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21 January 2019Americas

PTAB denies Novartis petitions to review Plexxikon patents

The US Patent and Trademark Office (USPTO) has declined to hear two petitions filed by Switzerland-based Novartis to review two patents owned by drug discovery company Plexxikon.

In its decision on January 16, the USPTO’s Patent Trial and Appeal Board (PTAB) said it would not review the patents related to Plexxikon’s skin cancer treatment, Zelboraf (vemurafenib).

The two patents concerned are US numbers 9,844,539 and 9,469,640, for “compounds and methods for kinase modulation, and indications therefor”.
Novartis’s challenges to the patents came after Plexxikon accused Novartis of infringing its ‘640 patent in August 2017.

The case relates to a deal between British pharmaceutical company GSK and Novartis. However, GSK was not named as a defendant in this case.

In its complaint, Plexxikon said that, in 2013, GSK received FDA approval for a drug named Tafinlar (dabrafenib) for treatment of melanoma.

Tafinlar directly competes with Zelboraf, Plexxikon claimed.

Plexxikon said that it had approached GSK back in 2005, disclosing the genetic target of Plexxikon’s selective kinase inhibitors, and offering to engage in a dialogue about possible collaboration.

The companies entered into a confidential disclosure agreement but could not reach a business arrangement.

There is substantial evidence to suggest that GSK built Tafinlar by copying Plexxikon’s invention, said Plexxikon’s filing.

In 2015, GSK transferred a portfolio of oncology drugs, including Tafinlar, to Novartis, the filing said.

In the case at hand, Novartis petitioned for post grant review (PGR) of 15 claims of the ‘539 patent and an inter partes review (IPR) of eight claims of the ‘640 patent.
Regarding the ‘539 patent, Novartis said the claims were invalid due to a lack of enablement.

For a patent application to be complete, the invention laid out in it must be enabled. This means that the patent must explain enough about the invention so that a person skilled in the art can make and use the invention.

In deciding not to institute the PGR, the board concluded Novartis’s lack of enablement argument failed.

It said the patent had a “sufficient written description”, which “need only reasonably convey to persons skilled in the art that the inventor had possession of the subject matter in question”.

The board ruled that it was not convinced by Novartis’s argument that a person of ordinary skill in the art would not be able to either make or use the claimed invention “without undue experimentation”.

Novartis also sought an IPR of eight claims of the ‘640 patent.

However, the PTAB rejected the request because “the same prior art arguments were previously presented to the office” during prosecution of the ‘640 patent.

The PTAB said it “recognised the burden and expense to Plexxikon in having to defend the ‘640 patent based on arguments already considered by the office” and would therefore decline to institute an IPR.

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More on this story

Americas
7 August 2017   Novartis has been hit with a patent infringement lawsuit by Plexxikon, a drug-discovery company.

More on this story

Americas
7 August 2017   Novartis has been hit with a patent infringement lawsuit by Plexxikon, a drug-discovery company.