Federal Circuit affirms Novartis Alzheimer’s patents as obvious

The US Court of Appeals for the Federal Circuit has affirmed rulings by the Patent Trial and Appeal Board (PTAB) that two of Novartis’s patents are obvious.

In 2015, pharmaceutical company Noven filed four inter partes reviews with the PTAB concerning US patent numbers 6,316,023 and 6,335,031.

Both patents, which cover pharmaceutical compounds, are titled “TTS containing an antioxidant”. This compound is useful for the treatment of Alzheimer’s disease.

In its decisions, the PTAB found that various claims of the patents-in-suit were obvious over the prior art and were therefore unpatentable.

The PTAB had maintained its findings when asked to reconsider them, and denied Novartis’s request to reconsider.

Novartis then appealed against the decision.

The Federal Circuit handed down its decision yesterday, April 4, ruling that the PTAB had properly concluded that the asserted claims of the patents were obvious.

The court added that Novartis’s argument fails on “factual and legal grounds”.

Novartis had alleged that the PTAB made a “fundamental legal error” in its final decision, because it had reached different conclusions from the US District Court for the District of Delaware in a previous decision which addressed the “same” arguments and evidence.

In response to this argument, the Federal Circuit said that the PTAB was not wrong in reaching a different conclusion, even though it was based on the same evidence.

This was because the PTAB used the “preponderance of evidence” standard in addressing unpatentability, while the district court assessed “clear and convincing evidence”.

The court also said it found additional reasons why the patents were unpatentable, but did not discuss these in the ruling because it had affirmed the  PTAB’s conclusion on obviousness.

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