The Importance of Freedom to Operate for Specialty Biopharmaceuticals (Article Sample)

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The Importance of Freedom to Operate for Specialty Biopharmaceuticals
By Dimitris Dogramatzis, RPh, PhD
Published Online:
Wednesday, February 22, 2012
The exploration of the freedom to operate in the specialty biopharmaceutical market, which requires specific steps and processes.
Biopharma companies developing specialty pharmaceuticals rise and fall by the strength of their intellectual property (IP). IP rights have evolved over the last 150 years, with one intention in mind: to offer protection of someone’s ideas from imitation, by conferring a period of exclusivity.


There are 2 main themes of creativity of the human mind. These are its artistic or commercial ideas. The first may come in the form of poetry, literature, music, painting, sculpture, or software. The second may come in the form of a new device, an industrial process, a tool, a chemical reaction, etc. Either of these forms may be protected by various forms of IP rights, for example, patents, trademarks, or copyrights.In today’s biopharmaceutical domain a myriad of specialized R&D professionals are focused on creating and preserving IP that can be profitably commercialized. An important aspect of this effort is getting the “freedom to operate.” As an introduction, let’s think of the following scenario. An aspiring pharmacist enjoys mixing and matching reagents in his home garage during the weekends. He has previously stocked various sophisticated reagents, some still under patent, from a well-known laboratory supplier. During a holiday he comes up with a mixture recipe that when tried on home-lab-grown bacteria makes them secrete a brownish excretion, proven to be a powerful new antibiotic. Should he rush to the patent office on Monday morning? He had better not.The same example applies to most specialty biopharmaceutical upstarts. They have a core team of bright scientists who continuously labor for the next “best thing.” In the process, they come up will all kinds of inventions, potentially useful in human therapeutics. Are they free to patent them as their own?