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7 October 2019AmericasSarah Morgan

Fed Circuit overturns Apotex’s PTAB victory

The US Court of Appeals for the Federal Circuit last week reversed a Patent Trial and Appeal Board (PTAB) decision, which found that claims in an OSI Pharmaceuticals patent for cancer treatment were obvious.

In a precedential opinion, handed down on Friday, October 4, the Federal Circuit concluded that the board’s finding that generics maker Apotex had a reasonable expectation of success was not supported by substantial evidence.

The PTAB, in January 2018, had found that four claims in US patent number 6,900,221 were unpatentable as obvious, as part of an inter partes review (IPR) requested by Apotex, which wants to make a generic version of OSI’s cancer treatment Tarceva (erlotinib). OSI was acquired by Astellas in 2010.

Tarceva is used to treat non-small cell lung cancer (NSCLC) which, according to the Federal Circuit was the leading cause of cancer deaths in 2000, claiming more than 1 million lives.

The PTAB cancelled the four claims, after finding them obvious over a prior patent (Schnur), in view either of an academic article on anticancer drug targets (Gibbs) or OSI’s own Securities and Exchange Commission filing (OSI’s 10-K).

But, on appeal, the Federal Circuit overturned the board’s decision, concluding that the PTAB’s finding that the asserted combinations of prior art would have “provided a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal” was not supported by substantial evidence.

Circuit Judge Kara Stoll said: As an initial matter, in reaching its conclusion, the board misinterpreted the asserted references to teach more than substantial evidence supports.”

Stoll added that the asserted references don’t disclose any data or other information about erlotinib’s efficacy in treating NSCLC.

None of the references contain any clinical (human) data or pre-clinical (animal) data, and the record doesn’t even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC, the judge said.

“At the same time, it is undisputed that NSCLC treatment was highly unpredictable with an over 99.5% rate of failure for drugs entering Phase II clinical studies,” Stoll added.

Based on this, said Stoll, the court was not persuaded that a reasonable factfinder could conclude that a person of ordinary skill would have reasonably expected success based on the combinations.

The court concluded with a caveat: “To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success’. We conclude only that, on these particular facts, a reasonable factfinder could not find a reasonable expectation of success.”

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