Document Type

Article

Publication Date

1995

Abstract

You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from a broader public policy perspective. We have therefore attempted to focus on issues that are likely to recur in other patent applications filed by other people and institutions involved in DNA sequencing rather than on questions that are peculiar to the facts of these particular applications. Nonetheless, we preface this opinion letter with the caution that the facts of each patent case are unique. We have before us for consideration only these three NIH filings, and we are not in a position to offer a definitive opinion on the patentability of other inventions that may be claimed by other parties and supported by different disclosures in different patent applications. The expertise we bring to this issue is legal rather than scientific. Many issues of patent law turn on the understanding of skilled practitioners working in the field of the invention. We have identified these issues throughout this letter. We begin with a brief description of the NIH patent applications and then turn to the patentability issues presented by these applications. In our view, the most significant of these issues concern the utility, nonobviousness, and disclosure requirements of the patent laws.