LSPN Connect: Protecting biologics at home and abroad

Biologics are playing an increasingly important role in healthcare, but for corporate patent counsel, the differences in rules between the US and Europe are a real cause for concern.

Duane Marks, assistant general patent counsel at Eli Lilly, and Ahmed Mousa, general counsel at Pieris Pharmaceuticals, joined LSPN Connect to discuss “Protecting Antibodies and Other Biologics” yesterday, September 3.

The US patent system has been beset with uncertainty over patent eligibility over the past decade. But new guidance from the US Patent and Trademark Office means that many practitioners see Europe as the more problematic jurisdiction now.

“Fortunately, we don’t have as much uncertainty in the US anymore,” Marks said, continuing: “The US is now much more consistent and we’re able to do a better job of providing business advice to our companies.”

But the rules of the European Patent Office are still a cause for concern, he added: “In Europe, at times, you can’t give them that business advice. If I’m looking for a potential freedom to operate issue, I don’t always know if a particular patent will fall under clarity or sufficiency.”

Marks and Mousa confirmed that adapting to the rules in different jurisdictions is a key part of a patent attorney’s role, especially in the life sciences where companies seek international portfolios.

“Build your patent from multiple perspectives,” Mousa advised. “Having different claim options will help you withstand a storm that you can’t necessarily predict at the time you’re prosecuting,” he said.

Mousa added: “That kind of claim strategy will serve you well in Europe, where they’re saying the process of generating an antibody is routine.”

The frustrations pharmaceutical companies have with the European rules is borne out in high-level business discussions, Marks said: “When you’re preparing to invest $1 billion, you have to talk about that uncertainty. At times companies will say, can we make a business case even if we leave the European market out?”

Some national jurisdictions present their own challenges as well. “You need to be cautious patenting in Asian countries where your biologics claims will be pushed to a narrow level,” Mousa said.

This can be challenging for smaller companies, which often face pressure to patent early.

It’s also important to maintain close communication across the company when preparing to file a patent, as some fine-tuning of the invention may still be going on, Mousa explained.

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