学会誌・資料 Journal

日本知財学会誌 第16巻第1号掲載

Patent-eligible Subject Matter in the Life Sciences in the United States

Joseph J. Koipally, Janis K. Fraser, Kazuyuki Ojima

日本知財学会誌 Vol.16 No.1 p.20-30 (2019-6-20)
Journal of Intellectual Property Association of Japan Vol.16 No.1 p.20-30 (2019-6-20)

<Abstract>
The concept of “patent eligible subject matter” -whether an invention fits into a category of subject matter recognized as eligible for patenting-has become an increasingly important factor in recent years when determining validity of life sciences claims in the United States, both in the courts and in the United States Patent and Trademark Office (USPTO). The Supreme Court of the United States formulated in 2012 a two-step test for patent eligibility that the lower courts and the USPTO have struggled to interpret and apply. Analysis of various court opinions in the years since 2012 provides some indication of what types of claims are or are not considered to pass this test, and the USPTO periodically issues guidance documents (most recently in January 2019) to help patent examiners understand how to apply the test when examining claims. Widespread unhappiness with the evolving standards for patent eligibility has led many in the life sciences industry to call for legislation resetting the standards to something less vague, subjective, and onerous to patentees. Meanwhile, careful claim drafting is essential to maximize the likelihood of obtaining patent-eligible claims.

<Keywords>
§101, patent-eligible subject matter, life sciences, methods, compositions