Danone Nutricia filed an opposition application two years ago and has since battled to prove its case in written arguments and oral proceedings.
The research company argued that the patent for medical nutrition product Vital01 lacked ‘sufficiency of disclosure, novelty and inventive step’. However, none of these arguments convinced the opposition division of the European Patent Office.
However, the application was finally upheld ‘in its entirety’ following oral proceedings in February. The opposition division ruled that all grounds of opposition filed by Danone Nutricia were rejected and all claims in the VitalNext patent were valid and could remain in force.
Dr Rein Strijker, CEO of VitalNext, commented: “While the costs of defending a European patent against an extensive and broad opposition are significant for a small company like ours it is gratifying that the novelty and the innovative nature of our product has again been confirmed.
“We remain committed to bring our product to patients who may benefit from its advantageous properties.”
The EU patent under dispute refers to a new medical nutrition product, Vital01, recently launched in The Netherlands under the VitalNext brand.
The submission is classified under “Compositions and Methods for the treatment of malnutrition” and relates to novel liquid or semi-liquid nutritional compositions, and powders beneficial in the treatment of malnutrition and malnutrition related disorders, such as weight loss and muscle wasting.
New inventions must be used to treat malnutrition that can help increase body weight and/or reverse the effects of muscle atrophy and supported by significant scientific data.
Danone Nutricia never fully explained its motive for submitting opposition to the patent, according to Dr Strijker, but expressed relief about the ruling which “removed uncertainty” about the product.
He added that, in his view, “this type of procedure does not add anything of value to a product or the business, let alone patients in need of such products”
While other medical nutrition focuses on muscle gain, Vital01 targets muscle loss in the elderly who suffer from malnutrition. The product contains 50% cow-derived whey protein and 50% casein and is fortified with additional amino acids (leucin, isoleucin, and valine), vitamin D, and ursolic acid (antioxidant and prophylactic). The powder can be mixed with any food or drink.
Although primarily designed to target medical nutrition, it can also be used for sports and performance nutrition in healthy people who want to improve muscle mass and function.
Vital01 has been validated in preclinical and clinical studies as safe and effective. In addition, a research program conducted to investigate mode of action observed higher gait speeds in the Vital01 group (up to 400m), which was attributed to increased muscle mass and more efficient energy metabolism as a result of supplementation.
Dr Strijker said: “Our product enhances muscle function and improves muscle/fat ratio. Even in the absence of exercise. This is clinically very relevant.”
VitalNext is currently preparing to expand into other markets and has submitted a worldwide patent application.