United States Patent 9,545,414: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,545,414, titled "Unitary Pharmaceutical Dosage Form," was granted on January 17, 2017, to Bristol-Myers Squibb and Gilead Sciences, LLC. This patent is significant in the pharmaceutical industry, particularly in the development of antiretroviral therapies. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Inventors
The patent was invented by a team of researchers including Terrence C. Dahl, Munir A. Hussain, Robert A. Lipper, Robert L. Jerzewski, Mark M. Menning, Reza Oliyai, and Taiyin Yang. These inventors are associated with various locations in California and New Jersey, reflecting the collaborative effort between Bristol-Myers Squibb and Gilead Sciences, LLC[4].
Scope of the Patent
The patent describes a novel pharmaceutical product that combines efavirenz, emtricitabine, and tenofovir disoproxil fumarate (tenofovir DF) into a single, unitary dosage form. This combination is designed for the treatment of HIV-1 infection and represents a significant advancement in antiretroviral therapy by simplifying the treatment regimen for patients.
Key Components
- Efavirenz: A non-nucleoside reverse transcriptase inhibitor.
- Emtricitabine: A nucleoside reverse transcriptase inhibitor.
- Tenofovir DF: A nucleotide reverse transcriptase inhibitor.
These components are formulated to provide a stable and effective dosage form that can be administered once daily, enhancing patient compliance and treatment outcomes[4].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes the unitary pharmaceutical dosage form comprising efavirenz, emtricitabine, and tenofovir DF.
- Claim 5 specifies the dosage form as a tablet or capsule.
- Claim 9 describes the method of treating HIV-1 infection using the unitary dosage form[4].
Dependent Claims
- Various dependent claims further detail the composition, formulation, and method of administration of the dosage form. For example, Claim 2 specifies the weight ratio of the active ingredients, and Claim 6 describes the use of specific excipients[4].
Patent Landscape
Prior Art and References
The patent cites numerous prior art documents, including U.S. and foreign patents, that relate to pharmaceutical formulations and antiretroviral therapies. These references highlight the evolution of HIV treatment regimens and the need for more convenient and effective dosage forms[4].
Related Patents
- Other patents, such as those related to multilayer orodispersible tablets (US-2007036861-A1), demonstrate the ongoing innovation in pharmaceutical formulations. These patents often focus on improving drug delivery systems and patient compliance[5].
Litigation and Enforcement
While the patent itself does not involve direct litigation, the broader context of patent enforcement in the pharmaceutical industry is complex. For instance, the case of Contour IP Holding LLC v. GoPro, Inc. illustrates the challenges in patent litigation, particularly in determining patent eligibility under Section 101 of the Patent Act[2].
Economic and Market Impact
Market Dominance
The combination of efavirenz, emtricitabine, and tenofovir DF in a single dosage form has significant market implications. This product, known as Atripla or similar combinations, has become a cornerstone in HIV treatment, offering a convenient and effective regimen that enhances patient compliance and outcomes.
Economic Benefits
- Simplified treatment regimens reduce the complexity and cost associated with managing HIV-1 infection.
- Improved patient compliance leads to better health outcomes, which in turn reduce the overall healthcare costs.
Competitive Landscape
The patent landscape in antiretroviral therapies is highly competitive, with multiple pharmaceutical companies developing innovative treatments. The expiration of patents can lead to the entry of generic competitors, which can significantly impact market dynamics and pricing strategies.
Technical and Scientific Significance
Formulation Challenges
Combining multiple active pharmaceutical ingredients (APIs) into a single dosage form poses significant formulation challenges. The inventors overcame these challenges by developing a stable and bioavailable formulation that maintains the efficacy of each API.
Bioavailability and Stability
The patent details the importance of ensuring the bioavailability and stability of the APIs within the unitary dosage form. This involves careful selection of excipients and manufacturing processes to ensure consistent drug delivery.
Regulatory Considerations
FDA Approval
The FDA approval process for such combination products is rigorous and involves extensive clinical trials to ensure safety and efficacy. The approval of this unitary dosage form reflects the regulatory body's recognition of its therapeutic benefits.
Patent Term and Exclusivity
The patent term, subject to any adjustments under 35 U.S.C. ยง 154(b), provides the inventors with exclusive rights to manufacture and market the product. This exclusivity period is crucial for recouping the significant investment in research and development.
Key Takeaways
- Combination Therapy: The patent represents a significant advancement in HIV treatment by combining efavirenz, emtricitabine, and tenofovir DF into a single dosage form.
- Market Impact: This product has become a cornerstone in HIV treatment, enhancing patient compliance and outcomes.
- Formulation Challenges: The inventors overcame significant formulation challenges to develop a stable and bioavailable product.
- Regulatory Approval: The product has undergone rigorous FDA approval processes, ensuring its safety and efficacy.
- Patent Landscape: The patent is part of a complex landscape of antiretroviral therapies, with ongoing innovation and competition.
FAQs
What are the key components of the unitary pharmaceutical dosage form described in US 9,545,414?
The key components are efavirenz, emtricitabine, and tenofovir disoproxil fumarate (tenofovir DF).
What is the primary use of this dosage form?
The primary use is for the treatment of HIV-1 infection.
Who are the inventors and assignees of this patent?
The inventors include Terrence C. Dahl, Munir A. Hussain, Robert A. Lipper, Robert L. Jerzewski, Mark M. Menning, Reza Oliyai, and Taiyin Yang. The assignees are Bristol-Myers Squibb and Gilead Sciences, LLC.
What are some of the challenges in formulating this unitary dosage form?
The challenges include ensuring the bioavailability and stability of the APIs within the dosage form and selecting appropriate excipients and manufacturing processes.
How does this patent impact the market for HIV treatments?
It simplifies treatment regimens, enhances patient compliance, and reduces the complexity and cost associated with managing HIV-1 infection.
Sources
- United States Patent and Trademark Office, "Unitary Pharmaceutical Dosage Form," US 9,545,414 B2, January 17, 2017.
- United States Court of Appeals for the Federal Circuit, "CONTOUR IP HOLDING LLC v. GOPRO, INC.," Case: 22-1654, September 9, 2024.
- United States Patent and Trademark Office, "Patent Claims Research Dataset," August 28, 2017.
- Google Patents, "Unitary Pharmaceutical Dosage Form," US 9,545,414 B2.
- PubChem, "Orally-dispersible multilayer tablet," US-2007036861-A1.
