4 December 2013Biotechnology

C5 Congress: Myriad decision "will not" affect patenting in Europe

Aliki Nichogiannopoulou, director of biotechnology at the European Patent Office, outlined best practices for patenting antibodies at the office while speaking at the 25th C5 Congress on Biotech and Pharma Patenting in London on Wednesday.

Antibodies are proteins produced by the body to fight disease. When isolated, they can be used to treat cancer. Monoclonal antibodies, which bind to specific antigens and can be grown indefinitely, “bear the promise for cancer therapy”, according to Nichogiannopoulou.

However, because of their structure, and as they are naturally occurring, antibodies are subject to different patenting rules compared with small molecule drugs.

Nichogiannopoulou said the EPO had been accused of treating antibody patents in a derogatory fashion, to which she countered: “We love antibody patents.”

She later added, after telling the audience that there are 30 immunologists working at the EPO: “We are not looking for reasons to kill your application.”

Although naturally-occurring molecules that have been isolated from the human body are not patent-eligible, as was the conclusion of the Myriad case earlier this year, Nichgiannopoulou said the Supreme Court's decision in this instance will not have an impact on patenting practice in Europe.

The question of inventive step is crucial with antibodies, Nichogiannopoulou said. Inventive step depends on whether the antibody has an unexpected effect. Where the antigen is known, the antibody must be novel, otherwise a patent will not be granted.

She recommended talking to the technicians to determine the difficulty of isolating a molecule to show its novelty.

However, with the rapid evolution of technologies, the rules laid out today are subject to change: “Technologies do not stagnate,” she said.

As soon as an antibody can be obtained by a routine method, the provision of a mere alternative without a surprising technical effect cannot be considered an alternative, which is not the case with small molecules, Nichogiannopoulou added.

All in all, it's “good news wrapped in bad news”, she said, as naturally-occurring antibodies and a plethora of scaffold molecules available today offer great possibilities for modifications and improvements.

Rather than a needle in a haystack, Nichogiannopoulou called it looking for a “needle in a needle stack”.

“We know the products are there; R&D just needs to find them,” she said.

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