Biotech Intellectual Property & Licensing

Biopharmaceutical companies typically incur extraordinary research and development costs. Without intellectual property (patent) protection, and the resulting right to prohibit potential competitors from unfairly competing (creating price competition) prior to patent expiration, the biopharmaceutical industry could not exist. Despite the longstanding importance of intellectual property to the biotechnology industry, biotech patent law and practice continues to evolve. For some critics, this evolution is too late, or misdirected. Biotech companies frequently are criticized for their acquisition and deployment of certain intellectual property protections: that patents on genetic sequences somehow usurp our common human legacy; that patent term “manipulation” and extensions unfairly prolong monopoly pricing; and that biotech intellectual property reduces access to, and affordability of, desperately-needed therapies, particularly in developing countries.

This half-semester course aims to provide high-level but practical information for KGI students who soon will join the ranks of biotechnology inventors, entrepreneurs, businesspeople and policy-makers. The course covers established principles of biotechnology patent law, but emphasizes current developments in this rapidly-changing area of the law. Beginning with a fictional scientist-colleague’s important (but imperfect) entry in a hypothetical laboratory notebook, students will steer their colleague’s “eureka” moment through the creation of intellectual property protection, and beyond - is the invention patentable subject matter? May the invention freely be practiced?  What “prior art” stands between the presumed inventor and a government grant of a patent monopoly?  What is required to in-license blocking patents, cross-license mutually-competing patents, or out-license the patented invention entirely, perhaps to a better-resourced pharmaceutical company?  Should attempts to out-license fail, what are the risks (and costs) associated with patent litigation?  What are the factors which companies should consider when entering a know-how collaboration?  Finally, is patent protection a moral “good,” to be valued over all other competing interests?  Is it ethical to patent “the natural and the human?”

>>> ALS 451 2008 SP -- Biotech Intellectual Property & Licensing (Spring 2008)

>>> ALS 451 2006 FA -- Biotech Intellectual Property & Licensing (Fall 2006)