Claiming Life: Biotechnology Patents, Written Description, and the Sequence You Cannot Quite Own
By Casey Scott McKay ·
Biotechnology is the field where patent law's basic categories fit least comfortably, because the subject matter is discovered as often as it is invented and described by function far more readily than by structure. This article works through the eligibility line that removed isolated genomic sequences and most diagnostic correlations from patentability, and the written description and enablement decisions that have progressively narrowed functional antibody claims. It then covers the mechanics that are specific to this field: sequence listings, biological deposits under the Budapest Treaty, and the priority disputes that arise when several groups reduce the same tool to practice within months of each other. The second half addresses the material and provenance questions — access and benefit sharing, digital sequence information, material transfer agreements, and donor consent — and the regulatory interfaces of biosimilar litigation and the research safe harbour.
IP and Technology > Patent Counseling Transactions | Article | Published 15 June 2026 - Updated 7 July 2026 | Casey Scott McKay - marksy.us
Summary. Biotechnology is the field where patent law's basic categories fit least comfortably, because the subject matter is discovered as often as it is invented and described by function far more readily than by structure. This article works through the eligibility line that removed isolated genomic sequences and most diagnostic correlations from patentability, and the written description and enablement decisions that have progressively narrowed functional antibody claims. It then covers the mechanics that are specific to this field: sequence listings, biological deposits under the Budapest Treaty, and the priority disputes that arise when several groups reduce the same tool to practice within months of each other. The second half addresses the material and provenance questions — access and benefit sharing, digital sequence information, material transfer agreements, and donor consent — and the regulatory interfaces of biosimilar litigation and the research safe harbour.
Keywords: biotechnology patents · patent eligibility · isolated DNA · cDNA claims · diagnostic method claims · natural phenomena · written description for antibodies · functional genus claims · sequence listings · biological deposits · Budapest Treaty · CRISPR priority disputes · access and benefit sharing · digital sequence information · research tools · reach-through royalties · biosimilar litigation · safe harbour for regulatory use · material transfer agreements · synthetic biology
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