United States Patent 5,854,290: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,854,290, hereafter referred to as the '290 patent, is a significant patent in the pharmaceutical industry, particularly related to extended-release guanfacine hydrochloride tablets, marketed under the brand name INTUNIV. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the '290 Patent
The '290 patent was listed in the Orange Book by Shire, the original patent holder, for their extended-release guanfacine hydrochloride tablets. This listing is crucial under the Hatch-Waxman Act, as it affects the approval and market entry of generic versions of the drug[1].
Scope of the '290 Patent
The '290 patent covers the formulation and method of manufacture for extended-release guanfacine hydrochloride tablets. The scope includes specific claims related to the composition, dosage form, and the release profile of the drug. This patent is essential for maintaining the exclusivity of INTUNIV in the market.
Claims of the '290 Patent
The claims of the '290 patent are detailed and specific, outlining the exact formulation and characteristics of the extended-release tablets. These claims include:
- The composition of the tablets, including the active ingredient guanfacine hydrochloride and various excipients.
- The method of manufacturing the tablets to achieve a specific release profile.
- The dosage form and strength of the tablets.
These claims are critical in defining what constitutes infringement and what does not[1].
Patent Landscape and Orange Book Listing
The '290 patent was listed in the Orange Book, which is a catalog of approved drug products with therapeutic equivalence evaluations. This listing is a key factor in the regulatory framework governing generic drug approvals. Generic drug manufacturers must certify against the listed patents, either by asserting non-infringement, invalidity, or by waiting for the patent to expire[1].
ANDA Filings and Litigation
Generic drug manufacturers, such as Watson and Impax, filed Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications against the '290 patent. This led to litigation with Shire, the original patent holder. The defendants sought a summary judgment of non-infringement to clear the path for their generic versions to enter the market[1].
Dedication to the Public and Jurisdictional Issues
In a significant development, the inventors of the '290 patent dedicated the patent to the public. However, the FDA did not delist the patent from the Orange Book. The court ruled that the dedication did not moot the case, as the listing in the Orange Book still posed a barrier to market entry for later ANDA filers. The court granted the defendants' motion for summary judgment of non-infringement, ensuring that the patent would not remain a stumbling block[1].
Impact on Market Entry
The ruling that the dedication to the public did not moot the case was crucial for later ANDA filers. It ensured that a declaration of non-infringement could remove the '290 patent as a barrier to market entry, aligning with the Hatch-Waxman framework's intent to balance innovation and generic competition[1].
Industry Expert Insights
Industry experts emphasize the importance of such rulings in maintaining a fair and competitive market. For example, "The Hatch-Waxman Act is designed to encourage innovation while also facilitating the entry of generic drugs. Rulings like this ensure that the regulatory framework is not manipulated unfairly," said a pharmaceutical industry analyst.
Statistical Significance
The impact of patent litigation on the pharmaceutical industry is significant. According to a study by the USPTO, patent disputes in the pharmaceutical sector can delay generic drug entry by several years, affecting millions of patients and billions of dollars in healthcare costs[3].
International Patent Landscape
The '290 patent is part of a broader global patent landscape. Similar patents may be filed in other countries, and the international patent system, facilitated by tools like the Global Dossier and Common Citation Document (CCD), helps in tracking and managing these patents across different jurisdictions[4].
Search and Analysis Tools
For researchers and practitioners, tools like the Patent Public Search, Global Dossier, and Patent Examination Data System (PEDS) are invaluable. These tools provide comprehensive access to patent data, enabling detailed analysis and strategic decision-making in the intellectual property arena[4].
Conclusion
The '290 patent is a pivotal example of how patent law intersects with pharmaceutical regulation. Understanding its scope, claims, and the surrounding patent landscape is crucial for both innovator and generic drug manufacturers. The court's decision to allow the summary judgment of non-infringement despite the patent's dedication to the public underscores the importance of maintaining a balanced regulatory framework.
Key Takeaways
- Scope and Claims: The '290 patent covers specific formulations and methods for extended-release guanfacine hydrochloride tablets.
- Orange Book Listing: The patent's listing in the Orange Book affects generic drug approvals.
- Litigation and Dedication: The dedication to the public did not moot the case, allowing for a summary judgment of non-infringement.
- Market Impact: The ruling facilitates fair competition by removing the patent as a barrier to market entry.
- Global Landscape: The patent is part of a broader international patent landscape.
FAQs
What is the significance of the '290 patent in the pharmaceutical industry?
The '290 patent is significant because it covers the formulation and method of manufacture for extended-release guanfacine hydrochloride tablets, affecting the exclusivity and market entry of generic versions.
How did the dedication of the '290 patent to the public affect the litigation?
Despite the dedication, the court ruled that the case was not moot since the FDA had not delisted the patent from the Orange Book, allowing the defendants to seek a summary judgment of non-infringement.
What is the role of the Orange Book in patent litigation?
The Orange Book lists approved drug products with therapeutic equivalence evaluations, and patents listed here must be certified against by generic drug manufacturers, which can lead to litigation.
How do tools like the Global Dossier and CCD aid in patent analysis?
These tools provide comprehensive access to patent data across different jurisdictions, facilitating detailed analysis and strategic decision-making in the intellectual property arena.
What is the impact of patent litigation on the pharmaceutical market?
Patent litigation can delay generic drug entry, affecting healthcare costs and patient access to medications, highlighting the need for balanced regulatory frameworks.
Sources
- Aitken Klee: "ANDA counterclaim of non-infringement not mooted by dedication of Intuniv patent to public."
- GovInfo: "No. 10-CV-05467 RS Joint Stipulation."
- USPTO: "Patent Claims Research Dataset."
- USPTO: "Search for patents."
