PHARMACEUTICAL IP

Biologics

At Evolve we have specialist knowledge of the unique requirements of IP strategy for large molecule pharmaceuticals and biologics, including therapeutic monoclonal antibodies, T-cell engagers (TCEs), antibody-drug conjugates (ADCs) and nucleic acid-based therapies.

We are dedicated to developing IP strategies that match the scientific and business vision for your products. The Evolve team provides a fantastic combination of both chemistry and biology scientific expertise that ensures that your innovations benefit from a high-level of IP protection.

Sector insights...

Alnylam v. Moderna and the judicious use of definitions: The European perspective

The recent decision of the US Court of Appeal of the Federal Circuit in Alnylam v Moderna relates to the ongoing complex and high-stakes dispute over mRNA vaccine delivery technology. In a blow for Alnylam, the Federal Circuit found that Moderna did not infringe Alnylam’s LNP platform patents in view of a definition of a…

Alexion’s Soliris sequence error saga (Alexion v Samsung Bioepis [2025] EWHC 1240)

The recent UK High Court decision in Samsung v Alexion [2025] EWHC 1240 (Pat) is a stark reminder that you can never be too careful with patent sequence data. Mr Justice Meade’s ruling in this case highlights that simple mistakes in the sequence information can be fatal for both the enforcement and validity of the claims. The case, relating…

First UPC decision to tackle infringement and validity of second medical claims (Sanofi v Amgen, UPC_CFI_505/2024)

The complexities of patenting new uses for known medical substances were recently considered by the Düsseldorf Local Division in the UPC’s first decision on second medical use claims. The case of Sanofi v Amgen (UPC_CFI_505/2024) specifically addressed the novelty and infringement standards applicable to second medical use claims. The case is part of the long-running dispute between Sanofi and…

Rose Hughes joins Evolve

Evolve Intellectual Property is pleased to welcome Dr. Rose Hughes as our new Patent Attorney. Rose joins us with an exceptional background and a wealth of experience gained from her time at AstraZeneca and previously in private practice. Her deep understanding of the pharmaceutical sector is a significant asset to our firm and, most importantly,…

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.

Beyond the process: Securing robust IP protection for cell therapies

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.

Securing market protection for cell therapies: Patents versus regulatory exclusivity

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.

Epitope claims stand firm: Board of Appeal upholds functional antibody patent despite insufficiency attack (T 0326/22)

The recent Board of Appeal decision T 0326/22 is yet further confirmation, if any were needed, that functionally-defined antibody claims remain viable at the EPO. In this decision, the Board of Appeal upheld Inhibrx’s European patent EP2812443 directed to a genus of anti-CD47 antibodies defined by their epitope binding and functional characteristics, finding both sufficient disclosure and inventive step. This decision once…

US Supreme Court decision in Amgen v Sanofi: The European Perspective

The US Supreme Court recently ruled in the high profile Amgen versus Sanofi patent dispute. Agreeing with the Federal Circuit (No. 20-1074, Fed. Cir. 2021), the Supreme Court found Amgen’s function and epitope defined PCSK9 antibody patents to lack enablement (Amgen Inc v Sanofi, No. 21-757). The US Supreme Court was keen to stress that…
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