• Advising and representing a global pharmaceutical company in the EU-wide enforcement of its second medical use patent for a blockbuster drug for the treatment of neuropathic pain and epilepsy.
  • Advising a global pharmaceutical company on supplementary protection certificates (SPCs) as well as regulatory data and market exclusivity requirements in connection with its novel antiretroviral active substance for the treatment of HIV/AIDS.
  • Advising a global pharmaceutical company on the experimental use privilege (Roche-Bolar exemption) and orphan drug regulations in connection with Phase-III clinical trials on a novel bi-specific monoclonal antibody for the treatment of a hematologic disease.
  • Advising and representing a global pharmaceutical company on a patent relating to a PD-1 inhibitor (monoclonal antibody) for the immunotherapy of cancers.
  • Advising and representing a client on patent and licensing disputes relating to an innovative biotechnology for the production of a recombinant blockbuster drug for the treatment of hemophilia-A.
  • Advising a leading US biotechnology company on patent and licensing issues in connection with the R&D of a novel gene therapy for the treatment of an orphan hereditary lysosomal storage disease (orphan drug).
  • Advising and representing a global diagnostics company in enforcing its patent relating to DNA amplification and sequencing (next generation sequencing).
  • Advising a leading biotechnology company on regulatory issues relating to drug pricing, market access, prescription and substitution requirements as well as licensing and marketing strategies for a novel gene therapy for the treatment of chronic lymphocytic leukemia (CLL) and multiple sclerosis (MS).
  • Advising a global diagnostics company on complex regulatory and strategic issues relating to R&D, reimbursement, prescription, advertisement, marketing, healthcare compliance and digital health marketing requirements regarding its innovative real-time continuous glucose monitoring (rtCGM) system for diabetes patients.
  • Advising a leading US pharmaceutical company on the R&D of an autologous cellular immunotherapy (TIL) for personalized treatment of metastatic melanoma and cervical carcinoma, including regulatory tissue establishment and procurement licenses requirements and licenses for manufacturing, importing and exporting human tissues and advanced therapy medicinal products (ATMPs) for clinical trial purposes.