Academic journal article Journal of Corporation Law

Patent Law as an Incentive to Innovate Not Donate: The Role of the U.S. Patent System in Regulating Ownership of Human Tissue

Academic journal article Journal of Corporation Law

Patent Law as an Incentive to Innovate Not Donate: The Role of the U.S. Patent System in Regulating Ownership of Human Tissue

Article excerpt

I. 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. …

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