Why does genetic material need patent protection?
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Key issues, which require clarification, are

  1. Why do scientists explore the human genome and its components, and
  2. Why does industry need patent protection for genetic material ?

The human body is made up of billions of cells, all of which contain genes composed of DNA strands of chemical building blocks called nucleotides. Such genes represent the instruction manual of an organism, containing the essential information for development and life of the organism. In humans these genes comprise sequences of about 3,000 million nucleotides amounting to some 100.000 genes.

Genes are present in the human body along with very many other chemical substances. The key chemicals of living organisms: amino acids, proteins and nucleic acids are made by living cells thanks to the instructions contained in these genes. Diseases can arise, if these genes contain errors or are processed inappropriately.

Often diseases can be treated successfully using traditional therapeutic medicines. However, there are many diseases for which no satisfactory traditional medical solutions are known and for which the best prospects for successful treatments require investigation and intervention at the level of the gene or genes involved in the disease process.

For such diseases the key to a therapeutic solution is to get to the root cause; namely to identify the responsible gene(s) or gene product(s), understand their role in the disease process, and take appropriate action to modify the situation, e.g. of providing a missing gene product, replacing a defective gene by a copy of the functional gene, or by rectifying the way in which the gene is processed.

The responsible gene, or its association with the disease, may be previously unknown and thus its identification may provide a new target for therapeutic intervention, or indicate a new way to treat a known disease. Examples of disease candidates for such gene therapy approaches include: Alzheimer’s disease, AIDS, heart diseases, cancers, multiple sclerosis, and muscular dystrophy.

To achieve these objectives and provide effective treatments for patients requires immense research and development effort and investment by industry Such effort and investment cannot be made unless effective (product) patent protection is available for the key biological chemical entities (proteins and nucleic acids). In the absence of such protection there would be no financial rationale for research as there would be little or no return on the enormous amounts of investments required.

The importance of (product) patent protection for proteins and nucleic acids has long been recognised. Patentability of these materials is essential to ensure timely and effective achievement of the fundamental objectives of curing diseases, preventing suffering and saving millions of human lives.