Gene Patents, Oil-Eating Bacteria, and the Common Law

The Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics today. A unanimous Court (with a short, quirky concurrence from Justice Scalia) held that the patent claims directed to isolated, purified DNA sequences did not recite patentable subject matter under 35 U.S.C. 101; by contrast, those directed to complementary DNA (DNA with the exons removed) did recite patentable subject matter. The case has generated much discussion but little controversy. Myriad’s stock price soared (presumably because the opinion wasn’t even more damaging) and then dipped. And the entire contretemps may be overtaken by whole-genome sequencing.

I think there are three interesting points to the case. First, it exemplifies the wonders and terrors of entangling the common law with complex statutory schemes. Second, it continues the War of the Roses between the Supreme Court and the Federal Circuit. Finally, despite the Court’s invocation of Chakrabarty, it shows how far the law and the society in which it is embedded have traveled since the fights over recombinant DNA in the 1970s and 1980s.

Unlike in copyright law, most of the Supreme Court’s precedent on patent law – at least, its modern precedent – deals with questions of statutory interpretation. Thus, we have KSR v. Teleflex interpreting obviousness (section 103), Microsoft v. AT&T interpreting extraterritorial infringement (section 271(f)(1)), and Merck v. Integra Lifesciences interpreting the research exemption to infringement (section 271(e)(1)). The question is not whether Congress has exceeded its powers under Article I, section 1, clause 8 of the Constitution. Rather, it is how to figure out what Congress meant when drafting the Patent Act. Section 101, which describes what constitutes patentable subject matter, is admirably, dangerously concise: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…”

Genes are a “composition of matter,” as are inoculants of multiple strains of plant root nodule bacteria. But the Supreme Court has held that neither is entitled to a patent. Why? The Court has read into Section 101 three exceptions: laws of nature, natural phenomena, and abstract ideas. The list is short, and yet the Court has had to return repeatedly to this trinity of exceptions to define their scope and meaning. The Court’s precedent has both principled and practical justifications for the exclusions. The principled theory is that none of these three is a product of human ingenuity; rather, they are pre-existing rules of nature that are not, in any sense, inventions. The practical reason is that granting patents over subject matter falling within these zones would confer too great a property right to the alleged inventor – it would hinder, rather than promote, innovation. The challenge is that the theoretical rationale forces the Court into difficult and even absurd line-drawing problems, and the practical one seems to invade Congressional prerogatives as to the best way to generate innovative effort. In short, the Court’s common law drafting of statutory exemptions may have arrived, eventually, at a workable balance, but at the significant costs of uncertainty, judicial effort, and institutional conflict. We might be better off if the trinity had never existed.

Second point: the Court lives to reverse the Federal Circuit. It did so on automatic injunctions for victorious patent plaintiffs, on the test for whether an invention comprises an ineligible abstract idea, on whether the CAFC has exclusive jurisdiction over patent malpractice cases, and now on whether isolated DNA is patent-eligible. (There are more!) My standard explanations for this perpetual battle are that the Federal Circuit was instituted to be pro-patentee, while the Supreme Court carries no such mandate, and that this debate has devolved into a contest of rules (the practitioner-oriented CAFC) versus standards (the more academically-inclined Court). But, if the goal of jurisprudence in the lower courts and courts of appeals is to do justice while not being reversed, the Federal Circuit has a pretty poor recent track record. On the other hand, the uncertainty in the Supreme Court’s opinions often means that the CAFC’s approach has significant gravitational effect, as the emphasis on the “machine or transformation” test in USPTO guidelines and post-Bilski jurisprudence proves.

Lastly, when the Supreme Court decided Diamond v. Chakrabarty in 1980, holding that a General Electric research scientist could patent an invented 0il-eating bacterium carrying four hydrocarbon-metabolizing plasmids, the result was met with no small amount of terror. It was the beginning of corporate control over life itself. It enabled soulless firms to manipulate the very stuff of living tissue, and to block countermeasures with the force of intellectual property law. Today, while advocates have complained about the high cost of Myriad’s breast cancer detection regime, and worried about the effects on women’s health, there is no such comparable disturbance in the Force. We’ve accepted the biotechnology industry (even with the occasional jitter about GMO crops). That’s an interesting commentary on technological change, and perhaps one that makes it easier for the Court to issue its decision in a contentious area.

We haven’t seen the last opinion from the Court on its trio of exceptions. Let the parsing of the opinion begin!

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