Susan Montgomery /
19 September 2016Americas

AIPPI 2016: Eli Lilly counsel criticises ‘lazy’ US Supreme Court

A patent counsel at Eli Lilly has blasted the US Supreme Court for being lazy in its approach to assessing the patentability of gene-based sequencing.

In a discussion today, September 19, at the 2016 AIPPI World Congress in Milan, Manisha Desai, assistant general patent counsel at the US company, criticised the court’s “troubling” approach in cases such as AMP v Myriad Genetics.

She said the court puts a threshold test on patentability and can move it “where they need it to be”, allowing judges to be lazy and avoid the examination of novelty, inventive step and sufficient description.

“If they don't like something about the claims, they’re Section 101 ineligible. I think the judges are being a bit lazy,” she claimed.

Referencing the 2013 Myriad decision, she said it was a politically charged time and the company was seen as being aggressive in asserting its patents.

Desai said she fears that the need to punish Myriad was partly behind the ruling, with the session moderator Penny Gilbert, a partner at Powell Gilbert in the UK, adding that it was a “bad set of circumstances that we will be living with for a while”.

Myriad’s claims were directed to isolated DNA sequences associated with predisposition to breast and ovarian cancers and to diagnostic methods of identifying mutations in those DNA sequences.

The court found that isolated DNA involving a naturally occurring segment of DNA was not patent-eligible, but held that complementary DNA (cDNA) was not naturally occurring and therefore was patentable.

The panel had earlier heard from Justice John Nicholas of the Federal Court of Australia.

He discussed the decision from October 2015 when the High Court of Australia unanimously held in D’Arcy v Myriad Genetics that isolated naturally occurring DNA cannot be patented.

The decision overturned two earlier Federal Court rulings that had unanimously upheld the patent eligibility of isolated DNA. The first of those, Cancer Voices Australia v Myriad Genetics in 2013, was decided by Nicholas.

He said that up until the High Court trial, in order to grant patentability in this area, the jurisprudence required claims to produce an artificial effect and have some economic significance/utility. At trial, the parties challenging the claims did not dispute the second factor, he said, so the focus was on the first.

The High Court made two critical findings, according to Nicholas, including that the genetic information was not man-made, but merely discerned by the inventors, “so what was claimed was not man-made at all”.

Nicholas said the court also considered policy matters, such as whether the claims gave rise to a large monopoly with a negative effect on innovation, and whether they had a chilling effect beyond the claim of exclusive rights.

The court said the claims were invalid under these new tests and the majority decision “did not really address products of nature”.

Noting that these policy considerations were most concerned with not stifling research and innovation, Nicholas said it was an “interesting way of approaching it”.

The 2016 AIPPI World Congress runs until September 20.

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