What was missing from this debate was any discussion of whether a cell line or a virus
found in the cell line constitutes patentable subject matter under section 101 of the Patent Act of
1952.8
That is, no one asked whether these are even the kinds of things on which patents can be
granted. Although the provisions of the Patent Act will be well known to readers of this journal,
it is important to our argument to recall its basic tenets. According to section 101, a patent
application must claim “a new and useful process, machine, manufacture, or composition of
matter.”9
As traditionally parsed, section 101 imposes three distinct and demanding
requirements.10 First, the invention must indeed be a “process, machine, manufacture, or