The Supreme Court's View
These Federal Circuit decisions set the stage for the oral arguments before the Supreme Court in the Myriad case presented on April 15, 2013. As can be expected, the different Justices had different views and concerns that they expressed during the oral arguments. For example, Justice Alito appeared to agree with the Federal Circuit's conclusion that isolated DNA has a different form and use than genomic DNA present in a cell. Justice Alito specifically commented that “[i]solated DNA has a very different function from the [genomic] DNA as it exists in nature. And although the chemical composition may not be different, it certainly is in a different form.”34 However, Chief Justice Roberts appeared to take a different view, commenting that “[h]ere you're just snipping, and you don't have anything new, you have something that is a part of something that has existed previous to your intervention.”35 In a similar vein, Justice Sotomayor asked, “I always thought that to have a patent you had to take something and add to what nature does. So how do you add to nature when all you are doing is copying its sequence?”36
Despite their differences, several of the Justices seemed to agree that claims directed to cDNAs are patent eligible, because these nucleic acid sequences are not naturally found in a human cell. For example, Justice Sotomayor distinguished cDNA from isolated genomic DNA, stating that “[cDNA] is artificially created in the laboratory, so it's not bound [sic, found] in nature. It's not taking a gene and snipping something that's in nature.”37
It is also noteworthy that Justices Kennedy, Alito, Scalia, and Kagan all brought up concerns about business incentives for the biotechnology industry. Justice Kagan asked “[w]hy shouldn't we worry that Myriad or companies like it will just say, well, you know, we're not going to do this work anymore?”38 Justice Scalia similarly inquired, “[w]hy would a company incur massive investment if it cannot patent.”39 Justice Alito commented that “if patent eligibility is denied here it will prevent investments that are necessary for the development of new drugs or it will lead those who develop the new drugs, new diagnostic techniques, to keep those secret, not disclose them to the public.”40
Thus, during the oral hearing, the Court raised many different views and concerns, making it difficult to predict how the Court will decide the case. However, given the Justices' comments, we would not be surprised if they decide that cDNA and recombinant DNA are eligible for patent protection because they are created by man's manipulations, but that genomic DNA, even if isolated, is not eligible for patent protection, because it is not markedly different from naturally occurring DNA. If the Court decides the case in this way, we also expect that in future cases expression vectors or recombinant algae, fungi, or bacteria that are not found in nature would also be patent eligible. On the other hand, new strains of bacteria or fungi, eg, isolated from some bit of water, soil, or mud, would not be eligible for patent protection under Section 101.
The Supreme Court is predicted to issue its decision in the Myriad case by the end of its term in June. In the meantime, many pundits will make predictions on the outcome. However, biotech patent applicants and owners alike can only wait for the decision, which, depending on its outcome, can have a major impact on certain sectors of this industry.