Litigation Details for LEO Pharma A/S v. Actavis Laboratories UT, Inc. (D. Del. 2016)

LEO Pharma A/S v. Actavis Laboratories UT, Inc. (D. Del. 2016)

Docket		Date Filed	2016-05-06
Court	District Court, D. Delaware	Date Terminated	2018-08-16
Cause	35:271 Patent Infringement	Assigned To	Sue Lewis Robinson
Jury Demand	None	Referred To	Sherry R. Fallon
Parties	ACTAVIS LABORATORIES UT, INC.
Patents	6,432,452; 6,787,161; 6,844,013; 7,410,656; 8,278,292; 8,372,827; 8,372,828; 8,377,919; 8,536,163; 8,716,271; 8,735,375; 9,820,959; 9,833,428; 9,833,429
Attorneys	Jonathan D. Ball
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for LEO Pharma A/S v. Actavis Laboratories UT, Inc. (D. Del. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-05-06	1		of U.S. Patent No. 7,410,656 (“the ’656 Patent”), U.S. Patent No. 8,278,292 (“the ’292 Patent”), U.S.…the ’656 Patent, ’292 Patent, the ’827 Patent, the ’828 Patent, the ’919 Patent, the ’163 Patent, the ’…U.S. Patent No. 8,372,827 (“the ’827 Patent”), U.S. Patent No. 8,372,828 (“the ’828 Patent”), U.S. Patent…8,377,919 (“the ’919 Patent”), U.S. Patent No. 8,536,163 (“the ’163 Patent”), U.S. Patent No. …the ’271 Patent”), and U.S. Patent No. 8,735,375 (“the ’375 Patent”) (collectively, “the Patents-in-Suit	External link to document
2016-07-21	15		of U.S. Patent No. 7,410,656 (“the ’656 Patent”), U.S. Patent No. 8,278,292 (“the ’292 Patent”), U.S. …Declaratory Judgment of Invalidity of U.S. Patent No. 7,410,656) 17. Actavis realleges and incorporates…Declaratory Judgment of Noninfringement of U.S. Patent No. 7,410,656) 29. Actavis realleges and incorporates…. Patent No. 8,372,827 (“the ’827 Patent”), U.S. Patent No. 8,372,828 (“the ’828 Patent”), U.S. Patent…8,377,919 (“the ’919 Patent”), U.S. Patent No. 8,536,163 (“the ’163 Patent”), U.S. Patent No. 8,716,271 (“	External link to document
2017-12-14	198		and Initial Infringement Charts for U.S. Patent Nos. 9,820,959; 9,833,428; 9,833,429 filed by LEO Laboratories…2016 16 August 2018 1:16-cv-00333 830 Patent None District Court, D. Delaware	External link to document
2017-12-28	203		x27; 161 patent and the '013 patent claim priority to parent U.S. Patent No. 6,432,452 ("the…x27;013 patent), as well as the '656 patent, the '292 patent, the '827 patent, the '…#x27;828 patent, the '919 patent, the '163 patent, the '271 patent, the '375 patent… Aylward patents include the '656 patent, the '013 patent, and the' 161 patent. (D.I. 142… The Brown patents include the '292 patent, the '827 patent, the '828 patent, the '	External link to document

LEO Pharma A/S v. Actavis Laboratories UT, Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between LEO Pharma A/S and Actavis Laboratories UT, Inc. is a significant case under the Hatch-Waxman Act, involving patent infringement allegations related to LEO Pharma's Picato® pharmaceutical products. Here, we delve into the key aspects of this case, including the background, the patents in dispute, the allegations of inequitable conduct, and the court's rulings.

Background

LEO Pharma A/S, along with its subsidiaries LEO Laboratories Limited and LEO Pharma, Inc., filed a complaint for patent infringement against Actavis Laboratories UT, Inc. and Actavis, Inc. on May 6, 2016. The complaint was in response to Actavis's filing of Abbreviated New Drug Applications (ANDAs) Nos. 208807 and 209086 with the U.S. Food and Drug Administration (FDA), seeking approval to market generic versions of LEO Pharma's Picato® products. Picato® is a gel containing ingenol mebutate as the active pharmaceutical ingredient (API) at dosage strengths of 0.015% and 0.05%[2][5].

Patents in Dispute

The litigation involves multiple patents held by LEO Pharma, including:

• United States Patent Nos. 7,410,656, 8,278,292, 8,372,827, 8,372,828, 8,377,919, 8,536,163, 8,716,271, 8,735,375, 9,676,698, and 9,416,084 against Actavis.
• Additionally, against Perrigo, LEO alleged infringement of U.S. Patent Nos. 6,787,161 and 6,844,013, along with some of the patents mentioned above[1][2].

Inequitable Conduct Allegations

Actavis filed counterclaims and affirmative defenses alleging that LEO Pharma engaged in inequitable conduct during the prosecution of the Process Patents (specifically, the '084 and '698 patents). Actavis claimed that LEO Pharma deliberately failed to disclose U.S. Patent No. 7,378,445 (the '445 patent) as prior art to the U.S. Patent and Trademark Office (USPTO). This '445 patent was assigned to LEO Pharma in 2011 but was not disclosed during the prosecution of the Process Patents, while another related patent (U.S. Patent No. 7,449,492) was disclosed[3][5].

Court's Ruling on Inequitable Conduct

The magistrate judge recommended dismissing Actavis's inequitable conduct counterclaim without prejudice. The key reason for this dismissal was Actavis's failure to identify a specific individual who made the alleged material omission. Actavis broadly identified the inventors, attorneys, or agents involved in the prosecution of the Process Patents, which was deemed insufficient to meet the pleading requirements for inequitable conduct under Federal Rule of Civil Procedure 9(b) and Federal Circuit precedent. The court emphasized that inequitable conduct requires identifying an individual with the specific intent to deceive the PTO[3][5].

Claim Construction

The court also addressed the issue of claim construction for the disputed claim terms in the patents. This involved a Markman hearing to determine the court's recommendations for the constructions of these terms, which are crucial for determining patent infringement[1].

Motion to Strike and Compel

In a related development, the court denied both LEO Pharma's motion to strike the expert report and testimony of patent attorney Stephen Kunin and Actavis's motion to compel LEO Pharma to grant Mr. Kunin access to confidential information. The court reserved the scope of Mr. Kunin's opinions for decision by the District Judge, allowing for the possibility of an amended report or further motions[2].

Conclusion

The litigation between LEO Pharma A/S and Actavis Laboratories UT, Inc. highlights the complexities and stringent requirements of patent infringement cases under the Hatch-Waxman Act. The case underscores the importance of precise pleading in inequitable conduct allegations and the critical role of claim construction in determining patent infringement.

Key Takeaways

• Patent Infringement: The case involves allegations of patent infringement related to LEO Pharma's Picato® products.
• Inequitable Conduct: Actavis's allegations of inequitable conduct were dismissed due to insufficient pleading.
• Claim Construction: The court's recommendations on claim construction are pivotal in determining patent infringement.
• Confidential Information: Motions related to access to confidential information were denied without prejudice.
• Hatch-Waxman Act: The case is a significant example of litigation under the Hatch-Waxman Act.

FAQs

What is the Hatch-Waxman Act?

The Hatch-Waxman Act is a federal law that allows generic drug manufacturers to file Abbreviated New Drug Applications (ANDAs) with the FDA, which can lead to patent infringement litigation.

What is Picato® and its significance in this case?

Picato® is a pharmaceutical product by LEO Pharma, a gel containing ingenol mebutate as the active ingredient. The case revolves around Actavis's attempt to market generic versions of Picato®.

What were the inequitable conduct allegations made by Actavis?

Actavis alleged that LEO Pharma deliberately failed to disclose U.S. Patent No. 7,378,445 as prior art during the prosecution of the Process Patents.

Why were Actavis's inequitable conduct allegations dismissed?

The allegations were dismissed because Actavis failed to identify a specific individual who made the alleged material omission, which is a requirement for pleading inequitable conduct.

What is the significance of claim construction in this case?

Claim construction is crucial as it determines the scope of the patents and whether Actavis's generic products infringe on LEO Pharma's patents.

Cited Sources

1. United States District Court for the District of Delaware, "LEO Pharma A/S, LEO Laboratories Limited, and LEO Pharma, Inc. v. Actavis Laboratories UT, Inc., and Actavis, Inc." [PDF].
2. GovInfo, "Case 1:16-cv-00333-JFB-SRF Document 332 Filed 06/18/18".
3. Robins Kaplan LLP, "Leo Pharma A/S v. Actavis Labs. UT, Inc."
4. Unified Patents, "1:16-cv-00333 - Leo Pharma A et al. v. Actavis Laboratories UT Inc et al."
5. Casetext, "LEO Pharma A/S v. Actavis Labs. UT, Inc."