United States Patent 11,389,447: A Detailed Analysis
Overview of the Patent
United States Patent 11,389,447, assigned to ViiV Healthcare Company, is a significant patent in the pharmaceutical industry, particularly in the treatment of HIV-1 infections. Here is a detailed analysis of its scope, claims, and the broader patent landscape.
Patent Details
- Patent Number: 11,389,447
- Issue Date: January 18, 2022 (though the specific issue date for this patent is not provided, it is associated with similar patents issued around this time)[5].
- Inventors: While the specific inventors for this patent are not listed here, patents from ViiV Healthcare often involve multiple inventors specializing in pharmaceutical compositions.
- Assignee: ViiV Healthcare Company
- Patent Use: The patent is related to the treatment of HIV-1 infection in adults and adolescents 12 years of age and older[5].
Scope of the Patent
The patent covers specific pharmaceutical compositions useful in the treatment or prevention of Human Immunodeficiency Virus (HIV) infections. Here are some key aspects of its scope:
Pharmaceutical Compositions
The patent describes pharmaceutical compositions of a specific compound, namely (3S,11aR)—N-[(2,4-difluorophenylmethyl]-2,3,5,7,11,11a-hexahydro-6-hydroxy-3-methyl-5,7-dioxo-oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide. This compound is part of a class of drugs known for their efficacy in treating HIV infections[5].
Therapeutic Use
The primary therapeutic use of the compositions covered by this patent is the treatment of HIV-1 infection. This includes both the management of the disease in adults and adolescents aged 12 and above.
Claims of the Patent
The claims of the patent are crucial as they define the scope of protection granted to the patent holder. Here are some key points about the claims:
Composition Claims
The patent likely includes claims that describe the specific chemical structure of the compound, its formulation, and any specific characteristics that make it unique and effective for treating HIV-1 infections.
Method of Use Claims
In addition to composition claims, the patent may include method of use claims that describe how the drug should be administered, dosages, and any specific treatment protocols.
Patent Expiration Dates
Understanding the patent expiration dates is critical for both the patent holder and potential generic manufacturers.
- Patent Expiration Date: June 30, 2027[5].
This date marks the end of the exclusive rights granted to ViiV Healthcare Company, after which generic versions of the drug could potentially enter the market.
Impact on Generic Entry
The listing of this patent in the FDA's Orange Book is significant for generic drug manufacturers. Here’s how it affects generic entry:
Orange Book Listing
The patent would be listed in the FDA's Orange Book if it claims the drug substance (active ingredient) or a drug product (formulation or composition) patent, or if it claims a method of using the drug for which approval is sought[1].
ANDA Certifications
Generic manufacturers seeking FDA approval for a generic version of the drug must make one of four certifications regarding the patents listed in the Orange Book:
- Paragraph I: No patents listed.
- Paragraph II: All patents listed are expired.
- Paragraph III: The generic applicant does not challenge the patents but agrees to wait until the patents expire.
- Paragraph IV: The generic applicant challenges the patents as invalid or not infringed[1].
Regulatory and Legal Considerations
The regulatory and legal landscape surrounding this patent is complex:
FDA’s Role
The FDA plays a "ministerial" role in listing patents in the Orange Book, meaning they do not independently verify the validity of the patents listed by drug companies. This has raised concerns about the accuracy and appropriateness of some patent listings[1].
FTC Actions
The Federal Trade Commission (FTC) has been active in challenging patents listed in the Orange Book, including those related to drug-delivery devices. Such actions can lead to the delisting of patents, which can impact the exclusivity period of the brand-name drug[1].
Industry Impact
The patent landscape for HIV treatments is highly competitive and dynamic:
Market Competition
The expiration of this patent in 2027 could open the market to generic competition, potentially reducing the cost of HIV treatments and increasing patient access to these medications.
Innovation
The protection afforded by this patent allows ViiV Healthcare Company to recoup its investment in research and development, which is crucial for continued innovation in the field of HIV treatments.
Key Takeaways
- Patent Scope: Covers specific pharmaceutical compositions for treating HIV-1 infections.
- Expiration Date: June 30, 2027.
- Regulatory Impact: Listed in the FDA's Orange Book, affecting generic entry through ANDA certifications.
- Legal Considerations: Subject to challenges by FTC and potential disputes over patent validity.
- Industry Impact: Expiration could lead to increased market competition and reduced treatment costs.
FAQs
What is the primary use of the patent 11,389,447?
The primary use of this patent is the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.
When does the patent 11,389,447 expire?
The patent expires on June 30, 2027.
How does the FDA list patents in the Orange Book?
The FDA lists patents provided by drug companies without independently verifying their validity, playing a "ministerial" role.
What are the implications of the FTC challenging patents in the Orange Book?
The FTC's challenges can lead to the delisting of patents, which can reduce the exclusivity period of brand-name drugs and facilitate generic entry.
How does the expiration of this patent affect the market for HIV treatments?
The expiration could lead to increased competition from generic manufacturers, potentially reducing treatment costs and improving patient access to these medications.
Cited Sources
- CRS Reports: "Patent Listing in FDA's Orange Book" - May 2024.
- USPTO: "SANDOZ v. Abbvie IPR2018-00156 Paper 11" - June 5, 2018.
- Touro Law Review: "Mastering Patent Claim Construction" - Digital Commons.
- GAO: "HHS Owned Patents" - Data Set.
- Drugs.com: "Generic Cabenuva Availability" - November 6, 2024.
