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.
Your biotech invention works, but can you prove it’s better? A recent EPO ruling on extracellular vesicles (T 0827/23) shows why the lack of comparative data can be fatal for a patent.
In cell therapy the industry mantra is that the product is the process. However, this case illustrates that the best patent protection for a cell therapy is derived from the product.
Understanding cell therapies for intellectual property protection is uniquely challenging because these living products are inherently complex and variable, making precise legal definitions difficult but crucial.
IP strategy for cell therapy also has unique challenges. The patent at issue in T 1259/22, although relatively old (expiring August 2024 with SPCs), nonetheless highlights some of the key challenges for cell therapy IP strategy.
The decision in Juno v Kite is not a surprise in light of the recent CAFC case law on written description for antibodies, and represents yet another nail in the coffin of functional genus claiming for biomolecules in the US.
