Allowing matter to lapse dooms patent suit filed over feverfew formulation

The maker of a dietary supplement focused on migraine relief has prevailed in a patent suit based on a legal doctrine relating to how long a case remains quiescent.

The company that came out on top, called Designs for Health, Inc. (DFH), markets a patented dietary supplement branded as Migranol. The supplement is based on an ultra-high dose of 150 mg of riboflavin (or vitamin B2) with 180 mg of magnesium.

It also has an herbal component, based on 300 mg of an extract of the aerial parts of feverfew (Tanacetum parthenium), 75 mg of rosemary extract (Rosmarinus officianalis) and 75 mg of Sabinsa’s Curcumin C3 Complex (Curcuma longa) turmeric extract.

Product based on feverfew

According to DFH, a practitioner channel specialist based in Parker, CO, the idea behind the product is this: “[Migranol] contains an extract of feverfew, a traditional herb that has been used since the first century and is known for its ability to support a healthy inflammatory response. Curcuminoids and rosemary are also included for their antioxidant properties as well as their role in supporting a balanced inflammatory response.”

According to information published in 1996 by the American Botanical Council, there is some traditional use information and some more recent research backing the effects of feverfew

“Feverfew (Tanacetum parthenium) has gained popularity in the past decade for a time-honored use-a pain-reliever for the treatment of migraine headache. Recent scientific research has resulted in new interest in the plant, given successful clinical trials in which the plant has been efficaciously used to provide symptomatic relief in migraine, a troubling condition that often does not respond to modern treatment methods,” the ABC publication said.

Letting matter lapse lynchpin to ruling

DFH had been sued for patent infringement by a company called Akeso Health Sciences LLC, based in Westlake Village, CA.

DFH has marketed Migranol for a number of years. According to the version of events ruled on by a judge in California, Akeso first contacted DFH about patent infringement relating to the Migranol formulation in April of 2006. When DFH let lapse a deadline for a more detailed response to the allegation, Akeso failed to pursue the matter further until it formally filed suit in October of 2016.

Judge James Otero of the US District Court of the Centeral District of California in a summary judgement dismissed the suit based on the doctrine of ‘equitable estoppel.’ According to the legal defintion site law.com, this doctrine rests on the legal maxim that: "He who seeks equity, must do equity." In this case, the judge agreed with the assertion that Akeso’s failure to pursue the matter in 2006 could have lead DFH to reasonably conclude that it did not intend to sue. 

Settlement would have been cheaper

“We have a reputation for ethical and fair practices and we wanted to protect that reputation,” stated DFH Co-founder and Chairman Jonathan Lizotte.

“From a purely financial standpoint, a settlement would have cost significantly less than the legal fees we expended, but that would just encourage other meritless claims. We are prepared to go to trial to protect our reputation and other parties should be prepared to do the same.”

Because the ruling bore on the legal doctrine and on not the patent matter per se, the judge had nothing to say on the validity of Akeso’s issues with DFH’s patent. Nevertheless, DFH declared itself satisfied.

‘We are very satisfied with the outcome of this case,” said DFH general counsel Stephen Carruthers. “We’re confident that DFH did not infringe Akeso’s patent and, in any event, that the patent is invalid, but the court never had to address those issues.”

Akeso Health Sciences did not respond for comment on the ruling before publication time.