Endo Pharmaceuticals v. Mylan, No. 11-220-GMS (D. Del.)
In an opinion filed on Monday, the U.S. District Court for the District of Delaware granted leave to Endo Pharmaceuticals to file an amended complaint to correct a defective initial complaint. In doing so, the court found that Endo's first complaint, while defective, properly triggered a statutory thirty-month stay.
On January 28, 2011, Endo received a Paragraph IV notice letter from Mylan concerning generic LIDODERM (lidocaine patch 5%) and asserting that U.S. Patent No. 5,741,510 is invalid or not infringed. According to Endo, LecTec Corp. (not Endo) was the owner of the '510 patent at the time. On March 14, 2011, Endo filed a complaint alleging that (1) Mylan failed to comply with the statutory requirements because it failed to notify the patent owner, LecTec (Count 1); and (2) "if the court determines now or at a future date that Mylan has complied with its obligations under the Hatch-Waxman Act to provide valid notice" then Endo pleads in the alternative that Mylan infringed the '510 patent by submitting its ANDA (Count 2).
In an order dated March 30, 2012, in response to a motion to dismiss from Mylan, the court dismissed Endo's complaint because: (1) Endo lacked standing to challenge Mylan's compliance with the statutory notice provisions; and (2) the court could not reach the infringement claim of Count 2 because Endo phrased Count 2 to be conditioned on a determination concerning Count 1.
Endo moved for leave to amend its initial complaint, arguing that the conditional language in Count 2 of the complaint was a technical defect in pleading. In its opinion Monday, granting Endo's motion, the court found that Endo did not unreasonably delay in filing its motion and that Mylan would not suffer undue prejudice as a result of the amended complaint.
In addition, the court rejected Mylan's argument that the amended complaint could not relate back to the initial complaint under Fed. R. Civ. P. 15(c). Mylan had argued that the statutory 45-day time period to invoke a 30-month stay is akin to a statute of limitations, and therefore Endo's initial complaint should be treated as if it never existed and "should not be allowed to anchor a thirty-month stay." In response, the court first noted that the 45-day time period for filing suit under the Hatch-Waxman Act is not properly characterized as a statute of limitations because failure to file suit within the 45-day window does not bar an infringement action. The court further stated, "While Endo's complaint suffered from certain pleading defects, there is no dispute that it was brought within the forty-five day timeframe, and, despite its pleading defect, the court believes it represents 'an action . . . brought for infringement of the patent that is the subject of the certification' within the meaning of the statutory language."
Losing this argument, however, does not appear to be a great loss for Mylan, since the thirty-month stay runs from January 28, 2011, and so will expire just four and a half months from now.