The loss of market share we are already seeing for on-market cell therapy products is a result of in-class competitors for the same target and indication from rival innovator companies, not copycat products with identical CAR sequences.
When do we need a freedom to operate opinion for our cell therapy product?
Only once the product is finalised and heading into the clinic. A full opinion on a construct, a formulation and a process that are all still moving will be out of date before it is delivered, so the right moment is…
It is difficult to find a field of patent law in pharma and biotech at the moment that is more complicated and fast-moving than the field of lipid nanoparticles (LNPs). IP strategy for LNPs involves sophisticated science, multiple and overlapping technology platforms, trade secret and ownership disputes and global patent cross-litigation.
On 22 June 2026, China’s National Medical Products Administration (NMPA) approved satricabtagene autoleucel, or satri-cel, making it the world’s first CAR-T cell therapy cleared for a solid tumour. Developed by Shanghai-based CARsgen Therapeutics, the therapy is approved in China for patients with Claudin18.2-positive, HER2-negative advanced gastric and gastro-oesophageal junction (GEJ) cancer who have already failed…
Patenting stem cell therapies in the US is a difficult business, especially if your cell therapy product is defined solely by natural surface cell markers and lacks any form of genetic modification.
A primary objective of a pharmaceutical patent is to provide robust protection for the drug product itself. Defining a cell therapy product represents a challenge in this respect, given their inherent complexity, heterogeneity and instability.
The patent in T 1555/23 is impressively broad. The claims covered a medical use invention comprising treating the side effects of CAR-T cell therapy using the now industry-standard class of cytokine inhibitor. The claim was not limited to any particular CAR-T cell therapy, target, type of cancer or specific inhibitor.
The cell therapy landscape is at a pivotal moment. There is a considerable pressure within the industry to solve the manufacturing and logistical challenges that have defined the first generation of cell therapies.
