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Patent Ethics in Clinical Trials
Clinical trials in India continue to be in the news. Recent reports have raised concerns about how clinical trials are being performed in the country. This article gives an insight on regulatory regime governing the conduct of clinical trials in India and ethical concerns in clinical trials that were conducted in India.

To analyse the ethics of patents in clinical trial in India vis-a-vis global benchmarks, one needs to distinguish the patentability criteria as per Indian Patent Act, 1970 in comparison with US standards (35 USC). In USA, consequent to the 1980 Supreme Court Judgment in Diamond versus Chakraborty case, anything and everything under the Sun involving human intervention is patentable. Debate on ethical concerns such as informed consent, not only on doing research on patients, but also of obtaining “uninformed consent” or “misinformed content” on comatose patients retained in hospitals on life support system, at the cost of the relatives (at least in India), purely for conducting research on the disease conditions, have not led to any consensus. This is mainly due to the conflict between private rights of the patients versus greed for patent in clinical research professionals and their findings on researching on human body parts.

Having said that, the issues of ethics are very complex. USPTO (US Patent Trademark Office) has been granting patents including on human genes for last 30 years. Human genes are easily accessible by Medical and Clinical Practitioners from deceased body part or patients without their consent or even with their informed (often relatively uninformed) consent. In a country where the practice of “informed consent” is mostly known only to the medical profession and not to the majority of illiterate patients, where “informed consent” is at best a signature on a form without reading or explaining and where the word “Patents”, “intellectual property” are not even in the awareness domain of most doctors, leave alone patients. “Ethics of patent in clinical studies” is a subject which needs to be explained from basics to all concerned.

It is indeed alarming that nearly 20 per cent of human genome is already covered by at least one patent as well as multiple patents. The US Supreme Court is currently hearing “Myriad human gene patent case”. Myriad genetics, which has patents on increased risks for cancer of the breast and ovary as well as prostrates in man has a monopoly on BRCA test. A coalition of scientists, cancer patent and medical professionals are trying to revoke the Myriads patent on breast and ovarian cancer genes which has led Myriad to charge USD 3000 for the diagnostic test, with exclusivity. More about the "Myriad case" later.

Violation of privacy implications have come to the forefront in recent times, bringing along with issues of personal privacy, property - both physical and intellectual in human genome and extending information not only on self but also about the family members past, present and future. The emerging technologies are potentially leading to ethical concerns beyond informed consent. The ease with which human generic samples and surgically removed human body parts are available for easy collection and the unlimited data about pedigree and progenies (including third parties such as family members) that it carries as well as potential disease patterns in future, are all areas of concern. The current extent of legal protection available even in economies like USA, leave alone India, is inadequate and is publicly acknowledged as such.

In this context, three important case laws substantially explain the historical background as well as current status. These cases threw up questions of ethics, personal property, ownership of human body parts and need for “informed consent” specifically for patenting research findings and products. The case of John Moore and the Hagahai are best summarised on the WIPO website. In both these cases, prior informed consent was not sought from the donors, which led to the subsequent litigation and grave concerns were expressed by the Supreme Court in USA and the public (NGOs), respectively. The first case commenced in 1976.

John Moore was operated for removal of diseased spleen (Splenectomy) by Dr David Golde. Dr Golde and his team researched on the discarded spleen and established a cell-line from the extracted T-lymphocytes. While Moore had agreed to discard the spleen, he was not informed of research and the consequent patenting (US4438032) of his cell line which brought huge licensing income to Dr Golde and his team. This led to a suit for ownership interest filed by Moore. Though the Supreme Court rejected his ownership claim, the court observed that there was clear lack of ethics and breach in “fiduciary duty” of the medical team. Eventually this dispute rests to that of patenting for commercial gain. “Deadly Monopolies” by Harriet Washington makes interesting analysis on patenting of the Human Body and throws light on the controversies involved.

The second case of Hagahai arose in Papua New Guinea among the indigenous community. A rare gene in this group commonly predisposed the community to leukemia, but without symptoms. A T-lymphotropic virus was identified with potential to develop a vaccine against leukemia. National Institute of Health (NIH) of USA applied for a patent for a cell-line developed from the DNA of a Hagahai donor (US5397696). The cellline and a vaccine for humans against leukemia caused by HTLV-1 were patented. This created huge controversy regarding lack of consent for patenting. Questions arose if benefit sharing is to be done with the donor or the Hagahai community. Anyway, the patent was later abandoned by NIH.
The latest is the ongoing “Myriad human gene patent case”.

“Myriad human gene patent case” which is currently “running” in the US Supreme Court can be summarised as follows. This lawsuit is filed by Association for Molecular Pathology versus Myriad Genetics as well as others. The Supreme Court is considering the question “Are human genes patentable?”. The association led by American Civil Liberties Union and the Public Patent Foundation (PUBPAT) is spearheading this challenge of our times. Breast Cancer Action, headed by Dr. Karuna Jagger is also part of this group. Friends of the Earth, USA, Knowledge Economy International, Force (Forum for Organised Resource Conservation and Enhancement), New Delhi, METAVivor and other NGOs have also come forward expressing solidarity with anti-gene patent groups. Patents (US5747282 & US5837492) on two human genes associated with breast cancer and ovarian cancer (BRCA1 and BRCA2) are being challenged as invalid and unconstitutional. While the Patentees, Myriad Genetics, claim validity of patents being for advancement of innovation in genetic research for human benefit, the opponents are alarmed at the monopoly which prevents others from conducting cancer research, which makes the cost of diagnostic tests extremely high (USD 3000 per test), and ethical issues in patenting of human genetic information. Hopefully, the last word will soon be said, at least for the US jurisdiction, but there is no doubt that the debate will go on for a longtime to come.

There are extensive research data compiled and published by the Journal of Academic Medicine on Patents and conflict of interest policies in Human Research at major North American Universities. The Academic policy including on journal publications as well as patenting varies substantially from one university to another. Hopefully, the Supreme Court Judgement on the subject, due anytime mid-2013, should provide some uniformity to these policies on patents of human body parts and issues related to ethics thereof. Let us now see the Indian scenario. Let us look at the provisions of the Patents Act, 1970, which is TRIPS compliant. TRIPS (Trade Related Aspects on Intellectual Property Rights) Article 27(2) and (3) permits exemptions from patentability. India has availed these exemptions fully, by incorporating Sec. 3 under “Inventions not patentable” or “What are not inventions”. (Sec. 3 (i)) “any process for the medical, surgical, curative, prophylactic (diagnostic, therapeutic) or other treatment of human being or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products” are not patentable in India but patentable in USA. Similarly, plants and animals, in whole or any part thereof other than micro-organisms, but including seeds, varieties & species & essentially biological process for production or propagation of plants and animals, under sec 3 (j) are not patentable in India. Most of these are patentable in countries like USA, at least as on date.

Consequently, even if clinical research professionals opt to be unethical in their inventive approach, they cannot get a patent in India on their clinical findings. What is patentable in India, however, is a devise or instrument which will help in measurement, detection, diagnosis or even treatment or surgical operation. As such, the concerns on ethics of patents in clinical research are not so very critical in India in view of the safeguards. However, nothing prevents an Indian clinical investigator to patent his invention, in overseas countries, such as USA (with a simple permission to file directly overseas, including under PCT (Patent Cooperation Treaty) international application. In addition to the “non-patentable” criteria in the Patents Act, 1970, India has further enacted the Biodiversity Act, 2002 and the Biodiversity Rules, 2004. India was one of the first countries to put in place a benefit sharing mechanism for living organisms and naturally occurring resource materials.

The Biodiversity Authority demands a 5 per cent Royalty on all domestically sourced naturally occurring materials, especially living organism, including microorganisms, plant resources, and herbal raw materials. The provisions of the Biodiversity Act work as a deterrent against exploiting and patenting Bio resources including human genes. In conjunction with this, the (India) Patents Act, 1970 further provides (Sec. 10) that all biological materials used in or resulting from patenting must have a declaration with regards to the source of origin. Both these acts further provide that a permission (NOC) from Biodiversity Authority is to be produced before grant of a patent in India. However, a review of the current inconsistent definitions and defective provisions of Biodiversity Act is called for to improve its legal standing in enforceability.

While ethical concerns are high in India, the awareness levels are extremely low, among patients and potential donors. However, the plethora of negative provisions though various Acts & Rules, protect the interests of patients against exploitation and patenting of human body parts or genes, at least in India. Further, there is (fortunately?) an alarming disconnect (a virtual ignorance) regarding “patenting” among the clinical and medical research community in India. A “Blessing in disguise?”