Docket No. 2011-1611
RADER, DYK, O’MALLEY
December 12, 2011
Brief Summary: The Federal Circuit vacated the DC decision because it failed to hold an evidentiary hearing and did not weight the evidence or make any findings regarding Mylan’s invalidity challenge.
Summary: Mylan appealed DC entry of a preliminary injunction prohibiting Mylan from launching generic version of 150 mg Doryx (delayed-release doxycycline hyclate tablets). The FC held that the DC did not hold an evidentiary hearing regarding certain disputed facts and therefore vacated and remanded the decision for further proceedings. Mylan filed an ANDA with a paragraph IV certification regarding U.S. Pat. No. 6,958,161. The argument turned on whether Mylan’s product has “a stabilising coat…between each core element and its modified release coating”. After a Markman hearing, the DC construed that a” stabilising coat” to mean ““a layer of material(s) between each core element and its modified release coating, which keeps the migration of core materials to a minimum such that the interaction of core materials with coating materials is reduced or prevented.” Following expert testimony, the DC noted that “that there existed ‘some serious factual disputes between the experts'” and “that ‘this would all be the subject of further testimony and examination and credibility'”. Mylan asked for a one- or two-day trial to review these issues but the DC refused because of an upcoming lengthy criminal trial. The DC concluded that Warner Chilcott had demonstrated that: (1) it was likely to succeed in proving that Mylan’s product infringed the ’161 Patent; (2) it would suffer irreparable harm absent an injunction; and (3) that the balance of hardships favored Warner Chilcott, and granted a preliminary injunction. The FC vacated the decision because the DC failed to hold an evidentiary hearing and did not weight the evidence or make any findings regarding Mylan’s invalidity challenge.