After months of wrangling over patent law, a court decision has cleared the way for generics of Pfizer’s $3 billion painkiller Celebrex. Analysts project the decision will cost the company billions in sales in coming months. Mylan, Actavis’ Watson Labs, and Lupin Pharma will come to market with authorized generics, after a US appeals court decision that also clarified law pertaining to reissued patents and 180-day exclusivity.

In reversing a June decision by a district court, the appeals court agreed with the generic firm petitioners that the FDA had improperly granted Teva Pharma 180-day exclusivity. The three companies had argued they should receive approval no later than the same date of first ANDA approval, which Teva had received from FDA in May.

The three generic makers’  gain with the ruling is Teva’s loss. With the reversal of the FDA decision concerning Teva’s right to exclusivity, Teva goes to the back of the pack of the first group of filers, and won’t be selling the drug until June at the earliest.

At the center of the back-and-forth litigation was the issue of how the FDA should treat reissued patents in relation to the 180-day exclusivity period. In its interpretation, the agency treats the patents as a single “bundle of rights” which can give rise to only a single 180-day exclusivity period.

“The court’s decision puts the kibosh on FDA’s ‘bundle of rights’ theory under which an original patent and a reissued patent are treated as a single bundle of rights for purposes of 180-day exclusivity,” wrote the FDA Law Blog.


The appeals court took the view that a reissued patent can be the basis for a new period of 180-day exclusivity, terming FDA’s interpretation contrary to statute which indicates that “each patent that is the subject of certification may trigger exclusivity.”

ANDA applicants Mylan, Watson and Lupin, along with Teva, announced the launch of authorized generic versions last week.