Munich, February 27, 2026: In opposition appeal proceedings before the European Patent Office (EPO) concerning European patent EP 2 968 172, the patent was upheld on 26 February with an even broader scope of protection than the Opposition Division had envisaged. The patent is of great importance, because it protects Rayaldee®, a medicinal product approved in the US, Canada and ten European countries for the treatment of secondary hyperparathyroidism.
The proceedings are based on an opposition filed by DSM Nutritional Products AG against EP 2 968 172 of EirGen Pharma Ltd. EP 2 968 172 protects formulations of the active ingredient Calcifediol. Dsm-firmenich has announced the approval of its ampli-D® Calcifediol monohydrate ingredient as a novel food in the EU by the European Commission.
In the hearing of February 26, 2026, the Board of Appeal accepted novelty and inventive step of the independent claims as granted and rejected DSM Nutritional Products AG’s requests to the greatest part. As a result, all independent claims of the patent remain as originally granted. Only a few of the dependent claims had to be amended respectively deleted.
The medicinal product Rayaldee® is approved for adult patients who have stage 3 or 4 chronic kidney disease (CKD) with secondary hyperparathyroidism (SHPT) and low vitamin D levels. Secondary hyperparathyroidism is a disorder which develops primarily because of Vitamin D deficiency. lt is characterized by abnormally elevated blood levels of parathyroid hormone and, in the absence of early detection and treatment, it becomes associated with parathyroid gland hyperplasia and a constellation of metabolic bone diseases. It is a common complication of chronic kidney disease (CKD). Secondary hyperparathyroidism can also develop in individuals with healthy kidneys, due to environmental, cultural or dietary factors which prevent adequate Vitamin D supply.
Rayaldee® is useful for the treatment of secondary hyperparathyroidism by controlled release of the active ingredient Calcifediol. The active ingredient calcifediol is a compound that occurs naturally in the human body and has been known for a long time. However, it is the special formulation protected by the patent that allows calcifediol to be used for the treatment of secondary hyperparathyroidism. EP 2 968 172 describes how the release profile of the medicinal product can be stabilized over longer periods of storage of the medicinal product.
The market for drugs and dietary supplements containing vitamin D and its derivatives and precursors is highly competitive.
EirGen Pharma Ltd. has been acquired in 2015 by OPKO Health, Inc., which is a leading publicly traded American pharmaceutical company based in Miami, Florida, USA (Nasdaq: OPK). The company's business areas include pharmaceuticals and diagnostics.
EirGen Pharma Ltd. respectively OPKO Health Inc. were advised and represented by a team of patent attorneys from the Meissner Bolte law firm in Munich, led by patent attorney Dr. Tobias Alexander Popp. Dr. Lukas Bischoff and Dr. Ole Trinks were also involved in the proceedings.
