Patenting Biotechnology Inventions

By P. Kandiah & Sharrmila Palanyandy

In recent years, research and development in biotechnology field, especially in medicine and agricultural biotechnology is emerging rapidly. Researchers are encouraged to patent their inventions in order to commercialise their inventions and enjoy the benefits obtained thereafter. Mostly, biotechnology inventions are associated with materials present in nature which require intervention of human being. For example, if the invention is related to Deoxyribonucleic acid (DNA), it needs intervention of human being to utilize genetic engineering techniques whereby genes are modified in order to produce altered genetic information which will be functionally and structurally different from the genes present in nature. The mere identification of the genetic information from a gene is not patentable because the gene is naturally occurring and at this stage there is no human intervention or input. Thus, it is classified as a discovery. In general, all the inventions including inventions in biotechnology field are examined on the basis of common patentability criteria which are novelty, inventive step and industrial applicability and the inventions are further evaluated for their subject matter eligibility. This is the main reason why most of the biotechnology inventions face challenges in obtaining a grant of patent. Examples of case studies in patenting biotechnology inventions and a proper way to patenting biotechnology inventions are discussed herein.

The pioneer case in biotechnology inventions in the United States is Diamond vs Chakrabarty case which was decided in 1980. The inventor Prof. Chakrabarty had developed a genetically modified bacterium (derived from the Pseudomonas genus and now known as Pseudomonas putida) capable of breaking down crude oil, which he proposed to use in treating oil spills. The patent claims included the (i) process of producing the genetically modified bacterial organism (ii) method of using the genetically modified bacterial organism and (iii) the genetically modified bacterial organism itself. The United States Patent and Trademark Office (USPTO) patent examiner allowed process claims related to process of producing the genetically modified bacterial organism and the method of using the genetically modified bacterial organism. However, he held that claims related to bacterial organism itself is patent ineligible as it appears to be a claim for naturally occurring organism. On appeal to the US Supreme court, the patent was allowed to be granted because Prof. Chakrabarty was able to prove that the bacterium is a genetically modified bacterium which does not occur in nature.

The next well known case study in biotechnology inventions is Association for Molecular Pathology vs Myriad Genetics Inc which was decided in 2013. Myriad Genetics Inc had identified BRCA1 and BRCA2 as genes associated with increased risk for breast cancer in women. Myriad Genetics Inc also created synthetic complementary DNA (cDNA) that mirrored the original isolated strands with slight alterations. Myriad Genetics Inc had filed 23 patents related to the BRCA1 and BRCA2 genes. In United States, the validity of the patents was challenged specifically on certain claims that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to produce drugs using isolated DNA sequences. During its 2013 term, the US Supreme Court ruling on a challenge to a patent held on genetic tests for BRCA1 and BRCA2. It was obvious that if the patents granted, it will give one company a monopoly on a genetic test that involved isolating natural deoxyribonucleic acid (DNA) strands and creating synthetic complementary DNA (cDNA). The Court ruled that synthetically created cDNA is patentable, while isolated natural DNA is not patentable. This is due to the discovery of BRCA genes and their role in risk of breast cancer is only a scientific discovery as there was no human intervention i.e. modifying the BRCA genes.

A recent case study in US biotechnology inventions is Ariosa Diagnostics Inc and DNA Diagnostics Center vs Sequenom Inc. Sequenom Inc had isolated cell-free fetal DNA (cffDNA) in maternal plasma and serum, which is the portion of maternal blood samples that other researchers had previously discarded as medical waste. Discovery of cffDNA was a significant contribution in the medical field as it does not require any invasive procedure to screen the fetal DNA. In 2001, Sequenom Inc filed a patent, which did not claim cffDNA or paternally inherited cffDNA, but it claimed the methods of using cffDNA to diagnose certain fetal characteristics based on the detection of paternally or maternally inherited cffDNA. The US Supreme Court held in Ariosa Diagnostics Inc and DNA Diagnostics Center vs Sequenom Inc case that the method claims for non-invasive prenatal screening of fetal DNA as a patent-ineligible subject due to cffDNA being a product of nature. Further, the method of isolation and screening of the cffDNA being common in the field was not patentable as the method of isolation was already known in the art.

In isolating and characterizing genes, researchers need to set a higher standard of scrutiny when applying for a patent. US Patent and Trademark Office does require disclosure of the sequence of the gene or protein in order for a patent to be issued. As the biological systems are complex it is advisable that, the researchers must collect greater amount of data and disclosure to support the patent claims. It will be helpful to protect the core aspect of the invention. For example, if an invention relates to genetically modified insects it is necessary for the inventor to be able to differentiate the structural and functional differences of the gene sequences between the genetically modified insects and the original insects. The disclosure of homologs of the gene, either from the same organism or from different organisms needs to be identified as well. Further, it is important for the researchers to make sure they do not claim a material occurring in nature.

Although, US case law is not binding in Malaysia it has a have a strong persuasive value how the Malaysian patent examiner and the court will consider and or examine patent claims in inventions related to biotechnology field.

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