Patents are important to give companies exclusivity in the business of biotechnology. In the patent court a “natural product” is not considered patentable since it is the act of nature and not necessarily an invention. However, one Japanese man – Jokichi Takamine, the first pioneer in Biotechnology nearly 120 years ago, patented a natural product an enzyme that he isolated. His first patent on the isolation of an amylase was the first patent granted for the process of separating a microbial enzyme from Koji that was called Taka-diastase. He then licensed this to Parke-Davis and generating a good amount of revenue that not only made him very prosperous but was the start of the Biotechnology industry. He then continued his research to isolate and patent adrenaline and that led to significant patent discussion when challenged in court. The history is that since the patent examiner’s objected that this was a simple isolation of a natural product – he countered by making the molecule a base instead of a salt. The history is more complex and can be read in the link below.

These discoveries set the precedence for the patenting of streptomycin by Waksman at Rutgers and other molecules after that such as Taxol covered in the previous blog which was another natural product that was patented by BMS.
Each of these patents, made the patent holder very rich from the licensing activity and continue to this day with supreme court evaluating the patent for testing BRCA gene mutations by Myriad. These were challenged in court lead to a reversal of the ability to patent natural products.
This discussion on patents stems from 35 U.S.C SS 101 which declares that abstract ideas, laws of nature and products of nature are unpatentable.
So, even though many products that were patented were natural products isolated from nature an exception was made until recently that purified and isolated substances could be patented. The Myriad ruling on non-patentability of natural products confirms that much more strongly – though it took about 120 years! To be clear, a patent holder can still claim a novel use of the product or process for isolation of the product.

Natural products have an interesting story. The story of Taxol or Paclitaxel is interesting from its discovery as a natural product extracted from the bark tree to use as a cancer therapeutic. This compound came out of a screening effort in 1962 and it took until 2001 to become the highest selling cancer therapeutic. Now, this  did arise from a National Cancer Institute funding for a screening of natural products but it was manufactured from the bark of the tree till very recently since the chemical synthesis was too expensive in time and money. What is also interesting is the role that endophytes play in the manufacture of paclitaxel, since one hypothesis is that the  fungus living inside the plant makes the actual molecule. However, there has been doubt that it can do the production by itself.
Currently the largest manufacturer of paclitaxel is a company called Phyton Biotech that performs plant cell fermentation reaction to produce the molecule in the presence of the fungus.
Endophytes fungi were covered in a movie about Dr. Gary Strobel called “Jewels of the Jungle” who discovered the science of endophytes and collected plants from various locations and extracted useful molecules from them. Dr Strobel’s paper referenced below highlights some of his remarkable discoveries and combining a biomarker study with treatment may help understand the diverse function of these complex molecules.

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