Patents are necessary to incentivize innovation because they grant owners the right to protect inventions. To be patentable, an invention must be useful, it must be novel, and it must not be obvious. But the judiciary has struggled to apply the latter requirement, non-obviousness, particularly for highly technical innovations subject to FDA regulations. For these innovations, the progression through the regulatory jungle can take ten to twenty years and millions of dollars (2.6 billion for a pharmaceutical drug). The complexities of the regulatory process can also render an innovation unprotected by patent rights because, by the end of the process, the patent office may determine that the invention is “obvious” as a direct consequence of the process itself. But rendering inventions unpatentable merely because they show a reasonable expectation for success goes against the public interest. Because of the changing landscape of the path to the public domain and significant disincentives in regulated technologies, incentivizing innovation requires a reinterpretation of the obviousness standard.
"Determining What’s Not Obvious: Should a Reasonable Expectation of Success Invalidate Patent Applications?,"
University of Massachusetts Law Review: Vol. 18:
1, Article 3.
Available at: https://scholarship.law.umassd.edu/umlr/vol18/iss1/3