There are many serious public policy objections to the patenting of DNA molecules. But the Patent Office has found it fairly easy to dismiss these objections with the response that until Congress and/or the courts change the patent laws, public policy considerations will be entitled to no weight in the patentability analysis:
"Whoever invents or discovers any new and useful ... composition of matter ... may obtain a patent therefor." 35 U.S.C. 101. Congress creates the law and the Federal judiciary interprets the law. The USPTO must administer the laws as Congress has enacted them and as the Federal courts have interpreted them. Current law provides that when the statutory patentability requirements are met, there is no basis to deny patent applications claiming DNA compositions, or to limit a patent’s scope in order to allow free access to the use of the invention during the patent term. (66 Fed. Reg. at 1095)
That's what makes this such an exciting proposal:
Chapter 10 of title 35, United States Code, is amended by adding at the end the following new section:
"Sec. 106. Prohibition on patent of human genetic material
"Notwithstanding any other provision of law, no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies."
Co-sponsored by Reps. Xavier Becerra (D-CA) and Dave Weldon (R-FL), the Genomic Research and Accessibility Act may finally bring the 25-year-old debate over the social costs and benefits of DNA patenting to the attention of the only people who can effectively respond to its conclusions.
In a press release announcing the legislation, Becerra and Weldon highlight the mounting evidence that DNA patents are impeding genetic and medical research (my own contribution to the pile is here). As my own pilot project (reported in another article) has demonstrated, the issuance of DNA patents may be viewed as a historical accident, contingent on a patent system that has mistakenly substituted formalistic rules for scientific standards of "skill in the art" (and, strangely enough, on the once substantial but now rapidly shrinking cost of publishing massive sequence databases on digital media).
Rep. Becerra also joins with my colleague John Conley in contending that "Genes are a product of nature," a view that will not sit well with a patent system that has viewed isolated and purified genes as distinct from their naturally occurring counterparts. While I agree with John, I've argued to him that even a revivified product-of-nature doctrine can't support a stable categorical exclusion of DNA molecules from patentable subject matter. The legislation helpfully elides what might otherwise become an unwieldy distinction by trumping the § 101 analysis with the "Notwithstanding any other provision of law" clause.
While the simplicity of the proposed § 106 leaves many details open for debate -- the "naturally occurring products" clause might need reworking, the transition to rationality is going to be a doozy for the biotech industry, and then there's this can of worms -- these are important debates to have right now, and this legislation is a masterstroke of a catalyst. If the bill passes, the Federal Circuit will have work to do in drawing the line between the "functions or correlations" of a "nucleotide sequence" and technologies that use these functions and correlations. This is basically the same question that the Supreme Court recently ducked in LabCorp v. Metabolite, so it's more than ripe for review. Bring it on.