Market exclusivity is the exclusive right of a single rights holder, usually the pharmaceutical company that developed the drug, to sell a drug or to use a particular invention. In the pharmaceutical industry, this period allows research-based pharmaceutical companies to recoup their investment in the research, development and marketing of a new brand-name drug by being granted a temporary monopoly on its sale before other companies can produce generic drugs or biosimilars.

Market exclusivity (German translation: Marktexklusivität) is enforced by various mechanisms like patent and document protection. In Germany, the German Patent and Trademark Office grants various types of intellectual property rights for pharmaceutical products:

• Patent protection (German translation: Patentschutz): An industrial property right that is granted for a certain period of time (usually 20 years after filing the patent application) and that protects a specific invention or — in this case — a specific drug. However, the actual duration of market exclusivity can be significantly shorter, as the development and marketing authorization of a drug can take up a considerable amount of this time span.
• Document protection: Protects clinical trial data submitted to regulatory authorities for product approval and prevents other companies from using this data for the marketing authorization of generic drugs for a certain period of time. The so-called "8+2+1 rule" applies: The study data is protected for eight years, after which a generics manufacturer may use it in the marketing authorization application, but must wait another two years before marketing the generic drug. If a new indication with a significant additional benefit is approved, this period can be extended by one year.
• Supplementary protection certificate (SPC; German: ergänzendes Schutzzertifikat): The patent term can be extended by up to five years if the development and approval of the new drug have taken a particularly long time.

Market exclusivity helps to encourage innovation and investment in the development of new drugs by creating a temporary monopoly in the market, allowing research-based pharmaceutical companies to earn a return on their investment in research and development. This should be viewed critically from the  point of view of patients, as market exclusivity leads to higher prices and less availability of new medicines.

As professional pharmaceutical interpreters and GMP translators, we are happy to assist you if your pharmaceutical company is facing a GMP inspection by foreign regulatory authorities.