[This piece has beeen authored by Uzairulla Khan, a student at the IFIM Law School, Bangalore.]
Introduction
On October 5, 1976, John Moore was diagnosed with hairy cell leukaemia and his physician David Golde, a cancer researcher at the UCLA Medical Centre, recommended a splenectomy and advised him to completely remove his spleen. Golde and his team performed a few experiments on Moore’s spleen and found that his blood cells were unique. After a few years, Golde discovered a new cell line from Moore’s blood cells and dubbed it “Mo” following which he also obtained a patent for this discovery. Moore filed a lawsuit against Golde and his team for a share in the profits obtained from the patented by-products of this surgery after learning about the patent. Moore’s case discussed multiple ethical issues prevalent in our society, which have been examined below.
This piece will discuss the ethical issues that arise due to the patenting of cells that are derived from the human body. The ethical issues include importance of obtaining informed consent, need for disclosure of financial interest of the doctor and a comparative study of the Indian and the US patents laws pertaining to patenting of dead cells.
This blog post has been divided into two main sections – Section 1 will discuss bioethical issues, and consists of two aspects (i) informed consent and (ii) the need for disclosure of financial interests of doctors involved. Section 2 discusses the importance of novelty of invention along with a comparative study of the US and the Indian patent law.
Bioethical Issues
The doctors are under the obligation to obtain consent from the patient and to disclose their financial interests. The above statement has been discussed in detail in the following parts. In each of the parts, arguments from both the perspectives of the doctors and the patients have been considered and argued below.
Informed Consent
Prior informed consent is a very important doctrine under medical ethics which gives the patients right to agree to or refuse certain scientific research and medical intervention. The Declaration of Helsinki (1964) defines the principles to be followed by the medical doctors and biomedical researchers involving human subjects. Sections 25 and 26 of this Declaration makes informed consent necessary by the subjects to participate in the research. If the patient rejects for the said course of research, then the sample collected should be discarded. The most important criteria to be noted here is the ‘Informed consent’ of the patient to be a part of the research.
In Moore’s case, he did not give a consent to use his cells for the purpose of research and Golde exploited his patient’s right by using the cells to gain financial benefits. Patients will be at a huge disadvantage when the doctors and researchers take biological products from them without consent and patent them to earn profits. Hence the Supreme Court ruled in Moore’s favour and concluded that the doctors should always disclose their financial interests and obtain an informed consent from the patient. The patient can claim benefits for exploiting them if the doctors fail to disclose this information.
Similar issues arose in the case of Henrietta Lacks. Henrietta Lack’s cells (abbreviated as HeLa cells) were the most important invention of the 1950s. HeLa cells were the first immortal cell line because they were the first human cells that could grow and divide endlessly in a laboratory. As seen in the case of Moore, Henrietta’s cells were also taken without an informed consent of Henrietta or her family. Scientists today buy Henrietta’s cells for about $595 per vial and the family of Henrietta Lacks gets no consideration for their mother’s contribution to the medical fraternity. Scientists and the biotechnological companies have made millions of dollars from these cells and the patient, and her family members were not given any compensation.
Absence of the patient’s informed consent is a common feature in the case of Moore as well as Henrietta Lacks. From the above stated facts it can be inferred that informed consent should be an essential part of the agreement between the patient and the hospital authorities. The fact that the patient depends solely on the doctor to treat their medical condition plays a vital role in the doctor – patient relationship. It portrays the trust the patient has in the doctor. However, in the case where the by-products of the surgery prove to be beneficial for future experiments, the doctor’s and the hospital authority’s top priority could be financial gain rather than the life of the patient. This would be a breach of duty of care that the doctor has towards the patient. There is a fiduciary duty that exists between the doctor and the patient. All fiduciary transactions must be good faith transactions. Every fiduciary is under a contractual obligation to safeguard and protect the interest of the beneficiary. No fiduciary must make profit at the cost of the interest of the beneficiary.
The Need for Disclosing Financial Interests
In the case of Moore, Golde had taken advantage of his position as a doctor and violated his patient’s trust. As discussed in the above section, according to the Declaration of Helsinki, the doctors are under the obligation to disclose the financial interests that they might have in those samples. There is a possibility that due to the disclosure of this piece of information, the number of obtainable tissues is reduced because the patients might start demanding financial benefits for every vial of blood that they donate, which might indirectly halt advancement of the medical field. This, in turn, might impact incentive(s) to conduct important medical research.
The point that revealing the financial interest of the doctor might stop the advancement of the medical fraternity is totally valid. However, obtaining an informed consent from the patient after revealing this information would be apposite because then the patient can be sure of the interests of the doctor and make an informed decision.
Hence it can be deduced that even though the number of obtainable tissues is reduced, disclosing the financial interests will ensure transparency of the doctor and make it easier for the patient to make informed decisions. It also cuts down on the possibility of manipulation or misuse of the cells. The other reason why doctors should disclose the financial interests is because they have a duty to protect their patient’s financial interests. The doctor’s personal interests may affect professional judgement if they do not disclose this useful piece of information. Therefore, the doctors should disclose their financial interests to the patient.
The Hippocratic Oath taken by the doctor binds the doctor with the duty to act in the best interest of the patient and to refrain from any act of exploiting the patients. Hence, the doctor should obtain an informed consent of the patient before conducting the research and always take decisions that are right for the patient irrespective of the future financial benefits.
Comparative Study of American and Indian patent law pertaining to ‘Discovery’ and ‘Invention’
According to US Patent Law, for any invention to be patented it should be a new product which is capable of industrial application, and it should be helpful improvement thereof. The key terms used to define patentable invention in the statute of the US Patent Law are that it should be novel, non-obvious and useful. A patent is granted only for the invention which has novelty and utility.
There is no clear distinction between the terms ‘invention’ and ‘discovery’ in the US Code on Patents as Section 100 (a) of the Code states that the term ‘invention’ can also mean ‘discovery’. Section 101 of this statute clearly states that a patent can be granted to a person if the invention or the discovery is an upgrade from an existing technology or a process. Therefore, patenting of discoveries under the US Patent Laws are allowed unless and until there is an improvement in the existing technology or the process. In the case of Moore, a patent could be granted to his cells under the US Patent Law because his cells were a unique discovery which helped in establishing a new cell line. The established cell line was immortal and it could be used in research instead of primary cells.
On the other hand, Moore claimed that his tissues should not be allowed to be patented under the US Patent Law because it was a product of nature and Golde’s product was just a discovery not an invention and it did not involve an inventive step. The Supreme Court of California rejected Moore’s claim about the patentability of his cells and inferred that the by-products in this case can be patented because the cells extracted from Moore’s body were not identical to the ones which were patented. They had been transformed into an invention and were now the product of Golde’s human ingenuity and inventive effort. The established cell line from these cells also revolutionized scientific research by producing cost effective cells, thereby proving their importance in the medical field.
On the contrary, ‘The Patents Act, 1970’ of India makes a clear distinction between the terms ‘discovery’ and ‘invention’. Section 2 (j) of the Patents Act, 1970 defines an invention as a “new product or process involving an inventive step and capable of industrial application.” However, Section 3 (d) of the act states that “mere discovery of a new form of substance which does not result in the enhancement of the known efficacy is not patentable.” The Patents Act focuses on the inventive step of the discovery rather than it being a discovery or an invention. Therefore, patenting of discoveries under the Indian Patent Laws are also allowed unless and until it involves an inventive step. Based on the above stated information, it can be concluded that a patent would not have been granted to Moore’s cells because the Indian Patent Laws do not grant patents for mere discoveries and moreover the process of discovering this immortal cell line did not include an inventive step thereby reducing its chances of getting a patent.
The patents laws in the US have a more illustrative approach as compared to the Indian laws. US’s patent code focuses on the products and processes that ‘can’ be patented whereas the Indian Patents Act focuses on inventions which ‘cannot’ be patented. Chapter II of the Indian Patents Act is specifically dedicated to the inventions that cannot be patented. Therefore, the Indian Patents Laws have a more restrictive approach.
Conclusion
Certain ethical and general issues pertaining to the patentability of the cells can be identified through the analysis Moore’s and Henrietta Lacks’s case . The ethical issues of patenting biological products are that of informed consent and disclosure of financial interests. Obtaining an informed consent from the patient for the purpose of research is very vital because it creates trust between doctor and patient by ensuring good understanding and it also reduces doctors’ risk of legal action. The disclosure of financial interest by the doctors portrays the transparency of the doctor and makes it easier for the patients to make informed decisions. Disclosing this information would avoid invasion of human privacy and dignity in the name of medical progress.
The final issue raised was that of the importance of novelty of invention under the US and the Indian Patent Laws. Both the countries have a very different approach pertaining to patents. Essentially because the US’s code does not differentiate between ‘discovery’ and ‘invention’, whereas the Indian laws do. Therefore, if a patent for a biological product is granted in the US, it is likely that Indian laws might not permit it.
It can finally be concluded that the cells can be patented only if the final cells are not identical to the ones extracted from the human body. Patenting of the cells should be allowed provided the process of producing the final cells involves an inventive step.