Judge Sue L. Robinson: Permanent Injunction Denied in ANDA Suit

The Hatch-Waxman statute provides that when an act of infringement is found, the court shall order the effective date of approval of any durg to be no earlier than the date of the expiration of the patent-in-suit. 35 U.S.C. 271(e)(4)(A). Judge Robinson in Alcon, Inc. v. Teva Pharmaceuticals USA, Inc., found that claim one of the patent-in-suit was valid and infringed. C.A. No. 06-234-SLR, Memo. Order (D. Del. Aug. 5, 2010). The judgment was amended to provide that the effective date of any approval shall not be prior to six months after the expiration date of the patent-in-suit. Id. at 3. Plaintiff also moved for entry of a permanent injunction. The Court denied plaintiff’s request finding that because of the relief related to the effective date, plaintiff cannot show any irreparable harm and further cannot show that remedies available at law are inadequate to compensate for defendant’s infringement. Id. at 5. Finally, the only hardship asserted by plaintiff, that it would be unable to exclude the defendant from experimental, private use of the patent, would actually “deprive the public of the benefit of [defendant’s] developmental efforts.” Id. at 6. Therefore, the Court declined to enter an injunction.

Alcon, Inc. v. Teva Pharmaceuticals USA, Inc., C.A. No. 06-234-SLR, Memo. Order (D. Del. Aug. 5, 2010).