BioMarin Announces Legal Action Against Ascendis Pharma A/S in European Unified Patent Court
Rhea-AI Summary
BioMarin Pharmaceutical (Nasdaq: BMRN) has initiated legal action against Ascendis Pharma A/S in the Unified Patent Court (UPC) in Munich, Germany, for alleged infringement of European patent EP 3 175 863 B1. The patent, which covers long-acting variants of C-Type Natriuretic Peptide (CNP), was confirmed by the European Patent Office's Opposition Division in 2024.
The legal action targets Ascendis' TransCon CNP investigational product and its development program in Germany and Europe. A decision is expected within 12-15 months. The UPC, operational since June 2023, has jurisdiction over European patents across 18 European member states that have ratified the Unitary Patents.
Positive
- Patent protection confirmed by European Patent Office in 2024
- Legal jurisdiction spans 18 European countries through UPC
Negative
- Potential legal expenses from patent litigation
- 12-15 month timeline for legal resolution creates uncertainty
Insights
This patent infringement lawsuit in the Unified Patent Court marks a critical strategic move by BioMarin to protect its intellectual property in the lucrative CNP market. The UPC's jurisdiction across 18 European states means a single ruling could effectively block Ascendis across major European markets. The 12-15 month timeline for a decision is relatively expedited compared to traditional patent litigation, potentially giving BioMarin a significant competitive advantage if successful.
The recent confirmation of BioMarin's patent by the European Patent Office's Opposition Division substantially strengthens their position. The timing is particularly strategic as it comes after the UPC's establishment in 2023, leveraging the new court's unified jurisdiction rather than pursuing separate actions in multiple countries. In simpler terms, BioMarin is using a new, faster European court system to try to stop a competitor from using their patented technology across many countries at once.
The focus on long-acting CNP variants is particularly significant as it relates to VOXZOGO, a key revenue driver for BioMarin and BMN 333, their pipeline candidate. A favorable ruling could effectively create a monopoly in the European CNP market for BioMarin, while an unfavorable one could open the door for increased competition.
The patent litigation has substantial financial implications for BioMarin's market position and revenue potential in Europe. VOXZOGO, their CNP-based treatment, generated
From an investor's perspective, this legal action demonstrates BioMarin's commitment to defending its intellectual property assets and future revenue streams. The relatively quick timeline for a UPC decision provides a near-term catalyst for the stock. A favorable ruling would likely drive positive sentiment and could lead to upward revisions in revenue forecasts, while an unfavorable outcome might pressure the stock as it would indicate increased competition in a key market.
For the average investor, think of this as BioMarin building a legal fence around their valuable property - if they win, they get to keep their exclusive rights to sell these important medicines in Europe, which means more predictable future earnings. If they lose, other companies could enter the market, potentially reducing BioMarin's profits.
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
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:
"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
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.
Contacts: | |
Investors | Media |
Traci McCarty | Andrew Villani |
BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. |
(415) 455-7558 | (628) 269-7393 |
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SOURCE BioMarin Pharmaceutical Inc.
FAQ
What patent is BioMarin (BMRN) defending against Ascendis Pharma?
When will the BMRN patent infringement case against Ascendis be decided?
Which products are involved in BioMarin's (BMRN) patent dispute?
How many countries are covered by BMRN's patent protection through the UPC?
