U.S. Patent Office Review Board Strikes Down Genzyme’s Biologics Therapy Patents

A U.S. patent office review board has struck three of Sanofi subsidiary Genzyme’s patents in what appears to be the first time such a review has nixed a biologics patent.

The Patent Trial and Appeal Board rejected claims on the ‘226, ‘712 and ‘410 patents protecting Genzyme’s Myozyme/Lumizyme (alglucosidase alfa), according to separate rulings. The therapies are indicated for treating Pompe disease, a rare genetic disorder.

Unlike Hatch-Waxman lawsuits, which are typically initiated by the patent holder following a Paragraph IV ANDA filing by the generics maker, BioMarin Pharmaceutical challenged Genzyme’s patents directly in 2013 using the PTAB.

BioMarin brought the challenge not because of a biosimilar application, but because the company is currently in Phase 3 clinical trials for its own Pompe therapy, dubbed BMN 701. A BioMarin spokeswoman says that while the company welcome’s the appeal board’s decision, it also believes BMN 701 doesn’t infringe on the patents in question.

While Genzyme owns the ‘226 and ‘410 patents, the ‘712 is owned by and licensed from Duke University. Duke attorney John White, a partner with New York intellectual property firm Cooper & Dunham, said that, to his knowledge, this is the first time a PTAB review has struck down any biologics therapy patents.

Duke and Genzyme have not decided whether they’ll appeal. The patent owners could ask the review board to reconsider or they could take their appeal to the U.S. Court of Appeals for the Federal Circuit, White says. Other patents protecting the therapies remain intact, he adds.

Genzyme did not respond to a request for comment by press time. — Bryan Koenig