Dr med Kokularajah PaheenthararajahHe/himCounsel
Kokularajah Paheenthararajah advises national and international clients on complex patent litigation and licensing disputes as well as regulatory matters with a heavy focus on the life sciences and healthcare sector.
He has particular experience with advanced therapies, diagnostics and biotechnologies, including cell, tissue and gene therapies, recombinant drugs, monoclonal antibodies, biotechnological tissue products, tumor vaccines, genome editing and, precision medicine. Kokularajah also regularly advises on complex regulatory and strategic topics in the life sciences and healthcare sector with a particular focus on regulatory data and market exclusivity, compliance and investigations, pricing and market access strategy, marketing, advertisement, R&D cooperation, clinical trials and digital health. His clients include some of the world’s leading research-based pharmaceutical, biotechnology, diagnostics and healthcare technology companies as well as medical research institutions and private equity firms.
Kokularajah is dual qualified, holding both a law degree and a degree in medical. He is admitted as a lawyer as well as a physician in Germany.
- 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.
- University of Cologne, Ph. D. (Medicine), 2014
- Higher Regional Court of Cologne, Second State Examination (Law), 2014
- University Hospital Cologne / University of Cologne, Second State Examination (Medicine), 2012
University of Cologne, First State Examination (Medicine), 2008
University of Cologne, First State Examination (Law), 2006
- Legal 500 Germany 2022: Recommended for intellectual property: patent litigation; “Extremely hardworking, his dual qualifications allow him a depth of knowledge and understanding rarely seen anywhere else.”
- Handelsblatt in cooperation with Best Lawyers 2023: Recommended for intellectual property law
- Managing Intellectual Property (MIP) – IP Stars 2020/2021: Recommended for IP/patent litigation
- Managing Intellectual Property (MIP) – Rising Stars 2019/2020: “Rising Star” IP/patent litigation
- Cepl/Paheenthararajah, “The enforcement of second-medical-use patents after the “estrogen blocker” [Östrogenblocker] decision of the Higher Regional Court Düsseldorf” GRUR-Prax, 2018, 225-227
- CJEU-Referral: SPCs for drug-device combinations? 15 December 2017
- Compulsory patent license for protected active substances for individualized therapies, 30 October 2017
- Paheenthararajah/Karenberg/Hick/Rothschild, “Medical sales representatives in the operating theatre: legal risks and medical-ethical conflicts” MedR, 2014, Volume 32, Issue 1, pp 7-17
- Paheenthararajah/Karenberg/Hick, “Medical sales representatives in the operating theatre: patients’ informed consent required” Dtsch Arztebl, 2013; 110(46): A-2190 / B-1927 / C-1872
- Bellinghausen/Paheenthararajah, “Counter attack: Action for damages versus US plaintiffs' attorneys for taking obviously abusive US class actions versus German companies” ZIP, 2008, 492-497
Prior to joining the Cologne office of DLA Piper in October 2017, Kokularajah worked as a lawyer at a leading international patent litigation and life sciences practice of a Magic Circle law firm in Munich (2014-2017). Before that, he worked as a legal assistant at the litigation and life sciences practice of another Magic Circle law firm (2006-2014).
Life Sciences Know-how
Kokularajah received additional medical training for physicians, inter alia, at the University Hospital Cologne, King’s College London/Cicely Saunders Institute of Palliative Care and St. John’s Medical College Bangalore. For his medical doctoral thesis Kokularajah received the 2016 Doctoral Dissertation Award of the Medical Faculty of the University of Cologne.
Kokularajah is admitted as a physician (Arzt) with the District Government of Cologne (Bezirksregierung) and is a member of the Medical Association of North Rhine (Ärztekammer Nordrhein).
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