19 Nov

Claudio Germinario

How do you stay abreast of developments in emerging technologies?

The most challenging emerging technologies at the moment are not in my field of competence (biopharmaceutical), but rather in electronics and telecommunications (eg, AI, the Internet of Things, blockchain and methods to guarantee and improve security in transactions).

In the medical pharmaceutical area, the big challenge right now is to develop patient-customised therapeutic treatment based on in-depth knowledge of the genetic characteristics of each patient.

Immunotherapy and other immunological tools are playing an increasingly central role in the treatment of many pathologies, such as cancer and autoimmune diseases. The latest technologies aim to stimulate or improve the body’s natural defences, rather than overloading the patient’s organism with chemotherapeutic agents. Two examples are the growing use of new monoclonal antibodies and the emerging technology of CAR T cells, which are collected from patients and genetically modified, before being injected back into the patient, in order to provide a new receptor that is specific for a cancer surface antigen.

I stay abreast of all this by assisting clients that are actively researching and applying new emerging technologies, as well as by following developments in scientific literature.

How would you characterise the current biotech and pharma markets?

As well as the main research directions discussed above, biological medicaments are quickly replacing classical chemical medicaments. Moreover, as the patents protecting the first generation of biological agents are now expiring, a growing number of biosimilar medicaments are receiving marketing authorisations in Europe and the United States. Biosimilar medicaments are following in the footsteps of generic ones.

What are the biggest challenges that SMEs face when it comes to patent portfolio development?

Developing a patent portfolio is not generally a primary goal for SMEs or big pharma companies, but rather the consequence of continuous scientific research by bio/pharmaceutical enterprises. That said, the difference between SMEs and big pharma companies in this respect is dramatic.

When a large company identifies a candidate blockbuster (product of first generation), it protects the whole family of the active molecule with a broad patent application or with a cluster of patent applications covering all aspects. Moreover, during examination, any one of these applications may be split into one or more divisional applications, broadening the size of the cluster. Thus, all commercial aspects relating to the blockbuster are efficiently protected.

Subsequent research will produce incremental innovation (eg, new formulations of the old blockbuster, new administration routes and new dosages or dosage regimens). Incremental innovation will be protected by a second-generation patent cluster.

This strategy offers the best protection, but costs can prove unsustainable for SMEs – this is the biggest challenge that these companies face.

How is patent activity developing in the field of biotechnology?

The two main research directions and patenting trends are in public health (medical-pharmaceutical field) and food (agriculture and breeding). I have already discussed the medical-pharmaceutical field, where a growing number of patents for biological medicaments and immunotherapy are being filed by a large cohort of players big and small.

In agriculture and breeding, we see a limited number of big players monopolising the sector.

Patent protection for genetically modified vegetables has been the object of many recent decisions of the EPO Boards of Appeal, which are trying to limit the undesirable overlapping between plant technology and traditional agriculture.

What are the most important considerations for pharma companies engaged in patent infringement proceedings in Europe?

Infringement cases are normally dealt with by national courts or will be dealt with by the UPC when it becomes operational.

First, before starting an infringement action, a pharma company must seriously assess the validity of the patent titles that will be enforced against the alleged infringer, lest the risk of a declaration of invalidity by the court be higher than the likelihood of a declaration of infringement. Second, the costs of judicial litigation are very high, specifically in jurisdictions such as the United Kingdom. A serious cost-benefit evaluation is therefore necessary.

Extrajudicial transactions are sometimes the best solution, yet under certain circumstances court action may be worthwhile; a Rome Court of Appeal judgment on 20 May 2020 awarded the holder of a pharmaceutical patent approximately €1.5 million (almost $1.8 million) in damages for an infringement lasting only 40 days.

Claudio Germinario

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Before joining Società Italiana Brevetti, Claudio Germinario spent more than 20 years at the EPO as a biotechnology examiner and a member of the board of appeal competent for pharmaceuticals. Mr Germinario’s practice focuses on providing technical counsel in patent litigation in the pharmaceutical field and representing Big Pharma originator and fine chemistry companies in infringement and nullity proceedings before the Italian and foreign courts. He often works on several parallel national and cross-border proceedings simultaneously.