A major problem with the soon-to-be-enacted patent reform act (H.R. 1249) is that its poor wording inevitably leads to uncertainty about how the law will be interpreted by the courts and by the patent office (USPTO). And, that uncertainty potentially stifles the innovation process. There are a number of examples. One examples involves Section 33 of the Bill titled "Limitation on Issuance of Patents." The amendment adds a limitation that blocks the patenting of human organisms and reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
The provision was originally proposed by Rep. Dave Weldon (R-FL) who was apparently motivated by his anti-abortion policy position. The apparent argument is that the statute helps preserve the sanctity of life by not allowing humans to be considered (intellectual) property.
Clearly, the statute would block the patenting that claims "a human organism" per se – and that is likely the primary intent of the provision. However, the proposal is poorly drafted because the language does not have clear limits or well defined terms. When is a patent claim "directed to . . . a human organism?"
Patently-O readers have already debated this provision in sua sponte comments.
The phrase "directed to" is not defined by the Patent Act or the USPTO Implementation Rules found at 37 C.F.R. § 1, et seq. However, the phrase often used by patent attorneys to describe the coverage of a particular claim and the statutory category. Even amongst patent attorneys, the usage is not uniform.
In my patent law course yesterday we discussed a common hypothetical claim of a method of treating a human disease. A major focus of the claim is certainly directed toward a human organism. The question for the courts and the USPTO will be whether new law the claim itself directed to a human organism? In all likelihood, the USPTO will not take an aggressive stance at implementing this particular rule – that means that any legal changes will not seen until years from now.
This general issue raises two important points that have also been discussed in the Patently-O comment section. First, although the Senate passage of H.R. 1249 likely signals the end of major congressional patent reform action for the next several years, it is likely that congress will implement a number of "technical amendments" that fix problematic language in the bill. As you may expect, the technical amendments often have major substantive impact. Second, this bill provides additional rulemaking and fee setting authority to the USPTO (and in-fact requires that the USPTO use its newfound power). These sources of future changes to the patent practice continue to require input from the practicing bar.
[Addendum - Sept 10, 2011] A few years ago, I likely would have not seen the same problematic ambiguity with the provision. As long as the claim was not formally claiming a "human organism" then the Federal Circuit would have no problem. A handful of cases – with Myriad at the center – have begun to shift the legal view of the patenting of inventions that are directly tied to human activity. An important element of Myriad is the Obama Administration's support for the public interest plaintiffs through the Department of Justice. In addition, a growing line of cases have begun to disregard claim formalism as a distinguishing factor.