The dispute started in August when OmniActive filed a complaint in the District Court for New Jersey for a declaratory judgment that its products do not infringe United States Patent Nos. 8,815,955 and 9,226,940 . This was filed in response to cease and desist demands from Kemin regarding OmniActive’s “What’s Your B.L.U.E.? (Blue Light User Exposure)” marketing campaign.
Kemin subsequently filed a motion to dismiss this complaint in September, and followed this up with a complaint under Section 337 of the Tariff Act of 1930 with the International Trade Commission seeking an investigation, which the ITC has since initiated.
“Kemin believes that OmniActive's marketing campaigns for its lutein and zeaxanthin products actively encourage infringement of Kemin's patent rights, which include claims directed to blue light,” said Anita Norian, president of the Human Nutrition and Health Division of Kemin.
“The purpose of the ITC is to protect the American public from unfair practices by foreign companies. Having the ITC open an investigation reinforces Kemin's position that OmniActive is in violation,” added Norian.
Kemin is seeking a limited exclusion order at the ITC, which means that if Kemin is successful, OmniActive will be forbidden to import Lutemax 2020 and potentially related infringing products into the US. Kemin is also seeking cease and desist orders, which would prohibit OmniActive from importing, selling, marketing, advertising, transferring and/or soliciting US agents and distributors the alleged infringing products.
Inter Partes Review
Since the ITC announced the launch of its investigation OmniActive has petitioned the US Patent and Trademark Office for Inter Partes Review , seeking cancellation of both the 955 and 940 patents. The IPR alleges that scientific publications that were publicly available before Kemin filed its patents were not considered by the USPTO.
“OmniActive has consistently maintained that Kemin’s allegations of infringement are unfounded. We also believe these patents are invalid and that they never should have been granted by the Patent Office. Our petitions filed with the Patent Office vividly demonstrate this to be the case,” said Abhijit Bhattacharya, OmniActive’s president.
“We are standing up for the industry by sending a message that those of us who innovate need to oppose unsubstantiated patent-related threats that seek to prevent fresh and innovative new products with scientific substantiation from reaching the general public,” added Bhattacharya.
Lawyer: “Whoever wins will be rewarded in the form of market share”
Commenting independently on the lawsuit, Kevin Bell, principal at law firm Porzio, Bromberg & Newman PC (which is not involved in this case), told NutraIngredients-USA: “Kemin and OmniActives have been at odds for years over OmniActive's Lutemax products which have been studied extensively to my knowledge. OmniActive has also enjoyed growth and success in the market for its product.
Regarding the ITC case, Bell explained: “The ITC does not award monetary damages to the prevailing party. That can be obtained in federal district court. There is already a pending litigation in New Jersey related to both of the asserted patents [which is now stayed following an OmniActive request].”
On the Inter Partes Review (IPR), Bell noted that patent assertions are increasingly complicated by the ability of defendants to a patent infringement lawsuit to seek review within the Agency, ie, the Patent Office or Patent and Trademark Office (PTO).
“Review at the Agency through an IPR lets the accused infringer rely on not only three technically trained patent attorneys as fact finders, but also permits the accused infringer to rely on the fact that the Agency will use a broader reading of the claims and a narrower determination of validity: broadest reasonable interpretation of the claims, thereby making it easier to find invalidating prior art for the former. For the latter, the accused infringer need only show that it is more likely than not that the patent claim is invalid, rather than needing clear and convincing proof of invalidity in court or at the ITC. These changing thresholds have meant that many of the claims that are attacked in an IPR are found invalid if the IPR is instituted by the PTO.”
Bell continued: “In the Kemin v. OmniActive patent war, we now have the full trifecta: district court litigation (now stayed), ITC litigation, and the filing of IPRs at the PTO. In the case of the two patents at issue, U.S. Patent Nos. 9,226,940 & 8,815,955, the IPRs not only have the potential to invalidate the claims at issue, but also to narrow the scope of claim coverage.
“The patents cover methods of treating the increased age-related macular degeneration present in a subject having age-related macular degeneration. The primary invalidating reference for both IPRs is a review article that was allegedly published more than a year before the filing date of Kemin's asserted patents, entitled "Evidence Supports New Approaches for Reducing the Risk of Macular Degeneration" where the author lays out methods which would appear to include or render obvious methods of treating the increased age-related macular degeneration present in a subject having age-related macular degeneration. Importantly, the patents embrace the idea that “[t]he methods of the present invention are not meant to cover damage that might be induced in the eye as a result of other conditions/diseases [other than hyperopia, presbyopia, or astigmatism] that might also result in AMD, including but not limited to inherited conditions (a genetic component) or damage from other forms of retinopathies aside from AMD.”
“Moreover, the patents provide an express definition of “treating,” which is consistent with the ordinary and customary meaning of the term: the terms ‘treated’ and ‘treating’ refers to preventing or delaying the appearance of clinical symptoms of a disease or condition in a subject that may be afflicted with or predisposed to the disease or condition, but does not yet experience or display clinical or subclinical symptoms of the disease or condition. ‘Treating’ also refers to inhibiting the disease or condition, i.e., arresting or reducing its development or at least one clinical or subclinical symptom thereof. ‘Treating’ further refers to relieving the disease or condition, i.e., causing regression of the disease or condition or at least one of its clinical or subclinical symptoms. The benefit to a subject to be treated is either statistically significant or at least perceptible to the subject and/or the physician. Similarly, the patents define the term ‘therapeutically effective amount’ as the amount/dose of a compound or pharmaceutical composition that is sufficient to produce an effective response (i.e., a biological or medical response of a tissue, system, animal or human sought by a researcher, medical doctor or other clinician) upon administration to a subject.”
A war on two fronts
Bell said that Kemin must now fight a war on two fronts at the PTO in responding to OmniActive's IPRs: “The prior art, which arguably is invalidating, and a forced narrowing of the scope for the claims, which could permit OmniActive as well as other potential infringers to craft their product labels so that they can no longer be accused of infringing the patent,” he said.
“Conversely, if claims of the patents make it through the IPR process and OmniActive is found guilty of infringing them at the ITC, OmniActive has to decide how to proceed if it wants to design around Kemin's method claims or otherwise avoid infringement to maintain the ability to continue to import and sell Lutemax 2020 in the United States.
“A fight at the ITC is a no-holds barred battle. Whoever wins will be rewarded in the form of market share in a rapidly growing area for eye care supplements,” said Bell.