IP Protection for Therapeutic Proteins
Because it is the foundation for customized or “personalized” medicine, much attention has been focused on recombinant therapeutic proteins, a monoclonal antibody technology combined with recombinant DNA technology. This technology has the potential to revolutionize the way preventive and therapeutic treatments are diagnosed and delivered.
Because of the expiration of patents of the first approved recombinant drugs, (insulin, human growth hormone and others) copying of these innovator drugs can now be offered by any other biotech company. Also known as “biologics” or “biosimilars,” or “biogenerics,” they are controversial because they are complex, made of living cells—bacteria, yeast, animal or human cell lines--and cannot be considered identical. For this reason, the Federal Drug Administration (FDA) held that new legislation was required to enable them to approve biosimilars. This legislation was passed in 2010, giving the FDA authority to approve biosimilars, but none have yet been approved.
Previously, patent expiry was less of a concern for biotech firms selling such therapeutic proteins, as no clear path for regulatory approval of generic versions of such proteins existed. The regulatory process required for approval of biogenerics is still not clear, but it is apparent that biotech firms face challenges to their patents that are similar to those in the pharmaceutical industry. Biotech firms with proprietary therapeutic protein technology must reexamine their patent portfolio to assure that they are able to optimize the value of their patents.
Currently, both in the U.S. and Europe, biotech companies are lobbying for the entry of biogenerics to the market. The path forward is unclear until regulatory and patent requirements are settled. These firms require flexibility in their IP and market planning, determining whether their strategy should involve invalidating proprietary biotech firm patents on one hand, or avoiding infringement of valid patents on the other.
GAI has both the expertise and experience to guide these biologic firms through this complicated regulatory domain. Whether deciding on a suitable IP strategy for protecting inventions or for avoiding infringement and/or invalidating the patents of others, GAI can optimize IP planning, strategy and execution.
GAI is particularly focused on start-up companies in the field of therapeutic proteins and handles diverse and complicated patent portfolios, optimizing IP strategy specific to the technology and business model.