Although Botox has been on the market since 1993, work continues to improve its composition. Currently, pharma innovators Allergan and Ipsen are locked in a battle over new Botox patents at the European Patent Office.
On 2 September 2021, the Technical Boards of Appeal ruled on their first Botox case (case ID: T 2797/18 – 3.3.07). The judges reversed the Opposition Division’s decision to quash Allergan’s EP 2 33 294. As a result, the Opposition Division must now retry the case and resolve further issues.
Allergan’s EP 294 protects a pharmaceutical composition of clostridial toxins. Clostridia are a type of bacteria, which includes clostridium botulinum. Its neurotoxin forms the basis of Allergan’s successful product Botox and Ipsen’s competing product Dysport. The best-known use of the neurotoxin is to smooth out wrinkles, but the substance is also used in medicine, for example to treat specific movement disorders and spasms.
Analysts estimate that Allergan alone will generate about $4.7 billion in global sales from Botox in three years.
A new generation
However, botulinum toxin compositions are very fragile and can be easily deactivated. For this reason, all suppliers rely on serum albumin for stabilisation. This albumin – a type of globular protein – is found in vertebrate blood and therefore often referred to as blood albumin. Innovators want to replace this with a synthetic stabiliser.
There is currently a competition for the best alternative at the EPO, where Allergan and Ipsen have filed objections against each other’s patents.
In early 2017, Ipsen filed an opposition against EP 294 claiming lack of inventive step, insufficiency and added subject matter to claim 1 of the patent. Subsequently, the Opposition Division revoked the patent in September 2018. This was because the subject matter of claim 1 as granted resulted from a generalisation which extended beyond the content of the application as filed. In its decision, the Opposition Division did not comment on the other two issues.
Allergan appealed the ruling. The Technical Boards of Appeal have now reversed the decision of the first instance. At the same time, they referred the questions of inventive step and insufficiency back to the Opposition Division.
Tried and tested
Morten Garberg
Allergan, which became part of AbbVie in 2020, has relied on mixed firm Hoffmann Eitle in oppositions, patent prosecution and filing for over 20 years. For example, Munich partner Elisabeth Engelhard acted for the US pharmaceutical company in the high-profile battle against the University of California over CRISPR/Cas technology. Allergan was one of the opponents.
Munich partner and patent attorney Morten Garberg also represents Allergan in other opposition proceedings involving Botox. Furthermore, he cooperates closely with in-house patent attorney Lorenz Siddiqi.
Plasseraud has represented Ipsen for years in filing and oppositions at the EPO, including for various patents related to Botox. The patent attorney firm is one of the largest outfits of its kind in France and covers a wide range of technical fields.
However, the team led by the renowned Cyra Nargolwalla is particularly strong in pharmaceutical and biotech patents.
Cyra Nargolwalla
For Allergan
Hoffmann Eitle (Munich): Morten Garberg, Adam Lacy (both patent attorneys)
In-house (Irvine): Lorenz Siddiqi
For Ipsen
Plasseraud (Paris): Cyra Nargolwalla, Nathalie Wajs, Clémentine Eap (all patent attorneys)
European Patent Office, Technical Boards of Appeal, Board 3.3.07
Eric Duval (chairman), Martin Steendijk, Yvonne Podbielski
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Source: https://www.juve-patent.com/news-and-stories/cases/allergan-wins-battle-over-botox-patents/
