VP Head of Biologics Patents
Sanofi (Paris, France)
Karine Crepin is the Vice President, Head of Biologics Patents at Sanofi. She will be joining PTAB, USPTO, Novartis, Pfizer, Eli Lilly, Regeneron Pharmaceuticals, Novo Nordisk, BeiGene and other leading pharmaceutical organisations for ACI’s 17th Advanced Summit on Life Sciences Patents on May 16th - 17th in New York.
Prior to her panel session on Antibody Patent Review: Global Perspectives on Enhancing Biologic Assets Protections, Karine gave her insights on the most notable pharmaceutical and biotech patent trends in the past year, what is driving these trends, and what she is most looking forward to learning at this year’s Life Sciences Patent event.
Q&A with Karine Crepin
Hi Karine, can you give us a brief introduction to your background?
I am Vice President and Head of Biologics Patents at Sanofi. I hold a Master Degree in Bioengineering (specialising in Biochemistry) and a PhD in molecular Biology. I am also a qualified European and Belgian Patent Attorney. Before joining Sanofi, I worked for 15 years in the Patent department of GSK, responsible for vaccine matters. At sanofi, I have built a global team of more than 40 patent attorneys worldwide. I am responsible for all patent matters relating to Sanofi Biologics including Vaccines and platform aspects. I coordinate a large variety of patent related activities, from the protection of innovation to freedom-to-operate and post-grant administrative and judicial proceedings.
What is the most exciting area of Life Sciences Patent you are currently working on?
I am working in the field of Biologics (products and platforms) which is fast evolving technologically, which is very diverse because it includes many different modalities, and which presents its share of challenges both legally, regulatory-wise and scientifically. In particular I want to note the field of monoclonal antibodies, antibody formats and gene therapy.
What Have Been the Most Notable Pharmaceutical and Biotech Patent Trends in the Past Year?
The number of ‘biotech’ patent disputes has continued, between Innovator competitors or between Innovators and Biosimilars as a result of the increased commercialization of these products in the US essentially but also in Europe, and because biotech companies engage in an effort to police and enforce their patent rights. We have also seen some big movements in the field of mergers or acquisitions, in particular in the field of Immuno-oncology, Immunology and Rare Diseases. Last, I would also note the evolving guidelines regarding the patentability of monoclonal antibody claims and examination thereof, both in the US and Europe, heterogeneity in the Legal systems and decisions across jurisdictions, the new referral by the UKIPO to the EUCJ on third party SPCs and, a little further from my field of expertise, the possible referral by the President of the EPO to the Enlarged Board of Appeal on the question of the patentability of plants produced by biological processes.
What Has Been Driving These Trends?
There are many factors. To cite just a few: One factor is the evolution of the technology which spawned new generations of Biological products resulting in fierce competition between companies rushing to develop and market products of the same or similar modality against the same target. Another factor is the expiry of patents for the first generation of biologics which fuels the pharmaceutical market for biosimilars and inevitably the associated litigations.
What are you most looking forward to learning at this year’s Life Sciences Patent event?
Besides fantastic networking opportunities, sharing one another’s experience is important as well as remaining at the forefront of tomorrow’s trends in the field of pharmaceutical patents.
Without giving too much away, can you give us a brief overview of what you will be covering at the Life Sciences Patents? And why it is important to the audience?
I hope to provide, with my co-panelists, some practical insight of the challenges faced by companies and practitioners in the field of monoclonal antibodies, as based on recent case law developments, focusing on claim scope and functional claims, highlighting the differences between the patent office patentability approaches in the two main jurisdictions (US and Europe).