Lueder Behrens
Boehmert&Boehmert, Germany
Title: The importance of IP protection and SPCs for biologics and biosimilar products
Biography
Biography: Lueder Behrens
Abstract
Research and Development nessecitates important financial investments, in particular in the pharmaceutical field, where clinicial studies costs easily hundreds of millions of Euros. Patents are important business tool to maintain exclusivity for the products provided in R&D and secure rights on the results of the underlying work. Pharmaceutical product development from lead compounds to the authorized drug easily takes more than 10 years. It is important to maintain product exclusivity in order to guarantee a satisfying return on investment. Biological products are used at increasing frequency in the pharmaceutical field, e.g. as therapeutics in the treatment of cancer and inflammatory diseases, as hormones, vaccines, etc. These products may also be subject to patent protection. It is of utmost importance for pharmaceutical companies to maintain exclusivity for a maximum period as the development and clinical testing up to market entry may be even longer than for small molecule drugs. Supplementary Protection Certificates (SPCs) provide legal means to extend protection for market authorized drugs. Recent decisions of the highest European Courts may provide guidance on the extent of protection conferred by such SPCs in the biopharmaceutical field. These decisions could provide guidance on how to protect biologicals and may influence the market entry of biosimilar products.