The Myriad case raised a plethora of issues that appeared to require some knowledge of molecular biology, yet just a single scientific reference, James Watson’s textbook, Molecular Biology of the Gene, was cited in the justices’ ruling.7 Nonetheless, they grappled with the distinctions between isolated genomic DNA and synthetically generated complementary DNA (cDNA). Lower court opinions that favored Myriad’s argument were swayed by the fact that because covalent bonds of isolated genomic DNA were cleaved from its chromosome, an isolated gene was, in fact, a new and patentable, chemical entity. The Supremes demurred.
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Explore This IssueOctober 2016
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The Court’s opinion, written by Justice Clarence Thomas, ruled that genes cannot be patented, although the justices agreed that cDNA, which are synthetic gene edits, could. The late justice Antonin Scalia, considered by some to be the wordsmith of the Court, penned a single-paragraph concurrence in which he confessed that although he didn’t know enough to sign onto the Court’s recitation of “the details of molecular biology,” he agreed with the decision.8
Although this opinion was initially considered to be a setback to the biotechnology industry, it hasn’t turned out that way. By granting cDNA and other synthetic molecules patent status, the Court signaled that it recognizes their importance in scientific discovery and drug development.
Another more recent case seemed to contradict this stance. The case revolved around the patent held by a California company on the technology that allowed for antenatal genetic testing to be performed on fetal DNA that is circulating in maternal blood. The Court refused to hear the case, reflecting the justices’ reluctance to interfere with a new set of administrative rules that govern how the USPTO interprets new patent applications. In court litigation, which is how patents were typically challenged in the past, patents are presumed to be valid and understood by their “plain and ordinary meaning.” But these new administrative rules, enacted in 2012, allow patents to be interpreted more broadly, and therefore, they are more likely to be overturned. Generic manufacturers and health insurers applauded the ruling, which let stand a lower court ruling; biotechnology firms were clearly disappointed.
In a similar vein, can a university claim patent ownership when one of its trainees develops a highly lucrative technology—HIV testing kits for example—while conducting the research at a for-profit entity?
This case, pitting Stanford University against Roche, centered on the concept that inventions or discoveries made with support from the National Institutes of Health allow the University to lay claim to the patent rights.9 Life is full of exceptions, and in this case the justices ruled that when the fellow began work on his project at the company, he was asked to sign a document assigning his discovery rights to them, and he complied. The Court ruled that this signature superseded the intent of the Bayh-Dole Act, the law passed by Congress to ensure that royalties went to the federal contractor, which in this case was Stanford. Fine print matters.
What sets the United States apart from many democracies, including those with a strong tradition of maintaining a robust set of freedoms & individual privileges, is the ability of its citizenry to successfully challenge any law in court. … Even though [the concept of the separation of powers] has spawned the explosive growth of the legal profession—now exceeding 1.2 million lawyers—& fostered a proclivity for some frivolous lawsuits, our society would suffer without having the courts overseeing the other branches of government.
What’s Going On in Vermont?
Vermont is a remarkable state. It boasts some of the finest mountain peaks and ski hills east of the Rockies; its leafy back roads are dotted with vintage covered bridges; its plentiful maple trees provide us with an abundance of sugary syrup every spring; it has spawned that phenomenal jam-band, Phish, and of course, Senator Bernie Sanders, too. As nearly the least-populous state (only Wyoming has fewer residents) and with a legislature based in the nation’s tiniest state capital, Montpelier, Vermont is clearly punching far above its weight. An inordinate number of state laws and regulations pertaining to healthcare have provoked controversy and legal clashes that have required SCOTUS to weigh in. Here is a sampling: