Last week a federal appeals court ruled in favor of NAI, based in Carlsbad, CA, in its lawsuit against Creative Compounds, based in Scott City, MO. NAI had alleged that Creative Compounds was infringing on patents it holds on its Carnosyn branded form of beta alanine that cover its use for muscle development.
Ruling hailed as landmark decision
The appeals court ruled that the lower court erred in how it decided that NAI’s patents on methods of treatment for beta alanine were invalid.
“This is the biggest decision regarding patents in the dietary supplement industry that has ever come out of the courts,” said attorney Kevin Bell, of the firm Porzio, Bromberg & Newman. Bell represented NAI in the case.
“This is the biggest case of this sort that I’ve seen,” said Dan Fabricant, PhD, president and CEO of the Natural Products Association. (Full disclosure: NAI is an NPA member company, and NAI CEO Mark LeDoux sits on the NPA board.)
“Without this kind of protection you would see nothing but a commodity market in ingredients. And there is not much innovation in a commodity market,” he added.
Confusing tests handed down by Supreme Court
The case hinged on some precedents in US patent law that have been reverberating through the sector for the past several years. The precedents are known by the names of some of the parties involved: Alice, Mayo and Myriad. These decisions resulted in new judicial ‘tests’ to be applied in future patent cases. The tests are complex and have proven to be difficult for lower courts to apply uniformly. The full implications of these decisions are still a matter of debate, but the consensus is that they have weakened patent protection in the US.
The district court had ruled that the patents were directed towards natural concepts, and lacked an “inventive step”. The judge in the original case applied one of these tests in an attempt to determine whether beta alanine supplementation, which according to NAI’s patents boosts carnosine levels in muscle tissue, gives rise to a ‘natural’ process within the body. If the answer to that question is yes, then the process in not patentable.
The lower court judge ruled that a rise in carnosine is a ‘natural’ result of higher beta alanine levels, making NAI’s patents invalid. NAI argued, unsuccessfully at that time, that its process of formulating its beta alanine as a dipeptide with histidine and supplementing in that form is what allows muscle tissue to rise above the carnosine homeostasis level and accumulate higher amounts of this beneficial compound. Thus, Carnosyn supplementation creates an ‘unnatural’ (and therefore patentable) situation in the muscle tissue in NAI’s view.
Don’t take ‘Alice’ too far, ruling states
“The claims not only embody this discovery, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits," the appeals court ruling said.
“We live in the natural world, and all inventions are constrained by the laws of nature . . . [A]s the Supreme Court has warned, we must be careful not to overly abstract claims when performing the Alice analysis,” the ruling said.
Case goes back to lower court
Attorney Brent Batzer, who is a patent law specialist with the firm Amin Talati Upadhye, agreed the case represents an important ruling, but stopped short of waving the flag of complete victory. It’s another brick in the precedent wall constraining the way the Alice tests are supposed to be used by the courts.
“The initial guidelines were very difficult to implement and they got a lot of pushback, not only from the supplement industry,” Batzer said.
But the appeals court ruled on procedural grounds, or rather on how the lower court judge put together his judgement, Batzer said. The lawsuit has been remanded back to the US District Court for the Southern District of California for further action, which could include a deeper look into the nitty gritty of the NAI patents themselves, Batzer said.