Brigitte Carion-Taravella: “The current situation with SPCs is a mess”

Brigitte Carion-Taravella currently manages Sanofi’s French and Belgium patent team for biologics support. In the run-up to her participation in a panel discussion “New Roads for Life Sciences” at next week’s AIPPI in Istanbul, JUVE Patent spoke with her about how harmonising SPC decisions in Europe could positively affect the way pharmaceutical companies enforce their IP rights.

The following interview reflects Brigitte Carion-Taravella’s personal opinion and should not be interpreted as a statement from Sanofi.

JUVE Patent: What is your opinion on the European Commission’s proposals to introduce a centralised application procedure for SPCs?
Brigitte Carion-Taravella: The current situation with SPCs is a mess. We have no transparency of information, not only as innovator companies but also for generics companies, so both will welcome the change. It will facilitate access to information, to reach a greater harmonisation of SPC decisions. It’s currently a huge cost that as soon as you have to file an SPC – due to the fact that it’s not centralised – you have to file it in each 27 EU member state. It costs a lot of time and money.

So, with respect to the current proposal, it’s really a way to simplify the current system and to improve the way to deal with SPCs in Europe. I think we’ll have also more legal certainty for innovators and generics companies.

Brigitte Carion-Taravella

What is likely to be the proposals’ biggest impact on pharmaceutical companies?
Since the reform is actually called a ‘recast’, it’s not a complete review of the current criteria for granting SPCs or the SPC duration time – at least for the time being – so it’s much more of a procedural change, albeit with a centralised process.

The purpose of the new regulation proposal is also to introduce the unitary SPC and, keeping in mind we now have the UPC and the Unitary Patent, it’s a logical way to deal with unitary SPCs.

However, the proposed procedure for examination is very complex; there are a lot of different stages where you can have third-party observation, opposition, different stages when you can appeal and at the end there’s also now the UPC for managing appeals. But, so far, there’s little information about the duration of each stage; for example, we must take care we don’t spend too long in litigation or examination, or the SPC might expire. But otherwise it’s a good improvement.

“Expertise can vary depending on country, so we will have to harmonise that”

What administrative challenges might the reforms pose?
The administration for dealing with filing and examination is in the EUIPO, and currently the EUIPO does not manage any patent or SPC matters. So there will be a need for training. We know the idea of the European Commission is to create a virtual examiner pool based on using examiners from different national offices, similar to what we have with judges at the UPC, so we need to think about the level of expertise of all examiners. The level can vary depending on country, so we will have to harmonise that and organise training.

What is the time frame for these proposals to take shape?
The information I have is that it is not the commission’s priority. Rather, the key priority is to deal with exclusivity matters, data protection and market exclusivity. The SPC is part of the patent package: you have the pharma package and the patent package. I was able to look at the feedback received by the commission from users, and there is not much feedback on the SPC matter. I have heard that the Spanish presidency is much more focused on exclusivity, and another issue is that the commission will have a new election in 2024 at parliament level. So, I’m not sure we will have any new information before the end of that year – at least about the SPC regulation proposal.

Are the proposals for a central application process different to the proposals for a unitary SPC? Or are these ideas bound together?
The idea is to use the same European administration for managing classical SPCs based on classical European patents, and unitary SPCs based on unitary European patents.

“There might be a period where we must deal with national SPCs, European SPCs and unitary SPCs all together”

This means that, during a certain period of time, it will be difficult to manage because as soon as we have a European patent and centralised marketing authorisation, the national routes will be closed. But there might be a period where we must deal with national SPCs, European SPCs and unitary SPCs all together, because not all territories are part of the agreement for the UPC. It is likely to be complex at the beginning, but we have to think about the future and how we’ll deal with SPCs in seven or 14 years’ time.

Has the notion of a unitary SPC been around for a long time, or did the UPC kickstart the idea?
I think it was in everyone’s mind when we proposed the unitary patent, and it’s a logical follow-up now to think about the unitary SPC. I think it’s a good idea. I remember when we first discussed the UPC and unitary patent, we were afraid pharmaceutical companies would not buy in. But if you look at the current ongoing litigation, that’s not the case. Clearly, it’s a good feature to prepare for the future of Europe.

What challenges does changing legislation pose for pharma practitioners?
Focusing on the patent, the concern that I have is not really about SPCs, because I would say that’s much more of an opportunity than a risk for pharma practitioners. But where we have some risk is the proposal to change the Bolar exemption and, specifically, to extend the Bolar exemption to some activities like pricing and reimbursement.

“With respect to an EU compulsory licensing framework, we’ll never reach an agreement”

With respect to compulsory licensing and the proposal to have an EU compulsory licensing framework, I am quite sure we’ll never reach an agreement. A lot of member states are against this proposal. In fact, there’s no need for that, since we have a good example of how pharmaceutical companies were able to react following the COVID-19 pandemic. Clearly, the issue was not about patents, or any other IP rights, it was much more about manufacturing facilities and being able to produce any medicine needed for a health crisis.

Concerning the pharma package, the main challenge that we have is not really linked to patent – it’s more about the proposal to decrease data and market exclusivity. Such a proposal will clearly undermine innovation and investment of innovation in R&D and the development of new medicines

Is the current SPC landscape fit for purpose?
No. As I said before, we have a lot of difficulties accessing information, there is no harmonisation of SPC decisions, and there is a high administrative burden. One of the key proposals of the new regulation is to have a unique European database managing all the information about SPCs.

“Having a unitary SPC or a centralised system for Europe will drastically decrease costs”

While the number of SPCs applied for each year is likely to increase, it is quite low for the time being, even in large Member States. For instance, in 2017, 70 SPC applications were filed in Germany and 72 in France. The average cost varies by country. Based on current average coverage (20 Member States) and duration (3.5 years), SPC protection for a given product would cost around €99,000 on average per country! In order to cover all 27 Member States for 5 years one would pay nearly €200,000 in total. Having a unitary SPC or a centralised system for Europe will drastically decrease these costs.

Furthermore, regarding SPC granting decisions, sometimes an SPC is granted in one country and not in other countries. So we start from the same original request and in the end we have a real patchwork of granted and not granted SPCs, which makes it difficult both for litigation and for anticipating risk and decisions. A centralised application and granting process will help us to anticipate any issues as a business.

Are pharma companies using the UPC well?
People were certainly surprised that pharma companies weren’t the last to use the UPC. It’s a new way to deal with patents; we have to be certain how the judges will manage the different cases. But as soon as we have the first two decisions from the judges, it will reassure pharma companies and we will use the system more.

In your opinion, what is the most important SPC judgment from the past five or ten years?
What was surprising for me is the last decisions that we had in France. Indeed, we have some cases related to the interpretation of Article 3a) of the SPC Regulation, which have been overturned by the French Supreme Court. All those decisions concerned decisions made by the Paris Court of Appeal in which it confirmed the rejections by the French PTO (INPI) of different SPC applications. In 2023 we have two or three cases like this, all around the same aspects. It was a surprise – especially currently, as we have no harmonisation regarding how to grant SPCs in the different EU countries.

“Working for a pharma company, it is important to give predictable advice to our partners”

But this judgment, in my opinion, clearly has the potential to lead to future harmonisation. Working for a pharma company, it is important to give predictable advice to our internal partners and business. It’s really difficult when we have to change the strategy because we expected to have a grant, but in the end we don’t get a grant. Having predictability and more legal certainty about our project will always be welcome – and, even if in the end we won’t have an SPC, at least it won’t come as a surprise. Surprise is not good for business.

Which are the most important countries in Europe for pharmaceutical companies?
It depends which type of pharma company you’re working for, but I work for an international pharma company, so all the European countries are very important. According to my knowledge, the majority of international pharmaceutical companies are systematically requesting market authorisation and launching their products in all 27 Member States of the European market.

“If we reach harmonisation in Europe that will be a good first step”

When you look at the other countries, do you see tendencies towards harmonisation?
Each member state deals with SPC law and there is no coordination, discussion or normalisation, so having a centralised way to file and examine SPCs will be a way to reach harmonisation. But this isn’t only harmonisation within Europe; it could be with the US, Japan or other countries. If we reach harmonisation in Europe, however, that will be a good first step.

How did your career in patent begin?
When I started studying science, biologics and so on, I never imagined that I would work in patents. I discovered patents when I did my PhD, far after starting my scientific education; if anything, I would say I’m an engineer.

In fact, I started at a very small familial company in France as an engineer and it was a nice opportunity. I worked on analytical and pharmaceutical development, and at the time there was no IP department. The company first discovered patents when they were confronted by the fact that the first generics of their blockbuster product arrived on the market and they realised they had to be careful about patents and SPCs. Their blockbuster only launched in a small number of European countries, they never requested an SPC and realised it was too late.

I was the only person taking an interest in IP and I started to discuss with external counsel working on patent protection. I became a European and French patent attorney about two or three years after starting work as an inventor.

What attracted you to stay in-house rather than go to private practice?
I’m a product of the industry and I will never change. When you’re working for a company in IP, it’s like your child: you follow everything from A to Z, and you’re part of the core strategy of the company. Of course, Sanofi is a huge company and I will never deal with the CEO like I did in my first role as head of IP at the corporate level for Besins Healthcare – but even so, you’re part of the project from the beginning.

Since I joined Sanofi twelve years ago, some projects have stopped while others are ongoing. What can be frustrating working for outside counsel is that you’re just consulted to give some advice at one time and then you have no news about how the project is progressing internally.

“Biologics is the future of medicine”

What does your ‘biologics support’ role in the Sanofi patents team cover?
We’re divided into two groups: one deals with small molecules – so, chemistry – and the other with biologics, because the development of small molecules and biologics is completely different. Manufacturing processes are much more complex and the molecules for biologics are much more complex. It’s a different kind of technical expertise. When I joined Sanofi, I would say 90% of the team had a chemistry background. Now I would say it’s 70 or 80% chemistry. Biologics is the future of medicine.

What current issues are you experiencing in IP recruitment at Sanofi?
One issue is that, in recruitment, our expectations are very high. We want European patent attorneys with at least a PhD, and sometimes we have difficulties recruiting people with that background. If you look at the current situation in France, fewer people are choosing to study science or do PhDs, and if you want to become a French or European patent attorney you need at least a master’s degree in science. I’m afraid about the future in this regard. We’re developing more and more complex molecules, which require individuals with a specialised and strong scientific background.

The interview with Brigitte Carion-Taravella was conducted by Amy Sandys and Christina Schulze.