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Gavin Reccia, © Gavin Recchia

Early Certainty Initiative: “Disincentive to patenting”

The decision of the European Patent Office to examine all patent applications within 12 months can unintentionally block companies from filing for life sciences patents in Europe, says Gavin Recchia, Principal of one of Australia’s largest patent attorneys’ firms.

EuroBiotech
What sort of clients do Davies Collison Cave represent?
Gavin Reccia
We are one of the largest specialist IP attorney firms in Australia, with offices in Singapore and New Zealand. We represent clients from around the world in the biotech, pharma, IT, and engineering industries.

EuroBiotech
The EPO wants to accelerate examination of patent applications, so that all patents will be granted 12 months after the examination. What impact does this have on your clients?
Recchia
The obligation for rapid examination is part of the EPO’s Early Certainty Initiative, which is aimed at creating legal certainty. It’s somewhat under the radar in Australia, but it will have a huge impact on patenting of inventions coming from the life sciences sector.

EuroBiotech
Why?
Recchia
Life sciences research in countries like Australia is typified by very early stage developments, often from academic research institutes and start-up companies. These applicants typically rely on being able to attract funding, support, or investment for their technology before significant IP prosecution costs arise. Filing patent applications in Europe is an advantage in terms of attracting investors, licensees, or assignees given the size and value of the European market. However, filing a European regional phase application is already more expensive than filing in other major jurisdictions, and there will be a significant disincentive to file if prosecution is going to advance too quickly and costs are going to be incurred earlier than they currently are. Early certainty means the likelihood of higher costs earlier on, not only in terms of prosecution, but also the filing of divisional applications before a commercialisation partner or investor has been found. 

EuroBiotech
How may filing of divisional applications by the original inventor affect commercialisation?
Recchia
The divisional application point is an important one. It not only means higher costs are incurred earlier, but also that the applicant needs to make a decision on subject matter to pursue in the primary European application versus a divisional earlier in the life of the European case, and potentially before it is clear what the most valuable commercial embodiment will be. When applicants file for a European patent, there may be multiple inventions in the one application, such as several candidate compounds, different therapeutic uses etc. As their research is typically very early stage, they often need time to generate additional data, e.g. from in vivo studies or clinical trials to identify the best lead embodiment. However, the applicant in most cases is not the party to commercialise the invention. In other words, applicants may under the Early Certainty Initiative be forced into a position of having to make decisions without the benefit of financial support or experience of a commercial partner. There is a real possibility that divisional applications will not be filed and/or that patent protection granted in Europe may not reflect the embodiment of most commercial interest in Europe. The effect of the Early Certainty Initiative may therefore be that fewer life sciences innovations from abroad make their way onto the European market. 

EuroBiotech
Do you think this is a problem limited to applicants coming from Australia, New Zealand, or Singapore?
Recchia
I think it’s not an Australian problem but an international one. In many countries, life sciences patents come out of universities or start-up companies. They do not all have the resources to support commercialisation and are seeking partners. So the problems with the Initiative may be felt widely.

EuroBiotech
Is there a way out that could preserve the attractiveness of patenting in Europe while giving third parties early legal certainty?
Recchia
I think schemes for voluntary accelerated examination can assist in providing legal certainty, while not locking all applicants into an unduly early examination.

Julien Le Guyader, © 大成 Dentons

大成 Dentons: All about taxes

大成 Dentons has announced the cooptation of Julien Le Guyader as partner in the Life Sciences Group of the Paris Office. Le Guyader has been a part of 大成 Dentons since 2014.

Trained as a tax specialist, he regularly advises healthcare companies but also major international groups on legal, tax and regulatory structuring issues. Le Guyader was formerly at Simmons & Simmons LLP, Ernst & Young Société d’Avocats and operated as Tax Director of the LEEM. He started his career at Laboratoires BOIRON as group tax specialist in charge of transfer prices. Le Guyader graduated from the ESC Lille and the University Paris I – Panthéon Sorbonne in Business and Tax Law, Public Law and Economics. He is also member of the Pharma Licensing Club France and administrator of the Association des Cadres de l’Industrie Pharmaceutique (ACIP).

Gerd Zettlmeissl, © TuBerculosis Vaccine Initiative

Asit biotech: Expertise in vaccines

Belgian clinical-stage immunotherapy developer  Asit biotech has appointed Gerd Zettlmeissl as its new Chairman of the Board. Zettlmeissl has been independent director of the company since 2011. 

Before joining Asit biotech, he was CEO of Austrian company Intercell AG – which in 2013 merged with French company Vivalis create European vaccine and antibody leader Valneva. Zettlmeissl holds a doctoral degree in biochemistry from the University of Regensburg in Germany and did a post-doctoral fellowship in virology at the Institut Pasteur in Paris. Since 1985, Zettlmeissl has held various R&D and managerial positions at a number of international pharmaceutical companies, among others Managing Director of German vaccine company Chiron Behring.

In 2010, he was named Vaccine Biotech CEO of the Year at the World Vaccine Congress. Zettlmeissl currently serves as non-executive director of Aeras, (USA). Until early 2015, he was chairman of GlycoVaxyn (Switzerland), an innovative vaccine company acquired by GlaxoSmithKline.

Erstwhile Asit biotech Chairman Béatrice De Vos has stepped down “to focus on new projects”.  

Matti Heikkilä

A clear path ahead for the bioeconomy

There’s no way around it: renewables are the future, Matti Heikkilä believes. European Biotechnology talked to the CTO of Finnish bioeconomy company MetGen about what bio-based products need to bring to the table to usurp their fossil-based counterparts. 

European Biotechnology 
Matti, you say we need to stop using fossil fuels. But right now there hardly seems to be a consensus on that – especially among politicians. Are you sure this is going to happen in our lifetimes?
Matti Heikkilä
It is hard to be sure about such things – there are sometimes political decisions that defy logic and reason. But I most certainly hope so! I think the key there is to stop wishing it will happen and work towards that goal, by making renewable fuels and chemicals and good alternatives a viable choice for the oil-based industry. In fact, I already see the transition happening. There are big industries, in pulp and paper and packaging, and they all, especially in Europe, seem to share the vision that the chemicals and the materials that are made of oil today can be replaced and, in some cases, even better materials can be found using renewable resources. 

European Biotechnology 
Has Europe advanced further down the path towards a bioeconomy?
Heikkilä
There is a much greater political will going in this direction, especially when compared with what is happening in the US. There are more market-driven approaches on the other side of the Atlantic, but I think there are not as many political drivers to go towards green objectives. Another benefit that we have in Europe is the strong co-operation that stems from the programmes like Horizon 2020, which puts together the best experts from both academia and the industry working towards common goals. This is getting much better nowadays – it’s a much more open and cross-disciplinary collaboration than it was before. One reason for this is: it’s a much more market-driven approach. People are sharing their information with their own benefit in mind. If they make the whole value chain work, it enables their business.

European Biotechnology 
So it is all about the value chains?
Heikkilä
Absolutely. For example, at MetGen, we have created an enzyme that is very good at converting the sugars in wood even at lower purity levels, just to help the value chain. It does not take anything away from us that the pre-treatment company makes a good pre-treated wood slurry as the substrate for our enzymes; and if a chemical company can then turn the result into a plastic bottle, that is also good for our business. It is all about collaboration to fix these value chains. So can we replace petrol-based chemicals in our lifetime? I believe we can do it much faster. Most of the technology already exists, and it is just a matter of connecting the dots, and the right capabilities and people.

European Biotechnology 
How does Finland compete within the European bioeconomy?
Heikkilä

Finland’s resources are almost all wood – similar to our Scandinavian neighbours, but different from many European countries. Even in the European-wide bioeconomy strategy, there are separate sections for different countries because the national capabilities and resources are so different. In Germany and the Netherlands, for example, the focus is heavily on biochemicals. The bioeconomy is driven by the industry that is strong locally. The same is true for Finland. Forestry and pulp and paper drives the bioeconomy relatively heavily here. At the same time, since we are up in the North, we do not have the same productivity when it comes to agriculture. We have the bioeconomy strategy implemented on the government level, and it also focusses on the wood-based biomasses. Our company, MetGen, also concentrates on those materials for the most part.

European Biotechnology 
Isn’t it risky to rely on one resource only?
Heikkilä
Actually, MetGen is not picky about the biomass. Wood is where our expertise really shines because that’s the harder substrate. As a rule of thumb, the more lignin you have, the harder it is to put it to economic use. However, the more we assess it, the more we realise that wood is actually a great resource. Wood is not really that expensive. It is also in year-round supply, while grass or straw need to be stored somehow, which then leads to practical issues that come with storing, like the risk of fire and the need for storage space. Also, wood has a lot of sugars to it. Eighty percent of it is sugar – you just need to know how to crack it. And not least, the supply chain is already there. Wood is already being utilised in large quantities. So to me, it is just about transitioning towards using bio­chemicals. MetGen aims to provide the new technologies for pulp and paper to do that.

European Biotechnology 
How exactly do you do that?
Heikkilä
Let me give you an example. We were requested to come up with a laccase that could survive a pH of 10 to 11, or even be at an optimum in this range, so that it could be used in Kraft pulping to help the bleachability and de­lignification of that process. The company that requested this hardly thought it was possible, but we agreed to give it a try. And five months later, we had that molecule industrially produced. And while it was requested by a single company, it now benefits the entire industry.

European Biotechnology 
What role does the consumer play? Can bio-based products only succeed if there is a demand for environmentally friendly alternatives?
Heikkilä
Not at all! The funny thing is: the Polyethylene Furanoate, or PEF for short, is not actually biodegradable. But it is a better alternative to PET. It is a better packaging material; it has better barrier properties than oil-based alternatives; it makes the beverage have a better shelf-life – the oxygen stays out and the carbonation stays in. So in a first step, it might not replace PET-bottles, but it is replacing aluminium cans and glass bottles. Because it has the same superior properties as those. Later, it will overtake the other plastic packaging. So the green alternative is actually better than we can get out of oil. And that’s the thing: For a bio-based alternative to succeed, it has to be as good as the petrol-based product but cheaper, or the same price but better. 

European Biotechnology 
So what is needed for the bioeconomy to come out on top?
Heikkilä
What is needed for that to happen is us in Europe starting to put down money and investment on piloting and market demonstration of technologies. We use a lot of resources and money on research, but then we fail to finance the commercialisation of those technologies. The same is not true of the Chinese or the Americans. We use roughly 90 percent of our resources on research and the remaining ten on development. The same numbers in the US are roughly fifty-fifty, and in China, they use more money on the development and scale-up and commercialisation of things than research. So, what happens in a globalised world is that we use taxpayer money here in Europe to create good products, and then we end up selling them to other continents. My second point is the brain leak if you will. We have to make sure we have incentives for experts globally to come to Europe and help us solve these value chain-wide challenges I mentioned. Europe cannot be the place where we start building walls. Every expert that we get, no matter from what country, will create more work around themselves. So we should not be afraid of losing our jobs if foreign experts come over. Rather, we should be giving them incentives to come. Right now, people are moving away from Finland, and from Europe, to other places where there are more incentives for the brightest and the best of us to succeed. We really need them here.

Matti Heikkilä is Chief Technology Officer of Finnish bioeconomy company MetGen Oy, which develops enzymatic solutions for processing lignocellulosic biomass. Last year, MetGen won the John Sime Award for Most Innovative New Technology at the European Forum for Industrial Biotechnology and the Bioeconomy (EFIB). Heikkilä has more than a decade of experience in European industrial biotechnology.

Reinhard Hoferichter © Securpharm

Europe’s shield against falsified medicines

The pharmaceutical industry of the European Union is currently toiling at a veritably Herculean task. They jointly took up the fight against falsified pharmaceuticals in the legal supply chain. Forgers have discovered that falsified drugs are a lucrative business. However, the EU legislature has recognised this risk, and responded by passing the Falsified Medicines Directive in 2011. In 2016, it was put in more concrete terms with the delegated regulation, which stipulates the implementation of the directive for prescription drugs.

As a result, there is now legislation across national borders, which represents an important measure when it comes to effectively taking action against falsified pharmaceuticals. At the same time, the new legislation creates technologically standardised protection against falsified medicines. Now we have clarity on how pharmaceuticals in the legal supply chain are to be rendered safe from falsification, and we know these measures must be implemented by 9 February, 2019. 

In the new legislation, the pharmaceutical companies have been assigned a central mandate. Each manufacturer must equip his own products with the anti-falsification features, but at the national level all manufacturers together are also responsible for the set-up and operation of the technical systems for the authentication of pharmaceuticals. Side-by-side, the pharmaceutical companies, as well as the pharmacies and wholesalers, are now forming a strong phalanx against organised pharmaceutical crime and for patient protection in Europe. However, it is in the nature of such a phalanx that any gap can become a weakness. Therefore, the participants must not only co-operate at the national level, but the national systems must be linked to form an anti-falsification network on a European scale.

In Germany, we started early on with the securPharm project and have made tremendous progress. In retrospect, this was the right way. The implementation of the requirements of the Falsified Medicines Directive and the delegated regulation has turned out to be the greatest infrastructure project of the pharmaceutical industry, and demands more time and effort than originally anticipated. In this respect, the manufacturers are shouldering the main financial and organisational burden. Therefore, they should no longer hesitate, and proceed to equip their products with safety features and set up national verification systems in the EU member states.

What’s important is closing the phalanx now and creating a gapless safety net to ensure that the pharmaceutical market in Europe becomes even safer.


Dr. Reinhard Hoferichter is spokesman for the board of directors of securPharm e.V., the organisation that develops the authentication system for prescription drugs in Germany. Hoferichter, a pharmacist, has held several management positions in the pharmaceutical industry in the fields of medicine, health policy, and quality management. Today, he is in charge of Public and Governmental Affairs at Sanofi-Aventis-Deutschland GmbH. He also serves on the management board of the State Chamber of Pharmacists for the state of Hesse.

Alain Dostie, @ Nanobiotix

Nanobiotix: Oncology expert

The nanomedicine specialist Nanobiotix announced ex-Novartis industry veteran Alain Dostie as new Chief Operating Officer. 

Dostie will be in charge of Nano­biotix’ operations, including development, manufacturing, market access, and sales, particularly for the lead product NBTXR3. The radio-enhancer could reach a CE market approval and a first phase II/III interim readout this year. Dostie, who holds a Bachelor of Science in Human Biology, joins the company after 25 years of international experience in the  pharmaceutical industry, especially in market access and oncology. Previously, he worked as Oncology General Manager at Novartis Pharma GmbH in Germany.