United States Patent 7,297,346: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,297,346, hereafter referred to as the '346 patent, is a significant patent related to the pharmaceutical formulations of modafinil, a drug used to treat conditions such as narcolepsy, obstructive sleep apnea, and shift work sleep disorder. This patent, held by Cephalon, Inc., has been a focal point in several legal and regulatory battles involving generic drug manufacturers.
Background and History
The '346 patent was granted on November 20, 2007, and it covers specific pharmaceutical formulations of modafinil. This patent is listed in the FDA's Orange Book, a publication that contains information on approved drugs and their associated patents[2].
Scope and Claims
The '346 patent specifically pertains to compositions of modafinil, including formulations that include modafinil and one or more diluents, disintegrants, binders, and other excipients. These formulations are designed to enhance the stability, bioavailability, and overall efficacy of the drug[4].
Key Claims
- The patent claims cover various aspects of modafinil formulations, including:
- Compositions of modafinil with specific excipients.
- Methods of preparing these compositions.
- The use of these compositions for treating sleep disorders.
Patent Landscape
The '346 patent is part of a broader patent landscape surrounding modafinil, which includes another significant patent, the RE 37,516 ('516 patent).
Relationship with Other Patents
- The '516 patent, which was listed in the Orange Book in 2001, covers a broader range of modafinil products and would have blocked the sale of generic modafinil until October 6, 2014, if unchallenged[1][2].
- The '346 patent, being a later-listed patent, covers a narrower class of modafinil formulations and was set to expire on May 29, 2024[2].
Generic Challenges and Litigation
The '346 patent has been challenged by several generic drug manufacturers, leading to significant litigation.
Paragraph IV Certifications
- On December 14, 2007, the first day the '346 patent could be challenged, Teva USA and Watson filed Abbreviated New Drug Applications (ANDAs) with paragraph IV certifications, declaring that the '346 patent was invalid, unenforceable, or not infringed by their generic versions of modafinil[1][2].
- Mylan filed a paragraph IV certification much later, on February 2, 2011, which led to disputes over the 180-day exclusivity period for marketing generic modafinil[2].
Legal Disputes and Settlements
The challenges to the '346 patent have resulted in several legal disputes.
Teva USA and Cephalon Litigation
- Teva USA's filing of the ANDA and paragraph IV certification led to a lawsuit by Cephalon. However, Cephalon had relinquished its right to sue based on the '346 patent due to settlement agreements with Teva USA and other generic manufacturers[1][2].
Mylan's Claims
- Mylan alleged that Teva USA's acquisition of Cephalon invalidated its paragraph IV certification and thus its entitlement to exclusivity. Mylan sought immediate approval for its own ANDA and exclusivity rights[2].
Impact on Generic Drug Approval
The disputes over the '346 patent have significantly impacted the approval and marketing of generic modafinil products.
FDA Involvement
- The FDA's decisions regarding the approval of ANDAs and the granting of exclusivity have been central to these disputes. The FDA's signaling of potential approval for competing generic applications led to further litigation[2].
Exclusivity and Market Implications
The '346 patent has played a crucial role in determining the exclusivity rights for generic modafinil manufacturers.
180-Day Exclusivity
- The dispute over who was the first filer and thus entitled to the 180-day exclusivity period has been a key issue. Teva USA claimed sole exclusivity based on its early filing, while Mylan argued for its own entitlement[2].
Conclusion and Current Status
The '346 patent has been a pivotal element in the complex legal and regulatory landscape surrounding modafinil.
Expiration and Post-Expiration Impact
- With the '346 patent set to expire on May 29, 2024, the exclusivity and market dynamics for modafinil are expected to change significantly. Generic manufacturers will no longer face the patent barrier, potentially leading to increased competition and lower prices for the drug[2].
Key Takeaways
- The '346 patent covers specific pharmaceutical formulations of modafinil.
- It was challenged by generic manufacturers through paragraph IV certifications.
- Legal disputes and settlements have shaped the exclusivity rights and approval timelines for generic modafinil.
- The patent's expiration will likely impact the market by increasing competition and reducing prices.
Frequently Asked Questions (FAQs)
1. What is the United States Patent 7,297,346 about?
The United States Patent 7,297,346 covers specific pharmaceutical formulations of modafinil, including compositions and methods of preparation.
2. When was the '346 patent granted?
The '346 patent was granted on November 20, 2007.
3. What is the significance of the '346 patent in the context of generic modafinil?
The '346 patent has been crucial in determining the exclusivity rights for generic modafinil manufacturers and has been the subject of significant litigation.
4. Which companies have challenged the '346 patent?
Teva USA, Watson, and Mylan are among the companies that have challenged the '346 patent through paragraph IV certifications.
5. What is the current status of the '346 patent?
The '346 patent is set to expire on May 29, 2024, which will remove the patent barrier for generic modafinil manufacturers.
Cited Sources:
- Mylan Pharms., Inc. v. Sebelius, 856 F. Supp. 2d 196 - Casetext
- First Dust Up Over Generic PROVIGIL 180-Day Exclusivity Quickly Ends With Tropi Motion Withdrawal - The FDA Law Blog
- Pharmaceutical patent landscaping: A novel approach to ... - bioRxiv
- US7297346B2 - Pharmaceutical formulations of modafinil - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp.com
