The National Institutes of Health, patents, and the public interest: an expanded rationale of justice Breyer's dissent in Stanford v. Roche.

• Author: Shakir, Nida

1. 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. (17) This Comment discusses the dissenting viewpoint set forth by Justice Breyer, who claimed that the majority's holding will adversely affect the carefully thought-out balance of interests between the public and private sector. (18) This Comment agrees with the dissenting opinion in Stanford v. Roche and seeks to assuage Justice Breyer's concern over this balance of interests by using the NIH as an example of how the government is actively seeking to balance this interest, even if the Court is not.

   Section II of this Comment will discuss the historical rationale behind creating the NIH and its enabling authority. Specifically, this Section will delve into the two opposing viewpoints leading up to the passage of the Bayh-Dole Act. Section III will briefly discuss the Bayh-Dole Act and the implications the Act has on the NIH's patent authority. Section IV will focus on the recent Supreme Court decision in Stanford v. Roche. Finally, Section V of this Comment will argue that Justice Breyer's dissenting opinion in Stanford v. Roche highlights an important public interest viewpoint on patent ownership. This Section will then argue that this viewpoint is a valid public policy concern that could tip the carefully balanced interests between the public and private sector, which are currently in place to facilitate patent innovation. This Section will lastly use the NIH to exemplify how the government uses existing statutory authority to balance this public-private interest.

2. HISTORICAL BACKGROUND OF THE NATIONAL INSTITUTES OF HEALTH AND PATENT AUTHORITY

   The NIH received its enabling authority from the passage of the Public Health Service Act (PHS Act). (19) Throughout the 1930s, the federal government began granting funds to states and local health departments and expanded their involvement throughout national health care. (20) Congress initially passed the PHS Act in two pieces of legislation; first in 1943 and then in 1944 when it codified its authority and strengthened its role. (21) Functioning through four main authorities: "the Office of the Surgeon General, the National Institute of Health, a new Bureau of Medical Services, and a new Bureau of State Services," (22) the PHS Act was the first piece of legislation unifying already existing programs and federal activities into a "linear relationship between investment in the supply of knowledge and health services and [the] reduction in the burden of disease." (23) It essentially set up a new approach to public health in the United States. (24)

   1. Two Decades of Careful Planning Created the National Institutes of Health

      Before the end of World War II, public health officials began laying the groundwork for a postwar medical research effort. (25) Thus, during the 1930s, the NIH worked hard to be a part of that effort. (26) Congress carefully crafted legislation to provide maximum flexibility for the NIH. (27) While the PHS had initially proposed solely intramural research, research conducted by the agency's own scientists and in their own laboratories, (28) other proposals believed that the government should limit its own research programs and award grants-in-aid to university scientists. (29) Slowly, this idea took off with the creation of the National Cancer Institute, which was the first institute to award grants-in-aid and fellowships to able researchers in institutions outside of the PHS. (30) This approach proved to be cost effective and successful as the NIH became "the principal biomedical and behavioral research agency within the Federal Government." (31) Now, as the premier public health agency, the NIH was ready for more power, principally in the patent arena.

   2. The Department of Health Education and Welfare

      Many post World War II U.S. presidents attempted to unify a patent policy across federal agencies, however, both sides of the debate were compelling, and Congress could not agree. (32) Thus, agencies followed ad hoc patent titles and licensing for many years. (33) The Department of Health, Education, and Welfare (HEW) (34) was one of the first agencies to negotiate an agreement with universities regarding technology transfer. (35) These agreements were known as Institutional Patent Agreements. (36) HEW specifically wanted to grant exclusive patent licenses and was the first agency to do so absent explicit statutory authority. (37) Under the financial umbrella of HEW, the NIH also granted patent titles in a similar fashion. (38) This approach to technology transfer of information was significant because the NIH controlled "nearly half of all federal financing of academic research." (39) Eventually, the HEW became a premier example of how the government could facilitate patent innovation that benefitted both the public and private sectors.

   3. Two Opposing Perspectives: The Bush-Kilgore Debates

      During the debates prior to the passage of the Bayh-Dole Act, the conversation focused on whether the government should have a uniform patent policy and who should primarily retain title to patents that were discovered in part through the use of public funding. (40) Prior to 1980, the government maintained full control of all patents resulting from government sponsored research. (41) Although this approach ensured that patents would be available to the public and fall in line with the goals of the PHS Act and the NIH, this approach prevented federally financed technology to translate into successful commercial products. (42) This often stifled innovation, and it was thought that "public ownership of research results was equivalent to 'dead-hand' control, and [that] the public domain was a treacherous quicksand pit in which discoveries [sunk] beyond reach of the private sector." (43) Without a uniform policy across all agencies, the government "lacked a consistent approach to determining who held clear title to federally-financed research." (44)

      Congress had been debating this issue for decades; however, the concerns over agreeing on a uniform government patent policy were becoming more pertinent due to a "massive expansion of federal [research and development] during World War II, [where]...