Case Overview
The litigation between Actelion Pharmaceuticals Ltd. and Natco Pharma Limited, filed as Civil Action No. 3:19-cv-12984 in the United States District Court for the District of New Jersey, revolves around patent infringement and the approval of a generic drug.
Background
Actelion Pharmaceuticals Ltd. and its US subsidiary, Actelion Pharmaceuticals US, Inc., are the patent holders for several pharmaceutical patents. Natco Pharma Limited filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Actelion's drug, specifically Bosentan Tablets for Oral Suspension, which is allegedly covered by Actelion's patents[2][3].
Patent Infringement Claims
Actelion initiated litigation against Natco within the statutory 45-day period after receiving notice of Natco's ANDA filing. Actelion alleged that Natco's ANDA product infringed claims 4, 6, 7, 8, and 9 of the '126 patent. Natco, in response, argued that these claims were either invalid or not infringed[2].
Consent Judgment and Order
In November 2019, the court entered a Consent Judgment and Order. Under this agreement, Natco acknowledged the validity and enforceability of claims 4, 6, 7, 8, and 9 of the '126 patent with respect to the manufacture, use, offer for sale, sale, and importation of the Natco Product in the United States. Natco also agreed that any commercial activities related to the product before the expiration of the '126 patent would constitute acts of infringement[2].
Licensing Agreement and FDA Approval
Although Natco obtained a license to the '126 patent, the FDA noted that the Consent Judgment and Order did not meet the requirements for terminating the 30-month stay under 21 CFR 314.107(b)(3)(vii) or (viii). Therefore, final approval of Natco's ANDA could not be granted until the expiration of the 30-month period or a court decision that the '126 patent was invalid or not infringed[2].
Key Issues and Rulings
- Validity and Infringement: The central issue was whether Natco's ANDA product infringed Actelion's '126 patent. Natco agreed to the validity and enforceability of the specified claims but sought to market the generic drug after resolving the patent issues.
- 30-Month Stay: The FDA's approval process was delayed due to the 30-month stay provision, which is a common mechanism in Hatch-Waxman litigation to allow patent holders to litigate infringement claims before generic drugs are approved[2].
Settlement and Dismissal
The case ultimately resulted in a settlement where Natco agreed to the terms of the Consent Judgment and Order. This included acknowledging the validity of Actelion's patents and agreeing not to infringe them until the patent expiration. All claims, counterclaims, and defenses were dismissed with prejudice, and each party bore its own costs and attorneys' fees[2][3].
Implications for Pharmaceutical Patent Litigation
This case highlights the complexities and strategic considerations in pharmaceutical patent litigation, particularly under the Hatch-Waxman Act. It underscores the importance of timely litigation, licensing agreements, and the role of Consent Judgments and Orders in resolving patent disputes.
Best Practices for Generic Drug Manufacturers
- Early Notice and Litigation: Generic drug manufacturers must be prepared for prompt litigation following the filing of an ANDA.
- Licensing Agreements: Securing licensing agreements can facilitate market entry but must comply with regulatory requirements.
- Regulatory Compliance: Ensuring compliance with FDA regulations, including the submission of necessary statements from patent owners, is crucial for approval.
Conclusion
The litigation between Actelion Pharmaceuticals Ltd. and Natco Pharma Limited illustrates the intricate legal landscape surrounding pharmaceutical patents and generic drug approvals. It emphasizes the need for careful strategic planning, compliance with regulatory requirements, and the potential for settlement agreements to resolve disputes.
Key Takeaways
- Patent Infringement Claims: Actelion alleged infringement of the '126 patent by Natco's ANDA product.
- Consent Judgment and Order: Natco agreed to the validity and enforceability of specified claims and not to infringe until patent expiration.
- 30-Month Stay: FDA approval was delayed due to the 30-month stay provision.
- Settlement and Dismissal: The case was resolved through a settlement, dismissing all claims with prejudice.
FAQs
Q: What was the primary issue in the litigation between Actelion Pharmaceuticals Ltd. and Natco Pharma Limited?
A: The primary issue was whether Natco's ANDA product infringed Actelion's '126 patent.
Q: What is the significance of the 30-month stay in Hatch-Waxman litigation?
A: The 30-month stay allows patent holders to litigate infringement claims before generic drugs are approved, delaying FDA approval.
Q: What was the outcome of the Consent Judgment and Order in this case?
A: Natco agreed to the validity and enforceability of specified claims and not to infringe until patent expiration.
Q: How did the settlement impact the litigation?
A: All claims, counterclaims, and defenses were dismissed with prejudice, and each party bore its own costs and attorneys' fees.
Q: What regulatory requirement was not met by Natco's submission?
A: Natco did not submit a written statement from the patent owner consenting to the approval of the ANDA as of a specific date, as required by 21 CFR 314.94(a)(12)(v).
Cited Sources:
- Actelion Pharmaceuticals Ltd. and Actelion Pharmaceuticals US, Inc. v. Natco Pharma Limited, Civil Action No. 19-12984, FDA Letter[2].
- Bosentan Tablets for Oral Suspension - accessdata.fda.gov[2].
- ACTELION PHARMACEUTICALS LTD. et al v. NATCO PHARMA ...[3].
