Background
The litigation between Bayer HealthCare LLC and Mylan Pharmaceuticals Inc. revolves around the generic version of Bayer's drug Xarelto®, which contains the active ingredient rivaroxaban. Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of Xarelto®, triggering a series of patent and regulatory disputes.
The Patents in Question
The dispute involves several U.S. patents held by Bayer, including:
- U.S. Patent No. 7,157,456 (the ’456 patent)
- U.S. Patent No. 9,415,053 (the ’053 patent)
- U.S. Patent No. 10,828,310 (the ’310 patent)[1][5].
Mylan's ANDA and Certifications
Mylan submitted ANDA No. 212220 to the FDA, seeking approval for its 2.5 mg rivaroxaban tablets. As part of the ANDA process, Mylan made certifications under the Hatch-Waxman Act:
- Paragraph IV certification against the ’053 patent: Mylan argued that the ’053 patent is invalid or not infringed by its generic product.
- Paragraph III certification against the ’456 patent: Mylan acknowledged that the ’456 patent is valid but will expire, with pediatric exclusivity set to end on February 28, 2025.
- No dispute over the ’310 patent: The parties agreed that Mylan’s ANDA could be approved notwithstanding the ’310 patent[1][5].
Bayer's Response and Litigation
Bayer had 45 days to sue Mylan for infringement of the ’053 patent after receiving Mylan’s Paragraph IV notice. However, Bayer did not file suit within this timeframe and instead granted Mylan a covenant not to sue effective August 4, 2023. Despite this, Bayer refused to waive pediatric exclusivity or stipulate to a consent judgment of non-infringement[1][5].
Mylan's Civil Action to Obtain Patent Certainty (CAPC)
To address the potential delay in FDA approval due to the ’053 patent, Mylan filed a civil action under the Hatch-Waxman Act’s CAPC provision on May 19, 2023. This action sought a declaration of non-infringement of the ’053 patent to ensure that the patent did not bar FDA final approval of Mylan’s ANDA[1][5].
Subject Matter Jurisdiction and Speculative Claims
Bayer argued that the court lacked subject matter jurisdiction because the covenant not to sue extinguished any case or controversy over the ’053 patent. Additionally, Bayer claimed that Mylan’s assertions about future FDA actions were speculative and did not establish jurisdiction.
However, the court rejected these arguments:
- Covenant not to sue does not divest jurisdiction: The court found that the covenant not to sue did not render the declaratory judgment action non-justiciable. The ’053 patent remained a barrier to Mylan’s market entry, giving rise to a justiciable case or controversy[1][5].
- Mylan’s claims are not speculative: The court determined that Mylan’s claims were not improperly speculative. The potential impact of the ’053 patent’s expiration and the FDA’s discretionary actions on Mylan’s approval were deemed substantial and concrete enough to support jurisdiction[1].
Pediatric Exclusivity and FDA Approval
A critical issue was whether the FDA would convert Mylan’s Paragraph IV certification into a Paragraph II certification upon the ’053 patent’s expiration on November 13, 2024. This conversion could potentially attach a new pediatric exclusivity period, delaying final approval until May 13, 2025. Mylan argued that this would unfairly forestall its market entry, despite all parties agreeing that Mylan does not infringe the ’053 patent[1].
Economic Stakes and Market Impact
The litigation has significant economic implications:
- Revenue Impact: The parties have substantial, concrete stakes in the outcome. Bayer stands to lose substantial revenues if Mylan enters the market, while Mylan will gain substantial revenues upon approval[1].
- Market Entry: The resolution of this litigation will determine when Mylan can enter the market with its generic version of Xarelto®, affecting both companies’ market positions and revenues[1].
Conclusion and Recommendations
The court's decision to deny Bayer's motion to dismiss and the alternative request for a stay underscores the importance of resolving patent disputes promptly under the Hatch-Waxman Act. This ensures that generic drug manufacturers like Mylan can enter the market without undue delay, promoting competition and potentially lowering drug costs.
Key Takeaways
- Hatch-Waxman Act Provisions: The Act’s CAPC provision is crucial for resolving patent disputes and ensuring timely market entry for generic drugs.
- Covenant Not to Sue: Such covenants do not necessarily divest courts of subject matter jurisdiction in Hatch-Waxman cases.
- Speculative Claims: Courts consider the concrete and substantial stakes involved in patent disputes, even if they depend on future regulatory actions.
- Pediatric Exclusivity: The potential for new pediatric exclusivity periods can significantly impact the timing of FDA approvals and market entry.
- Economic Implications: The outcome of these disputes has substantial economic implications for both brand and generic drug manufacturers.
Frequently Asked Questions (FAQs)
Q: What is the Hatch-Waxman Act, and how does it apply to generic drug approvals?
A: The Hatch-Waxman Act is a federal law that streamlines the approval process for generic drugs by allowing generic manufacturers to file ANDAs with the FDA. It also provides mechanisms for resolving patent disputes between brand and generic drug manufacturers.
Q: What is a Paragraph IV certification, and why is it important?
A: A Paragraph IV certification is a statement by a generic drug manufacturer that the brand drug’s patent is invalid or not infringed. This certification is crucial because it triggers a 45-day period for the brand drug manufacturer to sue for patent infringement.
Q: How does a covenant not to sue affect litigation in Hatch-Waxman cases?
A: A covenant not to sue does not automatically divest the court of subject matter jurisdiction. The court can still hear the case if there is a justiciable controversy, such as the potential impact of a patent on market entry.
Q: What is pediatric exclusivity, and how does it affect FDA approvals?
A: Pediatric exclusivity is a period of additional patent protection granted for conducting pediatric studies. It can delay FDA approval of generic drugs if it is attached to a patent that would otherwise expire.
Q: Why is the CAPC provision important in Hatch-Waxman litigation?
A: The CAPC provision allows generic drug manufacturers to seek a declaration of non-infringement to prevent brand drug manufacturers from delaying the resolution of patent disputes and thus delaying market entry.
Sources
- Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. No. 23-556-RGA, 2024 WL 359468 (D. Del. Jan. 31, 2024)
- Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GMBH et al, 23-556 - Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GMBH et al.
- United States District Court for the District of Delaware, Bayer HealthCare LLC, et al. v. Mylan Pharmaceuticals Inc., et al.
- Delaware District Court, Case docket and documents for 1:15-cv-00114 - Bayer Healthcare LLC et al. v. Mylan Inc et al.
- Mylan Pharm. v. Bayer Intellectual Prop. GmbH - Casetext
