What's the difference between a static data member and a regular data member?

Intellectual Property Law: What is the difference between data exclusivity and market exclusivity?

• In the pharmaceutical and other neighboring industries (biotech, agrochemicals...etc), innovative companies have their products protected in developed countries from copy-cat competition by patents. In new member countries of TRIPS, different forms of protection are applied, such as data exclusivity. However, the difference between data protection, data exclusivity and market exclusivity is confusing.

• Answer:

  Data protection: this is the term used in Europe for “data privacy”. A lot of people outside Europe (and not only the NSA!) don’t really get this term, but the European legislation in this area is extensive and complex, designed to protect the privacy rights of individuals. Its specific relevance to pharmaceuticals and similar industries is largely in the context of clinical trials. Data exclusivity: this protects innovators who have submitted scientific data to the appropriate authorities to obtain a marketing authorisation to sell a pharmaceutical product from competitors using that same data to support their own marketing authorisation applications. In other words, the competitor cannot simply “piggyback” off the results of the innovator’s research and development; the competitor must re-do the relevant scientific work independently. The period of data exclusivity protection differs between jurisdictions; in the EU the period is eight years from the date of the first marketing authorisation. Market exclusivity: in my experience this is not really a term of art, but is used sometimes to refer to the period of protection that may be given to certain pharmaceutical products after the underlying patent rights have expired. In Europe this is known as a Supplementary Protection Certificate and can run for up to 5 years after the expiry of the patent rights.