is a European Patent Attorney and has over 23 years of experience in the IP field. She graduated in Biological Sciences and completed a postgraduate specialization in Industrial Biotechnology at the University of Torino. She represents and advises clients ranging from academic and research institutions (mainly Italian and US Universities) to highly specialized local companies and multinational corporations. Elena has an extensive practice drafting and prosecuting patent applications relating to biotechnological and pharmaceutical inventions and as an ex parte Technical Expert in national and multinational patent litigation in Italy. She regularly lectures at Italian universities about the protection and patentability of biotechnological inventions and is the author of the Chapter relating to Biotechnological Inventions of the Volume “Proprietà Intellettuale, Mercato e concorrenza” in the Book Series “Trattario di Diritto Civile”, Giuffrè Ed. 2017.
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The European Patent Office (EPO) recently published its Guidelines for Examination 2022, which come into force on March 1. Compared to previous years, the volume of changes is much smaller, and this witnesses the effort by the EPO in past years to arrive at a more stable text of the Guidelines, particularly concerning the software patentability and biotech sections. Yet some changes have been made, mainly to software patentability guidelines, as well as to other important sections, such as partial priorities and amendments to the description. Continuing the trend of past years, the Guidelines continue to be enriched with helpful examples.
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.