The National Institutes of Health, Patents, and the Public Interest: An Expanded Rationale of Justice Breyer's Dissent in Stanford V. Roche

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   I. INTRODUCTION    II. HISTORICAL BACKGROUND OF THE NATIONAL INSTITUTES OF HEALTH AND       PATENT AUTHORITY       A. Two Decades of Careful Planning Created the National       Institutes of Health       B. The Department of Health Education and Welfare    C. Two Opposing Perspectives: The Bush-Kilgore Debates    III. THE BAYH-DOLE ACT AND ITS IMPACT ON THE NATIONAL INSTITUTES OF       HEALTH       A. The National Institutes of Health and Its Patent Authority       B. The Passage of the Bayh-Dole Act    IV. BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY V.       ROCHE MOLECULAR SYSTEMS, INC.    V. RATIONALIZING THE DISCUSSION RAISED IN JUSTICE BREYER'S       DISSENTING OPINION       A. Allowing Ownership of Title to Vest beyond a Federally Funded       Investor Could Tip the Scale       B. The National Institutes of Health: What Are They Doing Right?    VI. CONCLUSION 

I. INTRODUCTION

In February 2010, the Alzheimer's Institute of America (AIA] filed a patent infringement lawsuit against Jackson Laboratory, the largest repository of research mice in the world. (1) AIA sued Jackson Laboratory for infringing on AIA's patent covering a DNA mutation linked to Alzheimer's disease. (2) Jackson Lab allegedly violated that patent by distributing mice especially bred for Alzheimer's research. (3)

AIA also sued a number of other parties for infringing upon this same patent. However, in August 2011, only the case against Jackson Laboratory was dismissed. (4) What caused the dismissal of the lawsuit against Jackson Laboratory? The answer is simple: the National Institutes of Health (NIH) had funded Jackson Laboratory's research with the mice in question since 2003. (5) And due to the NIH's significant interest in the research, it retroactively granted Jackson Laboratory authorization and consent to distribute the mice. (6)

It is easy to see why Jackson Laboratory, and arguably the public, benefited from NIH's rare decision to intervene. (7) Currently, the NIH holds various patent rights that date back to the federal government's long-term vision of the agency. (8) Many of these rights come from the amendments to the Patent and Trademark Act, or more commonly referred to as the Bayh-Dole Act. (9)

Today, it seems like this vision falls seamlessly in line with the NIH's broader goals within the medical research community. For example, Francis Collins, the Director of the NIH, released a letter explaining the agency's decision to support Jackson Laboratory against the infringement suit. (10) He stated that it was not only to aid Jackson Laboratory, but also to effectuate the NIH's broader policy on access to research tools. (11) Specifically he stated, "[t]his is great news not only for those involved in Alzheimer's disease research, but for the entire biomedical research community ... [a]t [the] NIH, we believe that science advances most rapidly when new technologies and research tools resulting from federal funding are made available to others." (12)

In addition to having some authority over patents, the NIH has an underlying mission to uncover new knowledge that will lead to improved public health. (13) The Office of Technology Transfer, under the NIH, has a primary function to transition basic medical research into commercially successful inventions that will improve public health. (14) With such a stated mission, the NIH does not take this responsibility lightly and is heavily involved in balancing the interests of the public with those of the private sector. (15)

It is with this backdrop that this Comment analyzes the recent Supreme Court case Board of Trustees of Leland Stanford University v. Roche Molecular Systems, Inc. (Stanford v. Roche). (16) In Stanford v. Roche, the Court sets forth an interpretation of the Bayh-Dole Act with regards to patent ownership and holds that patent ownership can vest beyond the initial recipient of federal funding. …