entry biologics, the approval of subsequent also known as biosimilars.


Te guidelines are applicable to all biologic drug submissions where the sponsor seeks authorisation for sale based on demonstrated similarity to a previously approved biologic drug and relies, in part, on prior information regarding that biologic drug in order to present a reduced clinical and non-clinical trial package as part of the submission.


On the trademark front, in the US, a trademark for a drug cannot be used until it has been approved by the Food and Drug Administration (FDA), even though it may have been registered


16 Life Sciences Intellectual Property Review 2011


www.worldipreview.com


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