What considerations should biotech startups keep in mind when it comes to managing and expanding their patent portfolios? Firstly, in order to reduce costs as much as possible, applicants should consider applying for a fee discount, which can be applied to fees for requesting examination as well as patent right registration (for the first 10 years). If a biotech start-up satisfies the discount requirements, a maximum of two-thirds of the above fees will be discounted. Secondly, given that both the grant rate and the examination speed is high at the JPO, applicants should consider filing and prosecuting in Japan first, and then using the granted Japanese patent as a basis for examination under the PPH in other countries – particularly other Asian countries, where the JPO has a strong influence – in order to obtain geographically broader protection. Thirdly, if a biotech start-up is balancing whether to file a patent application (inevitably leading to disclosure of their invention) or to keep it as secret knowledge (in consideration of the risk of allowing competitors to imitate it), very careful consideration in this regard is necessary. This is because it is generally believed to be difficult to effectively argue prior user rights before the court. Specifically, in theory, even if a prior user is sued by somebody for patent infringement, the prior user may be entitled to continue the disputed business by arguing their prior user rights, if they had already initiated or had been preparing to initiate that business before the filing date of the patent in suit. However, the hurdle to do so is relatively high. In view of the fact that the grant rate is relatively high, a prior user may rather want to file their own patent in order to cover their business. During your years in practice, what changes have you observed in the patent prosecution landscape regarding biotech IP? There have been great developments in three areas: namely, a technical effect in the context of inventive step, support requirement, and inherent disclosure. The guidance on how to evaluate technical effect in the context of an inventive step has been developed in recent years before Japanese courts, including the Supreme Court of Japan, and I believe that now we have a clearer view of it. While this guidance 58 LAWYER MONTHLY AUGUST 2023 Lessexperienced patent attorneys will tend to blindly accept what an examiner argues before thoroughly analysing the argument.
RkJQdWJsaXNoZXIy Mjk3Mzkz