AlphaFold, a machine learning model for predicting protein structure, is arguably one of the greatest achievements of AI so far. Whilst large language models such as ChatGPT can write poems and make pretty pictures, AlphaFold has the potential to dramatically impact the life-and-death world of drug discovery. AlphaFold represents truly ground-breaking science for which its…
AI has been hailed as a potentially revolutionary tool for accelerating and enhancing the difficult and expensive process of drug discovery. Medicine perhaps represents the field in which AI has the most to offer humanity. However, the nascent field of AI-assisted drug design also highlights the need for IP strategy to be as forward-looking and…
The EPO Board of Appeal decision in T 0687/22 confirms beyond doubt the relevance of G 2/21 to software inventions. The decision in T 0687/22 links the case law from G 1/19 and G 2/21 to highlight the importance of establishing a credible technical effect of software invention. The Patentee in the case made several attempts to formulate an objective technical problem solved by the invention based…
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.
Cell therapy represents one of the most exciting fields of innovation, with the potential to provide long-term cures for previously incurable diseases. However, unlike traditional pharmaceuticals, these “living medicines” present unique IP challenges that can make or break a biotech’s future.
Conventional approaches to LoE fail to capture the complex reality of cell therapy products. IP strategy for cell therapy needs to be adapted to take account of these realities.
In Azurity v. Alkem the US Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s ruling that Alkem’s antibiotic formulation did not infringe patent claims owned by Azurity. The CAFC found that Azurity clearly and unmistakably disclaimed the presence of a key ingredient from the claimed formulation during prosecution. Given that Alkem’s formulation included this ingredient, the generic…
Following the high profile hearing last month, we are now waiting for the written decision of the Enlarged Board of Appeal (EBA) in G 1/24. Readers can catch-up on the full background to the case here. There is also still plenty to discuss while we wait.
G 1/24 relates to the question of how to interpret the…
The recent decision T 1913/21 highlights a crucial differentiation between second non-medical use claims and process claims. The Board of Appeal found that, according to the established case law, claims in which the technical effect of the invention occurs only as part of a process for producing a product, must be regarded as a process claim and…
The recent Board of Appeal decision in T 1865/22 considered the inventive step of a composition where the only distinguishing feature was a lower concentration of a component compared to the closest prior art. The prior art taught that higher concentrations of this component were advantageous. The Board of Appeal found that simply excluding a technical feature disclosed…
