U.S. courts have, time and again, struck down genus claims for undue experimentation. The most recent blow came last year in Amgen v. Sanofi, when the Supreme Court affirmed the lower court’s ruling that Amgen’s patent on antibodies with a specific target was invalid for lack of enablement. In that ruling, the Court invoked the rule that “the more one claims, the more one must enable.” Meanwhile, science is being revolutionized by computational experimentation, especially in the fields of medicine, biotechnology, nanotechnology, and chemistry. These changes are enabling research at a scale hitherto thought impossible. This Note analyzes the standard of patentability in the context of computational experimentation, with an emphasis on computer-aided drug design. With a focus on Amgen and the Wands factors, this Note will argue that computational experimentation is enabling of genus claims, especially in the area of chemistry and pharmaceutical research.
To read this Note, please click here: Undue Computational Experimentation: Can In Silico Experiments Allows Genus Claims to Survive?