Introduction
The litigation between LEO Pharma A/S and Perrigo UK FINCO Limited Partnership is a complex patent infringement case that has been ongoing in the United States District Court for the District of Delaware. This case involves multiple patents related to LEO Pharma's drug Picato® (ingenol mebutate gel) and allegations of infringement by Perrigo.
Background
LEO Pharma A/S, along with its subsidiaries LEO Laboratories Limited and LEO Pharma, Inc., filed patent infringement actions against Perrigo UK FINCO Limited Partnership and Perrigo Company under the Hatch-Waxman Act. The primary dispute revolves around the infringement of several U.S. patents held by LEO Pharma, which are crucial for the manufacture and sale of Picato®, a drug approved by the FDA for the treatment of actinic keratosis[3].
Parties Involved
- Plaintiffs: LEO Pharma A/S, LEO Laboratories Limited, and LEO Pharma, Inc.
- Defendants: Perrigo UK FINCO Limited Partnership and Perrigo Company.
Patents in Dispute
The litigation involves multiple U.S. patents, including but not limited to:
- U.S. 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. These patents cover various aspects of the drug Picato®, including its composition, methods of synthesis, and use[3].
Claims and Allegations
LEO Pharma alleges that Perrigo's submission of Abbreviated New Drug Applications (ANDAs) to the FDA for generic versions of Picato® infringes on the aforementioned patents. Specifically, LEO Pharma claims that Perrigo's ANDA products would infringe on the '656, '292, '827, '828, '919, '163, '271, '375, '698, and '084 patents[3].
Procedural History
- Initial Complaint: LEO Pharma filed the initial complaint alleging patent infringement.
- Amended Complaints: LEO Pharma filed amended complaints to include additional patent claims, such as the '698 and '084 patents, which cover methods of synthesizing ingenol mebutate[2][3].
- Perrigo's Response: Perrigo produced the relevant ANDAs and contested the validity and enforceability of LEO Pharma's patents. Perrigo also raised allegations of inequitable conduct, suggesting that LEO Pharma failed to disclose critical information to the USPTO during the patent prosecution process[2].
Key Issues and Arguments
Inequitable Conduct
Perrigo alleged that LEO Pharma engaged in inequitable conduct by submitting Oaths of Inventorship that did not credit all contributors to the invention. This claim suggests that LEO Pharma intentionally deceived the USPTO, which could render the patents unenforceable[2].
Claim Construction
The court conducted a Markman hearing to determine the construction of disputed claim terms. The decision emphasized the importance of intrinsic evidence, such as the patent specification, in determining the meaning of disputed terms[3].
Validity of Patents
Perrigo challenged the validity of LEO Pharma's patents, arguing that the subject matter of the claimed inventions was not conceived by the named inventors. This challenge is rooted in the same facts supporting Perrigo's inequitable conduct claim[2].
Court Decisions and Recommendations
- Memorandum Opinion and Order: The court granted LEO Pharma's motion to amend the complaint to include additional patent claims. The court also addressed Perrigo's allegations of inequitable conduct and patent invalidity, finding them sufficient to state a viable claim at the pleadings stage[2].
- Claim Construction Recommendations: The court provided recommendations on the construction of disputed claim terms, emphasizing the role of intrinsic evidence in claim construction analysis[3].
Current Status and Implications
The case remains ongoing, with both parties engaging in various legal motions, including summary judgments and pretrial proceedings. The outcome of this litigation will have significant implications for the pharmaceutical industry, particularly in the context of generic drug approvals and patent enforcement under the Hatch-Waxman Act[5].
Key Takeaways
- Patent Infringement: The case highlights the complexities of patent infringement litigation in the pharmaceutical sector.
- Inequitable Conduct: Allegations of inequitable conduct can significantly impact the enforceability of patents.
- Claim Construction: The importance of intrinsic evidence in determining the meaning of disputed claim terms is reiterated.
- Hatch-Waxman Act: The case underscores the role of the Hatch-Waxman Act in regulating generic drug approvals and patent disputes.
Frequently Asked Questions (FAQs)
What is the main dispute in the LEO Pharma v. Perrigo litigation?
The main dispute revolves around LEO Pharma's allegations that Perrigo's ANDA submissions infringe on several U.S. patents related to the drug Picato®.
Which patents are involved in the litigation?
The litigation involves multiple U.S. patents, including but not limited to U.S. 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.
What are the allegations of inequitable conduct raised by Perrigo?
Perrigo alleges that LEO Pharma engaged in inequitable conduct by submitting Oaths of Inventorship that did not credit all contributors to the invention, potentially deceiving the USPTO.
How does the Hatch-Waxman Act relate to this litigation?
The Hatch-Waxman Act regulates the approval process for generic drugs and provides a framework for resolving patent disputes between brand-name drug manufacturers and generic drug applicants.
What is the current status of the litigation?
The case is ongoing, with both parties involved in various legal motions, including summary judgments and pretrial proceedings.
Sources:
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE LEO PHARMA A/S, LEO PHARMA INC. and FOAMIX PHARMACEUTICALS LTD., Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC. and PERRIGO UK FINCO LIMITED PARTNERSHIP Defendants. [PDF]
- Case 1:16-cv-00430-JFB-SRF Document 161 Filed 12/28/17 Page 1 of 31 PageID #:
- Case Type. civil ; Nature of Suit. Patent ; Cause. 35:271 Patent Infringement ; Party Names. Perrigo Company, Counter Claimant Perrigo UK FINCO Limited Partnership
- LEO Pharma A/S et al v. Perrigo UK FINCO Limited Partnership et al ... Case #:, 1:18-cv-00401. Nature of Suit, 835 Property
Last updated: 2025-01-14
