BIO Latin America: Eli Lilly criticises innovation bar

A counsel for pharmaceutical company Eli Lilly has said that recent court decisions, including Ariosa v Sequenom, will create a bar to innovation.

Speaking about patentability for biotechnology products in the US, Manisha Desai, Eli Lilly’s assistant general counsel, said the decision would not incentivise innovation.

Desai was speaking at the BIO Latin America conference, hosted by the Biotechnology Industry Organization and currently taking place in Rio de Janeiro.

In June, the US Court of Appeals for the Federal Circuit invalidated a patent owned by Sequenom covering a method of detecting foetal abnormalities in pregnant mothers.

The federal circuit said the patent, directed to a method of detecting paternally inherited cell-free fetal DNA (cffDNA) in maternal plasma in pregnant women, lacked an inventive step and applied to a “natural phenomenon”.

The dispute concerned Ariosa Diagnostics’ Harmony Test, a non-invasive test for prenatal diagnosis of foetal qualities, which Sequenom claimed infringed US patent number 6,258,540, obtained in 2001.

Desai said Ariosa had created a “very innovative” test but that because it covered a DNA sequence it could not be patented.

“This is not going to create an incentive for innovation,” she said, adding that another case, the US Supreme Court’s 2013 decision in Association for Molecular Pathology v Myriad Genetics had also created a bar.

Desai also criticised Justice Antonin Scalia’s concurring opinion in the Mayo v Prometheus ruling, in which he admitted that he was “unable to confirm” some finer details of the biotechnological aspects, but that he was happy to concur.

“If you have a ruling, part of which essentially says ‘I didn’t understand that but I agree anyway’, then I think you have a problem,” she said.

Desai also referenced several other cases that she said had changed the face of patentability in the US, including Bilski v Kappos and Alice v CLS Bank.

She asked: “Are the changes in law regarding patentability reflecting developments in technology, or is it because they [the judges] do not understand these developments?”

The views formed part of a wider discussion on bars to patentability, which also included a conversation on delays at certain IP offices.

Desai revealed that Eli Lilly applied for one patent at Thailand’s Department of Intellectual Property but only received confirmation of its acceptance 14 days before it was due to expire.

Joining Desai was Karla Ribeiro, a biotech patent examiner at the Brazilian Patent and Trademark Office, which itself can take up to 14 years to grant patents.

Ribeiro, who stressed that she was speaking in a personal capacity, said a government decision was required to improve the situation.

“We also have the ANVISA [Brazil’s regulatory body for drugs] problem. It has to grant consent prior to any patentability assessment, which can stall proceedings,” she said.

The BIO Latin America conference, hosted at the Sheraton Rio Hotel & Resort, closes today, October 16