Transfer Pricing Associates

IP Specifics for the Biotechnology Industry


Biotechnology utilizes biological processes to develop or manufacture a product or a technical solution to a problem.  Biotechnology has progressed significantly since the discovery and identification of DNA. Biotechnology is not only applied in the medicine and engineering area, it is also widely used in the agricultural industry.  Many agricultural companies, such as Monsanto, have made great success by exploiting the economic benefits of its biotechnologies.  Patents are the main way most biotechnology companies choose to protect their intellectual property. The protection of intellectual property rights allow private firms to appropriate returns that would otherwise accrue to the public and, hence, justify investments. One of the issues faced by many biotechnology companies is the limited life of patents. Once a patent has expired, the technology becomes public and subsequently, a supply of similar products flood the market, which destroys the market leader position of the biotechnology company.

In recent years, patent applications from biotechnology companies have grown faster than in other industries. The thousands of biotechnology patents issued annually contribute to the protection of new products, services, and tools in agriculture, pharmaceuticals, and industrial products. This increasing number of patents granted in the biotechnology industry has given rise to antitrust and anti-competition concerns.  Many governments have developed antitrust polices to ensure innovation and customer welfare.  For example, in some OECD countries, it is possible for the government to unilaterally refusal to license IP that may violate competition laws. From the perspective of biotechnology companies, it is important to understand the process of how to apply for patents and the proper procedures in the event of infringement in the registered countries.


The U.S. Patent and Trademark Office grants patents and trademark registrations in the United States. Since biotechnology innovations can be classified into different categories, the applicant should make sure to properly categorize its patent and apply accordingly. For more information, please visit: USPTO also offers an illustration to better assist the applicant to understand the patent application process:


The European Patent Office is an intergovernmental organization that can grants European patents for the 38 EU member states.  When applying for a European patent, the application information can be found at:  Contrary to the USPTO, the EPO does not provide specific definitions on classifications, however, the EPO website does list existing biotechnology patents which can be helpful for the applicants.