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4 pages/≈1100 words
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Biological & Biomedical Sciences
English (U.S.)
MS Word
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Biopharma: Free-to-Operate or Die Biomedical Sciences Article (Article Sample)


A brief review article on biopharma intellectual property.


Biopharma: Free-to-Operate or Die
Biopharma companies around the world rise and fall by the strength of their intellectual property (IP). IP rights have evolved over the last one hundred and fifty years, with one intention in mind: to offer protection of someone’s ideas from imitation, by conferring a period of exclusivity.
There are two main themes of creativity of the human mind. These are its artistic or commercial ideas. The first may come in the form of a poetry, or 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 two 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 commercialised. An important aspect of this effort is getting the “freedom-to-operate”. As an introduction, let’s think of the following scenario. An aspiring biochemist enjoys mixing and matching reagents at his home garage during the weekends. He has previously stocked various sophisticated reagents, some still under patent, from a well-known laboratory supplier. During Thanksgiving 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’d better not.
The same example applies to most 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? Only, if they have not used any other patented products, processes, or tools in the process. If all this applies, then we can declare that they possess “freedom-to-operate”.
What is meant by “freedom-to-operate”?

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