Defendant

Wacker Biotech GmbH

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
2025
Top venue
ITC
1 case

Company profile

I'll research this company before writing the profile.

Let me verify the ITC case context.

Wacker Biotech GmbH is a German contract development and manufacturing organization (CDMO) headquartered in Jena, Germany, with additional German operations in Halle (Saale) and a biotech R&D center in Munich, plus sites in Amsterdam and San Diego. It was founded in 1999 as a spin-off from the Hans-Knöll Institute in Jena (originally named ProThera) and has been a wholly owned subsidiary of Munich-based, Frankfurt-listed chemical group Wacker Chemie AG (the WACKER Group) since 2005. WACKER Chemie reported roughly €6.4 billion in 2023 group sales and about 16,400 employees; Wacker Biotech's biopharma business is a small part of that, with management citing around 650 employees across five sites in a 2026 interview (an earlier source cited ~400).

Wacker Biotech is a microbial-expression CDMO serving pharmaceutical and biotech customers from preclinical development through commercial GMP supply. Its services cover strain and cell-line development, process and analytical development, cell banking, and GMP drug substance and drug product manufacturing. Product/modality areas include recombinant proteins and peptides produced in E. coli, classical vaccines, live microbial products, plasmid DNA (pDNA), and—since a ~€100 million mRNA competence center opened in Halle in mid-2024—mRNA drug substance and lipid nanoparticle (LNP) formulation. It markets proprietary platforms including ESETEC, FOLDTEC, PLASMITEC and LIBATEC, and is a partner in Germany's government-funded mRNA pandemic-preparedness program alongside CordenPharma.

Litigation posture: Wacker Biotech is an operating company, not a patent assertion entity. It has zero tracked plaintiff cases and one defendant case. Its sole tracked matter is a U.S. International Trade Commission Section 337 investigation—Certain Drug Products Containing C-Type Natriuretic Peptide Variants, Inv. No. 337-TA-1447—in which it is a named respondent, not an NPE target in the classic sense but a supplier drawn into a competitor dispute.

Case context: BioMarin Pharmaceutical Inc. filed the complaint on April 2, 2025 (instituted May 8, 2025), asserting U.S. Reissue Patent No. 48,267 against Ascendis Pharma entities, Wacker Biotech GmbH (Jena) and later Bachem AG (added September 2025). The accused product is Ascendis's TransCon CNP (navepegritide) for achondroplasia, a rival to BioMarin's Voxzogo. Wacker Biotech is implicated as the contracted manufacturer of TransCon CNP drug substance in Jena—a relationship dating to 2017. The investigation's target date is October 8, 2026.

BioMarin Pharmaceutical Inc. v. Ascendis Pharma, Inc. et al.

settled/dismissed
Docket:
337-TA-1447
Filed:
2025-04-02

ITC Section 337 investigation titled Certain Drug Products Containing C-Type Natriuretic Peptide Variants, and Components Thereof, brought by BioMarin against Ascendis entities and suppliers regarding TransCon CNP / navepegritide. The asserted patent was U.S. Reissue Patent No. RE48,267; US 8,377,884 was relied on by Ascendis as prior-art Exhibit 32, not asserted. Resolved by a global settlement announced August 30–31, 2026, with the investigation to be dismissed.