Patent law as an incentive to innovate not donate: the role of the U.S. patent system in regulating ownership of human tissue.

• Author: Coryell, Matthew W.

1. INTRODUCTION II. BACKGROUND A. Constitutional and Theoretical Justifications for the U.S. Patent System 1. Constitutional Origins of the U.S. Patent System 2. Theoretical Justifications for the U.S. Patent System B. Statutory Framework For Patentability C. Invention 1. Conception 2. Reduction to Practice D. Joint Inventors E. Industry and the Importance of Predictable Patent Protection for Innovation F. Moore and After G. The PXE Gene Patent: Joint-Inventorship for Tissue Donors III. ANALYSIS A. Case Law Defining Property Interests in Donated Tissues B. Defining the Invention: What is the Innovation 1. The Establishment of the Mo Cell-Line 2. The Identification of the Canavan Disease Gene Mutation in Greenberg C. Joint-Inventorship for Tissue Donors and the Law of Joint-Inventorship 1. Moore as a Joint-Inventor 2. The CDF as Joint-Inventors 3. Joint-Inventorship for PXE-International on the PXE-Gene Patent D. Joint-Inventorship for Tissue Donors and the Spirit of Inventorship Law: What Are We Incentivizing? IV. RECOMMENDATION V. CONCLUSION I. INTRODUCTION

   As researchers work to understand human disease and develop novel therapies, tissue samples and other biological materials from patients have become an invaluable resource. (1) Scientists study diseased tissue because understanding what is wrong at the molecular level is one of the best ways to figure out how to make it right. (2) Historically, ownership of human tissues used in research has been ill-defined. (3) With the increase in demand and value of these tissues has come an increase in disputes between researchers and patients, who are at times, the unknowing source of the tissue. (4) Because biotechnology and pharmaceutical companies rely on strong patent protection to justify significant investments in new treatments, the manner in which these disputes are resolved is of great import. (5) This Note will focus on the property rights of tissue donors in inventions subsequently derived from their tissues and analyze the approach of claiming the tissue donor as a joint-inventor for the purpose of obtaining a patent.

   Part III.A analyzes three seminal cases that define the scope of the case law regarding donor claim of property interests in inventions derived from donated tissue. These cases reveal that courts have been largely unwilling to entertain any claims of donor ownership in their donated tissues or in the inventions derived from them. Accordingly, some groups have resorted to the U.S. patent system in attempt to assert rights to inventions made from their tissues. (6) Because the goal of the U.S. patent system is to promote innovation, Part III.B examines the innovation involved in the inventions at issue in the cases discussed in III.A. With these innovations in mind, Part III.C examines whether under current U.S. patent law, the act of donating tissue could meet the statutory requirements for joint-inventorship status for the tissue donors in these cases. Finally, Part III.D considers whether granting joint-inventorship status to tissue donors would be consistent with the economic and public policy rationales that underlie the patent system and what effect such a policy would have on the firms that bring new treatments to market.

   Through this analysis it appears that tissue donation, without more, does not meet the statutory requirement to claim joint-inventorship. Furthermore, since donors have no control over the value of their tissues, rewarding them with a grant of patent rights is inconsistent with the public policy rationale of the patent system to promote innovation. This Note concludes that rather than resorting to the patent system, patient rights can be best protected through expansion of informed consent requirements for use of human tissues and patient advocacy group controlled tissue banks that allow patient groups to define terms of tissue use before research begins.

2. BACKGROUND

   1. Constitutional and Theoretical Justifications for the U.S. Patent System

      The U.S. patent system is rooted in the U.S. Constitution. (7) While the specific rules that govern the issuance and terms of patent grants have changed, much of the underlying rationale has remained the same. (8) Patents serve to promote innovation by rewarding an inventor a limited period of exclusivity in the invention. (9) Further, patents promote the dissemination of knowledge by making the patent grant contingent upon disclosing the invention to the public once the patent has expired. (10)

      1. Constitutional Origins of the U.S. Patent System

         The drafters of the U.S. Constitution recognized the importance of affording inventors protection for their innovations when they empowered Congress "[t]o promote the [p]rogress of ... useful [a]rts, by securing for limited [t]imes to [i]nventors the exclusive [r]ight to their ... [discoveries." (11) Thus the U.S. patent system is rooted in the Constitution itself. Congress, recognizing the importance of the patent system to the nascent country, passed the first Patent Act of 1790 in the early days of the first Congress. (12) While the structure of today's patent law is considerably more complex than the first Patent Act, the foundation and underlying policy rationales remain the same. (13)

      2. Theoretical Justifications for the U.S. Patent System

         Today there is a general consensus on the theory underlying the patent system. (14) Innovation is the major driving force behind our economy and provides great benefit to society. (15) Providing inventors limited periods of exclusive rights to their inventions in exchange for disclosing their invention promotes innovation in two major ways. (16) First, it provides an incentive for inventors to invest their time and resources necessary for invention. (17) Second, it promotes the disclosure and dissemination of new knowledge that may have otherwise been kept secret. (18)

         The inventive process is difficult, expensive, and has a high risk of failure. (19) Further, absent patent protection, many inventions could be readily copied. (20) This would allow the imitator to avoid the cost of invention and the inventor would be unable to recoup his investment. (21) The grant of patent protection "provides a market-driven incentive to invest in innovation, by allowing the inventor to appropriate the full economic rewards of her invention." (22) There is less agreement about the proper balance of protection to best achieve incentivization. (23) This is manifest in the changing standards for patentability that has characterized the U.S. patent system since its inception. (24)

         The patent system incentivizes disclosure of new knowledge by conditioning the grant of a patent on the inclusion of an enabling description of the claimed subject matter. (25) The disclosed information is then committed to public knowledge; after the patent has run, it may be used by anyone. In describing this quid pro quo the Supreme Court has stated:

         When ... [the disclosure] is circulated to the general public and those especially skilled in the trade, such additions to the general store of knowledge are of such importance to the public weal that the Federal Government is willing to pay the high price ... of exclusive use for its disclosure, which disclosure, it is assumed, will stimulate ideas and the eventual development of further significant advances in the art. (26) B. Statutory Framework For Patentability

         An invention is only eligible for a patent if it is patentable subject matter, (27) new, (28) useful, (29) and non-obvious. (30) These conditions ensure that the patentee is not taking from the public something it already enjoys (31) and that the invention constitutes a truly innovative step beyond what was already known. (32) Additionally, a patent application must contain a description of the invention that is enabling or would allow a person skilled in the relevant art to make the invention without undue experimentation. (33) The enablement requirement ensures that, in exchange for the grant of exclusivity, the patentee is truly committing the invention to the public once the patent has expired. 34

   3. Invention

      The United States awards patents to the first person to invent a patentable invention. (35) This is in marked contrast to all other countries; other countries award patents to the first inventor to file a patent application. (36) The U.S. first-to-invent system is arguably (37) a constitutional requirement because the patent clause gives "Inventors the exclusive [r]ight to their ... [d]iscoveries." (38) Therefore, patent rights in the United States hinge upon how we define the act of invention and the identity of the inventor.

      1. Conception

         The key to understanding how patent law determines a rightful inventor is the idea of conception. The Supreme Court has held that "[t]he primary meaning of the word 'invention' in the Patent Act unquestionably refers to the inventor's conception rather than to a physical embodiment of that idea." (39) Conception is the "formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice." (40) The idea must be definite and permanent enough "that one skilled in the art could understand the invention." (41) It is not sufficient that an inventor have a general idea or a research plan for approaching a problem. (42)

      2. Reduction to Practice

         once an invention has been conceived, the inventor must reduce it to practice. (43) Courts have recognized two forms of reduction to practice: actual and constructive. (44) Actual reduction to practice requires the inventor to first construct an embodiment or perform a process that meets all the claims of the invention, and second, determine whether the invention works for its intended purpose. (45) The invention does not need to be in a "commercially satisfactory stage of development," but the embodiment relied upon must work for its intended...