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...

Claim construction checkpoints: Application as filed versus granted patent (T 0715/24)

G 1/24 requires that the description must always be “consulted” to interpret a claim. The question remains whether a definition in the description can override an otherwise clear meaning in the claims. In T 0715/24, Bristol-Myers Squibb (BMS) sought to persuade the Board of Appeal that a negative feature, read together with a paragraph of…

Be careful what you wish for: Method of treatment claim for an antibody genus found to satisfy both written description and enablement requirement (Teva v Eli Lilly)

In a remarkable departure from what we might have expected it to do following Amgen v Sanofi, the US Court of Appeals of the Federal Circuit in Teva v Eli Lilly upheld a jury verdict finding that a method of treatment claim for a broad genus of antibody satisfied both the written description and enablement…

Human definitions versus biological reality (T 630/24)

As the recent furore over claim interpretation and description amendments illustrates, patent attorneys love nothing more than to argue about the meaning of words. As we know, words are contextual things, and can shift their meaning depending on the words around them and the perspective of the reader. Definitions are particularly unstable in biological sciences,…

Sequence identities and functional definitions – where is the limit? (T 0137/24)

Biotechnology patents often rely on defining protein and nucleic acid features by their sequence identity. However, it is often not necessary to define the exact sequence, but instead to define the sequence according to a limit of sequence identity, e.g. a sequence having a 90% sequence identity to a specified sequence.

Strict US written description and enablement requirement applied to ADCs and platform inventions (Seagen v Daiichi Sankyo)

The recent decision of the US Court of Appeals for the Federal Circuit in Seagen v. Daiichi Sankyo overruled the jury decision in the District Court to find an ADC linker platform patent invalid for both lack of written description and enablement. 

UPC Court of Appeal tackles broad functional antibody claims (UPC_CoA_529/2024)

The global litigation saga involving Amgen’s PCSK9 antibodies has long served as a high-stakes test case for jurisdictional approaches to broad, functionally defined antibody claims. Following the US Supreme Court’s landmark finding of lack of enablement in Amgen v Sanofi, and the UPC Munich Central Division’s initial revocation of the equivalent European patent, all eyes…

EPO pharma case law trends 2025: Antibodies and biologics

The science of biologics is rapidly progressing, with the development of ever more complex protein structures, incorporation of molecules into cell therapies and the increasing use of AI-assisted design and in silico modelling. Patent law must respond to these new challenges. What better time to take a look at the trends from the EPO case…

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

When drafting a patent, seemingly innocuous “boilerplate” definitions in the description can drastically narrow your claims, as demonstrated by the Alnylam v Moderna case in the US, highlighting the critical need for precise language to protect your invention.

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

Beware! The recent Samsung v Alexion UK High Court decision reveals that even a single-letter error in patent sequence data, coupled with vague descriptive language, can invalidate your claims and lead to costly legal battles.

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

Understand the UPC’s first ruling on second medical use patents, which clarifies novelty and infringement standards but creates new hurdles for patentees, especially concerning “skinny labelling” and proving off-label use.
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