Supreme Court Will Finally Say If Genes Are Patentable

Patents

from the can-they-punt-around-the-question? dept

This isn’t a huge surprise, but after a long series of intermediary steps, the Supreme Court has finally agreed to weigh in on whether or not genes are patentable. For a bit of background on gene patents, back in 2010, a district court ruled in the Myriad Genetics case that gene patents were invalid, noting that they “are directed to a law of nature and were therefore improperly granted.” A nice, clear and useful statement.

But, of course, it was just the first step in a long process. Myriad took the case to the appeals court for the federal circuit (CAFC), the notoriously patent friendly appeals court. The only surprise here was that the US Justice Department actually said it agreed that genes shouldn’t be patentable (showing a potential disagreement within the administration, as the US Patent Office was not happy). End result? CAFC decided genes are patentable because they’re “separate” from your DNA.

Then, before the Supreme Court could review that case, it ruled in a different case, the Prometheus v. Mayo case, involving medical diagnostics, which it ruled to be unpatentable subject matter. As expected, soon after that, the Supreme Court told CAFC to reconsider the gene patent case in light of its ruling in the medical diagnostics patents case. In August, CAFC said that it still believed genes were patentable.

And, of course, everyone fully expected this to end up before the Supreme Court again, which it will. Of interest, there were two questions appealed to the Supreme Court: (1) are human genes patentable and (2) did CAFC make a mistake in its application of the Myriad medical diagnostics patent ruling to this case — but the Supreme Court has only agreed to review the first question: are human genes patentable? This is both good and bad. As we’ve seen all too often lately, the Supreme Court has bent over backwards to come up with ways to make very, very narrow rulings (see: Bilsky), effectively punting on the bigger questions, and leaving a ton of uncertainty in the market. By directly having just a single question over the patentability of genes on the table, hopefully it can issue a crisp and clear ruling (preferably rejecting those patents!)

The potential downside, though, is that if it does somehow find genes patentable, then it would mean that the CAFC ruling stands. Considering that we found the CAFC’s reasoning troubling, this could be a larger problem. It would mean that CAFC can get away with dancing around the Myriad standard for rejecting patents, to leave in place potentially dangerous and ridiculous patents on elements of nature. This also means that we won’t get a broader ruling on how to apply the Myriad standards, which actually might have been useful for rejecting software or business method patents. Either way, the most important thing at this stage is that the court outright reject gene patents.

Filed Under: diagnostic patents, gene patents, patents, supreme court
Companies: myriad genetics