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May 19, 2012 | Posted By David Lemberg, M.S., D.C.

We (in America) live in a capitalist society. That is a given. We also live in a democratic society. The Declaration of Independence states that all men [humans] are endowed by their Creator with certain inalienable rights including life, liberty, and the pursuit of happiness. It is not clear that any of these specific rights can be fulfilled when access to a minimum standard of health care is denied, obstructed, or otherwise not available. In the case when health care is available, that care needs to be delivered stripped of any considerations other than those related to providing assistance for that patient.

But in America many ancillary considerations intervene. Care of a patient is confounded by care for special interests, often involving kickbacks (whether in the form of travel expenses, gifts, complimentary lunches and dinners, or even cash payments) rendered by obsequious agents of big pharma or medical device corporations. Worse, on a broader scale, the recent phenomenon (within the last 20 years) of the Patent and Trademark Office (PTO) blithely granting biomedical patents to any and all comers has seriously harmed medical practice and the health of Americans in need.

On this issue, the U.S. Supreme Court recently (3/26/2012) vacated (voided; overruled) the opinion of the Federal Circuit Court of Appeals in the case of Association of Molecular Pathology v. Myriad Genetics, ordering the appellate court to reconsider the case in light of the Supreme Court’s recent decision in Mayo v. Prometheus. Myriad Genetics holds patents on two human genes labeled BRCA1 and BRCA2. Both genes are associated with significantly higher risk of developing breast cancer and ovarian cancer. In effect, Myriad has been granted monopoly rights on the use of BRCA1 and BRCA2. No health care organization, research institution, scientist, or physician can develop tests, experiments, or diagnostic procedures based on these genes without paying for a license issued by Myriad to do so. Thus, owing to the protection granted by the PTO, Myriad patents interpose a formidable bottleneck to potentially life-saving research on cancers that affect tens of millions of women. In May 2009 the ACLU and the Public Patent Foundation filed a lawsuit against the PTO and Myriad Genetics. In March 2010 a New York federal court ruled that the patents were invalid. In July 2011 this decision was overturned by the federal appellate court. Now the Supreme Court has sent the case back to the Federal Circuit Court of Appeals.

The primary legal question is whether an isolated strand of DNA is patentable. Certainly, this notion is prima facie absurd. But the PTO has issued thousands of patents on human genes and almost 20% of human genes have been patented. However, contrary to the position of the biotechnology “industry” that the issuance of patents promotes innovation and protects the interest of researchers (read: the financial interests of the company’s board and executives), the real effect of most biomedical patents is to stifle research. When a company holds a patent, no other organization can conduct research without paying a substantial licensing fee. Beyond these practicalities is the fundamental consideration of what should be patentable. In Mayo, the Supreme Court reasoned “if a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.”

On this view an isolated strand of DNA, such as the strands known as BRCA1 and BRCA2, are “laws of nature”. Myriad had done nothing more than identify the sequence and isolate it. Their efforts were no more than “a drafting effort designed to monopolize the law of nature itself”. In contrast, as the Court explained in Mayo, a patentable process utilizes “other steps” which transform the process into an “inventive application of the formula”. In other words, the naturally occurring structure itself is not patentable. What may be protected under patent is a value-added process that utilizes that structure or “law”. In apt analogies, Justice Stephen Breyer (who wrote the opinion in Mayo) asserted that Albert Einstein could not have patented his discovery of mass-energy equivalence (E = mc2) and Isaac Newton could not have patented the law of gravity. These considerations should have equal applicability to AMP v. Myriad Genetics.

Capitalism need not be in conflict with medical ethics. Health care-related businesses are entitled to earn a reasonable profit. If this weren’t the case, capitalism as such would not exist. But corporations are not entitled to earn inordinate profits, and are certainly not entitled to earn profits at the expense of the welfare and well-being of others. Of course, this doesn’t mean there won’t be winners and losers. But people as patients cannot be the losers in the capitalist game of medicine as business. Those who issue patents in the field of biomedicine, and those who rule on the legality of such patents, need to have a very low level of tolerance for corporate greed. The business of medicine all too frequently considers the welfare of patients. Medicine as a profession needs to reassert itself. The welfare of patients, i.e., the welfare of the people, needs to be paramount in all medical practice.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

0 comments | Topics: Health Care Policy, Bioethics and the Law, Bioethics in the Media, Pharmaceuticals, Doctor-Patient Relationships, Bioethics and Public Policy


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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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