Biosimilars and Intellectual

Property

Graeser Associates International

• At the very heart of biosimilars lies the concept of intellectual property (IP). Without IP, there could be no biosimilars – but also no protection for biological drugs or indeed for most of the many technologies that we take for granted today. IP is intangible property related to an idea.

• Like physical property, such as land, cars, houses and so forth, intellectual property can be bought, sold, traded and even mortgaged. However, by its very nature, intellectual property cannot be fenced in, locked up or protected by physical walls. Instead, it is protected by laws governing patents, trademarks and trade secrets – all forms of intellectual property.

• Biosimilars, or follow-on biologics, are intimately entwined with various forms of IP. For example, until the patents protecting an originator biological drug expire, it is not possible to sell a biosimilar. Trade secrets may potentially be used to protect manufacturing processes for biological drugs – yet there is concern that the new law on biosimilars, the BCPIA (Biologics Price Competition and Innovation Act of 2009), and the accompanying FDA regulations, may expose both trade secrets of both originators and biosimilar applicants. Even the names of such biosimilars are uncertain in the US; while the biosimilar applicant would presumably apply for a trademark, or proprietary name, it is possible that the FDA may require that the biosimilar have a different non-proprietary name than the originator biological drug – a position urged by the industry groups PhRMA and BIO. Generic industry groups have, not surprisingly, argued that this will lead to more confusion.

• These issues of biosimilars and intellectual property, and their effect on the biosimilars industry, will be considered in our next blog posts, on trade secrets (Oct 2 2012); patents (Oct 16 2012); trademarks (Oct 30 2012); and the contentious issue of non-proprietary names (Nov 13 2012). Links will be added to these posts as they are published.

• In our next blog posts, Graeser Associates International will be exploring the different issues relating to biosimilars and intellectual property.

• We will also be providing powerpoint presentations, written reports, and short audio and video presentations through our Slideshare channel. We will also be selling more detailed reports and longer audio and video presentations – please see our biosimilars product page for a list of products

• D'vorah Graeser, PhD is the founder and chief executive officer of Graeser Associates International (GAI), an international health care intellectual property firm. Dr. Graeser has been a U.S. patent agent for over 15 years and has extensive experience in the biomedical field. Follow Dr. Graeser on Twitter: @DGraeser. Follow our biosimilar communications on Twitter: @GAI-biosimilars. Email us at biosimilars@gai-ip.com.