Peptides & Proteins
Invaluable technical understanding and sector knowledge in an established field
Inventions in this area have revolutionised therapy, diagnosis and research, most notably in the area of therapeutic proteins such as monoclonal antibodies. Our Biotechnology team has supported its clients on this exciting journey, having worked on some of the fundamental early patents for antibody humanisation, phage display and recombinant antigen vaccines, as far back as the 80s.
We handle patents and SPCs for inventions across the full range of this area, including antibodies, bispecifics, immunoconjugates, protein vaccines, small peptide therapeutics, cytokine fusions, recombinant and plasma derived blood proteins, and enzyme replacement therapy, to name just a few. We regularly advise our clients on issues that are particularly relevant to inventions in this field, such as the challenges stemming from the emerging biosimilars market.
Our Biotechnology team includes attorneys who specialise in this field and who have an unrivalled depth of technical understanding and sector knowledge. We have built this expertise over many years. We continue to be entrusted by large companies as well as start-ups with the protection of some of the most important innovations in this area, often for blockbuster and first-in-class products. As an example, we have worked with Johnson & Johnson for over 20 years and have helped them protect and defend some of their most important products, including Janssen Biotech’s antibody products STELARA®, DARZALEX® and SIMPONI®. We also represent Regeneron, for example, in connection with its PRALUENT® and DUPIXENT® products.
Meet the Peptides & Proteins team
Securing and defending teriparatide patents – Eli Lilly
Parathyroid hormone is an 84 amino acid product of the mammalian parathyroid gland that controls serum calcium levels. Teriparatide is a fragment of the 34 N-terminal amino acids and was recognised as being metabolically active and had been tested as a potential osteoporosis therapy since 1980 or earlier. Despite leading to increases in bone mineral density, no impact on whole-skeleton fracture incidence had been seen until a clinical trial conducted in the late-1990s.
This study led to the approval of Lilly’s FORSTEO product and underpinned a patent claim to the use of teriparatide for “preventing or reducing the incidence of vertebral and non-vertebral fracture”, which was granted by the EPO after an appeal against refusal by the examining division.
This patent received three oppositions which were rejected in 2019.
In parallel, a patent claiming both methods for preparing liquid formulations of teriparatide and also the FORSTEO formulation was granted in 2013 and was opposed by four parties. After the patent was upheld the opponents appealed, but these appeals were dismissed in 2018. Generic/biosimilar competitors were approved in Europe in 2016 but were not launched until late-2019 after both of these patents had expired. Carpmaels & Ransford successfully represented Eli Lilly during examination, opposition, and appeal.
