Patent Wars ~ In“gene”nious?

Introduction

Can valid and enforceable patent rights be obtained in respect of genetic sequencing or mutations?

The functioning and evolution of the human body still presents a mystery to the scientific community in many respects. The human body is indeed a marvel of nature and unravelling the origins of and understanding the manner in which it functions holds immeasurable value to the human race and its future development.

It was with this purpose in mind that the Human Genome project was established by the Reagan administration in the late 1980’s under the auspices of the US Department of Energy and the National Institute of Health to sequence and map human DNA. Of course no human being’s DNA is identical and therefore mapping the genome had to involve multiple strands or variations of each gene.

Due to the highly successful international collaboration between scientists in different countries, public research facilities and academic institutions this ambitious project was completed much earlier than anticipated and the full genome sequence was published in 2000. The Clinton administration was of the view that this research should be made freely available to the public in the interest of science, hence the decision was made to publish the full genome sequence on the internet.

The advantages of sequencing or mapping the human genome is extensive and at this point in time it is not possible to quantify or foresee all the scientific advantages that may accrue as a result of this critical research. What was foreseen at the time was that it would assist with understanding the evolution of human beings, understand which genetic mutations lead to illnesses like cancer and generally the potential to develop DNA specific products and treatments in respect of such illnesses.

Legal position in the United States

However far-fetched the initial goals of the Genome Project may have sounded it soon became a reality when researchers in the United States were able to identify very accurately which genetic mutations were responsible for certain ovarian and breast cancers. The initial breakthrough research into breast cancer linkage to gene mutations was conducted at the University of Berkeley but the complete mapping of the gene mutations now commonly referred to as BRCA 1 and BRCA 2 by geneticists was completed by Myriad Genetics Inc. (“Myriad”) and scientists at the University of Utah (“Utah”). This it must be said, however, would never have been possible had it not been for the critical ground-breaking work done by scientists participating in the Genome Project.

Myriad and Utah then proceeded to file and were subsequently granted seven patents by the United States Patent and Trade Mark Office in respect of the gene sequencing and mutations known as BRCA1 and BRCA 2.

In practice, what this meant was that no clinical pathologist practising in the United States could use the BRCA 1 and BRCA 2 gene sequencing for diagnostic purposes unless they had obtained a licence to do so from Myriad. These patents were strictly enforced and valid until 2014. This in turn spurred on the Association of Molecular Pathology and other parties to challenge the validity of the granting of these patents and the matter was recently decided by Supreme Court of Appeal in the United States.

In the interim, the well-known Hollywood movie star Angelina Jolie went public with her positive diagnoses for the BRCA 1 gene mutation and opted to have an elective mastectomy. The awareness created by her overnight of the consequences and possible treatment of genetic mutations causing certain ovarian and breast cancer caused a sensation globally and doctors and specialists were inundated with phone calls from concerned patients wanting to know more about genetic disorders not only in the United States but also in South Africa and their treatment options.

There was, however, a critical difference in the status of the BRCA 1 and BRCA 2 testing available when comparing the position in South Africa and the United States. In the United States the test was subject to patent rights and not freely available unless it was conducted by a licensed laboratory authorised by Myriad and was extremely costly ranging between $3000 -$5000 dollars per test. In contrast in South Africa the test was and remains freely available at most private laboratories at a cost averaging at about R1 500 per test as clinical pathologists and geneticists are not restrained from performing these tests as a result of patent rights held in this country.

The legal basis for the challenge to the validity of the BRCA patents by the Association of Molecular Pathology was that genes are “naturally occurring articles” which by its very definition could not be eligible in the United States for patent protection. The counter argument by Myriad to this was that their Polymerase Chain Reaction technique (also known as PCR technique which is the ability to artificially amplify or copy DNA) was not a naturally occurring gene and could be patented.

The outcome of the decision by the Supreme Court of Appeal in the United States was a mixed result with certain of Myriad’s patents being struck down and others declared partially valid.
The question of whether genes can be patented is of much wider importance than just the diagnoses of breast cancer as genetic testing is constantly evolving to test for other diseases.

Legal position in the South Africa

If we consider the South African Patents Act 57 of 1978 (the Act”) it is highly unlikely that genetic sequencing, the human genome or the identification of genetic mutations in itself would be patentable.

Section 25(2) of the Act clearly states what matter shall not be considered an invention for purposes of the Act and hence not patentable and included in this section is section 25 (2) (a) of the Act which states that a discovery is considered not to be an invention. We can therefore potentially argue that the mapping and sequencing of the Human Genome is a scientific discovery for the purposes of section 25(2) (a) of the Act and not patentable.

More importantly section 25 (11) of the Act states:

“An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnoses practised on the human or animal body shall be deemed not to be capable of being used or applied in trade or industry or agriculture.”

Genetic testing is currently used mainly for diagnoses of current or future illnesses and hence is unlikely to be patentable. If some material alteration is made to the gene by artificial or other method or intervention it may certainly alter the legal position in terms of patentability.

It is not that clear and remains untested in South Africa as to whether the human genome or discoveries relating thereto can be patented. What is clear though is that genetic testing and any scientific advancement made in terms thereof will play a critical role in the future treatment of illness and disease and whether or not such innovation is patentable will have to be very careful considered from both a policy and ethical perspective. The dilemma posed by genetic treatment and discoveries is not unique to the field of intellectual property law and similar questions are being asked as to whether the ethical rules of the Health Professions Council of South Africa regulating the medical profession should not be revised so as to regulate and enforce genetic counselling support to patients undertaking life changing decisions as a result of genetic testing.

Another potentially contentious issue would be whether medical schemes should be forced to pay for genetic testing and counselling.

These are important legal and ethical issues for consideration and we sure to see more debate and potentially litigation on in the near future in South Africa and abroad.