BioMarin Announces Legal Action Against Ascendis Pharma A/S in European Unified Patent Court

SAN RAFAEL, Calif., Jan. 13, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the company has initiated a legal action against Ascendis Pharma A/S for infringement of European patent EP 3 175 863 B1 at the Unified Patent Court (UPC) in Munich, Germany. The patent covers long-acting variants of C-Type Natriuretic Peptide (CNP).

The legal action, which would result in a decision in the next 12-15 months, is based on BioMarin's belief that Ascendis' TransCon CNP investigational product and its development program in Germany and elsewhere in Europe infringe BioMarin's patent. The BioMarin patent was confirmed by the European Patent Office's Opposition Division in 2024.

The UPC, which formally started in June of 2023, has jurisdiction over European patents for 18 European member states that have ratified the Unitary Patents (UPs), including: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovenia and Sweden.

"Intellectual property provides the foundation on which advances in the biotechnology industry are built, particularly for rare genetic conditions," said Alexander Hardy, president and chief executive officer of BioMarin. "We are committed to protecting the important inventions our scientists make for patients around the world, including the more than 15 years of scientific research that supported VOXZOGO^® and BMN 333, our long-acting CNP."

About BioMarin  

BioMarin is a global biotechnology company dedicated to translating the promise of genetic discovery into medicines that make a profound impact on the life of each patient. The San Rafael, California-based company, founded in 1997, has a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin pursues treatments that offer new possibilities for patients and families around the world navigating rare or difficult-to-treat genetic conditions. To learn more, please visit www.biomarin.com.  

Forward-Looking Statements 

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: the legal action BioMarin initiated against Ascendis Pharma A/S for infringement of one of BioMarin's European patents, including BioMarin's expectations regarding the timing and resolution of such legal action. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of the legal action BioMarin initiated against Ascendis Pharma A/S; the content and timing of decisions by the Unified Patent Court; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.

BioMarin^® and VOXZOGO^® are registered trademarks of BioMarin Pharmaceutical Inc.

SOURCE BioMarin Pharmaceutical Inc.