Protecting Your Intellectual Property as a Biotech Entrepreneur

Before a Life Sciences based idea generates revenue or no longer operates at a loss, this may take up to years. Indeed, conducting market analysis, speaking to experts in the field, analyzing competing businesses and developing the solution to the identified problem takes a lot of energy, time and money. On top of all the initial investments needed to kickstart the firm, clinical and food products often need to be validated. However, clinical trials may fail or approval denied from regulatory bodies (such as the Food and Drug Administration in the United States). If so, your products will be delayed entry in the market and give opportunity for others to benefit from your idea without having gone through the processes you have. 

It typically takes 10-15 years for example for a new drug to be commercialized in the market and then it needs to be successful. Communication between medical parties is fundamental to make your product known, subscribed and bought. Thus, You will make money from your product and need to protect it by securing the intellectual property (IP). As such, anyone who uses your technology has to pay royalties or may be subject to legal liabilities. IP also ensures exclusivity and is a key selling-point to potential investors, who see this as a competitive advantage. Below are examples of how you can protect your IP:

  • Patents: often considered the most common and important asset as it yields the inventor the commercial right to a product, apparatus, compound or is an improvement of any of the previously cited. The patented invention needs to be new, useful and non-obvious. In exchange, an official documentation is produced to prevent a third party from using an invention without requesting permission from the inventor and royalties are paid when used. Patent terms vary from country and should be looked into a case by case basis.
  • Trade secrets: refer to information, processes or formulas that are kept confidential by a company or individual. For example, the ingredients in Diet Coke may be listed but the manufacturing processes which gives it its unique taste is trade secret. These are maintained by contractual obligations and preventing large-scale disclosures which can ensure that manufacturing processes and recipes are kept secret long-term.

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  • Regulatory exclusivity: approved products may also have extra benefits depending on the country it was issued in. For example, the European Medicines Agency defines data exclusivity as “the period of eight years from the initial authorisation of a medicine during which the marketing-authorisation holder benefits from the exclusive rights to the results of preclinical tests and clinical trials on the medicine. After this period, the marketing authorisation holder is obliged to release this information to companies wishing to develop generic versions of the medicine”. The European Commission also delivers ten years of market exclusivity once they receive a marketing authorization in the EU” for orphan medicines which treat rare diseases and thus often discourage investments.