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

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.

II. BACKGROUND

A. 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

C. 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 purpose. (46)

Courts consider the act of filing of a patent application constructive reduction to practice. (47) It is constructive in the sense that while the invention may not actually be reduced to practice, the information disclosed in the patent application would enable one skilled in the art to make the invention without undue experimentation. (48) Constructive reduction to practice has the same legal effect as actual reduction to practice. (49)

Certain types of inventions require simultaneous conception and reduction to practice. (50) For these inventions, an inventor can only have a definite and particular idea of what the invention will be in practice once reduction to practice has occurred. (51) An example is a patent for the sequence of a novel gene coding for a protein with some known biological function. (52) It is not enough to have an idea that the invention will be a gene coding for the protein without knowing the actual sequence of the gene. (53) Once the sequence of the gene has been determined both conception and reduction to practice are complete. (54)

D. Joint Inventors

The law of joint inventorship has evolved to reflect the changing realities of the innovative process. While invention was once often an individual endeavor, today the complexities of the research undertaken to create an invention often require that large teams of individuals collaborate on a common project. Section 116 of the Patent Act (55) was amended in 1984 to recognize this trend and award joint inventorship status to anyone who materially contributes to the conception of the invention. (56)

A person is deemed a joint inventor if he collaborated with the other inventor(s) and materially contributed to the conception of at least one claim of the invention. (57) It is not required that all co-inventors contribute equally to the conception of the invention as a whole. (58) A material contribution to conception of one claim is enough. (59)

All inventors listed on the issued patent are presumed to be the correct inventors within the meaning of the Patent Act. (60) To remove a listed inventor or to join an omitted party against the will of the listed inventors requires a showing by clear and convincing evidence that the person was improperly included or omitted on the application. (61) This high bar to challenge inventorship of an issued patent is recognition of the significant interests at stake in inventorship status, especially on a commercially successful patent. All listed co-inventors on a patent application are entitled to a pro rata undivided interest in the entire patented invention--not just parts to which they may have contributed. (62) Critically, failure to list an inventor on the patent can result in the invalidation of the patent. (63)

E. Industry and the Importance of Predictable Patent Protection for Innovation

Because an expansion in the definition of joint-inventor could result in ownership claims of issued patents by newly deemed joint-inventors and possible patent invalidations for failure to list all inventors, it would likely lead to greater uncertainty in patent rights. (64) Firms invest in research and development (R&D) because of the likelihood the firm will see returns in the form of increased profits. (65) The probability that a firm will be able to realize these returns is affected by the inherent uncertainty that a given project will work and the likelihood that an innovation that does work will be afforded protection from appropriation by rivals. (66) Accordingly, factors or policies that make the enforceability of patents less certain decrease the value of patents and thus the incentive to innovate. (67) This was evidenced by a recent study comparing pre- and postpatent allowance licensing among start-up technology firms. (68) The increased certainty of patent rights associated with patent allowance accounted for a 70-80% increase in firms' success in licensing their technology. (69)

Under the current U.S. patent system, the biotech and pharmaceutical industries are among the largest investors in R&D of any industry. (70) The Congressional Budget Office reported that pharmaceutical firms spend up to five times as much on R&D as a percentage of revenues as the average manufacturing firm. (71) This inordinately high expenditure on R&D makes sense when considering the extremely high failure rate firms experience during the drug development process. According to one estimate, less than 1 in 5000 putative drugs make it from candidate compound to an FDA-approved drug. (72) A multitude of factors may account for the failure of a particular candidate drug, including: "toxicity, carcinogenicity, manufacturing difficulties, inconvenient dosing characteristics, inadequate efficacy, economic and competitive factors, and various other problems." (73) As a result of this high failure rate, the cost of bringing a novel drug to market may be over $800 million. (74)

In contrast to the high cost of drug development and approval, the cost of producing and distributing an approved drug is quite small. (75) Therefore, absent patent protection, new market entrants could avoid development costs and undercut the developing firm' s price for the new drug. (76) This is illustrated by the flood of generic producers that enter the market upon the expiration of a drug's patent. For example, when the patent protection for Prozac expired, Eli Lilly lost over 80% of its market share to generics within the first month of their entry into the market. (77) The importance of protecting a firm's investments in R&D has not been lost on executives of Biotech and pharmaceutical firms. (78) one survey of firm executives asked how the loss of patent protection would affect future R&D expenditures. (79) Pharmaceutical executives estimated they would reduce R&D expenditures over 60%. (80) This is in contrast to a 17% reduction estimated by firms manufacturing machinery. (81) Accordingly, changes in patent law that create uncertainty over patent rights could have considerable chilling effects on the willingness of firms to invest in R&D. (82)

F. Moore and After

Moore v. Regents of the University of California is a seminal case addressing a patient's rights to a patented invention derived from his tissue.83 This case involved a patient, Moore, who had hairy cell leukemia. (84) Moore's physician removed his spleen as a part treatment for the condition. (85) Without Moore's consent, his physician, Golde, then studied the tissue from Moore's excised spleen and invented a valuable cell-line for which he acquired a patent. (86) When Moore learned of the patent he brought suit, seeking damages for both breach of fiduciary duty and rights to licensing royalties from the patent. (87) The California Supreme Court found that while Golde was liable for breach of fiduciary duty for failure to disclose his financial interests, Moore had no rights to the patented cell-line. (88)

The court found that Moore's tissue and the invention subsequently derived from it were legally and factually distinct. (89) Explaining the distinction the court stated:
   Human cell lines are patentable because long-term adaptation and
   growth of human tissues and cells in culture is difficult--often
   considered an art, and the probability of success is low. It is
   this inventive effort that patent law rewards, not the discovery of
   naturally occurring raw materials. Thus, Moore's allegations that
   he owns the cell line and the products derived from it are
   inconsistent with the patent, which constitutes an authoritative
   determination that the cell line is the product of invention. (90)


Justice Mosk, in a forceful dissent, found great injustice in the majority's holding. While acknowledging that under current patent law Moore likely did not qualify as an inventor, he suggested that the concept of joint-inventorship be expanded to embrace tissue donors:
   What the patients did do, knowingly or unknowingly, is collaborate
   with the researchers by donating their body tissue.... By providing
   the researchers with unique raw materials, without which the
   resulting product could not exist, the donors become necessary
   contributors to the product.... [T]he uniqueness of the product
   that gives rise to its patentability stems from the uniqueness of
   the original cell. A patient's claim to share in the profits
   flowing from a patent would be analogous to that of an inventor
   whose collaboration was essential to the success of a resulting
   product. (91)


G. The PXE Gene Patent: Joint-Inventorship for Tissue Donors

Perhaps in response to the decision in Moore and subsequent cases, some patients wishing to assert rights to tissue-based innovations have adopted a new strategy working through the mechanisms of the U.S. patent system. (92) The first example of this new strategy came from an advocacy group for patients with a rare genetic condition that effects connective tissue known as pseudoxanthoma elasticum (PXE). (93) The leader of the PXE group, Sharon Terry, was the mother of two children with PXE and worked to organize other patients and collect and bank tissue samples for future scientific study. (94) Terry collaborated with a group of scientists and participated in running some of the experiments that gave rise to the patent for the disease gene. (95) As a result, Terry became the first layperson to be named as an inventor on a gene patent. (96) While the extraordinary circumstance surrounding this particular case makes its applicability to most cases involving tissue donation questionable, commentators and advocacy groups have nevertheless proposed this approach as a model for patients wishing to secure patent rights. (97)

III. ANALYSIS

A. Case Law Defining Property Interests in Donated Tissues

Federal statutes provide little guidance on the issue of ownership of donated tissues. (98) An analysis of the few court cases that have considered the issue provides the best indication of the current legal status of patient property rights in their donated tissues. (99) It is against this backdrop that patients have attempted to resort to the patent system to assert rights to inventions derived from their donated tissues.

In contrast to Moore, Greenberg v. Miami Children's Hospital Research Institute dealt with a situation where tissue was donated for the express purpose that it be used in medical research rather than as part of a medically necessary procedure. (100) Greenberg involved a patient advocacy group for the rare and fatal genetic condition known as Canavan disease (CD). (101) The Canavan Disease Foundation (CDF) worked to identify families with the disease and encouraged them to donate blood and tissue samples which the group collected in a tissue bank. (102) The CDF sought the help of Dr. Reuben Matalon to identify the gene mutation associated with the disorder. (103) The CDF hoped that this identification would lead to the development of a screening test for carriers of the disease gene as well as in utero tests to identify fetuses that would develop the disease. (104) Matalon received tissue and financial support from the group and was able to identify two mutations present in over 98% of patients with CD. (105) However, without the CDF's knowledge Matalon obtained a patent on the disease gene and methods for screening for mutations associated with CD and assigned the patent rights to his employer hospital. (106) When the CDF learned of the patent and hospital's intent to enforce its patent rights by requiring that institutions obtain a license to screen for the gene, the patients brought suit claiming, among other things, unjust enrichment and conversion of their genetic information. (107)

The Greenberg court, citing Moore, dismissed the group's conversion claim. (108) The court emphasized the donative nature of the group's provision of the tissue to Matalon, holding that the plaintiffs had "no cognizable property interest in body tissue and genetic matter donated for research under a theory of conversion" (109) and that any property interest the plaintiffs may have had in their tissue "evaporates once the sample is voluntarily given to a third party." (110) Further, the court reaffirmed the point made in Moore, that donated tissue and the patented invention derived from that tissue are "factually and legally distinct." (111) However, the court did find that the plaintiff's unjust enrichment claim survived the motion to dismiss. (112) In so doing, the Greenberg court distinguished between the propriety of the defendant's intellectual property interests in the invention, and the defendant's arguably inequitable conduct during the research collaboration with the plaintiffs. (113)

The most recent court to decide a dispute over patient rights to donated tissue was the Eight Circuit in Washington University v. Catalona. (114) In Catalona, a surgeon at Washington University (WU), recruited many of his patients to participate in prostate cancer research by donating their excised tumors to be banked at the WU Biorepository. (115) When Catalona left WU to take a position at Northwestern University, he sent consent forms to his patients that purported to release their donated tissue samples, allowing Catalona to take them to Northwestern. (116) WU filed a declaratory judgment action seeking to establish that ownership of the tissue resided with WU. (117)

The Eighth Circuit Court of Appeals affirmed the district court's judgment and held that the patients' donated tissue were gifts to WU and as such, the patients had no residual rights to determine how the samples would be used. (118) The court cited language in the original study consent form that disclaimed any future interest in the tissue itself or in any new material or process developed through research on the tissue. (119) Furthermore, the court noted that Catalona's use of the tissue was inconsistent with his claim that the patients retained a residual ownership interest in the tissue. (120) On multiple occasions, Catalona destroyed tissue samples when they were no longer useful or to make room for new samples and he did this without gaining consent from the donors. (121)

Catalona follows the approach taken in Moore and Greenberg in dealing with patient claims of property rights to donated tissues. (122) However, Catalona is distinct from Moore and Greenburg because it involves patient claims to the tissue itself rather than the patent rights to innovations derived from the tissue. (123) In this sense, the Catalona court goes further in limiting patient ownership claims since the Moore and Greenberg courts dealt with claims to inventions the courts found were legally and factually distinct from the donated tissue. (124)

Taken together these cases illustrate the courts' consistent hostility to any claim by patients to property rights in tissue post-donation. Given the lack of any statutory guidance to the contrary, these courts have treated tissue as they would other property and applied well-settled principles of property law governing gifts. (125) These principles generally preclude any post-donation claim of ownership by the donor. (126) These courts have also cited public policy concerns about the effect of allowing donors to make subsequent property claims to their tissue on the progress of science. (127) For example the court in Moore warned, "the theory of liability that Moore urges us to endorse threatens to destroy the economic incentive to conduct important medical research." (128) Similarly, the court in Greenberg cautioned that recognizing ownership interests in donated tissue would "give rise to a type of dead-hand control that research subjects could hold because they would be able to dictate how medical research progresses."129

B. Defining the Invention: What is the Innovation?

1. The Establishment of the Mo Cell-Line

The court in Moore held that the cells removed from Moore's spleen and the patented cell-line were legally and factually distinct. (130) To understand this distinction it is necessary to understand the inventive steps taken by the researcher Golde. The patent at issue in Moore was for an immortalized cell-line derived from Moore's spleen known as the Mo Line. (131) The establishment of the Mo Line represents at least two major innovations. Golde discovered that Moore's tumor cells produced large amounts of certain compounds known as lymphokines. (132) This property of lymphokine overproduction was valuable because lymphokines were thought to have significant therapeutic potential. (133) Endogenously produced lymphokines are generally present in the body at very low levels--equivalent to an eighth of a teaspoon in a full sized swimming pool. (134) Further, cells overproducing lymphokines could provide a powerful tool to discover the genetic coding for individual lymphokines. (135)

The second innovation was the invention of the immortalized cell line. Cells taken from the human body will generally only divide once or twice before becoming inactive and dying, thus limiting their usefulness to researchers. (136) An immortalized cell-line has the ability to divide and reproduce an indefinite number of times under laboratory conditions. (137) Yet, converting a primary cell (cells taken directly from the body) to an immortalized cell line was often a very difficult endeavor. (138) Because Golde was able to achieve this, he was able to couple his discovery of the unique properties of Moore's tumor cells with an invention that made the property available for researchers to study and potentially develop novel therapies.

2. The Identification of the Canavan Disease Gene Mutation in Greenberg

Prior to the collaboration between the CDF and Matalon, very little was known about CD. (139) Inheritance patterns demonstrated that CD was an autosomal recessive (140) condition that occurred primarily in Ashkenazi Jews and clinical observations and postmortem studies characterized the spongiform degeneration of the brain that accompanied progressive loss of motor function and eventual death. (141) However, the molecular and genetic underpinnings of the pathology were unknown. (142) While the identification of the disease gene was the ultimate goal of both Matalon and the CDF, this task would be close to impossible without some biological marker or clue to suggest which gene to investigate. Matalon found this clue when he identified elevated levels of N-Acetylaspartic acid (NAA) in urine and serum from several patients. (143) With the discovery that NAA levels were elevated in CD patients, Matalon was able to focus his research into genes responsible for the regulation of NAA levels. (144) The approach paid off. Matalon cloned the aspartoacylase (145) gene and identified two mutations in the gene present in nearly all patients with CD. (146)

C. Joint-Inventorship for Tissue Donors and the Law of Joint-Inventorship

As noted by the dissent in Moore "[patient donors] provid[e] ... researchers with unique raw materials, without which the resulting product could not exist, [thus] the donors become necessary contributors to the product.... [T]he uniqueness of the product that gives rise to its patentability stems from the uniqueness of the original cell." (147) The question then becomes whether this necessary contribution of tissue by patients is sufficient for the patient to qualify as a joint-inventor within the meaning of the patent law. As noted above, the relevant inquiry in determining joint-inventorship is contribution to conception. (148) The following sections will consider whether the tissue donations in the cases discussed can be considered contributions to conception of the patented invention.

1. Moore as a Joint-Inventor

In Moore, Golde's concealment of his research activities from Moore would likely preclude any claim that Moore participated in the conception of the cell-line. (149) Courts have emphasized that conception is a mental process: "the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention." (150) In the absence of any knowledge of either the unique lymphokine producing capacity of his cells or the process by which his cells were converted into a cell-line, it would be impossible for Moore to claim he contributed to the conception of the invention.

2. The CDF as Joint-Inventors

While the question of joint-inventorship status for the CDF is closer than in Moore, the patient group's contribution would still not likely rise to the level of a contribution to conception required by patent law. Unlike in Moore, the CDF did have an idea of what the ultimate invention would be, the identification of the gene mutation responsible for CD. (151) However, because the group had no idea about the underlying etiology of the disease and no idea which genes to search for mutations (152) in, they did not have the "definite and permanent idea of the complete and operative invention, as it [was] ... to be applied in practice" (153) that courts require for conception. The Federal Circuit recently held "[o]ne who merely suggests an idea of a result to be accomplished, rather than means of accomplishing it, is not a joint inventor." (154) The CDF suggested that Matalon identify the CD disease gene using patient tissue samples. (155) Yet as discussed above, the means of accomplishing gene mutation identification was significantly more complex then simply using the patients' tissue. (156) Thus, while donation of tissues is critical for new breakthroughs it does not constitute conception within the meaning of [section] 116.

3. Joint-Inventorship for PXE-International on the PXE-Gene Patent

In contrast to Moore and Greenberg, the PXE-gene patent was issued with Terry, of the PXE international patient advocacy group, listed as an inventor. (157) Similar to the patient group in Greenberg, Terry and her group indentified other patients and collected and stored tissue samples. (158) But Terry's contribution went even further in that she and group founders actually spent time in the lab with the researchers running experiments. (159) As Terry describes it:
   The founders of PXE International, despite having no scientific
   training, engaged in bench science as members of the research team
   that studied PXE, resulting in discovery of the causative gene.
   Scientists . . . who worked late at night in the laboratory
   alongside the founders of PXE International, appreciated
   "putting a face on the disease." (160)


However, the fact that Terry was listed as a joint-inventor on the patent does not necessarily mean her inventorship status was proper. The Manual of Patent Examining Procedures directs the examiner to assume that the inventors named on an application are correct. (161) Because of this assumption, Terry's claim of joint-inventorship has not been rigorously challenged as it would be had the group attempted to enforce their patent rights by bringing an action for infringement. (162) Whether Terry's inventorship status would stand up to such a challenge would turn on whether the court could find that she contributed to conception. (163) This raises the question of whether someone without any formal scientific training, and thus someone not skilled in the art in which the invention was made, could have "an idea that was definite and permanent enough that one skilled in the art could understand the invention" as courts require to find conception. (164) Given the complexity of the claimed subject matter165 it seems unlikely that someone with no formal scientific training would be able to conceive of the gene identity and the disease mutations in sufficient detail to allow another scientist to diagnose PXE disease.

D. Joint-Inventorship for Tissue Donors and the Spirit of Inventorship Law: What Are We Incentivizing?

While joint-inventor status is likely unavailable to tissue donors for inventions made from their tissues under [section] 116, it is nevertheless worth considering whether statutory expansion of the definition of joint-inventorship is desirable and consistent with the purpose of the patent laws. Because the constitutional purpose of the patent system is to promote progress of science and the useful arts,166 any proposed change in the patent system should be assessed in terms of its ability to more effectively achieve this goal. Examining the set of incentives a given policy creates and in turn what type of activities those incentives serve to promote indicates whether a given policy promotes the progress of science and useful arts.

Under current law, where conception serves as the determinative factor of inventorship, (167) it is conception that is incentivized. It is during conception that something new, useful, and non-obvious, comes into existence in the mind of the inventor. (168) Following a reduction to practice, it can be enjoyed by society as new innovation. In contrast, granting inventorship status to patient tissue incentivizes the contribution of unique tissue.

While contribution of tissues for research purposes is desirable, attaching such an incentive is problematic. A donor would not be rewarded for donating per se, but only if she were lucky enough that her tissue had some unique property. It makes little sense to incentivize something that people generally have little control over, such as the uniqueness of their tumor. Therefore it seems as though providing joint-inventorship to tissue donors would go against the constitutional and public policy rationale underlying the U.S. patent system, which aims to reward those making intellectual contributions giving rise to innovation, not those controlling resources that make innovation possible.

IV. RECOMMENDATION

Under current law, joint-inventorship status requires a joint-inventor to have a role in the conception of the invention. (169) Because conception is a mental process, (170) a party whose contribution is limited to tissue donation will not have contributed to conception within the meaning of patent law. (171) A judicial or legislative expansion of the definition of joint-inventor could be used to bring tissue donors within the definition of jointinventors. (172) For example, rather than conception, inventor status could hinge on a "but for" or "material" contribution to the invention standard. This would no doubt cover tissue donors in many instances. However, such an expansion could also present a number of significant problems.

Determining inventorship based on a material contribution standard would create substantial uncertainty over the validity of issued patents. It would essentially allow anyone whose donation of tissue arguably contributed materially to a patented invention to sue for joinder on the patent. Many of the thousands of new "inventors" may have forgotten that they donated tissue for research in the first place. While such a person may be unlikely to assert his new inventorship right on his own, patents worth millions or billions of dollars would provide a strong incentive for plaintiff's attorneys to raise public awareness. (173)

An additional effect of expanding the definition of joint-inventorship is the expansion of activities patent law rewards with exclusive rights. (174) This expansion is not without cost. Increasing the incentive to donate tissue comes at the expense of decreased incentives to conceive. (175) Because each additional joint-inventor is entitled to a pro-rata share of the invention as a whole, the amount of additional incentive is the amount reduced to the original inventor. (176)

The cost to bring a new treatment to market is extremely high. Studies estimate it may cost over $897 million to bring a new drug from early development through the FDA approval process. (177) Uncertainty in future patent rights undermines the incentive for industry to invest the substantial sums of money necessary to bring new treatments to the public. To recoup these investments, biomedical research corporations rely on sales during the period of exclusivity afforded by the patent system. (178) Changes in policy that weaken patent protection or call the validity of issued patents into doubt would significantly change the calculus of corporations increasing the risk associated with new innovations. The current standard--determining inventorship by a role in conception--is most faithful to the legal, constitutional, and public policy foundations of patent law (179) and thus it should be left undisturbed.

The impetus for tissue donors to resort to the patent system to assert their rights stems at least in part from a reaction to the inequitable conduct of some scientists, like those in Moore and Greenberg. (180) If joint-inventor status is unavailable to patient donors is there an alternative course to protect patients? The answer may vary depending on the relationship between the tissue donor and the researcher. For patients who donate tissue excised as a part of a medically necessary procedure, one possibility is to expand the informed consent requirements for tissue usage. (181) For individuals seeking to donate tissue to further research of a particular disease, doing so as a part of a patient advocacy group may allow for greater power in determining terms and conditions of tissue use. (182)

Under current guidelines set forth in the "common rule" (183) language, consenting to the use of tissue for research is often buried within the broader consent to the surgical procedure. (184) Because the language used in consent forms is often buried and unclear, patients may not understand what they are consenting to, or think that their access to a medically necessary procedure is contingent upon their consent to the research. (185) The "common rule" could be amended in the following ways to increase patient protection.

First, separate consent should be required for the use of patients' tissues in research and medically necessary procedures. This would avoid confusion over what the patient is consenting to and allow the patient to consider separately the implications of consenting to donate his tissues for research. Second, the physician or researcher should disclose to the patient the potential of future financial interests of the institution in the research products derived from the patient's tissues. (186) The consent form should further stipulate that by donating tissue the patient disclaims any interests in subsequent use of his tissues. (187) This allows patients the ability to make truly informed decisions about whether to donate their tissue and avoids potential feelings of surprise and betrayal that occur in cases such as Moore.

While donor contributions of tissue do not rise to the level of inventorship status under U.S. patent law, (188) it is nevertheless an essential part of biomedical progress. (189) As such, control of tissues can confer upon the patient considerable power. This power is amplified when patients organize within patient advocacy groups. (190) These groups have successfully compiled and managed their own tissue banks and are therefore able to negotiate with researchers and industry the terms of their tissues' use. (191) Terms can stipulate that the group be made an assignee on any patent resulting from use of the group's tissue or that licensing of any resulting therapy be at some pre-defined reasonable rate. (192) The advocacy group approach provides a model to empower patients to shape the direction of research while not disrupting the careful balance between incentivization and innovation achieved by the patent system.

V. CONCLUSION

Human tissues are, and will continue to be, a critical component of innovation in the biotech industry and advances in human health. The patent system should maintain policies that maximize incentives to invest in innovation and investment in research involving human tissue should be no exception. By continuing to condition jointinventorship status on conception of the invention rather than donation of valuable tissues, patent law can best achieve this goal. To protect the rights of patients to determine whether their tissue will be used in research, the informed consent requirements for the use of human tissues in research should be expanded to disclosed financial interests of the investigator. This would allow tissue donors to leverage the power that comes with possessing unique and valuable tissue by forming patient advocacy groups and facilitate negotiation with researchers to determine the terms of use for the tissue. Together these recommendations would have the effect of protecting the patient donor from undue surprise, empower donors who proactively seek to use their tissue to steer research in a particular direction, and preserve the incentive structure that allows firms to invest the resources to develop the next generation of treatments for human disease.

(1.) David Korn, Contribution of the Human Tissue Archive to the Advancement of Medical Knowledge and the Public Health, in 2 The National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance 3 (2001).

(2.) Id.

(3.) Rina Hakimian & David Korn, Ownership and Use of Tissue Specimens for Research, 292 JAMA 2500, 2501 (2004).

(4.) Id.

(5.) Dan L. Burk & Mark A. Lemley, Biotechnology's Uncertainty Principle, 54 Case W. Res. L. Rev. 691, 728 (2004).

(6.) See infra Part II.E (discussing the importance of predictable patent protection).

(7.) See infra Part II.A.1 (explaining constitutional origins of the U.S. patent system).

(8.) Id.

(9.) See infra Part II.A.2 (explaining incentive structure of U.S. patent system).

(10.) Id.

(11.) U.S. Const. art. I, [section] 8, cl. 8.

(12.) Robert Merges, Intellectual Property in the New Technological Age 121 (Wolters Kluwer, 4th ed. 2007).

(13.) Id. at 121-22.

(14.) See id. at 127 (describing basic theory underlying patent law).

(15.) Christine Greenhalgh & Mark Rogers, The Value of Intellectual Property Rights to Firms and Society, 23 Oxford Rev. of Econ. Pol'y 541, 541 (2007).

(16.) Amy Landers, Understanding Patent Law 13-14 (2008).

(17.) Id. at 13.

(18.) Id. at 14.

(19.) Greenhalgh & Rogers, supra note 15, at 541.

(20.) Id. at 544.

(21.) Id.

(22.) Merges, supra note 12, at 127.

(23.) Id.

(24.) See id. at 122 (noting historical shifts from overprotection to underprotection in U.S. patent law).

(25.) See infra Part II.B (describing the requirement that a patent application have an enabling description that would allow one skilled in the art to practice the invention).

(26.) Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 481 (1974).

(27.) See 35 U.S.C. [section] 101 (2006) ("Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor....").

(28.) See id. [section] 102 (describing how an inventor cannot obtain a patent if the invention is known).

(29.) Id. [section] 101.

(30.) Id. [section] 103.

(31.) If an invention is already known to the public it is unpatentable because it is not novel as required by [section] 102. Merges, supra note 12, at 134.

(32.) An invention lacking this innovative step, that would be obvious to one skilled in the area of invention, fails the non-obviousness requirement of [section] 103. Id.

(33.) 35 U.S.C. [section] 111 (2006).

(34.) William Francis et al., Cases and Materials On Patent Law 463 (6th ed. 2007).

(35.) Gerald Mossinghoff, The First-To-Invent Rule in the U.S. Patent System Has Provided No Advantage to Small Entities, 87 J. Pat. & Trademark Off. Soc'y 514, 514 n.1 (2005).

(36.) Until 1998 the United States and the Philippines both used the first-to-invent system. Id. In 1998 however, the Philippines joined the rest of the world adopting a first-to-file system. Id.

(37.) Those favoring the adoption of a first-to-file system in the U.S. argue first-to-file is consistent with framers intent to promote innovation and the disclosure of new knowledge to the public. See Doug Harvey, Reinventing the U.S. Patent System: A Discussion of Patent Reform Through an Analysis of the Proposed Patent Reform Act Of 2005, 38 Tex. Tech. L. Rev. 1133, 1177 (2006) (discussing constitutional arguments surrounding adoption of first-to-file system).

(38.) Id. (emphasis added).

(39.) Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 60 (1998).

(40.) Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986) (quoting William C. Robinson, The Law on Patents for Useful Inventions 532 (Boston, Little, Brown, and Co. 1890)).

(41.) Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994).

(42.) Id.

(43.) U.S. Pat. & Trademark Office, U.S. Dep't of Commerce, Manual Of Patent Examining Procedure [section] 2138.05 (8th ed. 2008) [hereinafter MPEP].

(44.) Id.

(45.) Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998).

(46.) Scott v. Finney, 34 F.3d 1058, 1061 (Fed. Cir. 1994) (quoting In re Darduck, 496 F.2d 1234, 1238 (C.C.P.A. 1974)).

(47.) Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986).

(48.) See supra Part II.B (explaining that the enablement requirement for patentability requires a description that would allow one skilled in the relevant art to practice the invention).

(49.) Hybritech, 802 F.2d at 1376.

(50.) Landers, supra note 16, at 200-01.

(51.) Id.

(52.) Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991).

(53.) See id (explaining that the idea to isolate the gene for the human EPO protein was not conception and could not be until the gene was actually isolated and sequenced).

(54.) Id.

(55.) 35 U.S.C. [section] 116 provides,
   When an invention is made by two or more persons jointly, they
   shall apply for patent jointly and each make the required oath,
   except as otherwise provided in this title. Inventors may apply for
   a patent jointly even though (1) they did not physically work
   together or at the same time, (2) each did not make the same type
   or amount of contribution, or (3) each did not make a contribution
   to the subject matter of every claim of the patent.


35 U.S.C. [section] 116 (2006).

(56.) Kimberly-Clark Corp. v. Proctor & Gamble Distrib. Co., 973 F.2d 911, 917 (Fed. Cir. 1992).

(57.) Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998).

(58.) Id.

(59.) Id.

(60.) Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d 976, 980 (Fed. Cir. 1997) (citing Amex Fly Ash Corp. v. United States, 514 F.2d 1041 (Ct. Cl. 1975)).

(61.) Ethicon, 135 F.3d at 1461 (describing the evidentiary standard for amending a patent). However, if the listed inventors request the joinder of an additional inventor or removal of listed inventor after the patent has issued it will generally be allowed when all parties are in agreement. MPEP, supra note 43, [section] 2137.01.

(62.) Ethicon, 135 F.3d at 1465.

(63.) See Pannu v. Iolab Corp., 155 F.3d 1344, 1349 (Fed. Cir. 1998) ("[I]f nonjoinder of an actual inventor is proved by clear and convincing evidence a patent is rendered invalid.") (internal citations omitted).

(64.) See supra Part II.D. (explaining that each joint-inventor is entitled to pro rata share of the invention and failure to list all inventors on a patent can result in invalidation of the patent).

(65.) Greenhalgh & Rogers, supra note 15, at 544 (discussing incentives to innovate).

(66.) Id. The product of research and development is often non-rival, that is "it can be used by many without being used up; and it is non-excludable, as it cannot be easily defended from imitators." Id.

(67.) See Joshua Gans et al., The Impact of Uncertain Intellectual Property Rights on the Market for Ideas: Evidence from Patent Grant Delays, 54 Mgmt. Science 982, 984 (2008) (examining patent enforcement uncertainty).

(68.) Id. at 983.

(69.) Id.

(70.) Henry Grabowski, Patents and New Product Development in the Pharmaceutical and Biotechnology Industries 2 (Duke Univ., Dept. of Econ., Working Paper No. 02-25, 2002) available at http://EconPapers.repec.org/RePEc:duk:dukeec:02-25.

(71.) Congressional Budget Office, Research and Development in the Pharmaceutical Industry 9 (2006) [hereinafter CBO Report] available at http://www.cbo.gov/ftpdocs/76xx/doc7615/10-02DrugR-D.pdf.

(72.) Carolyn Buck Luce & Glen Giovannetti, The 2009 Ernst & Young Business Risk Report Life Sciences 5 (2009) available at http://lifesciencesbc.ca/files/life_sciences_business_risks_2009.pdf.

(73.) Grabowski, supra note 70, at 4.

(74.) CBO Report, supra note 71, at 19.

(75.) Grabowski, supra note 70, at 4.

(76.) Id.

(77.) Id. at 8.

(78.) Edwin Mansfield, Patents and Innovation: An Empirical Study, 35 Mgmt. Sci. 173, 175 (1986).

(79.) Id.

(80.) Id.

(81.) Id.

(82.) Luce and Giovannetti, supra note 72, at 5.

(83.) Moore v. Regents of the Univ. of Cal., 793 P.2d 479 (Cal. 1990), cert denied, 499 U.S. 936 (1991).

(84.) Id. at 480.

(85.) Id. at 481.

(86.) Id. at 481-82.

(87.) Id. at 482.

(88.) Moore, 793 P.2d at 497.

(89.) Id. at 493.

(90.) Id. (citing U.S. Congress, Office of Tech. Assessment, New Dev. In Biotech.: Ownership of Human Tissues And Cells 31-46 (1987)).

(91.) Id. at 512 (Mosk, J., dissenting).

(92.) Paradise, infra note 97, at 105.

(93.) Eliot Marshall, Patient Advocate Named Co-Inventor on Patent For the PXE Disease Gene, 305 Sci. 1226, 1226 (2004).

(94.) Id.

(95.) Id.

(96.) Id.

(97.) Jordan Paradise, Patient Advocacy Group Collaboration In Genetic Research and the Scope Of Joint Inventorship Under US Patent Law, 3 Intell. Prop. Mgmt. 97, 105 (2009); See Sharron Terry et al., Advocacy Groups As Research Organizations: The PXE International Example, 8 Nature Rev. Genetics 157, 157 (2007) (explaining the collaboration between scientists and patient groups from the point of view of a patient advocate).

(98.) Hakimian & Korn, supra note 3, at 2501.

(99.) Id. at 2500.

(100.) Greenberg v. Miami Child. Hosp. Res. Inst., Inc., 264 F. Supp. 2d 1064, 1067 (S.D. Fla. 2003).

(101.) Id. at 1066.

(102.) Id. at 1067.

(103.) Id. at 1066.

(104.) Id.

(105.) Greenberg, 264 F. Supp. 2d 1067; see Reuben Matalon & Kimberlee Michals-Matalon, Spongy Degeneration of the Brain, Canavan Disease: Biochemical and Molecular Findings, 5 Frontiers in Bioscience 307, 307 (2000) (describing the two mutations that account for 98% of Ashkenazi Jews with CD).

(106.) Greenberg, 264 F. Supp. 2d at 1067; Aspartoacylase Gene, Protein, & Methods of Screening for Mutatons [sic] Associated with Canavan Disease, U.S. Patent No. 5,679,635 (filed Sept. 9, 1994) (issued Oct. 21, 1997).

(107.) Greenberg, 264 F. Supp. 2d at 1068.

(108.) Id. at 1074-76.

(109.) Id. at 1074.

(110.) Id. at 1075.

(111.) Id.

(112.) Greenberg, 264 F. Supp. 2d at 1073.

(113.) Id.

(114.) Wash. Univ. v. Catalona, 490 F.3d 667 (8th Cir. 2007).

(115.) Id. at 670. The Biorepository is a large storage facility housing over 3500 prostate tissue samples from patients of Catalona's as well as patients from other Washington University (WU) physicians. Id. at 671-72.

(116.) Id. at 672. These communications were sent without the knowledge or consent of the WU administration. Id.

(117.) Id.

(118.) Id. at 677.

(119.) Catalona, 490 F.3d at 671.

(120.) Id. at 676.

(121.) Id.

(122.) Lisa Edwards, Tissue Tug-of-War: A Comparison of International and U.S. Perspectives on the Regulation of Human Tissue Banks, 41 Vand. J. Transnat'l L. 639, 659 (2008).

(123.) Id.

(124.) See Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 493 (1990), cert denied, 499 U.S. 936 (1991) (explaining the legal and factual distinction between donated tissue and patented invention derived from the tissue).

(125.) Catalona, 490 F.3d at 674-75.

(126.) Id. at 675. It is important to note that in each of the decisions above, the courts were interpreting state law so the decisions are not binding outside of California, Florida, and Missouri.

(127.) Moore, 793 P.2d at 495; Greenberg v. Miami Child. Hosp. Res. Inst., Inc., 264 F. Supp. 2d 1064, 1070-71 (S.D. Fla. 2003).

(128.) Moore, 793 P.2d at 495-96.

(129.) Greenberg, 264 F. Supp. 2d at 1071.

(130.) Moore, 793 P.2d at 492.

(131.) Id. at 481.

(132.) Id. at 482 n.2.

(133.) Id.

(134.) U.S. Cong., Office of Technology Assessment, OTA-BA-337, New Developments in Biotechnology: Ownership of Human Tissues and Cells--Special Report 40 (1987).

(135.) Id.

(136.) Id. at 5.

(137.) Id.

(138.) See id. (explaining that probability of establishing a cell line from a primary cell could be as low as .0001 with some tissue types).

(139.) Greenberg v. Miami Child. Hosp. Res. Inst., Inc., 264 F. Supp. 2d 1064, 1066 (S.D. Fla. 2003).

(140.) An autosomal recessive disease requires that an individual inherit two copies of the gene, one from each parent. If a person only inherits a disease gene from one parent he will be a carrier of the disease gene but will have no manifestations of the disease.

(141.) See Matalon & Michals-Matalon, supra note 105, at 307-09 (describing the history of CD as well as its clinical presentation and pathophysiology).

(142.) Id.

(143.) Reuben Matalon et al., Aspartoacylase Deficiency and N-Acetylaspartic Aciduria in Patients with Cadavan Disease, 29 J. Med. Genetics 463, 467 (1988). This discovery was an important advance in its own right since it would allow for the diagnosis of CD with a simple blood test rather than an invasive brain biopsy--previously the only way to definitively diagnosis CD. Matalon & Michals-Matalon, supra note 105, at 307.

(144.) Matalon & Michals-Matalon, supra note 105, at 307.

(145.) Aspartoacylase is the enzyme responsible for breaking down NAA. Id.

(146.) Rajinder Kaul et al., Human Aspartoacylase cDNA and Mis-Sense Mutation in Canavan Disease, 5 Nature Genetics 118, 118 (1993).

(147.) Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 512 (Cal. 1990) (Mosk, J., dissenting).

(148.) See supra Part II.D. (explaining contribution to conception as a requirement for inventorship).

(149.) See Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1378 (Fed. Cir. 1986) ("[Conception is] the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention as it was thereafter applied in practice.").

(150.) Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998) (citing Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986)).

(151.) Greenberg v. Miami Child. Hosp. Res. Inst., Inc., 264 F. Supp. 2d 1064, 1065 (S.D. Fla. 2003).

(152.) See supra Part III.B.2 (describing limited knowledge about causes of CD before Matalon conducted his studies).

(153.) Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986).

(154.) Nartron Corp. v. Schukra U.S.A. Inc., 558 F.3d 1352, 1359 (Fed. Cir. 2009).

(155.) Greenberg, 264 F. Supp. at 1065.

(156.) See supra Part III.B.2 (describing that Matalon had to discover biochemical irregularity, identify a candidate gene, clone the gene, and find a disease-related mutation in the gene).

(157.) Methods for Diagnosing Pseudoxanthoma elasticum, U.S. Patent No. 6,780,587 (filed Feb. 23, 2001) (issued Aug. 24, 2004) [hereinafter PXE patent]; See supra Part II.E.

(158.) See Terry, supra note 97, at 159.

(159.) Id.

(160.) Id. at 160. See also Marshall, supra note 93, at 1226 (quoting Terry describing her role in the basic research as "I extracted DNA, ran gels, read the gels" and helped write the paper announcing the gene's discovery).

(161.) See MPEP, supra note 43, [section] 2137.01 ("The party or parties executing an oath or declaration under 37 CFR 1.63 are presumed to be the inventors.").

(162.) Misjoinder of a party who is not a true inventor can render a patent invalid. Pannu v. IOLAB Corp., 155 F.3d 1344, 1349-50 (Fed. Cir. 1998). However 35 U.S.C. [section] 256 provides that a patent should not be held invalid if misjoinder occurs without deceptive intent and the parties take action to remove the misjoined name from the patent. Id.

(163.) See Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998) ("Because conception is the touchstone of inventorship, each joint inventor must generally contribute to the conception of the invention.") (internal quotes omitted); See also supra Part II.C (explaining that a joint-inventor must contribute to conception of one or more claims).

(164.) Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994).

(165.) The sole independent claim in the patent reads:
   A method for screening a patient for the presence of a PXE
   mutation, the method comprising the steps of: a) interrogating an
   MRP6 nucleic acid in a patient sample for the presence of a
   mutation shown to be associated with PXE, wherein said mutation is
   selected from the group consisting of: i) at codon 1114, nucleotide
   3341G>C; [lists eight other mutation locations] and b) identifying
   said patient as having a PXE mutation if the mutation from step a)
   is detected in said MRP6 nucleic acid.


PXE patent, supra note 157.

(166.) U.S. Const. art. I, [section] 8, cl. 8.

(167.) See supra Part II.C. 1 (explaining conception as the determinative factor for inventorship).

(168.) Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986) ("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.").

(169.) Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998).

(170.) Id.

(171.) See supra Part III.C (explaining contribution to conception is a requirement for inventorship status).

(172.) Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 519 (Cal. 1990), cert denied, 499 U.S. 936 (1991) (Mosk, J., dissenting) (describing how a reasonable judicial interpretation of inventorship in light of the goals of the patent law could allow for inventorship status for tissue donors).

(173.) It is easy to imagine television commercial campaigns similar to those seen with toxic tort suits such as: "Have you had prostate cancer surgery at the University of X hospitals within the past 5 years? You may be entitled to...." (174.) See supra Part III.D (explaining the shift in activities incentivized by rewarding tissue donors as joint-inventors).

(175.) See supra Part II.E (discussing the high cost of drug development for pharmaceutical companies).

(176.) Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1464 (Fed. Cir. 1998). For example, if a patent with a sole inventor is worth $1000, the joinder of tissue donor as a joint-inventor will mean the tissue donor will be entitled to $500 of the patent's worth. Conception of the invention will be reduced from $1000 to $500.

(177.) Hugh Wellons et al., Biotechnology and the Law 204 (2007).

(178.) Burk & Lemley, supra note 5.

(179.) See supra Part III.D (explaining the conception standard in terms of public policy behind patent system).

(180.) Radhika Rao, Genes and Spleens: Property, Contract, or Privacy Rights in the Human Body?, 35 J.L. Med. Ethics 371, 374-75 (2007).

(181.) Hakimian & Korn, supra note 3, at 2503.

(182.) See generally Terry et al., supra note 97, at 158-62 (explaining the patient advocacy group approach to asserting rights of tissue research).

(183.) The criteria for informed consent for human research participants are set forth as part of the Federal Policy for the Protection of Human Subjects frequently termed the "common rule." 45 C.F.R. [section] 46 (2009). The "common rule" governs all researchers that receive funds from the federal government and any company that is conducting research with the intention of submitting it as a part of the FDA approval process. Hakimian & Korn, supra note 3, at 2501.

(184.) See Hakimian & Korn, supra note 3, at 2501 (describing how buried language in consent forms conveys right to use any "extra" excised tissue for unspecified research purpose, educational use, or disposal as the institution sees fit).

(185.) Id.

(186.) A broad exemption to this requirement should apply to tissue that already exists in tissue banks. A retroactive application of a rule requiring financial interest disclosure could have the effect of access to millions of stored samples where obtaining consent is impossible. Id. at 2502.

(187.) One criticism of this approach is that the patient may be distracted by the potential of significant financial interests in his tissues and make decisions concerning his health he would not have otherwise made. Id. at 2503. Nevertheless, the knowledge that financial interest exists in the donor's tissue is the only way the donor can make a fully informed decision about whether to donate.

(188.) See supra Part III.D (explaining that the requirement that an inventor contribute to conception would likely bar a tissue donor from inventorship status).

(189.) Korn, supra note 1, at 3.

(190.) See supra Part II.G (describing the PXE patient advocacy group and their use of banked tissues to dictate the terms by which their tissue would be used).

(191.) Terry et al., supra note 97, at 157.

(192.) Id. at 161.

Matthew W. Coryell, J.D. Candidate, University of Iowa College of Law, 2011; Ph.D., University of Iowa Neuroscience Program, 2008; B.A., Cornell College, 2002.
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