Two weeks after the Supreme Court held isolated naturally occurring DNA unpatentable in Association for Molecular Pathology v. Myriad Genetics, Inc., there’s been quite a lot of commentary about the case’s implications for the biotech industry and medical science. I’ll just mention a few here, with the certainty that there will be more to come. On the practical side, Quest Diagnostics has already announced plans to offer testing for BRCA1 and BRCA2.
Paul Cole wrote about how Myriad lines up with international views on gene patenting, and concluded it doesn’t, at least not well – in the E.U. and Australia isolated DNA is patentable. On the other hand, at least the Federal Court of Australia opinion (also against Myriad Genetics), the court relied in part on its conclusion that “in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and ‘isolated’ nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell.” The amicus brief filed by Dr. Eric Lander on behalf of neither party, and co-authored by Glenn Cohen here at the Petrie-Flom Center, points out the error of this conclusion, noting that there is a tremendous amount of isolated DNA present in the human body outside of cells. Glenn posted extensively on this, and the importance of the brief in the Supreme Court’s reasoning, here.
Dennis Crouch has an interesting meta-take on Patently-O, gathering sub-40-word reactions from 20 different IP scholars and practitioners. There have also been a few posts questioning, applauding, and exploring Justice Scalia’s concurrence about not knowing the science underlying the opinion.
It’s also worth re-noting that, even before the opinion came out, some doubted whether the case would have much impact. Kevin Noonan wrote on PatentDocs to that effect, noting that the number of extant gene patents was declining. On the other hand, since the decision came out, Kevin has argued that Myriad’s other patents, on methods of sequence comparison, survive Myriad and are also likely to survive Mayo v. Prometheus Labs. More limited sequence-comparison claims are worth watching carefully. Myriad also has a large body of trade-secrecy protected data that it’s gathered from years of exclusive testing, which has been criticized, but which is unaffected by the Supreme Court’s decision – though there are efforts underway to duplicate that database as well.
On the topic of implications for whole-genome sequencing, an important part of personalized medicine: I wrote in 2012 that the Myriad decision was unlikely to have much of an impact on whole-genome sequencing, because patents on naturally occurring genes are usually not infringed by modern whole-genome sequencing techniques. (Chris Holman has a similar analysis, with some more empirical work, here). But even if most whole-genome sequencing didn’t infringe most gene patents, the uncertainty about those patents existing might have still been a significant negative for companies looking to spread and use whole-genome sequencing techniques, particularly in the context of personalized medicine. The Myriad decision should help alleviate that uncertainty by invalidating those gene patents. Since whole-genome sequencing relies–by definition–on using just natural genome sequences, the cDNA’s or other altered DNAs that the Supreme Court ruled patent-eligible shouldn’t block any whole-genome sequencing techniques.
A few folks have opined generally on business implications of Myriad for the industry, but Myriad itself isn’t finding much favor. After jumping from $32 to $38 a share on the day the opinion was released as investors focused on the court’s upholding cDNA patents, Myriad’s stock has fallen to around $26 dollars a share.
