Federal Appeals Court Permits Apotex to Contest First-Filer Exclusivity With Patent Suit

Generics makers may soon have a new way to challenge first-filer marketing exclusivity held by their rivals under certain circumstances after a federal appeals court reinstated a lawsuit from Apotex.

The U.S. Court of Appeals for the Federal Circuit last week reversed a decision by the U.S. District Court for the Northern District of Illinois that had dismissed Apotex’s lawsuit for lacking in sufficient controversy.

Apotex’s lawsuit — filed in 2012 — is trying to circumvent the 180 days of marketing exclusivity reserved for Mylan Pharmaceuticals once brandmaker Daiichi Sankyo’s patent protection on its hypertension drug Benicar (olmesartan medoxomil) runs out in October 2016.

Apotex already earned tentative FDA approval and wants to go to market with its generic before Mylan’s exclusivity period expires in April 2017, according to the precedent-setting ruling in Apotex Inc. v. Daiichi Sankyo Inc. To do that, Apotex’s lawsuit is seeking a declaratory judgment that its generic of Benicar won’t infringe the drug’s ’703 patent.

Daiichi Sankyo disclaimed the ’703 after Mylan’s 2006 Paragraph IV ANDA, making the protection the patent could have granted null and void. However, Mylan has maintained its Paragraph IV certification against the ’703, which entitles it to the exclusivity unless another generics maker such as Apotex wins a judgment of non-infringement.

The district court had sided with Daiichi Sankyo because the patent already has been disclaimed. The appellate court, however, found that just because the patent had been disclaimed does not mean there is insufficient controversy for a case — in particular because of the economic impact on Daiichi Sankyo and Mylan should another generics maker enter the market before the end of the 180 days of exclusivity. The appellate court also allowed for Mylan to enter the lawsuit in opposition to Apotex’s bid.

Daiichi Sankyo said that it plans to file for reconsideration or rehearing of the ruling. Mylan did not respond to a request for comment by press time. — Bryan Koenig