10 December 2013Americas

IP Summit: life sciences IP challenges

The rapidly-evolving field of life sciences presents a variety of unique IP challenges, which were debated at this year's PanEuropean IP Summit in Paris.

Penny Gilbert, partner at Powell Gilbert LLP in London, chaired a discussion on biotechnology patents. She said that the EU Biotech Directive goes some way in harmonising the different approaches taken by different jurisdictions, though some difficulties remain in an area she described as “emotive”.

She said that the long process of product development throws into question the adequacy of patent terms. While it was agreed that is becoming more difficult to get biotech patents, Phillippe Bessière, former IP lead at Syngenta International, said: “Getting a patent is one thing, getting a patent with a reasonable scope is another."

Like some technologies, biologicals can be easily replicated, so it is important they have strong IP protection, he added.

Nicolas Ruiz, director of IP and European patent attorney at Esteve, observed that many biotech inventions are made outside the companies that may ultimately produce and market them, by smaller entities and start-ups. “You need to have more licensing and cross-licensing earlier than in other fields,” he said.

Bessière added that the rising cost of drug development means that many companies will try to license their invention before performing Phase I trials. As every step in a biosimilar's development is patented, this must be considered in the company's business model, he said.

It is becoming more important to perform freedom to operate studies earlier, as there is “more and more complex prior art to study,” Ruiz added.

“We have to pay more attention to validity."

The business of patenting medical devices is rife with pitfalls, as Jörg Dreyhsig, vice president of Fresenius Medical Care explained in another discussion.

Different jurisdictions have different ideas of what medical devices patents are permissible. The Australian High Court recently ruled methods of treatment are permissible as patents, while in Canada, methods of treatment are not patent-eligible.

After receiving a patent in one jurisdiction, an inventor will have to redraft their application for another taking care not to include claims, like those covering methods of treatment, that could jeopardise the entire application, he said.

Al Tramposch, deputy executive director at the American Intellectual Property Law Association, said that process patents are not allowable in the EU, presenting problems for American inventors applying there.

There was some trepidation when the panel was asked whether they would opt in to using the United Patent Court.

Dietmar Pressner, vice president of global IP at DSM, said he was supportive of harmonisation though noted major players in the industry had already suggested they would be opting out.

Dreyhsig said: “We'll try the system, but not first.”

Tramposch agreed: “It's an appealing idea, but it needs to pan out by either being as simple as or simpler than the current procedure.”

The PanEuropean IP Summit takes place in Paris from December 9 to 11 2013.

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