commentaries

Institute on Biotechnology & the Human Future
565 W. Adams Street
Chicago Illinois
312.906.5337
info@thehumanfuture.org

Gene Patents

Who Owns Your Body?
Policy Challenges for Biotechnology and Human Subjects Research

Joseph P. Oldaker
Administrative Associate
Institute on Biotechnology & the Human Future

On June 16, 2006, the Institute on Biotechnology and the Human Future (IBHF) hosted a Congressional briefing at the Rayburn House Office Building in Washington, D.C., during the noon hour. Attended by well over 100 policymakers and staffers, the briefing, which was moderated by IBHF President and Co-founder Nigel M. de S. Cameron, and arranged by IBHF Co-founder Lori Andrews, focused on three pending legal challenges that address gene patents, genetic privacy, and the commercialization of human tissue. The briefing brought together panelists who have been engaged in the litigation of these cases -- either as advocates or as victims of the inadequacy of policies governing biotechnology research involving human subjects. These panelists shared their stories about losing all rights to their own bodily tissue, losing access to their own genetic information, and losing control over the privacy of such personal data.

The briefing set out to illustrate several different challenging policy issues in the field of biotechnology and human subjects research. Existing laws have failed to protect the financial interests, property interests, privacy interests, and dignity of those who contribute to biomedical research. Furthermore, the ultimate goal of such research has arguably been turned upside down with the granting of de facto monopolies on information that should be part of the public domain, free for all to use.

Gene Patents
Genes have been assumed to be patentable, as long as the subject of the patent has been isolated or otherwise changed from its naturally occurring state.¹ And, for the past 25 years, the U.S. Patent and Trademark Office has issued patents for biotechnology inventions that include genetic sequences.² This has raised a number of concerns. First, it is in direct conflict with the notion of free dissemination of information that underlies science and academic research, because, in the U.S., gene patents grant a monopoly on the patented genetic sequence for 20 years from the date of filing. In addition, intuitively, it would seem that genes are unpatentable as either obvious or products of nature. However, this is not how the case law governing this issue has been interpreted.³ Another major concern that has arisen is who deserves to profit from the patented gene -- the researchers who discovered it, the research subjects who literally possess the gene as a part of their genetic sequence, or the institution where the research was conducted.

Dan Greenberg, an Illinois lawyer and the father of two children who died of a rare genetic disease, spent more than a decade raising money and convincing patients from around the world to give tissue samples so the gene for that disease could be discovered. Once the gene was discovered, it was patented without his consent, which resulted in litigation.⁴ At the briefing, Mr. Greenberg made a strong case for implementing a policy that disallows the patenting of genetic code. He argued that genetic code is an unpatentable product of nature, and that gene patents are interfering with research and raising the cost of health care.

Ownership of Bodily Tissue Donated for Medical Research
A vast number of Americans have bodily tissue on file -- whether in a DNA data bank, a biorepository, or various other locations.⁵ When such tissue is still attached to a living person, the tissue obviously belongs to that person; when the tissue is excised, however, the question of the ownership of that tissue can become substantially complicated. With various public health laws requiring that such tissue be destroyed in the interests of general welfare and disease control, it is difficult for patients to argue that they should be in control of their excised tissue, and patients generally lose their tangible property interest in such tissue.⁶

The case of Dr. William Catalona has spurred a debate about whether a patient's surgeon who collected tissue samples with the patient's consent for use in research should retain an interest in those samples. Dr. Catalona worked for Washington University (W.U.) in St. Louis, Missouri, for many years as a prostate cancer surgeon. He performed thousands of operations on patients, and those patients willingly donated their tissue samples to him, under the understanding that he would maintain those samples for use in research on the disease. When Dr. Catalona left W.U. and moved to Northwestern University, W.U. claimed that the university owned the samples.

James Ellis, Senior Vice President and General Counsel of AT&T;, a prostate cancer survivor, is one such patient who gave his tissue to Dr. Catalona for research purposes. Mr. Ellis and 6,000 other patients requested that their tissue samples go with Dr. Catalona so that he could continue this research. Mr. Ellis spoke at the briefing about how, as part of the human subjects research informed consent process, he and the other patients signed forms stating that they had the right to withdraw from the research at any time. But in April 2006, a federal district judge in Missouri ruled, in a case styled Wash. Univ. v. Catalona, 2006 U.S. Dist. LEXIS 22969 (N.D. Mo. 2006), that W.U. owned the tissue and could do whatever it wanted with these samples. Presently, Mr. Ellis and other patients are appealing the case.

In deciding the case, the district court accepted W.U.'s argument that this case was in line with the precedents set by Moore v. Regents of the University of California and Greenberg v. Miami Children's Hosp. Research Inst., Inc.. Nevertheless, the Catalona case is distinguishable from those prior cases because the physician and the patients are asserting that they retained ownership of these tissue samples and that W.U. simply served as a storage facility.

Genetic Discrimination and Defective Informed Consent
Carletta Tilousi, President of the Red Rock Foundation and a leader of the Havasupai, an Arizona-based Native American tribe, addressed genetic privacy issues. In so doing, she gave a personal account of being a victim of defective informed consent and the misuse of genetic information. She and other members of the Havasupai provided their blood for diabetes research, explicitly consenting only to such research.⁷ Without their consent, however, researchers at Arizona State University undertook stigmatizing research on schizophrenia and inbreeding, as well as research that violated the Havasupai's religious beliefs.

Ms. Tilousi gave an impassioned speech on the additional studies that were performed and how those studies affected the privacy interests of the Havasupai. Ms. Tilousi and the Havasupai are currently involved in litigation with Arizona State University, alleging several causes of action.⁸ This case has yet to be decided.

Closing Comments
Joan Abrahamson, president of the Jefferson Institute and former assistant chief of staff to Vice President George Bush, provided closing remarks during the briefing. Specifically, she discussed the types of legislation necessary to address the problems raised by each of these cases. She stated that, at the very least, a statutory change disallowing gene patents is in order and that a statute protecting genetic privacy should be enacted. Furthermore, she stressed that legislators should attempt to gain a better understanding of these issues and push for other legislation that protects the interests of patients and human subjects.

Several pieces of legislation have been introduced to amend existing patent law in a way that would: exclude genetic sequences; provide patients with an intellectual property right in commercial products resulting from their tissue; enforce genetic privacy; and outlaw genetic discrimination. However, none of these bills have passed.

In closing, Lori Andrews also noted that the U.S. Supreme Court was deciding a case, Lab Corp. v. Metabolite, Inc.,⁹ which could impact the patentability of abstract ideas. Less than a week after the briefing, on June 22, the Supreme Court dismissed the case on grounds of an "improvident grant of certiorari."¹⁰ The dismissal was accompanied by a 15-page dissent by Justice Breyer, joined by Justices Stevens and Souter, stating that the patentability issues raised by Lab Corp. v. Metabolite should be addressed. The dissent argues that, even though the patentability issue was not raised in the lower courts, the Supreme Court has the power to hear the merits of the previously unstated claim and should have decided the case.¹¹

Joseph P. Oldaker is a J.D. candidate at Chicago-Kent College of Law, expected to graduate in 2007. He is a Research Assistant and an Administrative Associate at both the Institute on Biotechnology and the Human Future and the Center on Nanotechnology and Society.

¹There is no court case or statute that explicitly states that genetic code in the form of a gene is patentable. The assumption that genes are patentable, however, has been based on interpretations of Diamond v. Chakrabarty, 447 U.S. 303 (1980), in which genetically-altered bacteria was determined to be eligible subject matter for patent protection. This case was decided in light of Parke-Davis & Co. v. H. K. Mulford & Co., 196 F. 496 (2d Cir. 1912), in which purified adrenaline was found to be eligible subject matter for patent protection, because pure adrenaline does not exist in nature. As a result, human genes have been patented.
² CHISUM ON PATENTS, § 5.04.
³ See, supra, note 1.
⁴ Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003).
⁵ Rebecca Skloot, Taking the Least of You, NEW YORK TIMES MAGAZINE, 38 (Apr. 16, 2006) (estimating the number of Americans with tissue on file to be 178 million).
⁶ See Moore v. Regents of the University of California, 51 Cal. 3d 120 (Cal. 1990); see also Hecht v. Superior Court, 16 Cal. App. 4th 836 (App. Ct. 1993), where a deceased sperm donor's wife sought to retrieve the sperm from the sperm bank, and was denied for public health reasons, overruled by Hecht v. Superior Court, 50 Cal. App. 4th 1289 (App. Ct. 1996).
⁷ Lori B. Andrews, Havasupai Tribe Sues Genetic Researchers, 31 PRIVACY JOURNAL 5-6 (2005).
⁸ See Court Link Docket Information, "Lexis Nexis" Havasupai Tribe. v. Arizona State University, civil docket no. 3:04-CV-1494 (D. Ariz. 2004); Tilousi v. Arizona State University, civil docket no. 3:04-CV-1290 (D. Ariz. 2004); Tilousi v. Arizona State University., civil docket no. 2:04-CV-1290 (D. Ariz. 2004).
⁹ Lab Corp. v. Metabolite, Inc., 370 F.3d 1354 (Fed. Cir. 2004), cert. denied by Lab Corp. v. Metabolite, Inc., 548 U.S. ____(2006) (per curiam).
¹⁰ Id.
¹¹ Specifically, Justice Breyer stated in his dissent:

In my view, claim 13 is invalid no matter how narrowly one reasonably interprets that doctrine -- that correlation is an unpatentable "natural phenomenon," and I can find nothing in claim 13 that adds anything more of significance.... If I am correct in my conclusion in Part III that the patent is invalid, then special public interest considerations reinforce my view that we should decide this case. To fail to do so threatens to leave the medical profession subject to the restrictions imposed by this individual patent and others of its kind. Those restrictions may inhibit doctors from using their best medical judgment; they may force doctors to spend unnecessary time and energy to enter into license agreements; they may divert resources from the medical task of health care to the legal task of searching patent files for similar simple correlations; they may raise the cost of healthcare while inhibiting its effective delivery.

Id.