Monday, March 7, 2011

Robin Feldman on Owning You

The fourth paper in my review of Stanford's Bilski Symposium is Whose Body Is It Anyway? Human Cells and the Strange Effects of Property & Intellectual Property Law by Robin Feldman (U.C. Hastings Law). Feldman's thought-provoking paper was presented in the same panel as the paper on genetic diagnostic patents by Dreyfuss and Evans, and she expresses a similar concern about genetic patents. Although the title and beginning of the paper led me to believe that it would focus on moral and ethical concerns of patenting DNA (which I have argued are not as significant as potential concerns about healthcare and basic research), Feldman actually presents a "modest and practical approach." She concludes that genes should be patentable, but only under a narrow claim scope.

Part I is about neither patents nor Bilski: Feldman argues that Moore v. Regents of the University of California (holding that a patient who consented to removal of his cells did not have a property interest in those cells) was wrongly decided, and that a person should have a property right in cells that are removed from his or her body. (If I were editing this piece, I might recommend that this Part be cut or reduced to a paragraph in the Introduction: this argument isn't new, and I think it detracts from the more interesting arguments in Part II.)

Part II examines "the extent to which inventors can tie up human genes and related substances" in light of Bilski and Association for Molecular Pathology. Like Dreyfuss and Evans, Feldman focuses on the use of "pre-empt" in Bilski, arguing that "[i]n gene-related inventions, pre-emption problems can emerge ... in the context of attempts to tie up a natural phenomenon." Under this preemption test, inventors should not be allowed to patent "the relationship between elevated blood sugar levels and diabetes" but should be able to patent "personalized medicine diagnostic methods, which may involve hundreds of biomarkers and complex statistical modeling." Considering the breast cancer genes at issue in Molecular Pathology, Feldman argues that the diagnostic claims are closer to personalized medicine, while the therapeutic claims (for "the 'method' of determining whether a cancer therapeutic is effective") have "greater problems."

"The more interesting question," writes Feldman, "involves the claims to particular DNA and cDNA sequences created outside the human body." She argues that the common analogy between gene patents and isolated and purified natural products (like the paper pulp in the 1874 American Wood-Paper case) is outdated because "the modern creation of genetic inventions no longer requires purification"; instead, genes can be built "from the ground up" through chemical synthesis. Feldman argues that genes should be patentable if researchers can develop specific uses for them, and that "the fact that genes exist in a natural form in the human body should not prevent patenting of genes in laboratory form." The subject matter test is related to novelty and utility: "we ask whether the invention allows us to accomplish something that we could not accomplish with the natural product. Applying that yardstick to isolated DNA and cDNA would suggest that such products should be considered human invention, rather than the handiwork of nature."

Feldman says that the problem is not gene patents per se; rather, it is "allowing patent holders to reach beyond the state of knowledge at the time of the invention," and "[t]he solution lies in properly limiting the scope of the allowed claim." But unlike Lemley et al., who argue that § 101 independently limits claim scope, Feldman says that "this limitation could be accomplished through the disclosure requirements of section 112." Myriad's BRCA1 patent claims, for example, should be limited to the BRCA1 sequence "for the purposes of breast cancer diagnosis in a designated patient population." (Feldman doesn't explain what "a designated patient population" would be, but presumably it would be something like "women at risk for breast cancer.") These restrictions might be important in some hypotheticals, but they wouldn't satisfy the Molecular Pathology plaintiffs, since the use of the BRCA1 gene for breast cancer diagnosis is what they care about. But presumably Feldman would argue that under our current patent laws, that makes doctrinal sense.

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