New US guidelines for assessing patentability issued The United States Patent and Trademark Office (“USPTO”) has just issued its guidelines to examiners for assessing the patentability of claims involving or reciting laws of nature, natural principles, natural phenomena, and/or natural products. The newly issued guidelines follow in the wake of some big US Supreme Court decisions from 2012 and 2013 in which isolated DNA was found to be not patentable, and that a law of nature and application of that law of nature is not patentable if the application merely relies upon elements already known in the art. Under the guidelines, all claims which recite or involve laws of nature/natural principles, natural phenomena, and/or natural products will be assessed for patentability according to a 3-step approach. The steps include the following questions: 1. Is the claim directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? 2. Does the claim recite or involve one or more judicial exceptions, for example, abstract ideas, laws of nature/natural principles, natural phenomena, and natural products? 3. Does the claim as a whole recite something significantly different than the judicial exception(s)? The crux of the questions is question 3, which assesses whether the claimed subject matter is “significantly different” from the excluded subject matter. In assessing question 3, examiners are to consider all the relevant factors and reach a determination by weighing the factors in favour of patentability against the factors against patentability. A non-exhaustive and non-exclusive list of factors is provided in the guidelines for examiners. While little comment can be made on the guidelines to date due to their recent issuance, one area of concern raised by US attorneys is the lack of clarity of when a product becomes “significantly different” or “markedly different” from its natural occurring form, so as to be patentable. The issuance of these guidelines provides some much needed guidance for both biotech companies and attorneys, who have both largely been left in limbo following the US Supreme Court’s recent decisions, particularly the most recent in which the longstanding belief that isolated DNA sequences were patentable was overturned.
Posted on: Fri, 14 Mar 2014 06:08:41 +0000
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