Looking back to the recent challenge of new technology, we can also trace some clues concerning the impacts to the traditional property right system. In the US, emerging case law, particularly in the tax area, has held that electronic business information is "tangible personal property" subject to certain taxes. For example, in
South Central Bell Telephone Co. v. Barthelemy,
251the Court held that switching249 What this author argue is that, according to the traditional property right principle, the property right might not be extended a third party automatically, neither the unborn. Therefore, a new property model might be justifiable.
250 This is the Jewish ethic code.
251 643 So.2d 1240, 1245-1246 (La. 1994), citing cases ("The software at issue is not merely knowledge, but rather is knowledge recorded in a physical form which has a
system software and data-processing software purchased by a regional telephone company was "tangible personal property" subject to municipal use taxes.252 Now, in similar setting, the Biobank development also cast the doubts on the applicability of traditional property right principles. These issues are widely allayed and occurred in different Biobank approaches.
1. Issues Encountered in Biobank Project of UK
In UK Biobank project, most of the property right related issues center on the hypothetical process of commercialization.253 Among variable issues envisioned, the accessibility and benefit sharing problems have been the main theme to be
deliberated.
(1) Accessibility
It was recognized that the access to the UK Biobank database by third parties would need to be carefully controlled. Restrictions were necessary to prevent any unethical or unscientific use of the database, and to ensure that research was within the boundaries laid down in the consent process.
Decisions on requests for datasets to be made available to commercial researchers would be regulated by the Biobank’s oversight body. The involvement of an independent body was felt to be necessary to ensure due probity in regulating the relationship between material and data donated by participants to the Biobank, and the interests of commercial bodies whose ultimate aim was to gain financial advantage from their use.
Some proposed that the Biobank should carry out all research itself. If a commercial organization wished to make use of the data and material from
physical existence, takes up space on the tape, disc, or hard drive, makes physical things happen, and can be perceived by the senses."); and see Norwest Corp. v.
Commissioner of Internal Revenue, 108 T.C. 358 (T.C. 1997) (computer software is tangible property eligible for investment tax credit); Comshare, Inc. v. US, 27 F.3d 1142 (6th Cir. 1994) (master source code tapes and discs are tangible property eligible for investment tax credits).
In addition, plaintiffs might also rely on cases treating computer software as goods under the UCC. See Charles Kerr, "Y2K and the Contractual Basis For Liability:
Current Problems and Issues," 541 PLI/P at 84-87 (1998), citing cases.
252 Sterling, Hillard M. Sterling & Baker, Lynne M. The Federal Y2K Statutes: Clarity or Confusion? 3 Computer Law. 17, 21 (March, 2000).
253 The UK Biobank, Ethic Workshop April 2002, available at http://www.ukbiobank.ac.uk/ethics.htm.
（visited 2004/8/10）
the Biobank, it could commission the Biobank to carry out a specific line of research on its behalf. It was not likely that this approach would be
acceptable to potential commercial partners.
The main stream opinion of the UK was of the view that while researchers in the commercial sector should have access to data and information, including DNA sequences, they should not be given access to DNA itself. Opinion differed as to whether or not access should be granted to other samples such as plasma or serum. It was acknowledged that some commercial organizations would be very keen to have access to blood plasma to carry out proteomic analyses. It was also the UK policy that there should be no monopoly access by any one company to data held by the Biobank. All datasets that had been mined from the Biobank would eventually have to be returned to the“hub”so thatotherresearcherscould accessthem.Any agreement between the Biobank and a third party to restrict access to data should only be for a strictly circumscribed period.
Obviously,theseaccessibility issuescouldn’tbesolved completely withoutdefining thecharacterofBiobank’slegalstatusasmentioned above in Part II of this paper. The problems include; On what standing the Biobank may exclude the infringement? With what entitlement, the Biobank may apply to enforceits“right?”And,whatkind ofthe“right”arethey? Further, would the Biobank be treated as a market subject who should be governed by the market competition rules?
(2) Benefit sharing and intellectual property rights
The potential for commercial companies to establish intellectual property rights (IPR) from projects using data or material from the Biobank would have to be carefully regulated. It was necessary to ensure that the interests obtained by the commercial sector were fair and transparent and that, on behalf of the Biobank participants, some financial advantage would
accrue to the community. From an ethical perspective, it was of the greatest importance that the community as a whole should not only benefit from the altruistic motives of the individual Biobank participants, but that it could be seen to do so.
The issues surrounding IPR, licensing and royalty payments have
complex legal ramifications and expert legal advice would be needed. In the UK some advocated a system by which the Biobank would be remunerated for the granting of access to commercial interests. It was not clear whether this should be set at a level to cover only administrative and other costs or whether it should be set a much higher rate. There was also support for the view that royalty payments to the Biobank should be made to the Biobank if the use of the dataset resulted in financial gains for the company concerned.
Others suggested that academic and health researchers, while not being asked to pay as much as commercial researchers, might also have to pay a fee for access to the Biobank's data. One suggestion was made that IPR generated by publicly funded research on material from the Biobank should rest with the Biobank. It was unlikely that this could be achieved, but the majority opinion appeared to support the contention that access to data should be accompanied by a contractual agreement for a share in the license fees generated as a result of any IPR obtained by its commercial partner.
This IPR issue deeply concerned with the foundational issue raised by the application of property right rules mentioned above. Indeed, to this author, before we agree to take the property right model in governing the Biobank case,it’salmostimpossible to solve the deriving IPR related issues occurred accompanying with the operation of Biobank. To make it simpler; Who is going to be the IPR owner? According to what kind of the IP laws? On what way the IPR be created? Should there be a central registration required? Or.
It is going to be a secret right? And, finally, how far the scope of IPR and how to enforce it? By Whom? Sometimes, people tend to take the traditional positive provisions of law as the general legal principle available for any kind of new challenges. However, with the special features of DNA in mind, wouldn’tthatbefairerto setback from thecontemporary legalrulesand reconsider the appropriateness to apply the rules.
2. Issues Encountered in deCODE of Iceland
For deCODE, a private institute by nature, cares more about the business side of the operation. Therefore, deCODE addressed a lot on the risks Related to the running ofits“Business.”254 These concerns include;
254 deCODE genetics,Inc., 2003 Annual Reports II , available at http://www.decode.com/. (visited 2004/8/10)
(1) Not able to successfully develop or derive revenues from any products or services.255
For this concern, the property right issue are mainly related to the product developmentand marketbehaviors,including themarketability ofthe“Biobank product,”thepossibleinfringementto others’proprietory rightsand other
transaction related issues.
(2) If the assumption about the role of genes in disease is wrong, it may not be able to develop useful products.256
The concern like this indicates to us that the welfare vision to promote Biobank might still be vague. In turns, the intrinsic value of Biobank is uncertain which might be in contradictory to the general civil rule in defining a valid
contractthatthetransaction subjectmattershould be“dertain.”Therefore,when referring to the property right issue, with deCODE’sconcern likethis,itbecomes skepticalwhetherornotit’sworkableto apply traditionalproperty rightrulesin dealing with the Biobank related market issues.
(3) Clinical trials required for the product candidates are expensive and time-consuming, and their outcome is uncertain.
Obviously, this is the concern mainly addressed relating to the affection incurred from the ethic code in regulating the Biobank related activities. It seems that the concern is something to do with the impacts brought against the creation ofsaid “product,”viz,theproperty.With thisethicalconcern in mind,it becomesillogicalto takeitforsurethatthereisgoing to be“something”
qualified as the subject matter to be protected under the traditional property right legal principle, to the extent the ethical concern might generate sever uncertainty concerning theempowermentofaproperty right.That’swhy thedeCODE so worried.257
255 It’s indicated by the deCODE that:
“Any pharmaceuticalordiagnosticproductsthatweorourcollaboratorsareableto develop willfailto produce revenues unless we:
•establishesthat they are safe and effective;
•successfully competeswith othertechnologiesand products;
•ensuresthatthey do notinfringeon theproprietary rightsofothers;
•establishesthatthey can bemanufactured in sufficientquantitiesatreasonablecosts;and
•can marketthem successfully”Id.
256 It was declared by the deCODE that “If our assumption about the role of genes in the disease process is wrong, our gene discovery programs may not result in products, the genetic data included in our database and informatics products may not be useful to our customers and those products may lose any competitiveadvantage.”Id.
257 These concerns include:
“•to slower than expected patient enrollment due to the nature of the protocol, the proximity of patients
(3) Other factors might affect the commercial operation of the deCODE.258
To this author, what deCODE concerned with aremainly the“downstream”
issues we all have to face, before the fundamental propieotory issues can be solved. In short, without a mature legal environment for product definition and for setting the transaction rules for the product, the anticipation for the
insufficiency of market conditions might already lose its focus.
3. Issues Encountered in Human Tissue Project of Singapore
Building on existing ethical practices in the city-state, Singapore's Bioethics Advisory Committee (BAC) has issued new guidelines covering human tissue research and banking. Since its inception in December 2000, the
to clinical sites, the eligibility criteria for the study, competition with clinical trials for other drug candidates or other factors. •lowerthan expected retention ratesofpatientsin aclinicaltrial;
•inadequately trained orinsufficientpersonnelatthestudy site to assist in overseeing and monitoring clinical trials;
•delaysin approvalsfrom astudy site'sreview board;
•longertreatmenttimerequired to demonstrateeffectivenessordeterminetheappropriateproductdose; and
•lack ofsufficientsuppliesofthe product candidate; (vii)adverse medical events or side effects in treated patients; (viii)lack ofeffectiveness of the product candidate being tested and (ix)regulatory changes. Id.
258 Those are;
1.Because revenues are concentrated, the loss of a significant customer would harm our business.
2. If we are not able to obtain sufficient additional funding to meet our capital requirements, we may be forced to reduce or terminate ours research programs and product development.
3. If we cannot successfully form and maintain suitable arrangements with third parties for the manufacturing of the products we may develop, our ability to develop or deliver products may be impaired.
4. Our reliance on the Icelandic population may limit the applicability of our discoveries to certain populations.
5. If we fail to protect confidential data adequately, we could incur a liability or lose the Icelandic Health Sector Database license.
6. Some parts of our product development services create a risk of liability from clinical trial participants and the parties with whom we contract.
7. Use of therapeutic or diagnostic products developed as a result of our programs may result in product liability claims for which we have inadequate insurance.
8. We may be unable to hire and retain the key personnel upon whom our success depends.
government-appointed BAC has been examining ethical, legal, and social issues arising from biomedical research and development. Earlier this year, the committee announced research-friendly recommendations relating to the use of human
embryonic stem cells specifically for therapeutic cloning. According to Professor Lim Pin, chairman of the BAC, the guidelines aim to address two key issues--respect and welfare of the donor, and confidentiality. The new guidelines stress the importance of informed consent, especially in cases where surplus tissue from therapeutic or
diagnostic purposes may be used for research. Also, all donated tissue samples for research use must be donated, without any claim to property or future rights.
Individual tissue banks and research centres currently adhere to these principles, and the new set of regulations formalizes these on a national level. "We are the first country to have such focused national guidelines," Prof. Lim Pin said. "We require informed consent before we collect cord blood stem cells for research," Dr. Stephen Bartelmez, Director of stem-cell based therapies firm ViaCell Singapore, told Reuters Health. "It is an industry practice." 259 The BAC also recommended the setting up of a statutory board to oversee and license institutions and companies that carry out human tissue research and banking, making it necessary that all such activities be approved and monitored.
Obviously, Singapore takes a government regulation approach in dealing with thepossibleindividualrightissues.Subjectto theso called “donation”model,the government demanded that the donation should be done irreversibly and non-regretful.
To this author, this kind of approach might further incur the possibility constitutional issue in the future, at least in the international level.
To sum up, the property right issues anticipated so far can be divided into the following categories; (1)Access right, (2)Intellectual Property Right,(3)Product definition and Market Regulation, and (4) Unconstitutionality concerning the Taking ofan Individual’sRightofProperty.