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Public disclosure of biological sequences in global patent practice

Public disclosure of biological sequences in global patent practice

Abstract

Biological sequences are an important part of global patenting, with unique challenges for their effective and equitable use in practice and in policy. Because their function can only be determined with computer-aided technology, the form in which sequences are disclosed matters greatly. Similarly, the scope of patent rights sought and granted requires computer readable data and tools for comparison.

Critically, the primary data provided to the national patent offices and thence to the public, must be comprehensive, standardized, timely and meaningful. It is not yet. The proposed global Patent Sequence (PatSeq) Data platform can enable national and regional jurisdictions meet the desired standards.

1. Introduction

In the traditional working of the patent system, an inventor secures governmental rights to exclude others from making, using, or selling his/her invention for a limited time in exchange for publicly disclosing the full details of the invention - what is called ‘the teachings’. The teachings derived from the disclosure and the practice of an invention enable the public to use the invention through licensing, to use the invention freely without license outside the jurisdiction, scope and timeframe of protection, build upon the invention through research and development, improve upon it, or design around it to advance scientific and technological capabilities and ultimately to benefit society.

In the contemporary use of patents to secure rights over genetic material, the quality of these teachings has come under public scrutiny and the role of patent offices in the disclosure process has been challenged.

Within patent documents, genetic sequences have been viewed both legally and practically as either chemical compounds or as information-encoding elements, and within the context of patent eligibility or infringement issues, their structure and function value has gained more importance as various jurisdictions – including the United States and Europe - attempt to balance competing interests either in favor of the inventors, as the case in Europe, or the public, as the case in USA.

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