LSIPR 50 2017: Stéphane Drouin—Innovation in a volatile climate

“In the United States of America, healthcare is not a privilege for the fortunate few—it is a right,” Barack Obama said in 2013 when he spoke as President about the Patient Protection and Affordable Care Act, which had been signed into law in 2010.

The act, also known as ‘Obamacare’, aims to give more Americans access to affordable health insurance.

President Donald Trump is now trying to repeal Obamacare with the help of Republican lawmakers.

If Obamacare is repealed, this could potentially have a negative impact on patients. However, some pharmaceutical companies, such as UCB, are focused on the continued health of their patients.

LSIPR spoke to Stéphane Drouin, global head of IP at biopharmaceutical company UCB, about the company’s IP policies.

Drouin started his career in IP when he worked at law firms in Canada and France. During his time there, he focused on technology areas such as small molecules, antibodies, vaccines, devices and transgenic plants.

He has focused on patent litigation, drafting and oppositions.

In 1998, he joined pharmaceutical company Pfizer, where he led the New York IP team and the EU patent team in the UK. He also led Pfizer’s international patent organisation teams in Europe, Japan, Dubai and the US.

Drouin has worked in his current role at UCB since 2013.

“The team oversees all IP-related activities in UCB and all strategic considerations related to IP, essentially across three major areas,”
he says.

“These three major areas are creating IP linked to innovation at the company, defending and asserting our IP rights, and engaging with external stakeholders on IP policy matters.

“A fundamental role of the IP organisation is to work very closely with the teams that innovate to rapidly identify valuable IP. As the IP attorneys are strongly embedded in teams engaged in innovation, IP identification is optimal,” he adds.

“UCB is a very innovative, very patient-centric company that injects a significant amount of its revenue into research and development (R&D).”

Last year, the company’s total revenue grew to €4.2 billion ($4.4 billion), and 27% of that is spent on R&D.

Discussing how UCB defends its IP, Drouin explains that “there is a significant amount of litigation in the pharmaceutical area; mainly this is with generic companies, but not solely”.

“An important role of the IP organisation is to assert and defend UCB’s IP portfolio and to assert its rights against various companies that are trying to attack it,” he says.

UCB also spends a significant amount of time engaging with external stakeholders in order to explain how IP policies can “significantly impact” the company’s ability to deliver transformational first-in-class medicines to patients.

Drouin adds that we are living in a changing environment.

“Politically the environment is more complex and volatile, but recent advances in technology and science present promising opportunities for patients,” he says.

“There’s some level of dissatisfaction with regard to access to medicines, and IP is often a target in those debates. There’s a need for constructive dialogue with healthcare stakeholders and government, and also with insurance companies, to come to a common understanding of the complexity and risk associated with biopharmaceutical research.

“We need to find a way to promote both risk and benefit-sharing with stakeholders to try to find an acceptable global view on IP, innovation and access that will benefit patients.”

Driven by science

UCB was founded in Brussels by Emmanuel Jannsen and is considered a ‘mid-sized’ pharma company. Drouin says the business is “inspired by patients, driven by science”.

“At UCB everything starts with a question: ‘how can we bring value to patients living with severe diseases?’

“We have a limited number of areas where we focus and try to develop medicines tailored to our patients’ needs,” he adds.

UCB’s main areas of focus are epilepsy, Parkinson’s disease and inflammatory diseases such as arthritis, psoriasis and lupus.

Its core products include Cimzia (certolizumab pegol), used to combat rheumatoid arthritis, and Neupro (rotigotine), a drug to relieve the symptoms of Parkinson’s disease.

“UCB is often cited as being ‘the epilepsy company’. We have a number of epilepsy drugs that are already on the market and we are strongly dedicated to epilepsy research and the well-being of epilepsy patients,” Drouin explains.

“The root causes of epilepsy are still very difficult to determine and broadly diverse, and 30% of epilepsy patients have difficulty in controlling their seizures. UCB continues to be actively involved in epilepsy research.”

UCB has three epilepsy drugs on the market: Briviact (brivaracetam), Vimpat (lacosamide) and Keppra (levetiracetam).

“Also in the works is a new compound for the treatment of epilepsy, as some patients are not responsive to the current treatment and we’re trying to help this,” says Drouin.

“UCB has a diverse and quite extensive R&D portfolio largely focused on neurology, bone and immunology,” he adds.

“We try to stay one step ahead of developing disruptive technologies and areas such as data analytics and digital.”

The role of licensing

“External collaboration is important for UCB because of the extent of our research programme,” Drouin says.

“We have more drug candidates in our pipeline than we can actually develop ourselves, so licensing becomes a very important part of how UCB develops itself.”

UCB licenses some of its compounds and technology to third parties.

But, he says, “UCB strongly believes in its IP and is generally taking a very proactive approach to asserting and enforcing its rights.”

In August 2016, the US District Court for the District of Delaware confirmed the validity of UCB’s anti-epilepsy drug Vimpat.

The case centred on US patent number RE38, 551, which is due to expire in 2022.

In 2013, UCB had sued various generic companies, such as Argentum, after they applied to produce a generic version of Vimpat.

Innovation

Innovative technology in the biopharmaceutical area is making a difference to patients’ lives.

“We try to stay one step ahead of technological developments such as the sequencing of the genome and the development of big data.

“To some extent these developments are changing the way we approach our IP,” Drouin says.

“It will continue to change in the future because the availability of data and digital capabilities will increase. Healthcare is taking a different direction in the sense that patients are increasingly demanding to be more in control of their health.

“These patients are increasingly empowered; they change the way we see our relationship with healthcare,” he adds.

Healthcare, he says, is developing into something more holistic than simply selling a pill.