At the end of the year, we defended two patents of our client OPKO Health Inc, against which oppositions had been filed with the European Patent Office. The patents are very important as they protect the medicinal product Rayaldee®, which is approved for the treatment of secondary hyperparathyroidism in the USA and ten European countries, including Germany.

We defended the patents EP 2 968 172 and EP 3 332 773 in slightly amended and amended form respectively, so that Rayaldee® is now patent-protected in Europe until March 2034. With the supplementary protection certificates dependent on patent EP 2 968 172, whose application we are coordinating throughout Europe, protection is even possible until July 2035. 

Secondary hyperparathyroidism is a disease primarily caused by vitamin D deficiency and chronic kidney disease. The disease is characterized by abnormally elevated parathyroid hormone levels in the blood and, if not detected and treated early, is associated with parathyroid hyperplasia and a number of metabolic bone diseases.

The medicinal product Rayaldee® enables the treatment of secondary hyperparathyroidism with the active ingredient calcifediol. The active ingredient calcifediol is a naturally occurring compound in the human body and has been known as such for a long time. However, it is only the special formulation protected by the patents that allows the use of calcifediol for the treatment of secondary hyperparathyroidism. The patents describe how the controlled release profile of the drug can be stabilized for storage of the medicinal product. The medicinal product Rayaldee® is a masterpiece of galenics and thus deserves patent protection.