If I mention the name Henrietta Lacks, I am sure it will not ring a bell for many. However, it is because of Henrietta that we have the polio and COVID-19 vaccines1. While undergoing treatment, her cells were extracted from the biopsy of her tumor sample to be used in research, without her knowledge or consent1,4. In fact, cells that were harvested from her also played and continue to play a major role in the study of leukemia, the AIDS virus and cancer2,3. The cells were also used in the development of some in vitro fertilization techniques2.
Let us start from the beginning. Henrietta Lacks, then a 31-year-old African American woman, was diagnosed with cervical cancer1. When she went for treatment during 1951, researchers started using some of her cancer cells for research purposes1. The researchers were interested in these particular cells because of their unique ability to grow and divide continuously in the laboratory3. These cells were then dubbed “immortal cells” and named HeLa cells using the first two letters from Henrietta’s name and surname1. The immortal cells were so named because all other cells collected before then had died, Henrietta’s cells were the first to grow continuously and reproduce outside the human body3. For this reason, they proved to be an invaluable tool for research.
Source: https://osp.od.nih.gov/hela-cells/
Unfortunately, Henrietta died during 1952 but her cells continued to be used in biomedical research which enabled us to have a deeper understanding of the fundamentals of human health and disease1. Just looking at the research aspect, the research from Henrietta’s cells was the subject of over 110 000 scientific publications between 1953 and 20182. In addition, Henrietta’s story inspired the best-selling book “The immortal life of Henrietta Lacks” (Crown, 2010)2. That is a lot of intellectual property inspired by just one person. The copyrightable works that arose from the study of Henrietta’s cells is mind-blowing.
The use of Henrietta’s cells did not just lead to the generation of thousands of papers spurning decades, it also led to the 2013 NIH-Lacks Family agreement2. In this agreement, the US National Institutes of Health reached an understanding with the family of Henrietta Lacks to allow researchers in the biomedical field, controlled access to the to the whole genome data of the cells that were obtained from her tumor (HeLa cells)2. HeLa cells are the most used human cell line in existence2.
What led to the 2013 NIH-Lacks Family agreement is the publishing of a scientific paper by German scientists which made public the first ever sequence of the full genome of the HeLa cells2. The paper compared the genome of HeLa cells to that of healthy human tissues. There was an uproar from various stakeholders as they were of the opinion that the publishing of the HeLa cells genome was a violation of privacy of the Lacks family. This is because the family’s possible disease risk was made public2. The Lacks family expressed this concern to the German scientists, and this resulted in all the data being removed from the public domain2.
Source: https://www.nih.gov/news-events/news-releases/nih-lacks-family-reach-understanding-share-genomic-data-hela-cells
To avoid any future unauthorized publishing of the HeLa cells genome, the NIH reached an agreement with the Lacks family to the effect that researchers who abide by the terms contained in the HeLa Genome Data Use Agreement will be able to apply to the NIH for access to the full genome sequence of these cells2. Interestingly though, HeLa cell lines are available for sale (see picture below), and one wonders how the privacy of the Lacks family will be protected should some researchers buy these cell line and publish the entire sequence once again.
Source: https://www.atcc.org/products/ccl-2
This interface of science and the protection of personal information raises a lot of questions of how this matter would be handled had it occurred in present day South Africa. Section 14 of the Constitution of South Africa provides that everyone has the right to privacy5. This right to privacy includes the right to protection against the unlawful collection, retention, dissemination, and use of personal information. Further, we have the POPI Act which aims to promote the protection of personal information processed by public and private bodies5. It would have been very difficult indeed to extract the cells from the patient and share as much information on them as has been done in the case of HeLa cells. Particularly due to restrictions imposed by the National Health Act of 2003 and its accompanying regulations.
Section 3 of the National Health Act Regulation: Use of human biological material states that
“(1) A competent person may not remove any biological material from the body of another living person for the purpose of genetic testing, genetic training, genetic health research or therapeutics, unless it is done –
(a) with written informed consent of the person from whom such biological material is removed…”
We have tight controls on who has access to the patient biological materials as well as what these materials can be used for. The genetic sequence of HeLa cells could not have been released without the consent of the patient or their next of kin. In terms of the publication of genetic material, this is what the regulation states “An authorised institution that keeps or discloses genetic material records and other individually identifiable or related health information in any form, whether electronically, orally or on paper must ensure that:
- the information is treated confidentially;
- health care providers or planners give users a clear explanation of how the user can use, keep and disclose their information;
- users have access to their records;
- user’s written informed consent is obtained before information is released to health insurers, other health care providers or any other relevant person…”6
This matter of the use of HeLa is further complicated by the existence of a biotechnology company that has been using the HeLa cells and improperly benefiting from this usage. The family instituted proceedings against the company in 20214. The hospital that collected the cells originally, Johns Hopkins, stated that they have never profited from the cell lines however, some companies have filed patents pertaining to the use of these cells4.
Source: https://www.msnbc.com/opinion/henrietta-lacks-family-s-suit-against-biotech-company-hela-cells-n1281168
The lawsuit against the biotechnology company, Thermo Fisher (with a $32.2 billion revenue), listed about a dozen of the company’s products that use HeLa cells3. These include Pierce HeLa Protein Digest Standard, T-REx HeLa Cell Line, and Cervical Adenocarcinoma (HeLa-S3) Total RNA7. It was further stated that the company made astounding profits whilst the Lacks family have not received a single cent from the exploitation of IP arising from exploitation of Henrietta’s DNA4. Thermo Fisher was in the process of attempting to get the lawsuit dismissed on the grounds of the statute-of-limitations7. However, the company reached a settlement with the Lacks Family7.
Having read the extensive history of HeLa cells, what can we learn about the South African patenting system pertaining to human DNA? Section 25(2) states that “anything which consists of
- a discovery;
- a scientific theory…
shall not be an invention for the purposes of this Act”. The Act also states that “The provisions of subsection (2) shall prevent only to the extent to which a patent or an application for a patent relates to that thing as such, anything from being treated as an invention for the purposes of this Act.”8
Further, the Act states that “A patent shall not be granted for any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological process or the product of such a process.”8
It has been argued that a DNA sequence can be considered as a discovery. As a result, an isolated DNA sequence could be considered as not patentable. However, if the sequence can be subject to industrial application, such an isolated sequence could be patentable. In the same way that the Patents Act states that “In the case of an invention consisting of a substance or composition for use in a method of treatment … the fact that the substance or composition forms part of the state of the art immediately before the priority date of any claim to the invention shall not prevent a patent being granted for the invention if the use of the substance or composition in any such method does not form part of the state of the art at that date.”8 As such, it appears that an isolated human DNA sequence can be patented provided that the sequence has industrial application for instance, use in gene therapy provided that such use is new.
Be sure to read the second part of this topic where we will be discussing more about the South African Patents Act and the international case law that may assist us in interpreting South African statutes pertaining to the use of human genetic materials.
Written by: Tumelo Mashabela, Managing Director and Registered Patent Attorney
For all your IP, commercial and corporate law services, please contact us on 012 942 8710 / tumelom@tm-attorneys.africa. You can also find us on social media platforms with the handle @TshayaMashabelaAttorneys (@TshayaMashabela on Twitter).
References:
- https://osp.od.nih.gov/hela-cells/
- https://www.nih.gov/news-events/news-releases/nih-lacks-family-reach-understanding-share-genomic-data-hela-cells
- https://www.msnbc.com/opinion/henrietta-lacks-family-s-suit-against-biotech-company-hela-cells-n1281168
- https://www.smithsonianmag.com/smart-news/henrietta-lacks-family-settles-lawsuit-over-the-use-of-her-cells-without-consent-180982644/
- https://www.gov.za/sites/default/files/gcis_document/201409/3706726-11act4of2013protectionofpersonalinforcorrect.pdf
- https://www.gov.za/sites/default/files/gcis_document/201409/35099rg9699gon177.pdf
- https://www.washingtonpost.com/history/2023/08/01/henrietta-lacks-settlement-cells/
- https://www.gov.za/sites/default/files/gcis_document/201504/act-57-1978.pdf
