Tagged: law and science

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Stanford Law Review Online: Anticipating Patentable Subject Matter

Stanford Law Review

The Stanford Law Review Online has just published an Essay by Dan L. Burk entitled Anticipating Patentable Subject Matter. Professor Burk argues that the fact that something might be found in nature should not necessarily preclude its patentability:

The Supreme Court has added to its upcoming docket Association for Molecular Pathology v. Myriad Genetics, Inc., to consider the question: “Are human genes patentable?” This question implicates patent law’s “products of nature” doctrine, which excludes from patentability naturally occurring materials. The Supreme Court has previously recognized that “anything under the sun that is made by man” falls within patentable subject matter, implying that things under the sun not made by man do not fall within patentable subject matter.

One of the recurring arguments for classifying genes as products of nature has been that these materials, even if created in the laboratory, could sometimes instead have been located by scouring the contents of human cells. But virtually the same argument has been advanced and rejected in another area of patent law: the novelty of patented inventions. The rule in that context has been that we reward the inventor who provides us with access to the materials, even if in hindsight they might have already been present in the prior art. As a matter of doctrine and policy, the rule for patentable subject matter should be the same.

He concludes:

“I can find the invention somewhere in nature once an inventor has shown it to me” is clearly the wrong standard for a patent system that hopes to promote progress in the useful arts. The fact that a version of the invention may have previously existed, unrecognized, unavailable, and unappreciated, should be irrelevant to patentability under either novelty or subject matter. The proper question is: did the inventor make available to humankind something we didn’t have available before? On this standard, the reverse transcribed molecules created by the inventors in Myriad are clearly patentable subject matter.

Read the full article, Anticipating Patentable Subject Matter at the Stanford Law Review Online.

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Partial Birth Abortion and Scientific Uncertainty

Although my area of research is primarily environmental law, I also explore how lawmakers deal with scientific uncertainty. And so the recent decision in the consolidated partial-birth abortion cases of Gonzales v. Carhart (05-380) and Gonzales v. Planned Parenthood (05-1382) really interests me.

In these cases, Justice Kennedy states that “when medical uncertainty persists . . . The Court has given state and federal legislatures wide discretion to pass legislation in areas where there is medical and scientific uncertainty.” Accordingly, the Court deferred to Congressional findings in 2003 that partial-birth abortion is never medically necessary. While this is definitely a blow for advocates of abortion rights, I can’t say (without further deeper reflection) that I automatically disagree with this approach, in which the majority deferred to Congressional findings, albeit not “uncritically.” This approach, after all, affects many areas in which Congress has made decisions to regulate in the face of scientific uncertainty, including environmental and health regulation. For example, how much can the presence of scientific uncertainty allow Congress to authorize agencies to protect the environment under the Commerce Clause?

The key, though, is how this “not uncritical” examination plays out in the future, and how “uncertainty” is defined. How much medical disagreement is necessarily to overcome a Congressional finding? If the bar is too high–which it could be, given how one could argue that all of science is “uncertain” and “unstable” to some extent–then Congress is free to entirely ignore scientific determinations. Yet if the bar is too low, then Congress would be unable to act in the face of predicted, yet “uncertain” risks.

What I would have liked to have seen, therefore, is a more thorough delineation of the nature of uncertainty and degrees of uncertainty, setting out ways for courts to inquire into its legal existence, which of course could be distinct from its epistemological existence. (This, by the way, seemed incomplete in the global-warming case of Massachusetts v. EPA as well.) Instead, it’s treated as almost an on-off thing, rather than recognizing degrees (and kinds) of uncertainty.

I would also like to have seen some recognition that scientific findings and legal findings are often intermingled. As many scholars observe, much of the science at issue in legal decisions involve “trans-scientific determinations”–determinations that involve both scientific and policy components. Because of this, a judicial determination could go either way depending on whether you look at a given determination as scientific, or legal (despite the presence of both elements). On one hand, you’ve got courts deferring to Congress when it “act[s] in areas fraught with medical and scientific uncertainties,” but you’ve also got the canon that courts apply (somewhat inconsistently) to construe statutes to avoid constitutional risks–which also involve areas of uncertainty, albeit legal uncertainty. And so without delineating how you “tell” what counts as science (for legal purposes) or law (for legal purposes), you end up with a situation where the rule of deference that one applies (or doesn’t apply) will depend heavily on a standardless characterization of the nature of a determination.

Anyway, I’m still thinking this through! So I’d really appreciate further thoughts and suggestions!