Rafi Allos
Rafi is a Partner in the IP Litigation practice in London. Rafi specialises in contentious life sciences patents work and advising clients on regulatory issues in the life sciences sector. Rafi's patent litigation experience includes both representing clients in U.K. proceedings and assisting clients with multi-jurisdictional proceedings and preparation for potential litigation. In addition, Rafi has a particular interest in the impact of life sciences regulatory issues on patent litigation.
Rafi has spoken on life sciences regulatory matters at the Pharmaceutical Law Academy in Cambridge from 2014 to 2017. He has been recognised since 2017 as a “rising star” in the Patents section of Managing Intellectual Property's IP Stars and as a Next Generation Lawyer / Rising Star in Legal 500 (both in Life Sciences and Healthcare and in Patents). Rafi was also awarded a European Rising Star Award in the Life Sciences and UK categories in the Euromoney LMG Europe Rising Star Awards 2019.
Practice Area
Panel
- Contributing Author
Qualified Year
- 2013
Experience
- A&O Shearman (previously Allen & Overy LLP) (2022 - Present)
- Allen & Overy LLP (2016 - 2022)
- Simmons & Simmons (2011 - 2016)
Membership
- The Association of the British Pharmaceutical Industry (ABPI)
- The International Association for the Protection of Intellectual Property (AIPPI)
- The BioIndustry Association (BIA)
Qualifications
- BA (First Class Hons), Jurisprudence (Law) (2009)
- Postgraduate Diploma in Intellectual Property Law and Practice (Distinction) (2014)
Education
- University of Oxford (2009)
- University of Oxford (2014)
2 Contributions by Rafi Allos
PRACTICE NOTES
EU paediatric medicines regime: PIP obligations, waivers and deferrals; SPC paediatric extensions; PUMAs; sanctions; and 2023–2026 reform proposals, with comparative US and international developments
Also prepared in partnership, with contributions from Marylis Clerc of Bird & Bird and Sapna Palla of White & Case LLP.
What are paediatric medicines and why do we need them?
Paediatric medicines are medicinal products intended for children from birth up to, but not including, 18 years of age. Over recent decades, very limited research and development in this area occurred. Numerous medicines were neither studied nor authorised for paediatric use, compelling clinicians to modify dosage and presentation of adult medicines according to their own judgement. Unsurprisingly, such widespread off-label practice carried a higher likelihood of poor efficacy and adverse reactions in children. A report by the European Medicines Agency (EMA) states that, despite scarce data, harm did occur and was frequently underreported. Multiple factors explain the shortfall in paediatric R&D, including the perception that enrolling children in clinical trials was unethical. Creating medicines for children is also far more complicated than for adults, because children are not a single homogeneous subgroup, but have differing requirements and biological and physiological profiles. Physicians relied on personal experience to tailor adult formulations to children, adjusting strengths and forms without formal guidance. Such practice became widespread in routine clinical care. This inevitably...
EU Law
PRACTICE NOTES
Paediatric Medicines: EU and post‑Brexit UK regimes on PIPs, waivers, deferrals, incentives (paediatric extensions, PUMA), enforcement and reforms; plus US overview and international standards (ICH E11A, WHO)
Also produced in partnership with contributions from Marylis Clerc of Bird & Bird and Sapna Palla of White & Case LLP.
What are paediatric medicines and why do we need them?
Paediatric medicines are medicinal products intended for children from birth up to, but not including, 18 years of age.
For decades, research and development in this field was minimal. Numerous medicines were neither studied nor authorised for paediatric use, leaving clinicians to modify adult formulations and doses using their own judgement. Unsurprisingly, such widespread off‑label prescribing brought a higher risk of poor efficacy and adverse reactions in children. According to a report by the European Medicines Agency (EMA), despite limited available data, harm did occur and was frequently underreported.
Several factors explain the lack of paediatric R&D, including the view that enrolling children in clinical trials was unethical. Creating medicines for younger patients is also far more challenging than for adults, as children are not a uniform group and have varied needs alongside distinct biological and physiological profiles. This inevitably requires additional...
Life Sciences
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