The Myriad case – with its embedded nuclear bomb that would abolish most gene patents in the US – has been languishing on the Supreme Court’s desk ever since last year. The Supremes hadn’t accepted the appeal, or rejected the appeal, or said anything about the appeal, which was causing unbearable anxiety because gene patents are the bedrock on which the modern biotech industry – including medical and agri biotech – is built.
Quick background: this case is about a challenge to Myriad’s patent on the BRCA1 and BRCA2 genes (some variants of which predispose women to breast and ovarian cancer), and on Myriad’s use of them in diagnostic tests. The plaintiffs argued that not only was the patent on the diagnostic test invalid, but so were patents on genes themselves. Gene patents are the bread and butter for medical biotech firms like Genentech and agri-biotech firms like Monsanto. But they have been controversial ever since they appeared in the 1980s. Products of nature, after all, are not supposed to be patentable.
But — as explained in an earlier blog — genes have been patented by the thousands, largely on the rationale that when a stretch of DNA is isolated and purified (as it always is in making GMO’s), it isn’t “natural” anymore.
The key argument against gene patents is that all a gene is really good for is providing a recipe for a protein, and even if you isolate and purify it, it’s still a recipe for the same protein.
The Myriad case was argued in Federal District court in 2010. The judge agreed with the plaintiffs in a decision that, as the NY Times pointed out, “could throw into doubt the patents covering thousands of human genes and reshape the law of intellectual property.” The patents should never have been granted in the first place, wrote the judge; claiming genes to be patentable because they have been isolated is just “a lawyer’s trick.”
The case was appealed. Patent cases aren’t appealed to the normal local court of appeals, but to a strange court in Washington called the Court of Appeals for the Federal Circuit (CAFC) which exists mainly just for patent cases. The CAFC has 15 justices but usually appoints a random 3-judge panel to decide each patent case. From here, appeals go straight to the Supreme Court.
The unexpected twist was that when the case got to the CAFC, the US Dept of Justice weighed in with an amicus brief — supporting the challenge to gene patents. Whoa. (It’s a good read.)
But the CAFC tends to be pretty patent-happy and its decision sided with Myriad on 2 of 3 issues. It said:
- The challenge to DNA patents based on isolation/purification is rejected. The patented DNA products don’t exist in nature. This was huge, but not a major surprise; the CAFC is not inclined to totally nuke the biotech industry.
- Myriad’s method of screening cancer therapeutics is an invention, so this part of the patent stands.
- Myriad’s method of analyzing DNA sequences is not an invention, so this part of the patent is out.
This too was appealed. So why didn’t the Supreme Court take the appeal? Apparently because they were already deciding another case, Mayo v. Prometheus, which they thought would set the record straight. On March 20 they issued their Prometheus decision, then a few days later they vacated the CAFC’s Myriad decision and told the CAFC to try again, “in light of” the Prometheus decision.
So what was this Prometheus decision, which is supposed to guide the CAFC’s reconsideration? I’ll tell you but you still won’t know what the Supremes are hinting about gene patents.
Prometheus isn’t actually about gene patents, but it is about products of nature and the human body. Prometheus Labs is suing Mayo Labs for infringing their patent for a medical treatment. Prometheus’s patent isn’t for the medicine but for its use: the patent describes the process of giving a medicine, checking to see how the medicine is working with the use of a formula, and indicating if the dosage needs to be adjusted.
The Prometheus case was before the patent-happy CAFC last year and the CAFC found the patent claims solid. It was appealed and the SC remanded it, ordering them to try again. The CAFC issued the same decision the second time around. Then a clearly impatient SC accepted the appeal and bitchslapped the CAFC with a quick 9-0 reversal, invalidating the patents.
Their Prometheus decision says look, formulae are never patentable, and if you want a patent you have to use the formula in a real “invention.” How much invention do you have to add? Well, they said, we’ll give you an example of a case where they did add enough (the Diehr case) and one where they didn’t (the Flook case).
- In Diehr the equation was integrated into an invention for making molded rubber objects. The invention included collecting data, feeding it into a computer which made calculations based on the equation, and then signaled when the process was complete. The invention was specific to the manufacture of molded rubber. This was patentable.
- In Flook the equation was integrated into an invention for computing alarm limits in a process of catalytic conversion. The formula was novel but not patentable, and the invention only involved putting numbers into the formula and then using results to adjust the system. The invention was not specific to a particular application. This was unpatentable.
This is what the Supreme Court wants to guide the CAFC in reconsidering Myriad.
But 3 claims are at stake in the Myriad case. #3, Myriad’s method of analyzing DNA sequences, is already toast. #2, Myriad’s method of screening cancer therapeutics, might be re-thought in light of Prometheus, although I doubt it; after all, the CAFC ignored the SC in the Prometheus case.
But let’s face it, it’s claim #1 that is the main event: gene patents. And the Prometheus decision doesn’t guide them one way or the other. It doesn’t say anything about genes or the isolated/purified theory. The Patent Office read the decision and immediately issued guidelines – but they don’t mention genes either.
If the CAFC reaffirms Myriad’s patents, they may get on the SC’s last nerve and be treated to another 9-0 spanking. In the process, might the Supremes invalidate the basis of gene patents in the US? If so, then that yee-haw you hear is Slim Pickins riding the nuclear bomb down.