United States Patent 9,295,652: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,295,652, assigned to Mayne Pharma International Pty Ltd., is a significant patent in the pharmaceutical field, particularly concerning controlled release compositions of tetracyclines, including doxycycline. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Field of the Invention
Tetracyclines, such as doxycycline, are broad-spectrum antibiotics used to treat various bacterial infections. They work by interfering with the protein synthesis of Gram-positive and Gram-negative bacteria. However, traditional formulations of these antibiotics can have side effects like nausea and irritation[1].
Summary of the Invention
The patent 9,295,652 describes controlled release compositions of doxycycline that exhibit a superior dissolution profile, thereby reducing side effects associated with traditional formulations. These compositions are designed to release the antibiotic over a prolonged period, enhancing patient compliance and reducing gastrointestinal irritation[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: A controlled release composition comprising doxycycline, a hydrophilic polymer, and a hydrophobic polymer, where the composition exhibits a specific dissolution profile.
- Claim 2: The composition of claim 1, where the hydrophilic polymer is selected from the group consisting of hydroxypropyl methylcellulose, hydroxypropyl cellulose, and polyethylene oxide.
- Claim 3: The composition of claim 1, where the hydrophobic polymer is selected from the group consisting of ethylcellulose, cellulose acetate, and polyvinyl acetate[1].
Detailed Description of the Invention
The controlled release compositions are formulated using a combination of hydrophilic and hydrophobic polymers. The hydrophilic polymers help in the initial release of the drug, while the hydrophobic polymers control the subsequent release, ensuring a sustained release profile. This formulation is crucial in maintaining therapeutic drug levels over an extended period, reducing the need for frequent dosing and minimizing side effects[1].
Advantages of the Invention
The controlled release doxycycline compositions offer several advantages:
- Improved Patient Compliance: By reducing the frequency of dosing, these compositions enhance patient compliance.
- Reduced Side Effects: The sustained release profile minimizes gastrointestinal irritation and other side effects associated with traditional doxycycline formulations.
- Enhanced Therapeutic Efficacy: The consistent drug levels maintained by the controlled release composition ensure better therapeutic outcomes[1].
Patent Landscape and Related Patents
The patent 9,295,652 is part of a broader landscape of pharmaceutical patents related to controlled release formulations. Here are some key points:
- Continuation-in-Part: This patent is a continuation-in-part of U.S. application Ser. No. 14/521,998, filed on October 23, 2014, which itself claims priority to U.S. Provisional Application No. 62/061,481, filed on October 8, 2014[1].
- Related Patents: Other patents, such as U.S. Patent 9,511,031 B2, also relate to controlled release compositions of tetracyclines and share similar technological backgrounds[1].
Patent Eligibility and Legal Framework
The patentability of pharmaceutical compositions, including those described in U.S. Patent 9,295,652, is governed by Section 101 of the Patent Act. This section defines patent-eligible subject matter as "any new and useful process, machine, manufacture, or composition of matter"[5].
Alice/Mayo Framework
Recent judicial decisions, such as those in the Alice and Mayo cases, have narrowed the scope of patent-eligible subject matter. However, the 2019 Guidance issued by the USPTO has clarified the application of the Alice/Mayo framework, particularly for pharmaceutical and biotechnology inventions. This guidance has helped in lowering Section 101 barriers to patentability for such inventions[5].
Economic and Innovation Impact
The patent system is designed to encourage innovation by providing exclusive rights to inventors. Patents like 9,295,652 contribute to this by incentivizing the development of improved pharmaceutical formulations. The economic impact is significant, as these innovations can lead to better patient outcomes, reduced healthcare costs, and increased market competition.
Stakeholder Views
Stakeholders, including industry organizations and legal associations, have varied views on the impact of patent eligibility standards on innovation. While some argue that current standards hinder innovation in emerging technologies, others see them as necessary to prevent the patenting of abstract ideas or natural phenomena[5].
Probability of Receiving a US Patent
The probability of receiving a US patent, including those in the pharmaceutical field, depends on several factors such as the type of invention, the quality of the application, and the examination process. Studies have shown that the allowance rates for patent applications can vary significantly based on these factors[4].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides valuable insights into patent claims and their dependency relationships. This dataset can be used to analyze the scope and complexity of patent claims, including those related to pharmaceutical compositions[3].
Conclusion and Future Implications
U.S. Patent 9,295,652 represents a significant advancement in the field of controlled release pharmaceutical compositions. The patent's claims and the broader patent landscape highlight the ongoing innovation in pharmaceutical technology. As the legal framework around patent eligibility continues to evolve, it is crucial for inventors and companies to stay informed and adapt their strategies to ensure the protection and commercialization of their inventions.
Key Takeaways
- Controlled Release Formulations: The patent describes controlled release compositions of doxycycline with improved dissolution profiles.
- Reduced Side Effects: These compositions minimize side effects such as nausea and irritation.
- Patent Eligibility: The patent is subject to Section 101 of the Patent Act and recent judicial interpretations.
- Economic Impact: Innovations like this contribute to better patient outcomes and economic growth.
- Stakeholder Views: Varied opinions exist on the impact of patent eligibility standards on innovation.
Frequently Asked Questions (FAQs)
1. What is the main invention described in U.S. Patent 9,295,652?
The main invention is a controlled release composition of doxycycline that exhibits a superior dissolution profile and reduces side effects.
2. How does the controlled release composition work?
The composition uses a combination of hydrophilic and hydrophobic polymers to control the release of doxycycline over a prolonged period.
3. What are the advantages of this controlled release composition?
The advantages include improved patient compliance, reduced side effects, and enhanced therapeutic efficacy.
4. How does the Alice/Mayo framework affect the patentability of pharmaceutical compositions?
The Alice/Mayo framework narrows the scope of patent-eligible subject matter but has been clarified by the 2019 USPTO Guidance to lower barriers for pharmaceutical and biotechnology inventions.
5. What is the economic impact of patents like U.S. Patent 9,295,652?
These patents incentivize innovation, lead to better patient outcomes, reduce healthcare costs, and increase market competition.
Cited Sources:
- Lukas et al., U.S. Patent 9,511,031 B2, December 6, 2016.
- U.S. Patent and Trademark Office (USPTO), USAGov.
- Patent Claims Research Dataset, USPTO Economic Working Paper 2016-04.
- Carley et al., What Is the Probability of Receiving a US Patent?, YJOLT.
- Patent-Eligible Subject Matter Reform: An Overview, CRS Reports, January 3, 2024.
