Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharma. Inc.

December 29, 2011

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name:  Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharma. Inc.,  2011-1611, 2011 U.S. App. LEXIS 24602 (Fed. Cir. Dec. 12, 2011) (Circuit Judges Rader, Dyk, and O'Malley presiding; Opinion by O'Malley) (Appeal from D.N.J., Martini, J.)

Drug Product and Patent(s)-in-Suit: Doryx® (doxycycline hyclate delayed-release tablets); U.S. Patent No. 6,958,161

Nature of the Case and Issue(s) Presented:  Whether the district court erred when it granted a preliminary injunction before expiration of the thirty-month stay.  Warner Chilcott (WC) sued Mylan in May 2009 after Mylan had filed its ANDA and certified against the '161 patent.  WC's lawsuit triggered the thirty-month stay, which was set to expire in September 2011.  A month before the expiration of the stay, WC moved the district court for a temporary restraining order and preliminary injunction to prohibit Mylan's launch of its generic product.

The district court received briefs on WC's motion and heard oral argument.  During the oral argument, the district court noted a disagreement between the parties' experts on the primary claim term in dispute.  But the district court failed to conduct an evidentiary hearing.  When Mylan pressed for the evidentiary hearing, the district court refused because of its busy docket and its belief that limited testimony would not be helpful.  The district court granted WC's motion, including a finding, based on disputed facts, that WC was likely to succeed on its infringement claim.  The district court did not make any findings on Mylan's invalidity claim.  Mylan appealed the district court's granting of the preliminary injunction.  The Federal Circuit vacated the injunction and remanded the proceedings back to the district court.

Why Mylan Prevailed:  (No evidentiary hearing and no invalidity findings result in vacating preliminary injunction).  The Federal Circuit vacated and remanded the case because the district court made two errors.  First, the district court did not conduct an evidentiary hearing, which is required under Third Circuit precedent when there is a dispute of material fact.  Second, the district court did not make any findings related to Mylan's invalidity claim as required under Federal Circuit precedent and Federal Rule of Civil Procedure 52(a).

Though the Federal Circuit empathized with the district court's busy docket, Third Circuit precedent was clear that when considering such an extraordinary remedy like a preliminary injunction, a district court must conduct an evidentiary hearing when there is a material fact in dispute.  In particular, the Federal Circuit noted that the district court specifically identified that there was a dispute over whether one claim element was present in Mylan's generic product.  Thus, without an evidentiary hearing, the district court could not properly issue a preliminary injunction to resolve the question of whether the disputed claim element was present in Mylan's generic product.

The Federal Circuit also found error in the district court's failure to make any findings on Mylan's invalidity claim.  Without the appropriate findings, the appellate court cannot make any meaningful review of the district court's decision.  This failure is contrary to Supreme Court precedent and Federal Rule of Civil Procedure 52(a).  This was yet another ground for vacating the district court's ruling.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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