Thomas Wolter

Thomas works primarily in the biopharma sector, mainly with big pharma companies undertaking drug discovery and development. He advises on all stages of a drug’s lifecycle, from initial discovery through clinical trials to regulatory approval. Working closely with in-house IP teams and scientists, he has extensive experience of the prosecution and European opposition and appeal procedures as well as SPCs. Thomas was involved in litigation and/or opposition proceedings concerning dasatinib, nivolumab, ipilimumab, eptinezumab, abatacept, belatacept, crenezumab, etanercept, calcipotriol, levofloxacin, and others.

Areas of Expertise

• Immunology and immuno-oncology
• Therapeutic antibodies
• Fusion proteins
• Human blood plasma products
• Iron carbohydrate complexes
• Production and formulation of biologics
• Special drug forms, e.g., polymorphs and enantiomers
• Combination therapies
• Patent term extension (PTE) and supplementary protection certificates (SPCs)

Clients

Thomas works mainly with biopharma companies including large US and European multinationals, SME's and small biotechs.

Background

Thomas has a double Master’s degree in chemistry and biology from Ruhr-Universität Bochum, Germany, and a PhD from Université Louis Pasteur Strasbourg, France.

He qualified as German and European Patent Attorney in 1999. He has practiced at a German patent law firm before joining Mewburn Ellis in 2020.

Opposition highlights 

BMS vs. Genetics Institute, EP 0606217, T0411/02: Thomas acted on behalf of BMS in defending the foundational patent for the groundbreaking anti-CTLA-4 cancer immunotherapy (Yervoy®; ipilimumab). This not only covered anti-CTLA-4 antibodies for cancer treatment but also protected abatacept (Orencia®) and belatacept (Nulojix®), two of BMS’s products for treating rheumatoid arthritis and organ transplant rejection.

BMS vs. Merck EP 1537878, T1994/14: Assisted counsel for Ono Pharmaceuticals in defending a foundational patent for groundbreaking anti-PD-1 / anti-PD-L1 cancer immunotherapy (such as Opdivo®; nivolumab) in opposition proceedings at the EPO. The rejection of the opposition was instrumental in the overall outcome of worldwide litigation and the settlement.

BMS vs. multiple opponents EP 3597216 & EP 2905030, T2552/22: Acted on behalf of BMS in defending the foundational patent for the third approved immune checkpoint LAG-3 (Opdualag®; relatlimab).

BMS vs. five opponents EP 1610780 & EP 1169038, T0950/13; T0689/19; T0488/16: Thomas acted on behalf of BMS in defending patent protection for its product Sprycel® (dasatinib) against generics. While the product patent was revoked, the medical use patent was maintained, resulting in extended patent protection for Sprycel® beyond the expiry date of the product patent and its SPCs.

AstraZeneca vs. multiple opponents EP 2069374; EP 3045466; EP 2498759; et al. T2730/16; T0215/20; T1503/21 : Acted on behalf of AstraZeneca in defending their patent estate for Forxiga® (dapagliflozin) against challenges by generics in EPO opposition proceedings.

BMS vs. Biotempus EP 2100615,  T0967/18: Acted on behalf of BMS in challenging the validity of a patent in the field of cancer therapy. This is a very interesting case with numerous unusual issues, including separate proceedings before the EPO’s Legal Division and Legal Board of Appeal. J0009/21. Due to the interruption of proceedings, the initial outcome (successful revocation of the patent) was annulled, and the case was sent back to the Opposition Division to start anew.

BMS vs. GITR EP 2175884, T0176/19: Acted on behalf of BMS in challenging the validity of a patent in the field of cancer combination therapies alongside 9 other opponents in EPO opposition proceedings – patent successfully revoked.

BMS vs. Greenovation Biotech EP 2368913: Acted on behalf of BMS in challenging the validity of a patent in the field of glycol-engineered antibodies alongside 4 other opponents – patent successfully revoked.

Alder Biopharmaceuticals vs Teva EP 1957106, T0860/17: Acted on behalf of Alder Biopharmaceuticals in challenging the validity of a patent in the field of anti-CGRP antibodies for migraine treatment alongside Eli Lilly and Company.