BioMarin Announces Legal Action Against Ascendis Pharma A/S in European Unified Patent Court
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.
BioMarin Pharmaceutical (Nasdaq: BMRN) ha avviato un'azione legale contro Ascendis Pharma A/S presso il Tribunale Unificato dei Brevetti (UPC) a Monaco, Germania, per presunta violazione del brevetto europeo EP 3 175 863 B1. Questo brevetto, che riguarda varianti a lunga durata del Peptide Natriuretico di Tipo C (CNP), è stato confermato dalla Divisione di Opposizione dell'Ufficio Brevetti Europeo nel 2024.
L'azione legale si concentra sul prodotto in fase di studio TransCon CNP di Ascendis e sul suo programma di sviluppo in Germania e in Europa. Una decisione è attesa entro 12-15 mesi. L'UPC, operativo dal giugno 2023, ha giurisdizione sui brevetti europei in 18 Stati membri europei che hanno ratificato i Brevetti Unità.
BioMarin Pharmaceutical (Nasdaq: BMRN) ha iniciado acciones legales contra Ascendis Pharma A/S en el Tribunal Unificado de Patentes (UPC) en Múnich, Alemania, por supuesta infracción de la patente europea EP 3 175 863 B1. La patente, que cubre variantes de acción prolongada del Péptido Natriurético Tipo C (CNP), fue confirmada por la División de Oposición de la Oficina Europea de Patentes en 2024.
La acción legal se dirige al producto en investigación TransCon CNP de Ascendis y su programa de desarrollo en Alemania y Europa. Se espera una decisión en un plazo de 12 a 15 meses. El UPC, operativo desde junio de 2023, tiene jurisdicción sobre patentes europeas en 18 Estados miembros europeos que han ratificado las Patentes Unitarias.
BioMarin Pharmaceutical (Nasdaq: BMRN)이 독일 뮌헨의 통합 특허 법원(UPC)에 Ascendis Pharma A/S를 상대로 유럽 특허 EP 3 175 863 B1의 위반으로 법적 조치를 시작했습니다. 이 특허는 C형 나트륨이뇨 펩타이드(CNP)의 장기 작용 변형을 다루며, 2024년에 유럽 특허청의 이의 제기 부서에 의해 확인되었습니다.
법적 조치는 Ascendis의 연구 중인 TransCon CNP 제품과 독일 및 유럽에서의 개발 프로그램을 겨냥하고 있습니다. 12-15개월 이내에 결정이 예상됩니다. 2023년 6월부터 운영 중인 UPC는 통일 특허를 비준한 18개 유럽 회원국의 유럽 특허에 대한 관할권을 가지고 있습니다.
BioMarin Pharmaceutical (Nasdaq: BMRN) a engagé une action en justice contre Ascendis Pharma A/S devant le Tribunal Unifié des Brevets (UPC) à Munich, en Allemagne, pour violation présumée du brevet européen EP 3 175 863 B1. Ce brevet, qui porte sur des variantes à action prolongée du Peptide Natriurétique de Type C (CNP), a été confirmé par la Division d'Opposition de l'Office Européen des Brevets en 2024.
L'action en justice vise le produit expérimental TransCon CNP d'Ascendis et son programme de développement en Allemagne et en Europe. Une décision est attendue dans un délai de 12 à 15 mois. L'UPC, opérationnel depuis juin 2023, a compétence sur les brevets européens dans 18 États membres européens ayant ratifié les brevets unitaires.
BioMarin Pharmaceutical (Nasdaq: BMRN) hat rechtliche Schritte gegen Ascendis Pharma A/S vor dem Einheitlichen Patentgericht (UPC) in München, Deutschland, wegen angeblicher Verletzung des europäischen Patents EP 3 175 863 B1 eingeleitet. Das Patent, das langwirksame Varianten des C-Typ natriuretischen Peptids (CNP) umfasst, wurde 2024 von der Einspruchsabteilung des Europäischen Patentamts bestätigt.
Die rechtlichen Schritte zielen auf das investigational Produkt TransCon CNP von Ascendis und dessen Entwicklungsprogramm in Deutschland und Europa ab. Eine Entscheidung wird innerhalb von 12 bis 15 Monaten erwartet. Das UPC, das seit Juni 2023 in Betrieb ist, hat die Zuständigkeit für europäische Patente in 18 europäischen Mitgliedstaaten, die die einheitlichen Patente ratifiziert haben.
- Patent protection confirmed by European Patent Office in 2024
- Legal jurisdiction spans 18 European countries through UPC
- 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.
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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?
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