PHARMACEUTICAL IP

Cell & gene therapies

At Evolve, we are excited to be involved in protecting the innovative science behind advanced therapies. We recognise that these new modalities have the potential to transform the treatment paradigm for previously incurable diseases. We are passionate about ensuring that IP strategy enables further investment in these ground-breaking scientific and clinical developments. We have extensive experience of crafting and implementing IP strategies for advanced modalities that take account of the complex and unique scientific, commercial and regulatory environment for these highly innovative technologies.

As the former IP lead for the biopharma cell therapy department at AstraZeneca, Evolve’s biotech IP attorney Rose Hughes is ideally placed to assist you with securing robust protection for your cell therapy technologies. At AstraZeneca Rose led the IP strategy for a range of cell therapy programs, including CAR-T, allogenic/off-the shelf and regenerative cell therapies. Rose also has extensive transactional experience in the cell therapy space, including platform technologies and clinical stage products.

Sector insights...

CAR-Macrophage (CAR-M) cell therapy: Advantages, challenges, and emerging innovations

Are macrophages the next big thing in cell therapy?

Overcoming the freedom to operate and patentability challenges for cell therapies

How do you navigate the freedom to operate and patentability challenges in a field as complex, competitive and crowded as cell therapy?

Bridging the innovation and commercialisation gap: IP strategy for advanced therapies

Three principles of effective IP strategy for cell and gene therapies.

IP strategy for the universal cell therapy revolution

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.

The great consolidation: Big pharma buys the advanced therapy technology, not just the drug

The latest cell and gene therapy industry trends reveals a shift in strategy towards platforms.

The reproducibility challenge for advanced therapies (T 0827/23)

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.

Pitfalls of cell therapy manufacturing IP – A case study (T 0868/23)

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. 

Defining the undefinable: The challenges and opportunities for cell therapy IP

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.

Falling between the cracks: The challenges of patent strategy for stem cell therapies (T 1259/22)

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.

Strict US written description requirement applied to CAR-T-cell therapy (Juno v Kite)

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.
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