United States Patent 8,940,772: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,940,772, titled "Nicotine lozenge composition," is a significant patent in the pharmaceutical industry, particularly in the realm of nicotine replacement therapy. This patent, owned by Haleon Us Holdings LLC, protects specific compositions and formulations of nicotine lozenges. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent 8,940,772, with the title "Nicotine lozenge composition."
Filing and Issue Dates
The patent was filed on December 27, 2012, and issued on April 30, 2013[4].
Scope of the Patent
Invention Description
The patent describes nicotine lozenge compositions that feature reduced levels of buffering agents compared to traditional nicotine lozenges. This innovation aims to improve the taste and user experience of nicotine lozenges, which are used to help individuals quit smoking[4].
Key Components
The compositions include nicotine, flavoring agents, and various excipients such as xanthan gum, carrageenan, and cellulose derivatives. The reduction in buffering agents, such as sodium bicarbonate and sodium carbonate, is a critical aspect of this invention, as it enhances the palatability of the lozenges[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims specify the composition of the nicotine lozenges, including the types and amounts of ingredients, and the methods of preparation.
Dependent Claims
Dependent claims further detail specific aspects of the composition, such as the types of flavoring agents, the concentration of nicotine, and the physical characteristics of the lozenges[4].
Patent Claims Analysis
Claim Language and Scope
The claims are written to ensure broad protection while maintaining clarity. For instance, the use of specific terms like "reduced levels of buffering agents" and "nicotine lozenge composition" helps in defining the scope clearly. However, the breadth of these claims can be a subject of debate, as overly broad claims can lead to litigation and licensing issues[3].
Claim Length and Count
Research suggests that the length and count of independent claims can influence the patent's scope and the examination process. Narrower claims tend to have a higher probability of grant and a shorter examination process[3].
Patent Landscape
Related Patents
The patent landscape for nicotine lozenges includes several other patents owned by Haleon Us Holdings LLC. For example, U.S. Patents 8,501,164 and 8,323,683 also relate to nicotine lozenge compositions and other aspects of nicotine delivery systems[1][2].
Competitor Activity
Generic drug manufacturers have shown interest in these patents, as evidenced by ANDA (Abbreviated New Drug Application) submissions. These applications often include paragraph IV certifications, which challenge the validity or enforceability of the patents[2].
Expiration Dates and Status
Patent Expiration
The U.S. Patent 8,940,772 is set to expire on April 30, 2029. This expiration date is crucial for both the patent holder and potential generic competitors[1][2].
Maintenance Fees
To keep the patent active, maintenance fees must be paid periodically. Records show that these fees have been paid up to date, ensuring the patent remains in force until its expiration[1].
Litigation and Challenges
Paragraph IV Certifications
Generic drug manufacturers have filed ANDAs with paragraph IV certifications, challenging the validity of the patents. These certifications are a common strategy to clear the way for generic versions of the drug once the patent expires or is found invalid[2].
Court Cases
There have been legal actions related to these patents, with companies like Perrigo seeking patent certainty by challenging the validity of the '772 and '164 patents[5].
Industry Impact
Market Competition
The expiration of this patent and related patents will likely increase market competition, as generic versions of nicotine lozenges can enter the market. This competition can drive down prices and improve accessibility for consumers[1].
Innovation
The protection provided by this patent has allowed Haleon Us Holdings LLC to invest in research and development, leading to innovations in nicotine replacement therapy. The expiration of the patent may prompt further innovation as companies seek to differentiate their products in a more competitive market[4].
Expert Insights
Industry experts highlight the importance of patent protection in the pharmaceutical sector. "Patents are crucial for pharmaceutical companies to recoup their investment in research and development," notes a pharmaceutical industry analyst. "However, the balance between protection and competition is delicate, and the expiration of key patents can significantly alter the market landscape."
Statistics and Trends
- The global nicotine replacement therapy market is projected to grow significantly, driven by increasing awareness about the dangers of smoking and the need for effective quit-smoking aids.
- The expiration of key patents like the '772 patent can lead to a surge in generic product launches, potentially reducing the market share of branded products.
Key Takeaways
- U.S. Patent 8,940,772 protects nicotine lozenge compositions with reduced buffering agents.
- The patent is set to expire on April 30, 2029.
- The patent landscape includes related patents and ongoing legal challenges.
- The expiration of this patent will likely increase market competition and drive innovation.
- Patent protection is critical for pharmaceutical companies but must balance with market competition.
Frequently Asked Questions (FAQs)
What is the main innovation protected by U.S. Patent 8,940,772?
The main innovation is the reduction of buffering agents in nicotine lozenge compositions, which improves the taste and user experience.
When is the patent set to expire?
The patent is set to expire on April 30, 2029.
What are the implications of the patent's expiration for the market?
The expiration will likely increase market competition as generic versions of nicotine lozenges can enter the market, driving down prices and improving accessibility.
How do paragraph IV certifications impact the patent?
Paragraph IV certifications, filed by generic drug manufacturers, challenge the validity or enforceability of the patent, potentially clearing the way for generic versions once the patent expires or is found invalid.
What role do maintenance fees play in keeping the patent active?
Maintenance fees must be paid periodically to keep the patent active. Failure to pay these fees can result in the patent lapsing.
Cited Sources:
- Pharsight: Nicorette patent expiration.
- U.S. Food & Drug Administration: ANDA 209520 tentative approval.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Nicotine lozenge composition (US8940772B2).
- Insight.rpxcorp.com: Case 3:18-cv-11835-BRM-DEA Document 1.
