[JURIST] The US Supreme Court [official website] heard oral arguments [day call, PDF] Monday in Association for Molecular Pathology v. Myriad Genetics, Inc. [transcript, PDF; JURIST report], which deals with the issue of whether human genes are patentable. Myriad Genetics [corporate website] patented two genes, BRCA1 and BRCA2 [NCI backgrounder], which are isolated genes—different from native genes because the process of extracting them changes their molecular structure but not their genetic code. Counsel for the Association for Molecular Pathology (AMP) [advocacy website] argued that Myriad has not invented anything: “the genes themselves, … where they start and stop, what they do, what they are made of, and what happens when they go wrong are all decisions that were made by nature, not by Myriad.” AMP argued that although isolated or extracted natural products are patentable, there must be some further manipulation of the product so that it is no longer as it exists in nature. Myriad, AMP asserts, has not done any further manipulation and is simply trying to patent a natural product of nature. AMP also argued against the idea that if companies could not patent genes, then they would not invest the required amount of money to further research:

the whole point of the product of nature doctrine is that when you lock up a product of nature, it prevents industry from innovating and—and making new discoveries. That’s the reason we have the product of nature doctrine, is because there may be a million things you can do with the BRCA gene, but nobody but Myriad is allowed to look at it and that is impeding science rather than advancing it.

Chief Justice John Roberts suggested that all Myriad had done was take a sequence of naturally occurring molecules snipping off the top and bottom. In response, Myriad analogized its process of isolating genes was akin to a baseball bat. A baseball bat does not exist until it is “isolated” from the tree and it takes human ingenuity and intervention to decide where to start and stop cutting the tree to form the bat. Similarly, the isolated genes exist only as a part of a whole DNA genome and deciding where to start and stop cutting the DNA so as to isolate the gene involves the requisite level of human intervention to qualify for patent protection. Commentators have suggested that counsel for Myriad struggled [SCOTUSblog report] to properly analogize Myriad’s product to other patentable products.

The Supreme Court also heard oral arguments in United States v. Davila [transcript, PDF], which addresses whether any degree of judicial involvement in plea negotiations merits automatic reversal in violation of Federal Rules of Criminal Procedure (FRCRMP) Rule 11(c)(1) [text], regardless of whether the judicial involvement actually prejudiced the defendant. Davila was charged with filing over 130 false tax returns in the name of Florida inmates. During an ex parte hearing with the judge where Davila was seeking to discharge his lawyer, the judge urged Davila to plead guilty to the charges. FRCRMP Rule 11(c)(1) specifically forbids judges from participating in plea negotiations, but commentators thought that the court would likely rule against Davila [SCOTUSblog report]. Some of the justices expressed concern that if Rule 11(c)(1) was applied maximally, then minor actions of the judge could be used as an argument that the judge was influencing the negotiations and therefore be a basis for voiding a guilty plea. Counsel for the US argued that significant violations of Rule 11(c)(1), such as a judge pressuring the government outside of the defendant’s presence to offer a plea, must be distinguished from minor violations, such as a judge indicating too strongly what type of new plea deal he would be willing to accept after rejecting the initial plea deal. Counsel for the US further argued that applying the rule too rigidly would trap judges in a corner where they couldn’t guard against later ineffective assistance of counsel claims by discussing plea deals with the defendants because it would risk automatic reversal as a Rule 11(c)(1) violation. Counsel for Davila argued that this was not a trivial matter and that the judge had “abandoned his role as neutral arbiter and fundamentally distorted the pretrial process.” Because of the judge’s unique position as a alleged neutral arbiter, any influence that he has on the plea negotiation process is magnified and it puts an incredible amount of pressure on defendants.