Gene Patent(s?) Invalidated:

When I teach the patent law material in my Introductory Intellectual Property class, we discuss the (very fundamental) principle that “naturally-occurring” things are not patentable subject matter – that patents only cover creations springing from the human mind. “But wait a second,” someone often asks, “what about all those ‘gene patents’ I read about in the newspaper? How can someone have a patent on a human gene if naturally-occurring things aren’t patentable?”

It’s a very good question. The answer, in a nutshell, is that the PTO, and the courts, have developed a doctrine under which the “purified” and “isolated” form of the gene is deemed to be a patentable composition of matter (because it does not, in fact, occur in nature in that form), as opposed to the gene as it actually sits on your chromosome. This allows all of us, thankfully, to do things like beget children without obtaining the authorization of the patent holder (even though the process of begetting children constitutes a “use” of the gene in question . . .).

I’ve always thought it dubious law and even-more-dubious policy (though I’m no expert in the matter), and a federal judge, for the first time, seems to agree. In a very important decision (though it will undoubtedly be subject to review, and quite possibly may be reversed), Judge Sweet (SD NY) invalidated the patent held by Myriad Genetics, Inc. on a gene thought to be associated with breast and ovarian cancer. [The full text of the opinion is here] The language is strong, and calls into question pretty much all 2000 or so of the patents issued in recent years to parts of the human genome (and the many other animal/plant gene patents as well). Noting that many people regard the notion of patenting the isolated form of the gene (but not the gene itself) as nothing more than a “lawyer’s trick,” the court wrote:

“DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an isolated form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable . . .”

I think the judge got it right. There’s a little bit of an “emperor’s new clothes” feel to the opinion — why has it taken everybody so long to realize the obvious? [Kudos to the ACLU, and the Cardozo law School clinic, which managed the litigation on behalf or the Association of Molecular Pathology, and thanks to Tom Bednar for the pointer]

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