HUMAN PATENTING

Life Within The Double Helix

The essence and diversity of life lies within each living being and organism. Deoxyribonucleic acid (DNA) has created the assortment of all things existing from butterflies to humans. The discovery of DNA structure in 1953 has fundamentally transformed and challenged the study of biology and application of jurisdictions. Since then, researchers have made substantial progress in understanding the function of DNA in a variety of organisms. An innovative breakthrough occurred in 2001; a map of the human genome was published, identifying approximately 30,000 to 40,000 human genes. Many of these genes, DNA segments that carry genetic information, have a major role in detecting human diseases and disorders. Furthermore, their identifications may be a vital step in developing new diagnostic tests and potential treatments. Human genetic coding has been the focus of many platforms of discussion due to the growing public and private concerns on “Genetic Research and Patent Protection.”

Biotechnology Patents defines patents as follows: “A patent is an agreement between the government and an inventor whereby, in exchange for the inventor’s complete disclosure of the invention, the government gives the inventor the right to exclude others from using the invention in certain ways.(…) What is granted is not the right to make, use, offer for sale, sell or import, but the right to stop others from making, using, offering for sale, selling or importing the invention.” (U.S. Constitution, Article I, Section 8.) Furthermore, the rationale for a patent system was to stimulate and promote research as well as provide an incentive to benefit societal needs. Genetic patenting has been a subject of controversy in numerous categories: human, animal, agricultural (plant) or microbial genes. The on-going concern and debate is due to the rising rate of patenting human DNA sequences, thus the applicability of patent laws with respect to DNA sequences and possible consequences for societies are in question.

Until 1980, all living organisms were deemed “alive” thus not of patentable subject matter. However, in June of 1980 a landmark case Diamond v. Chakrabarty changed the judicial approach of patenting. Chakrabarty had modified bacteria by inserting specific genes that gave them the ability to break down hydrocarbons (geared towards the clean up of oil spills). According to the U.S. Supreme Court, the modified bacteria of Chakrabarty was in fact an “invention” since it could not be found in nature, and therefore was patentable (U.S. Pat. No. 4,259,444). This lead to the U.S. Patent Office stating a one-sentence decree in 1987: “Patent anything in the world that is alive, except a full birth human being.” Subsequential to this judgment, countless patents have been granted for a large number of genes, sections of genes and to the proteins they produce. Such rights and privileges have created an incentive for private as well as public institutions to pursue genetic coding. With great development and “invention” several new medicines were produced based on human proteins: Erythropoietin

(EPO) treating anemia and tissue plasminogens activator (t-PA) used for tissue remodeling. In spite of the obvious benefits, various problems arise such as preventing or delaying the development of new or improved medicines or treatments, exploiting information and hindering exchange between researchers.

DNA Sequence Monopoly: Case of BRCA1 Gene

In 1994, U.S. Myriad Genetics discovered the BRCA1 gene, located on chromosome 17, which has the capability of identifying susceptibility to breast cancer. A patent granted asserted property rights over the gene and all possible diagnostic methods thus providing Myriad Genetics monopoly over BRCA1. In 2001, Institut Curie, Assistance Publique-Hôpitaux de Paris and Institut Gustave-Roussy challenged Myriad Genetics on grounds of preventing or delaying the development of new or improved medicines or treatments pertaining to BRCA1. Therefore, the exclusive right to all subsequent uses is the main concern because BRCA1 has the possibility of identifying other related or non-related diseases, which would also give authority over the diagnostic methods and treatments to Myriad Genetics.

A plausible option would be to more stringently apply or amend patent criteria on DNA sequence by not allocating full proprietorship over the gene in question. For instance, when postulating for a patent, as in this case specific to the use for diagnosis, only the initial “invention” BRCA1’s capability of identifying breast cancer, is revealed thus only it should be recognized and patented. Furthermore, all patent rights pertained to the diagnosis of breast cancer from BRCA1 will be owned by the “inventor”, in this case Myriad Genetics until it reaches patent maturity date. This will not only provide the freedom to further research the gene and develop potential “inventions” by other organizations but also provide a dialogue for exchange of knowledge between researchers and organizations.

Patents In The Treatment Context: Case of HIV/AIDS Drugs

It is estimated that 2.4 million people died in Africa, of HIV-related illnesses, in 2005 alone. India, Russia and China have followed with the highest infection rates and growing epidemics increasing by a quarter since 2003. The latest innovative drugs on the market are antiretroviral (ARV) treatments. ARVs have the ability to not only limit the damage on the immune system caused by HIV but also prevent mother-to-child HIV transmission. However, all ARV medicines are currently under patent rights jurisdiction of developed countries, namely the United-States. In comparison to the Westernized world, where a large majority benefits from antiretroviral treatment, less than 5% of the population in developing countries has access to similar treatment. This brings strong evidence, that under the current patent laws, patent holders have legal right to prevent the production of a cheaper ARV medicine for third-world countries. This was brought to light in 1998 when the Pharmaceutical Manufacturers Association (PMA), representing 39 pharmaceutical companies, sought to prevent the South African government from revamping a law intended to make essential medicines more affordable in particular to HIV/AIDS medicines. This law would have allowed the generic substitution of patented brand-name drugs. However, this act was cancelled due to claims of law violations of patent and property rights.

As flagrant as the HIV/AIDS epidemic is, developing countries still suffer the burden of being at the mercy of pharmaceutical patents and property rights over much needed medicines. A proposed model called “Compulsory license” should be implemented to facilitate access to critical medical innovation. Under this model, the court will oblige patent holders to license their rights over to developing countries that are experiencing epidemics or life-threatening conditions.

Research and developments, specific to gene identification, provide an opportunity to cure and prevent life-threatening diseases. However, jurisdiction over such “inventions” should be highly controlled in order to protect the general benefit of society at a global level.