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10 January 2017Americas

Federal Circuit dismisses Phigenix patent appeal in ImmunoGen case

Pharmaceutical research company Phigenix lost an appeal at the US Court of Appeals for the Federal Circuit yesterday, after the court found that the company lacked standing in a patent case against ImmunoGen.

In the opinion, given by Circuit Judge Evan Wallach, the court held that because Phigenix had not offered sufficient proof establishing that it had suffered an injury, the company lacked standing to bring suit in federal court.

Back in 2015, Phigenix sought inter partes review of US patent number 8,337,856, assigned to biotechnology company ImmunoGen.

The patent, called “Methods of treatment using anti-ERBB antibody-maytansinoid conjugates”, covers the drug Kadcyla (ado-trastuzumab emtansine). The product is produced by Genentech, which has an exclusive licence to the patent.

Kadcyla is approved to treat HER2-positive breast cancer that has spread to other parts of the body.

Phigenix alleged that claims 1-8 of the patent were unpatentable as obvious over various prior art references. But in its final written decision, the Patent Trial and Appeal Board (PTAB) found the claims non-obvious.

Phigenix claimed that its patent, US number 8,080,534, covers Genentech’s “activities relating to Kadycla” as well as the subject matter claimed in the ‘856 patent.

The research company appealed against the decision to the Federal Circuit.

Before the parties fully briefed the appeal, ImmunoGen filed a motion to dismiss, asserting that Phigenix lacked standing to appeal.

This was denied by a single judge, who deemed it “the better course for the parties to address the standing issue in their briefs”.

Then, in its response brief, ImmunoGen again argued that Phigenix lacked standing.

The court agreed, explaining that Phigenix lacked standing under article III of the US Constitution. It dismissed the suit.

The court found that Phigenix didn’t argue that “it faces risk of infringing the ‘856 patent, that it is an actual or prospective licensee of the patent, or that it otherwise plans to take any action that would implicate the patent”.

Instead, Phigenix claimed that it has “suffered an actual economic injury because the ‘856 patent increases competition between itself and ImmunoGen” and that the patent has “encumber[ed] Phigenix’s licensing efforts”.

But the court found that Phigenix hadn’t substantiated these arguments with “record evidence developed before the PTAB”, but had relied principally upon the declarations accompanying its response to ImmunoGen’s motion to dismiss and another document.

The documents were found to be “insufficient to demonstrate injury” and there was “simply no allegation here that Phigenix has ever licensed the ‘534 patent to anyone, much less that it licensed the ‘534 patent to entities that have obtained licences to the ImmunoGen ‘856 patent”.

Eldora Ellison, director in Sterne Kessler Goldstein Fox’s biotech/chemical and litigation practice groups, and representative of ImmunoGen, said: “On behalf of our client, we're very pleased with the Federal Circuit's decision.”

She said that the decision followed a “long line of precedent” that requires an injury in fact, or an imminent injury, for a party to seek review in federal court.

“Though almost anyone can challenge a patent at the PTAB, not everyone has a right to appear in court. Going forward, parties to contested cases will certainly bear in mind this limitation on the ability of some petitioners to appeal against an agency's decision,” added Ellison.

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