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18 June 2015Americas

BIO 2015: The ‘silent killer of innovation’

Philip Johnson, Johnson & Johnson’s senior vice president of intellectual property and policy, told the BIO International Convention yesterday that uncertainty around patent eligibility of inventions is a “silent killer of innovation”.

In a session on day three of the conference, a panel discussed whether amendments should be made to section 101 of the US Code, which governs patent eligibility.

Robert Armitage, former general counsel at Eli Lilly, noted the unfortunate timing of the climate of uncertainty, as the life sciences industry is on the brink of huge progress. Furthermore, he said, investment into research and development is falling.

The discussion came at an opportune time, as the US Court of Appeals for the Federal Circuit’s decision in Ariosa v Sequenom last Friday, June 12, has made the future of diagnostic method patents uncertain.

In that ruling, the court found that Sequenom’s patent covering a “method of detecting a paternally inherited nucleic acid of foetal origin performed on a maternal serum or plasma sample from a pregnant female” is invalid, as it applied to a natural phenomenon.

The decision was based on the standard set in Mayo v Prometheus.

Even though Judge Richard Linn recognised the innovation as “ground breaking”, that it was a “paradigm shift” and that the facts of Mayo were completely different from this case, he concurred with the court’s decision that the patent was invalid, stating that he was bound by the Mayo standard.

Kristin Neuman, an executive director at patent pool management company MPEG LA, said the decision has left molecular diagnostics with “nowhere to go”.

“We’re in a state of chaos”, added David Kappos, former director of the US Patent and Trademark Office.

He noted that uncertainty about the patent eligibility of life sciences inventions will have a financial impact on the sector, as investors direct capital to other industries.

The patent statute has been reduced to an abstract “litmus test”, Kappos said.

We shouldn’t expect the quality of patents to improve under this regime, he added. This is not the fault of the USPTO, he said, as it is “trying to solve an insoluble question”.

The  2015 BIO International Convention is taking place in Philadelphia from June 15 to 18.

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