Monika is a life sciences specialist with a track record of achieving successful outcomes for clients in challenging cases. She has particular expertise in contentious proceedings at the European Patent Office, often involving multiple parties, and in advising on strategically significant patent portfolios. She regularly provides freedom to operate and validity opinions and has also coordinated and advised on major IP due diligence projects. Her dual qualification as a Patent Attorney and Solicitor has led to involvement in multi-forum and multi-jurisdictional patent litigation in the life sciences sector and she is well placed to represent clients in this sector before the new Unified Patent Court (UPC).
With a background that is legal as well as scientific, and by combining a strategic approach with attention to detail, Monika has built a reputation for her advocacy in EPO examination and opposition proceedings. She has represented some of the world's most innovative organisations in the healthcare and pharmaceutical sector in technical areas including cancer immunotherapy, microbiome therapeutics, gene therapy, therapeutic nucleotides and peptides, personalised medicine using AI and machine learning, antibody discovery and diagnostics. She also advises clients harnessing the power of biotechnology and microbiology in the agriculture, food and cosmetics sector.
Monika’s professional experience of over two decades includes private practice experience in the UK and India as well as in-house experience supporting the biologicals and biopharma teams at a global healthcare company. She is also well placed to advise clients on the Unified Patent Court (UPC).
Experience
- Achieving revocation of Translate Bio, Inc. mRNA therapy patents EP3318248 (T0197/22) and EP2506857 (T1302/21) after EPO Board of Appeal hearings in March 2024.
- Achieving revocation of CureVac patent EP2101823 relating to mRNA coded antibodies at the EPO.
- Representing a leading diagnostics company in EPO oppositions and due diligence projects relating to various biomarkers and assays. This included representing them before EPO Opposition Division and Board of Appeal in achieving revocation of Bio-Rad patent EP1504266 relating to HCV and HIV assays.
- Representing Seres Therapeutics before EPO Opposition Division in opposing EP2575835 relating to microbiome therapy in the name of University of Tokyo.
- Representing Sanofi in EPO prosecution of gene therapy portfolio and in opposing Silence Therapeutics patents EP1857547 and EP2258847 in the field of RNAi.
- Defending EP2569633 in the name of General Hospital Corporation and Dana Farber Cancer Institute against 5 oppositions, obtaining grant of divisional EP3023788 and related EPO prosecution in the field of neoantigen cancer vaccines.
- Defending EP1639112 in the name of Genzyme Corporation relating to Novel beta-actin promoters.
Published articles
- August 2024
EIP News Flashes, UPC Jurisdiction over Ireland: Not so fast says Court of Appeal (link) - July 2024
EIP News Flashes, Paris central division maintains Edwards patent in amended form (link) - January 2024
EIP News Flashes, Admissibility before Boards of Appeal at the EPO: Current state of play (link) - October 2023
EIP News Flashes, Opt-out Withdrawal Ineffective: Choices have Consequences! (link) - July 2023
EIP News Flashes, High Court maintains status quo on SPCs: Combination patent cannot get extension using Marketing Authorisation of single active agent (link) - March 2022
EIP Talks, #BreakTheBias: International Women’s Day Special (link) - October 2021
EIP News Flashes, Proud to be “myself” (link) - May 2021
Lawyer Monthly, Patenting Trends in Microbes and Food (link) - April 2021
Quoted in Food Navigator, 'A strong patent portfolio is a valuable asset': Patent filings shine light on microbial innovation trends (link) - March 2021
EIP Newsflash, Rare EPO decision regarding biological deposits and biological material used in an invention being "available to the public" (link) - January 2021
The Times, Vaccine nationalism, not laws, is the cause of bottlenecks (link) - December 2020
C&I, Incentivising vaccines - October 2020
Lawyer Monthly, Microbes and Skincare - Insights from Innovator Activity at the European Patent Office (link) - August 2020
Quoted in The Times, The profit motive puts Big Pharma on the spot as it hunts for a vaccine (link) - September 2018
BioPharm International, Antibody Claims at the EPO - February 2008
CIPA Journal, Roche v CIPLA - a generic case?
Education
-
2002 — 2003
LLM (Intellectual Property), London School of Economics and Political Science, University of London -
1999 — 2002
LLB, Campus Law Centre, University of Delhi -
1996 — 1999
BSc (Hons) Botany, Zoology and Chemistry, University of Delhi
Career history
- 2020 — present
Partner, EIP - 2016 — 2020
Partner, Mathys & Squire - 2014 — 2016
Associate, Mathys & Squire - 2012 — 2013
Consultant, GlaxoSmithKline - 2008 — 2012
European Patent Attorney, Olswang - 2007 — 2008
Technical Assistant, Kilburn & Strode - 2004 — 2006
Advocate, Groser & Groser
Awards and recognition
- Recommended patent attorney, Legal 500 2025 (link)
- IAM Patent 1000 2024: "highly skilled when it comes to taking on difficult matters at the EPO. She is able to see the details alongside the big picture, to craft and present compelling arguments on behalf of life sciences companies." (link)
- Recommended in JUVE Patent UK rankings 2024: “2020 hire and renowned patent attorney Monika Rai is increasingly present in life sciences cases.” (link)
- IAM Patent 1000, 2023. 'Rai is a life sciences specialist and has represented some of the best-known names in the pharmaceutical world before the EPO.' (link)
- Recommended in JUVE Patent UK rankings 2023. “She is one of the best EPO litigators in the sector” (link)
- Ranked in 'Influential Women in IP' list by WIPR Diversity, 2022 (link)
- Legal 500, 2022 (link)
- Legal 500, 2021
- Legal 500, 2018: Recommended patent attorney
Languages spoken
- Hindi
Speaking engagements
- May 2023
LSPN North America (Boston), Priority Pitfalls Panel Discussion - May 2022
LSPN North America, Life sciences patent open table - Solving in-house counsel challenges - February 2021
CIPA, Women in STEM -Two IPs In A Pod (link) - November 2018
World IP Forum, Antibodies at the EPO - January 2012
Global IP Convention, Developing a Cost-Effective Patent Strategy for Europe (Protection and Litigation) - August 2005
ICAR-IPA National Conference on IPR and Management of Agricultural Research, Elements of IP Portfolio and Management Strategies
Additional information
CIPA Council Member 2021-2023
Specialisms
Digital
- Digital health
Elements
- Food & flavour ingredients
- Pharmaceuticals
HealthTech
- Digital health
- Medical devices
- Personalised healthcare
Life
- Agritech
- Biologics
- Biotech
- Cell therapy
- Gene editing
- Immunotherapy
- Microbiome
- Pharmaceuticals