Reproduction and Responsibility:

The Regulation of New Biotechnologies

Table of Contents

Commerce

With advances and innovations in assisted reproduction, embryo research, and genetic screening and selection, there have arisen new markets for elements of these technologies and practices, including markets for gametes and embryos. Developments in patent law, meanwhile, have raised issues concerning the ownership of human genes, tissues, gametes, and embryos. These developments have significant implications for society's approach to reproductive biotechnologies, and for the formation of public and private attitudes about the ethical and social significance of these technologies and practices. They also have significant implications for the way we understand property in the human body more broadly.

This chapter discusses commerce involving (1) gametes and embryos (2) assisted reproductive technologies (ART) services and (3) the patenting of human organisms.

I. Gametes and Embryos

There has long been a market for donated sperm in the United States.¹ According to one commentator, there are at present "thousands of sperm banks . . . in this country offering modest, yet significant remuneration."² In 2000, the average payment to sperm donors was between $60 and $70 per donation.³ At the margins, there are individuals who aggressively market their sperm for thousands of dollars per vial, and Internet sperm brokers⁴ such as ManNotIncluded.com, which offers baby-making kits to its customers.⁵ In the early 1980s, multimillionaire Robert Graham established the "Repository for Germinal Choice," which offered infertile couples the opportunity to buy sperm donated by Nobel laureates.^{i 6}

Donated ova are generally procured by one of the following means: informally, from a close relative; indirectly, through a brokerage; or directly, from an individual or an ART clinic.⁷

In vitro fertilization (IVF) clinics, brokers, and infertile couples advertise for gamete donors.⁸ The structures of the ensuing transactions vary. Typically donors are compensated for their time, efforts, and reasonable expenses, rather than for the gametes themselves. While there do not seem to be any definitive studies on the subject, it appears that the vast majority of donors provide gametes anonymously and without regard to specifically desired traits. There is, however, evidence of some noteworthy exceptions to this approach.

For example, some brokerages ("pooled brokerages") solicit a pool of potential donors, create individual profiles (including photographs, biographical data, information on physical characteristics, medical histories, etc.), and establish a database. One such brokerage, Egg Donation, Inc., seeks in a donor someone who is "bright and attractive, between the ages of 21 years to 30 years, of any ethnic background, preferably who has completed a college degree or is presently pursuing a college degree and is in excellent health."⁹ Another brokerage, Tiny Treasures, specializes in Ivy League ovum donors. Its database includes photographs, SAT scores, grade-point averages, and compensation requests. Compensation for ovum donors from pooled brokerages varies. Egg Donation, Inc., advises potential donors that the donor fee "will range from $3,500 to $12,000." As to which variables drive cost, the website explains: "Asian and Jewish ovum donors are always in demand. A tall, attractive donor with a masters [sic] or doctorate degree will always receive higher compensation than most other donors." Ivy League donors from Tiny Treasures seek anywhere from $8,000 to $20,000 compensation for a cycle of ova retrieval.

Pooled brokerages charge potential recipients a fee to browse their database of donors. Once a donor is selected, the brokerage begins the "matching process," which includes psychological screening, medical screening, and legal consultation. Thereafter, a contract is executed between the parties, and the process of stimulation and retrieval is initiated.

Some couples advertise directly for ovum donors. Many advertise in campus newspapers at prestigious colleges and universities. One such advertisement at Vassar College offered $25,000 in exchange for the ova of a "healthy, intelligent college student or college graduate, age 21-33 with blue eyes and blonde or light brown hair."¹⁰ Another advertisement in the Stanford Daily offered $50,000.¹¹

An alternative means of acquiring ova is through so-called "oocyte sharing," an arrangement by which women undergoing infertility treatment are given a price discount in exchange for agreeing to share their ova with other patients. According to the American Society for Reproductive Medicine (ASRM), few details are published on how these transactions are structured, but "[i]t seems that IVF patients in these sharing programs generally donate up to half the oocytes retrieved in a single cycle to another patient, in return for a 50%-60% reduction in the total costs of the IVF cycle."¹²

There does not seem to be a market in human embryos. There is no evidence that early extracorporeal embryos are bought or sold in the United States. As discussed in Chapter 2, individuals and couples may donate to researchers and to other infertile couples any "excess" embryos that remain after the completion of infertility treatment.

B. Ethical Considerations

Payments for human gametes raise several ethical concerns. Some argue that the commercialization of reproductive tissues might diminish respect for the human body and human procreation. By putting human reproductive tissue-the seeds of the next generation-up for sale in the marketplace, it is argued that we stand to introduce a commercial character into human reproduction, and to introduce commercial concerns into the coming-to-be of the next generation. If the essential materials of human procreation are regularly bought, sold, and esteemed in accordance with market valuations (and indeed valued differently based on the desirability of certain traits, as in ads in college newspapers that offer premium prices for donors with particular characteristics), the human meaning of bringing forward the next generation may be obscured or undermined.

Others see such concerns as misleading and unjustified. They argue that commerce in human gametes is no different from commerce in other meaningful activities of life (like paying one's doctor) or commerce in other articles of special significance (like a religious text or a wedding ring). They point out that the clinics and laboratories are making money from assisting reproduction, and they suggest that it is unfair that only the donor is excluded from financial benefit. They further argue that the ability to buy and sell gametes helps otherwise infertile couples to participate in the activities of human procreation and child-rearing.

Ovum sales raise additional ethical concerns. The process of retrieving ova is onerous and risky for donors. The high fees paid to ovum donors-who are often from financially vulnerable populations, such as full-time students-might create pressure to undergo these invasive procedures. For those undergoing infertility treatment themselves, incentive programs like oocyte sharing may reduce the probability of successful pregnancy, because such a program reduces the number of ova a donor has available for transfer during a given ART cycle. An additional concern is that a free market in ova could lead to discrimination and greater inequality. The 1994 National Institutes of Health (NIH) Human Embryo Research Panel speculated that an open market for ova would lead to a two-tiered system in which wealthy white ovum donors would receive high payments primarily from IVF patients, whereas poor minority women would receive substantially lower payments primarily from researchers.¹³

Finally, financial incentives for donation encourage individuals to become the biological parents-sometimes many times over-of children they will never know.ⁱⁱ Alternatively, with the advent of laws providing children with the right to know their biological parentage, such donors may become involved in the lives of these children despite their wish to remain anonymous.

However, not compensating individuals for donating gametes raises still other ethical concerns. Financial incentives increase supply in other markets and are likely to do the same in the market for gametes for IVF. If there are no payments for gametes, some couples might remain childless because of an inadequate supply of eggs and sperm. Furthermore, given the sacrifice that is made by many gamete donors-especially ova donors-many argue that it would be unjust not to compensate them. Finally, some argue that a free market in gametes ultimately benefits all parties: those willing to provide their gametes get the compensation they desire, and those willing to pay for such gametes get the reproductive tissues they need to undergo assisted reproduction.

C. Regulation

There are now no federal laws directly regulating the sale of gametes. The National Organ Transplantation Act "makes it unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce."¹⁴ While the term "organ" in this statute has been construed to include fetal organs, it has never been extended to include sperm, ova, or embryos. A number of states ban or otherwise restrict the sale of embryos.ⁱⁱⁱ Only Louisiana explicitly bans the sale of ova. Virginia, on the other hand, explicitly exempts ova from its prohibition on the sale of body parts. California bans the sale of ova for use in attempts at cloning-to-produce-children. Some states broadly prohibit or limit the sale of organs or nonrenewable tissues, but it is an open question whether ova fall within the ambit of such prohibitions.^iv

ASRM has issued ethical guidelines for its members on financial incentives for oocyte donation. Following a discussion of the ethical considerations implicated in payment or oocyte-sharing programs, it concludes that these transactions are acceptable, subject to certain limitations. First, ASRM calculates a "reasonable" payment for oocyte donation by taking the average fee for sperm donation ($60 to $75 for one hour) and multiplying it by the number of hours spent in a medical setting during oocyte donation (fifty-six hours). Thus, ASRM concludes that the reasonable fee for an oocyte donor is $3,360 to $4,200. But because this calculus might not account for the more onerous nature of oocyte donation, ASRM concludes that "at this time sums of $5,000 or more require justification and sums above $10,000 go beyond what is appropriate."¹⁵

ASRM concludes that oocyte sharing is permissible provided that programs "formulate and disclose clear policies on how oocytes are allocated, especially if a low number of oocytes or oocytes of varying quality are produced." The Society advises that the reduction in fees resulting from oocyte donation should not be contingent on the number or quality of ova retrieved. Additionally, ASRM advises its members to adhere to certain guidelines: to ensure that there is a physician assigned to the oocyte donor (preferably not the fertility specialist for the ova recipient), to disclose policies regarding medical coverage for any complications experienced by the oocyte donor, to ensure that advertising is accurate and responsible, to avoid donors from recruiting agencies who have been paid exorbitant fees, and to limit the number of times a woman undergoes retrieval procedures "purely to provide oocytes to others."¹⁶

In a separate Practice Committee Report, ASRM advises its members to limit the number of stimulated cycles per oocyte donor to six, in light of health risks associated with the procedure. In the same document, ASRM advises its members to "strive to limit successful donations from a single donor to no more than 25 families per population of 800,000, given concerns regarding inadvertent consanguinity in offspring."¹⁷

II. Sale of ART Services

A. Current Practices

Assisted reproduction is a growing economic enterprise, with gross revenues of $4 billion per year, serving one in six infertile couples in the United States.¹⁸ The costs of assisted reproduction services are variable, depending largely on the particular procedures undertaken. For example, at one prominent clinic, the cost of an initial consultation is $370, one IVF cycle using never-frozen embryos is $9,345 (while transfer of cryopreserved embryos is only $4,000 per transfer), preimplantation genetic diagnosis (PGD) (for sex selection or disease screening) is $4,000, and intracytoplasmic sperm injection (ICSI) (generally a prerequisite for PGD) is $2,000. Preconception sex selection (by sperm sorting) adds another $2,000. Most couples must undergo more than one cycle to achieve a successful result-the most recently reported percentage of live births per cycle (using never-frozen, nondonor embryos) was 27 percent.¹⁹

ART clinics advertise for business, emphasizing the range of procedures they offer to infertile couples.

Most infertility patients pay for ART services out-of-pocket, for reasons discussed below. To reduce their financial burdens, some clinics offer alternatives. One alternative, discussed above, is oocyte sharing. Another offered by some clinics is a "shared-risk" or "refund" program, in which infertile patients pay a higher fee, with the understanding that if they achieve an "ongoing pregnancy or delivery, the provider keeps the entire fee."²⁰ However, if the treatment fails, "90%-100% of the fee is returned."²¹

B. Ethical Considerations

The commercialization of ART services raises ethical concerns. Some of these are similar to those already raised in other contexts. Irresponsible clinicians may exploit the vulnerability and despair of the infertile with misleading advertisements and solicitations. As discussed in Chapter 2, commercial competition may induce IVF clinics to try to boost their success rates by adopting risky procedures (such as the transfer of an excessive number of embryos per cycle) or by selectively excluding certain types of patients (such as older patients or those whose chances of becoming pregnant are for other reasons low). Finally, given that infertility treatment is expensive and that in the United States insurance coverage for such services is rare, inequality becomes a real concern, with ART available only to those who can afford it. Many advocates for the infertile argue that the absence of insurance coverage for assisted reproduction is the single greatest problem facing such patients. They argue, for example, that the high costs to patients create incentives to transfer many embryos per cycle, leading to a greater incidence of multiple gestations.

Ethical questions may also be raised regarding ova sharing and shared-risk programs. Ova sharing might induce women who are providing the sharable supply of eggs to undergo risks in greater superovulation, in order to harvest as many ova as possible, or it may reduce a woman's ultimate chances for success, given that fewer ova are available for her own use. Ova sharing also causes individuals to become biological parents to children they will never meet. Shared-risk programs may promote unrealistic expectations for success. Such programs may induce clinicians to undertake unnecessary risks, or they may create a conflict of interest between doctor and patient.

Many see this range of concerns as unjustified or excessive. They argue that competition among clinics improves the quality of ART services, by making each clinic accountable in the marketplace. Some argue that the variety of treatment options-such as ova sharing and shared-risk programs-allow patients to choose which form of treatment and payment plan is best for them, and that normal informed consent procedures ensure against coercion and exploitation. To criticize irresponsible clinicians, they argue, is not to criticize the commercialization of assisted reproduction as such, but simply those who behave as irresponsible practitioners of medicine, who should be held accountable not through restrictions of commerce but enforceable standards for all ART practitioners. Some argue that the high cost of assisted reproduction is not a case against commerce as such, but rather a case for states to require insurance coverage of ART or for public subsidies for ART treatment. Finally, some argue that competition among ART clinics is the only way to control or reduce the cost of fertility treatment.

C. Current Regulation

Fourteen states now regulate insurance coverage of infertility treatment.^v Some of these states mandate coverage of IVF, subject to certain conditions: for example, by requiring that the treatment be provided in conformity with guidelines of the American College of Obstetricians and Gynecologists and ASRM.²² Certain states require coverage only of fertilization of a donor's own ova with her spouse's sperm.^vi

Although most states do not specifically mandate coverage of assisted reproduction services, an insurance company's failure to cover such services may in some cases be challenged by patients as a violation of the terms of their particular contract. For example, if the contract provides coverage for "illness" or "medically necessary procedures"-as most do-and does not specifically exclude infertility services, patients may argue that infertility falls into these categories and must be covered. Courts are divided on such questions. For example, in Kinzie v. Physician's Liability Insurance Co., an Oklahoma appellate court held (as a matter of law) that IVF is not medically necessary but rather elective. In Egert v. Connecticut General Life Insurance Co., the court rejected the defendant insurance company's claim that infertility is not an illness but rather the result of an illness, holding such a claim to be an improper construction of the insurance contract's provisions and the insurance company's internal guidelines. Some insurance companies have refused to cover IVF on the grounds that it is experimental, citing its less than 50 percent rate of success.²³

The Federal Trade Commission (FTC) has the authority to investigate deceptive claims in advertising by health care providers, including ART clinics, engaged in interstate commerce. It has jurisdiction, for example, to investigate claims of pregnancy success rates. FTC has the specific authority to investigate claims made in promotional materials, advertisements, contracts, consent forms, and other point-of-sale materials. To prove deception, FTC must show that there has been a "representation, omission, or practice that is likely to mislead the consumer" and that such deception is likely to affect the consumer's choice regarding the purchase of a service or product. For those clinics or individuals found to be engaged in deceptive advertising or unfair competition, FTC can impose civil penalties and cease-and-desist orders.^{vii 24}

ASRM has issued guidelines on the subjects of advertising and shared-risk or refund programs. ASRM enumerates eight principles for advertising that should be followed by members: (1) advertising must comply with FTC guidelines; (2) claims must be supported by reliable data; (3) clinics should not rank or compare success rates; (4) advertisements should not unreasonably inflate expectations about success; (5) advertisements including references to outcomes may not selectively omit unfavorable data; (6) the method used to calculate success must be clear; (7) the Practice Director is ultimately responsible for all advertising content; and (8) when quoting statistics, the following statement must be included: "A comparison of clinic success rates may not be meaningful because patient medical characteristics and treatment approaches may vary from clinic to clinic."²⁵

In a separate ethics opinion, ASRM sets forth the ethical concerns raised by "shared-risk" or "refund" programs, whereby patients pay a higher initial fee that is refunded if the treatment fails. Such concerns include the risks of exploitation, unreasonable expectations, overly aggressive and unsafe efforts to maximize chances for success, and conflict of interest. Following this discussion, ASRM concludes that shared-risk transactions may be ethically offered to patients lacking health insurance coverage for treatment, provided certain conditions are satisfied, namely, "that the criterion for success is clearly specified, that patients are fully informed of the financial costs and advantages and disadvantages of such programs, that informed consent materials clearly inform patients of their chances of success if found eligible for the shared risk program, and that the program is not guaranteeing pregnancy and delivery." Additionally, ASRM advises its members to clearly inform patients that "they will be paying a higher cost for IVF if they in fact succeed on the first or second cycle than if they had not chosen the shared risk program, and that, in any event, the costs of screening and drugs are not included." To prevent the danger that shared-risk programs may create incentives for clinicians to take actions that might harm patients in pursuit of success (and to avoid a refund), ASRM advises that patients be informed of the potential conflicts of interest. Moreover, such patients should not be given unusually high doses of hormones, and should be advised of the risks of multifetal gestation.²⁶ As with all other ASRM guidelines, these are suggestions rather than directives.

III. Patenting Human Organisms

A.Current Practices

The Constitution confers upon Congress the authority to regulate patent rights: Article I, Section 8, provides in part that Congress shall have the power "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." Although the concept of patents (and intellectual property more generally) predates the Constitution, the patent is a form of property right expressly permitted by the Constitution.

A patent is an exclusive property right granted to an inventor for a limited time (currently, in most cases, twenty years from the filing date of the application). A patent grants an inventor the right to exclude all others from making, using, offering to sell or selling within, or importing into the United States the process or article that is the subject of the patent.²⁷ The holder of a patent has a right to bring an enforcement action in court against others who infringe the patent.²⁸ A patent is a right to exclude others, not necessarily a right to practice, make, or own the invention. A patent does not necessarily grant the inventor a right to the tangible product that results from the patented process. As a general matter, Congress may define and restrict what is patentable, and otherwise restrict patent rights by statute (for example, to promote national security²⁹).

The Patent Act, which has changed little since it was authored by Thomas Jefferson and enacted in 1793, provides patent rights for three types of patents: plant patents, design patents, and utility patents. About 95 percent of all patents issued are utility patents.³⁰ A utility patent may be claimed by whoever "invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof."³¹

To receive a patent, an invention must be novel, nonobvious, and useful. A rich body of law, precedent, and agency practice defines these terms; but in general the bar for meeting them is not terribly high. Although traditionally, the inquiry into a proposed invention's "usefulness" might have considered the moral value of the invention, current U.S. patent practices do not take "morals" into account.

B. Ethical Considerations

To date, there have been patents issued on modified human tissues and cell lines, and DNA molecules of human origin. The future prospect of patenting human gametes and embryos is a source of much ethical disquiet. First, a patent creates a quasi property right, and the idea of one person or entity owning another-or part of another-raises deep worries. Second, patents imply a seal of state sanction, making it a matter of public concern which processes and products are made patentable; some question whether human organisms or human parts, modified or otherwise, ought to be among them. Finally, there is the practical concern that patents on genes and the like create a property right in a limited resource with wide utility, a resource that is arguably part of our common human heritage. Patents, in this way, erect a potential obstacle to the use of such resources for the benefits of many.

A powerful counterpoint to these claims, however, is that patents are a crucial mechanism to encourage the research and development of useful advances in biomedical science and biotechnology. By permitting researchers to protect the fruits of their labors for a limited time, patents give investors the incentive to commit resources to research and researchers the incentive to make discoveries that ultimately benefit the public by improving medicine and increasing the store of scientific knowledge. As Lincoln famously said, patents "add the fuel of interest to the fire of genius."

Yet a strong case can be made for drawing boundaries that limit patentability to parts of the human organism and that would exclude the developing human organism (embryos and fetuses) from the domain of patentable matter. It is one thing to have a property right in human cells or tissues; it is quite another to have a property right in a whole human organism, even at its earliest developmental stages.

C. Current Regulation

1. Patenting Living Things.

The foregoing analysis presupposes that the claimed invention consists of patentable subject matter. The test for determining this question is quite broad, with some limitations. The Supreme Court has relied on the assertion that the statutory subject matter for a patent includes "anything under the sun that is made by man."³² The Court recognized that "laws of nature, physical phenomena, and abstract ideas" are not proper subject matter for patents.³³ For example, minerals found in the earth, plants found naturally occurring, and physical laws such as E=mc² are not patentable subject matter.³⁴  With respect, however, to those compositions of matter and manufactures that are not naturally occurring (but are made by man), the Court, interpreting the relevant existing patent laws, held that the nature of the subject-including whether or not the subject consists of a living organism-is irrelevant to the issue of patentability. These were statutory, not constitutional, interpretations. Congress, of course, retains its unquestioned authority to enact legislation that could exclude certain subject matter from patentability.

For about the first one hundred ninety years of its existence, the Patent and Trademark Office (PTO) declined to grant patents for inventions that were "products of nature," including living organisms.^{viii 35}   With a few possible exceptions, such as Pasteur's 1873 patent for a form of yeast, the "product of nature" doctrine prevailed. In 1980, the Supreme Court departed from the "rule of nature" doctrine in the landmark case, Diamond v. Chakrabarty. The applicant sought protection for a form of bacteria that had been genetically engineered to break down multiple components of crude oil, useful, for example, to clean up oil spills.³⁶ The patent examiner rejected the patent on two grounds: first, the bacterium was a "product of nature," and, second, as a living thing, the bacterium was not patentable. The PTO's Board of Appeals upheld the rejection on the basis that the bacterium was a living thing.³⁷ 

The Supreme Court had to consider whether living organisms could constitute a "new and useful process, machine, manufacture, or composition of matter" within the meaning of the Patent Act. Reviewing the history of the Act and relevant case law, the Court embraced the notion that "anything under the sun that is made by man"-whether a chemical compound, a machine, a process, or a living organism-is proper subject matter for a patent.³⁸ The Court held that the nature of the subject matter for the patent-even if a living thing-was not a proper basis on which to deny an application. It concluded by noting that Congress was free to amend the law either to expressly exclude living organisms from coverage under the Act, or to add special provisions similar to those that exist for plants.

In 1988, the Court of Appeals for the Federal Circuit extended Chakrabarty's holding beyond microbial organisms to multicellular organisms (in this case, oysters), confirming that higher life forms may constitute "anything under the sun that is made by man" for purposes of patentability.³⁹ The PTO has adopted the position that "nonnaturally occurring, nonhuman multicellular living organisms, including animals, [are] patentable subject matter within the scope of 35 U.S.C. 101."⁴⁰ In 1988, the PTO issued the first patent granted on a higher animal, a transgenic mouse modified to be susceptible to cancer (the "Harvard Mouse").⁴¹

2. Patenting of Human Organisms.

Can a human organism at the embryonic, fetal, or any other stage be the subject of a patent? Until recently, the only express limitation on patents that cover human organisms was an interpretative ruling of PTO, which states that the agency will not grant a patent if "the broadest reasonable interpretation of the claimed invention encompasses a human being."⁴²

It is not clear, however, what precisely the PTO meant by "human being." The PTO has issued at least one patent, US 6,211,429, which includes a "method for producing a cloned mammal" that also covers "the living, cloned products produced by each of the methods described." This patent lacks the "nonhuman" disclaimer that has previously been required for approval under the relevant provisions of the Manual of Patent Examination Procedure. While it is not clear how this broad patent squares with the PTO's policy of refusing to issue patents that "encompass a human being," a spokesman for the PTO has reiterated that this policy remains in force, and there will be no "patent claims drawn to humans."⁴³ A spokesman for the University of Missouri (the patent holder) has asserted that the University would not grant permission to use the patented process to clone a child.⁴⁴

In 1997, a team of inventors sought to obtain a patent for an invention that covers the production of human-animal chimeras that could be up to (but not more than) 50 percent human.^ix  Two years later, the PTO rejected the application, at one point during the process issuing a "media advisory" suggesting that a "morals" requirement still exists with respect to measurement of utility.⁴⁵ The PTO ultimately rejected the application on the grounds that a claimed invention that "encompasses a human being" is not patentable.⁴⁶ The then-Commissioner of the PTO, Bruce Lehman, declared: "There will be no patents on monsters, at least not while I'm commissioner." But the PTO did not explain why, given that the application sought to cover only those organisms that would be less than 50 percent human, the application "encompassed" a human being. The agency has given no guidance about whether there is a minimum threshold at which such a patent could be obtained (for example, organisms that are up to 10 percent human, or 5 percent human, or 1 percent human).

The only constitutional provision suggested to have any bearing on this question is the Thirteenth Amendment, which prohibits slavery and involuntary servitude; but it is possible this provision could be found by the courts to apply only to live-born humans, not human organisms at the embryonic or fetal stage.

Recently, Congress enacted a measure effectively prohibiting the issuance of patents on human organisms. The Consolidated Appropriations Act of 2004 provides, "None of the funds appropriated or otherwise made available under this Act may be used to issue patents on claims directed to or encompassing a human organism." ⁴⁷ As further indication of the intended scope of this provision, the manager's statement for this amendment points to a June 22, 2003, colloquy wherein Rep. David Weldon (the amendment's sponsor) assured Rep. David Obey (the ranking minority member of the House Committee on Appropriations) that the amendment "would not interfere" with any existing patents on human genes or human stem cells. Weldon further noted that the purpose of the amendment was to affirm that "human life in any form should not be patentable." The Weldon Amendment thus proscribes the patenting of human organisms at any stage of development. It will remain effective for the duration of the relevant appropriations period, namely, for the fiscal year ending September 30, 2004. To continue in affect, it would have to be included in subsequent appropriations bills or be enacted as a freestanding, permanent law.

IV. Conclusion

Innovations in the reproductive biotechnologies and practices have given rise to new markets and opportunities for commercialization. There are currently no federal regulatory mechanisms that explicitly govern the sale of gametes. Very few states have laws that speak to this issue. There are voluntary professional standards that provide guidance relating to gamete-donor protections and financial incentives for gamete donation. The practice of assisted reproduction is subject to governmental regulations that relate to insurance coverage and truth in advertising. Professional societies have issued voluntary statements providing guidance on advertising and on various approaches to the payment for services. Finally, while patents have been issued for living organisms (and even for certain processes for creating human organisms), it is not now possible to patent a human organism itself at any stage, in light of the Weldon Amendment and the policy of the PTO.

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Footnotes

47. Pub. L. No. 108-199, 118 Stat. 3.

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