Biotech Marathon: Vaccines And Open Innovation, But Less IP?

In a mad-dash 34-hour marathon, biotechnology and pharmaceutical industry professionals met on 1-2 February in Geneva in what was intended to be a hearth of partnering opportunities. About 600 participants debated future trends and current challenges along with open innovation, global health and vaccines.

Contracts were discussed at all hours in cosy salons or individual confessional-like booths, and some participants were finding the compressed agenda overwhelming with an early start in the morning, networking dinners late into the night and the VIP lounge open till dawn.

Although the biotechnology and pharmaceutical sectors are being challenged by the economic crisis and the inherent difficulties of innovation, participants said that some sectors were promising, such as vaccines, and biotech innovations, in particular in healthcare. However, the current systems for research and development and intellectual property protection might be obstacles for which solutions have to be designed, they said.

According to speakers, greater convergence between different sectors is important, as is the development of partnerships between the public and the private sectors, in particular a closer collaboration with governments in the public health sector.

The event is called BioSquare, a yearly occurrence which alternates between France and Switzerland and organised by BioEvents, a commercial subsidiary of the Fondation Scientifique de Lyon. According to the organisers, 25 pharmaceutical, 241 biotech, and 58 start-up companies attended the 2010 event, and 3,266 one-to-one meetings were arranged.

On a panel on open innovation, Ludo Lauwers, senior vice president for Johnson & Johnson pharmaceuticals, said that the current innovation model is not sustainable for the pharmaceutical sector, and companies should seek open innovation solutions. Open innovation is a network of partnership, beyond classical networks, he said, and implies a change of mentality.

IP Backlash on Innovation?

Intellectual property seems to be at a crossroads where industry still strongly favours it but some speakers voiced concerns about the possible counter-effects of too much IP protection on innovation.

Some departments inside companies are afraid of the risk of weak IP protection, and IP conditions should be worked out up front when an agreement is being negotiated, said Lauwers. “What we are doing today is not sustainable,” he said, arguing that beyond the intense IP discussions in courts, the patient should be central and if solutions can be brought to the market, everybody wins. Other ways must be used to protect inventions, he said, such as market exclusivity, which can delay the introduction of competing versions.

Bernard Munos, advisor on corporate strategy for Eli Lilly and Company, said industry has a strong proprietary culture and a non-disclosure policy, but a change of mentality is critical and although it is happening, progress is slow. Eli Lilly, he said, is publishing the audited results of their clinical trials.

“A lot of the things that we protect do not really need to be protected. They could be out there on the internet for the world to analyse,” and this would help a lot of people, he said.

“Maybe we created our own problem,” Munos said, adding that today any innovation has so much prior art that “to secure the access to this prior art so that you can practice your innovation it is almost an endless process,” taking years and raising costs so high that sometimes it is not worth pursuing the project, he said.

This is a paradoxical situation where a patent system that was designed to foster innovation is now actually hindering it, Munos said. The patent system was created in a pre-internet days, he said, and internet changed the dynamics of innovation. There are no longer giant advances but rather a rising number of smaller scientific contributions that need to be aggregated, he said.

Vaccines: Best Still to Come

Industry has derived significant economic benefits from the global pandemic influenza crisis and industry representatives at BioSquare were confident vaccines are a promising sector, despite rising scrutiny of the decision to declare the flu a pandemic (IPW, Public Health, 25 January 2010).

In the past, vaccines were an area of little interest for the pharmaceutical industry because of their low profit margins, said Hedwig Kresse, a senior analyst on infectious diseases for Data Monitor. However, in the last 10 to 15 years, the situation has changed considerably and vaccines are now a key revenue driver for the sector, she said.

This change has been brought about by the better understanding of the human immune system and development of new products that could be sold at premium prices, such as the Merck vaccine against the human papillomavirus, launched in 2006 and yielding important benefits, she said.

However, the market is not growing as rapidly as it used to be, and sales figures are showing stagnation, if the pandemic flu stockpiling sales are subtracted.

According to Jacques-François Martin, CEO of Mymetics, three major phenomena are creating a favourable economic environment for vaccines. The first phenomenon is evidence, as health ministers’ planning is based on evidence and “vaccine will come first” because prevention is the best way to spend money, the second is economical because “prevention always happens to have a better result” even for expensive vaccines, and the third is that the top five pharmaceutical companies no longer are producing 80% of the world’s need and new vaccine manufacturers are appearing, and they will provide cheap solutions to cover the need of developing countries. All of this will contribute to a solid growth for the sector, he said.

The key to the success in the vaccine sector has been innovation, said Jacques Cholat, vice president of commercial operations for Sanofi Pasteur. Some 20 years ago, the basic immunisation of a child would have “cost a few dollars, even in developed countries,” he said, compared to US$130 today with the arrival of new vaccines such as that for hepatitis B.

The Global Alliance for Vaccines and Immunisation (GAVI) process has “made credible the opening of the developing world to becoming a potential customer,” Cholat said. Even at low prices “like our industry is willing to do,” when multiplying that price by the number of children in developing countries, “you reach a very significant amount of money.”

“Today, with institutions like the Gates Foundation supporting GAVI,” real market for vaccines in developing countries has become credible, Cholat said.

If technological and scientific developments are promising, existing tools still have a lot to yield, said Cholat, taking the example of whooping cough, in which nowadays, in most cases in the developed world, adults are contaminating children. “We are at the very early stage of an immunisation strategy that will go far beyond children,” and which will address the immunisation status of adults all through life, bringing a very substantial development of the market, he said.