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Pfizer Loses Patent Appeal, But Wins FDA Approval

By William Vogeler, Esq. on May 21, 2018 | Last updated on March 21, 2019

At a multi-national monster like Pfizer, good news and bad news happens daily.

Last week, the good news came from government approval of its anemia treatment. The bad news came from a court invalidating one of its patents.

In Anacor Pharmaceuticals v. Iancu, a federal appeals court said a process for using tavaborole was too obvious for patent protection. That's a treatment for "toenail fungus," if you wanted to know.

Non-Obviousness

Pfizer, which owns Anacor, said it was "disappointed" with the decision from the Federal Circuit Court of Appeals. "We are reviewing the decision and considering our options," a spokesperson said.

The market for toenail fungus treatments can't be bigger than Pfizer's Lyrica, but the company response had an undertone to it. The fact that Pfizer paid $5.2 billion for Anacor Pharmaceuticals two years ago may have had something do with it.

On the bright side, Pfizer won FDA approval for a biosimilar treatment that should help the company keep up with products like Amgen's Retacrit. Amgen took in $1 billion in sales from the anemia product last year.

Whether a federal agency is giving or a federal court is taking, it's just another day for Pfizer. The Federal Circuit decision may mean more to other patent holders.

Inter Partes Review

In the case, the appeals court upheld an inter partes review requested by the Coalition for Affordable Drugs. The Patent and Trademark Appeals Board found the claims would have been obvious in light of other patents.

In its appeal, Anacor argued the board violated its procedural rights by adopting a theory that was raised in the petition. The company also complained that the board brought in new evidence without notice.

"There is, however, no blanket prohibition against the introduction of new evidence during an IPR proceeding," Judge William Bryson wrote for the court.

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