Apotex fails to invalidate Wyeth patent at Federal Circuit

The US Court of Appeals for the Federal Circuit has affirmed a ruling of the US Patent and Trademark Office that a patent challenged by Apotex is valid.

Apotex challenged the patent, which is owned by Wyeth, in an inter partes review (IPR) at the Patent Trial and Appeal Board (PTAB). Apotex argued that the patent was not valid because it was obvious.

In an appeal filed by Apotex and decided by the Federal Circuit yesterday, August 16, the patent in the dispute was cleared of being unpatentable as obvious.

The case centred on US patent number 7,879,828, which protects a composition comprising tigecycline, a suitable carbohydrate, and an acid or buffer.

Tigecycline is an antibiotic which may be used as a treatment against drug-resistant bacteria and often “works where other antibiotics have failed”, as said in the court case.

Apotex filed a petition with the PTAB to initiate an IPR of the ‘828 patent back in March 2013.

The PTAB said in its ruling that Apotex “failed” to provide an explanation of why the patent was obvious.

But Apotex’s attempt to challenge the board’s decision at the Federal Circuit regarding obviousness of the patent failed.

The Federal Circuit said in the ruling: “We have considered all of Apotex’s remaining arguments, but conclude that they are without merit.”

It added: “The board’s decision was supported by substantial evidence and not erroneous as a matter of law.”

Wyeth is represented by Williams & Connolly and Apotex is represented by Steptoe & Johnson.