Happy Wednesday, readers! I’ve decided to lay the coverage of same-sex marriage cases to rest for a little while and bring you up to Supreme Court speed. This past Monday, April 15, the Court heard a case called Association for Molecular Pathology v. Myriad Genetics, Inc. (isn’t that a mouthful?). While the name might be complicated, the question behind the case is a seemingly simple one: are human genes patentable under §101 of the Patent Act? Yes, that’s right—this week, the Court tries to determine whether certain research companies have the right to patent human genes after discovering them. Hopefully I’m not the only one who, upon hearing about this case, looked around and said, “Wait, what?” several times before looking into the specifics. First of all, I didn’t know that human genes could be patented in the first place! That seems sort of crazy to me. And, secondly, it’s interesting to note that there’s not a constitutional question in Myriad—instead, it’s an “interpretation of the law” issue.
Let’s first look at the background of Myriad, and then I’ll try to give you a sense of how the arguments played out on Monday. A long time ago in an America far, far away (more specifically, in 1990), a “molecular diagnostic company” called Myriad Genetics “located and isolated the BRCA1 and BRCA2 genes” that “indicate whether a woman is more susceptible to breast cancer” (from the Atlantic Wire’s case coverage). As Myriad Genetics was the company that located and discovered these genes, it patented “the decoded snippets of DNA.” These patents “barred [other companies] from making the tests that women would use to see if they carried the BRCA1 and BRCA2 genes,” and as such the patents “gave Myriad a complete monopoly over the [breast cancer testing] market.” Because of this monopoly, much of the American medical community is deeply opposed to Myriad’s patent, and in March 2010, the Association for Medical Pathology (along with the University of Pennsylvania and a slew of other litigants) sued Myriad for its supposed violation of §101 of the Patent Act.
Specifically, §101 of the Patent Act states, “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 [sic], subject to the conditions and requirements of this title.” Given the phrase “whoever… discovers any new… composition of matter,” Myriad believes that it is granted by law the right to patent the BRCA1 and BRCA2 genes. In March 2010, though, the United States District Court for the Southern District of New York disagreed with Myriad and dismissed its claims, ruling 1) in favor of the Association for Medical Pathology (called AMP hereafter) and 2) that all of Myriad’s patents were invalid. Myriad appealed, and in July 2011, the United States Court of Appeals for the Federal Circuit ruled in an interesting way: it decided that “isolated DNA sequences are patent-eligible,” but also that Myriad’s specific patents for “comparing DNA sequences are patent-ineligible” (from the decision).
Myriad once again appealed, and on March 2012, the Supreme Court granted certiorari, vacated the Federal Circuit decision, and remanded the case back to the Federal Circuit. They declined to hear arguments because of their recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which stated that “claims directed to a diagnostic method that involved observing a natural correlation were not patent eligible subject matter,” i.e. that certain “natural phenomena” claims were not valid for medical diagnostics patents. Despite the Mayo decision, in August 2012 the Federal Circuit ruled once again in favor of Myriad Genetics. As such, in September 2012, the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari with the Supreme Court, and the court granted cert in November 2012.
Okay, that’s sort of a crazy history, but the problem is actually larger than just Myriad and its breast-cancer-related patents. Due to the large amount of genetic research that has taken place over the past few decades, many companies like Myriad hold genetic patents, and, according to Christopher Mason, a genetic researcher at Weill Cornell Medical College, “about 40 [sic] percent of the human genome has now been patented.” This patenting is a problem because, says Mason, “Individuals have an innate right to their own genome, or to allow their doctor to look at that genome.” Proponents of the patents disagree, though—apparently, the incentive of a patent (and the monopoly and monetary gain that comes along with it) is what motivates much of today’s genetic research. And, based solely on the text of §101 of the Patent Act, genes can technically be patented: they are indeed “compositions of matter,” which are covered by §101. There’s no “constitutional guiding light” that would help provide an answer to the question of patentable genes, either, making this a bit of a “nonstandard” Supreme Court case. What seems like a very simple question is actually quite tricky; the Nine have their judicial work cut out for them.
As SCOTUSblog’s Lyle Denniston reports, in today’s oral argument the Supreme Court “seemed to be worried about two conflicting possibilities.” If it were to set strict limitations “on patent eligibility for experimenting with natural products,” it would remove any “financial incentive for scientific innovation.” If, on the other hand, it were to “expand patent eligibility for such experiments too broadly, it [would] scare off other inventors who might also make breakthroughs” if not for these problematic, patent-driven monopolies. The justices were, apparently, a little stumped by the complex science behind the issue, but Chief Justice Roberts explained the problem with the analogy that Myriad Genetics’ patents had “[taken] a string of molecules out of the body, and [snipped] it off.” Denniston also reports that “No one on the Court was in doubt that Myriad would have been entitled to a patent if it found some unique way to make use of the genes it has isolated, but the Justices drew a sharp distinction between creative applications and the core natural item, the gene itself.” Given that Justice Alito “suggested that the Court might be wise not to try to decide the whole issue of when manipulating nature can be treated as human invention,” and that Roberts “commented that the Court might be asking the wrong patent question at this point” and stated that the Myriad patents might be unconstitutional “because its method of extracting genes would have been obvious to any trained scientist in the field,” it seems that the Court will give a narrow ruling, if not actually strike down Myriad’s patents.
However, whatever the Court decides, we all need to consider the implications of this case carefully. What does it say about our country and culture in this day and age that large companies can patent parts of our genetic code? Are these patents beneficial or detrimental to medicinal research in the long run? When approaching healthcare research, should scientists prioritize personal monetary gains or wider societal advancements? Association for Molecular Pathology v. Myriad Genetics, Inc. is just the first piece of the puzzle, and it’s time that we all start to examine these genetics-related issues. The future is now, apparently, and it’s the job of the Supreme Court to navigate us through it.