As discussed in Part I of this article, the European Patent Office (EPO) recently published its Guidelines for Examination 2021, which came into force on March 1. In the previous article, we detailed changes affecting computer-implemented inventions and with respect to procedural matters. Here, we will address the Guidelines’ changes for biotech. In addition to some specifications regarding the interpretation of terms relating to amino and nucleic acid sequences and the definition of the concept of “therapy” and of the products that can be claimed in view of their new medical use, the main additions that have been made to the part of the Guidelines relating to biotechnological inventions concern the exclusions from patentability, and in particular the ineligibility of inventions relating to plants or animals and human embryos. A full section has also been added relating to the patentability of antibodies.
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