Case Overview
The case of Actelion Pharmaceuticals Ltd v. Aurobindo Pharma USA Inc. (3:19-cv-15437) involves a patent infringement dispute related to Actelion's drug Opsumit® (macitentan tablets). Here is a detailed summary and analysis of the key points in this litigation.
Background
Actelion Pharmaceuticals Ltd, the plaintiff, holds the patent for Opsumit® (macitentan tablets), which is used to treat pulmonary arterial hypertension. Aurobindo Pharma USA Inc., the defendant, filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Opsumit®.
Patent-in-Suit
The patent at the center of this dispute is U.S. Patent No. 7,094,781 ('781 patent). This patent covers the composition and use of macitentan, the active ingredient in Opsumit®[2][5].
Paragraph IV Certification
Aurobindo's ANDA included a Paragraph IV certification, which asserts that the '781 patent is invalid, unenforceable, or not infringed by Aurobindo's generic product. This certification is a prerequisite for the FDA to approve a generic drug when the brand-name drug is still under patent protection[2][5].
Litigation Proceedings
Actelion filed a lawsuit against Aurobindo alleging patent infringement under 35 U.S.C. § 271(e)(2)(A), which states that the submission of an ANDA with a Paragraph IV certification constitutes an act of infringement.
Settlement and Consent Judgment
The parties reached a settlement agreement, which was reflected in a consent judgment. Here are the key terms:
- Admission of Infringement: Aurobindo admitted that the claims of the '781 patent are valid and enforceable and that they would be infringed by Aurobindo's ANDA product[2][5].
- Injunction: Aurobindo was enjoined from infringing the '781 patent until the expiration of the patent, except as permitted by the settlement agreement. This means Aurobindo cannot commercially manufacture, use, offer for sale, or sell its generic version of Opsumit® until the patent expires[2][5].
- Dismissal of Claims: All claims, counterclaims, affirmative defenses, and demands in the action were dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party[2][5].
- Paragraph IV Certification: Aurobindo was allowed to maintain its Paragraph IV certification, and the FDA was not prohibited from reviewing or approving Aurobindo’s ANDA[2][5].
Implications
- Patent Protection: The settlement ensures that Actelion's patent rights are protected until the expiration of the '781 patent, preventing Aurobindo from entering the market with a generic version before then.
- Generic Entry: The agreement allows Aurobindo to prepare for market entry once the patent expires, ensuring that generic competition can begin as soon as the patent protection ends.
- Legal Precedent: This case sets a precedent for how similar disputes might be resolved, emphasizing the importance of settlement agreements in ANDA litigation to avoid prolonged legal battles.
Key Takeaways
- Patent Validity: The settlement acknowledges the validity and enforceability of the '781 patent.
- Infringement Admission: Aurobindo's admission of infringement underscores the legal risks associated with filing an ANDA with a Paragraph IV certification.
- Settlement Terms: The terms of the settlement provide a clear roadmap for both parties, ensuring that Actelion's patent rights are respected while allowing Aurobindo to plan for future market entry.
FAQs
Q: What is the '781 patent related to in the Actelion v. Aurobindo case?
A: The '781 patent covers the composition and use of macitentan, the active ingredient in Opsumit®, a drug used to treat pulmonary arterial hypertension.
Q: What is a Paragraph IV certification in the context of ANDA filings?
A: A Paragraph IV certification is a statement by the generic drug applicant that the brand-name drug's patent is invalid, unenforceable, or not infringed by the generic product.
Q: What was the outcome of the litigation between Actelion and Aurobindo?
A: The parties reached a settlement agreement where Aurobindo admitted to patent infringement, was enjoined from selling the generic product until the patent expires, and was allowed to maintain its Paragraph IV certification.
Q: Can Aurobindo still seek FDA approval for its generic version of Opsumit®?
A: Yes, Aurobindo can still seek FDA approval, but the approval cannot be effective until the '781 patent expires, as per the settlement terms.
Q: What are the implications of this settlement for future ANDA litigation?
A: The settlement sets a precedent for resolving similar disputes through agreements that respect patent rights while allowing generic companies to plan for market entry after patent expiration.
Cited Sources:
- Robins Kaplan LLP Law Firm - ANDA Litigation Settlements Fall 2019[1].
- Robins Kaplan LLP Law Firm - ANDA Litigation Settlements Fall 2020[2].
- RPX Corporation - Case 2:23-cv-03371 Document 1 Filed 06/20/23[3].
- McDermott Will & Emery - ANDA Update - March 2016[4].
- Robins Kaplan LLP Law Firm - ANDA Litigation Settlements Spring 2020[5].
