Protecting a Biotechnology Invention: A Practitioner's Guide to Sequence Claims, Deposits, Written Description, and Genetic Resources
By Casey Scott McKay ·
This guide takes a biotechnology invention from laboratory result to defensible position, in the order the decisions actually arise. It starts with publication management, because in this field the disclosure that builds a career destroys the foreign patent family, and no later step recovers it. It then works through eligibility-aware claim drafting, the sequence-defined and epitope strategies that replace the functional genus claims recent decisions have foreclosed, and the specification architecture that gives written description an alternative route. The middle sections cover the mechanics unique to this field — sequence listings, deposits, derivation records — and the provenance regime that now governs biological inputs from acquisition through commercialisation. The closing sections address freedom to operate across a densely patented tool landscape, the regulatory exclusivities that frequently outlast the patents, term selection, and diligence.
IP and Technology > Patent Counseling Transactions | Guide | Published 28 December 2023 - Updated 23 February 2025 | Casey Scott McKay - marksy.us
Summary. This guide takes a biotechnology invention from laboratory result to defensible position, in the order the decisions actually arise. It starts with publication management, because in this field the disclosure that builds a career destroys the foreign patent family, and no later step recovers it. It then works through eligibility-aware claim drafting, the sequence-defined and epitope strategies that replace the functional genus claims recent decisions have foreclosed, and the specification architecture that gives written description an alternative route. The middle sections cover the mechanics unique to this field — sequence listings, deposits, derivation records — and the provenance regime that now governs biological inputs from acquisition through commercialisation. The closing sections address freedom to operate across a densely patented tool landscape, the regulatory exclusivities that frequently outlast the patents, term selection, and diligence.
Keywords: biotechnology filing strategy · eligibility drafting · sequence defined claims · complementarity determining regions · percentage identity limits · epitope claims · sequence listing compliance · Budapest Treaty deposits · derivation proceedings · publication management · material provenance records · access and benefit sharing · material transfer agreements · research safe harbour · biosimilar exclusivity · manufacturing patents · term extension selection · freedom to operate on tools · donor consent scope · computational discovery
This is premium Marksy content — the full document is available to subscribers.