Understanding the Scope and Claims of United States Patent 9,457,036
Introduction
United States Patent 9,457,036 is a significant patent in the pharmaceutical industry, particularly related to the drug Truvada, which is a combination of emtricitabine and tenofovir disoproxil fumarate used for the treatment of HIV. To delve into the details of this patent, we need to analyze its scope, claims, and the broader patent landscape it operates within.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent 9,457,036, titled "Pharmaceutical Compositions and Methods of Using the Same." This patent is owned by Gilead Sciences, Inc., a leading pharmaceutical company.
Drug and Indication
The patent pertains to Truvada, a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate. Truvada is approved for the treatment of HIV-1 infection in adults and pediatric patients and for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk[5].
Claims Analysis
Types of Claims
Patent 9,457,036 includes various types of claims that are crucial for understanding its scope and protection.
- Chemical Compound Claims: These claims cover the active ingredients themselves, in this case, emtricitabine and tenofovir disoproxil fumarate.
- Formulation Claims: These claims pertain to specific pharmaceutical preparations, such as the fixed-dose combination tablets of Truvada.
- Method of Treatment/Use Claims: These claims cover the methods of treating specific diseases or conditions with the combination of emtricitabine and tenofovir disoproxil fumarate.
Specific Claims
The patent includes detailed claims about the composition and method of use. For example:
- Claim 1 might describe the pharmaceutical composition comprising a combination of emtricitabine and tenofovir disoproxil fumarate.
- Subsequent claims might detail the dosage forms, such as tablets, and the methods of administering these drugs for HIV treatment or PrEP.
Patent Landscape
Secondary Patents
In the pharmaceutical industry, secondary patents are common and play a significant role in extending the patent life of a drug. These include formulation patents, method of treatment patents, and minor modifications like polymorphs, isomers, prodrugs, esters, and salts (PIPES)[1].
For Truvada, Gilead Sciences has secured multiple secondary patents that extend the patent protection beyond the initial chemical compound patents. These secondary patents can significantly delay generic entry by protecting various aspects of the drug, such as its formulation and method of use.
Litigation and Settlements
Patent litigation is a critical aspect of the pharmaceutical industry, especially when generic manufacturers file Abbreviated New Drug Applications (ANDAs). For Truvada, Gilead Sciences has been involved in several ANDA litigations to protect its patents.
For instance, in the case of Gilead Sciences, Inc. v. Strides Pharma, Inc., all claims and counterclaims were dismissed with prejudice, indicating that the parties reached a settlement that allowed Strides Pharma to enter the market under certain conditions[5].
Expiration Dates and Patent Life
The expiration dates of patents are crucial for understanding when generic competition can enter the market. For U.S. Patent 9,457,036, the expiration date is a key factor in determining the remaining patent life.
- Chemical Compound Patents: These typically have the earliest expiration dates.
- Secondary Patents: These can extend the patent life. For example, method of treatment patents like those related to Truvada can expire later than the chemical compound patents, providing extended market exclusivity[4].
Patent Analytics and Claim Coverage
To effectively manage and understand the patent landscape, companies use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities.
For a patent like 9,457,036, a Claim Coverage Matrix would show which specific claims are actively protecting the intellectual property and where there might be opportunities or gaps. This is particularly useful for engineers, scientists, and management to review and determine the applicability of scope concepts to target products or methods[3].
Impact on Generic Entry
The presence of multiple patents, including secondary patents, can significantly impact when generic versions of a drug can enter the market. Generic manufacturers must navigate these patents carefully to avoid infringement.
For Truvada, the combination of chemical compound patents and secondary patents has delayed generic entry. Generic manufacturers submitting ANDAs must ensure their products do not infringe any of the valid claims of these patents, or they must wait until the patents expire or are invalidated[5].
Key Takeaways
- Patent Scope: U.S. Patent 9,457,036 covers the combination of emtricitabine and tenofovir disoproxil fumarate, including formulation and method of treatment claims.
- Secondary Patents: These extend the patent life and protect various aspects of the drug, delaying generic entry.
- Litigation: ANDA litigations are common, and settlements can allow generic entry under specific conditions.
- Expiration Dates: Understanding the expiration dates of both chemical compound and secondary patents is crucial for market exclusivity.
- Patent Analytics: Tools like Claim Coverage Matrix help in managing and understanding the patent landscape.
FAQs
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What is the primary drug covered by U.S. Patent 9,457,036?
- The primary drug covered is Truvada, a combination of emtricitabine and tenofovir disoproxil fumarate.
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What types of claims are included in U.S. Patent 9,457,036?
- The patent includes chemical compound claims, formulation claims, and method of treatment/use claims.
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How do secondary patents impact the patent life of a drug like Truvada?
- Secondary patents, such as formulation and method of treatment patents, can extend the patent life beyond the initial chemical compound patents, delaying generic entry.
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What is the role of ANDA litigations in protecting pharmaceutical patents?
- ANDA litigations are filed by brand-name manufacturers to protect their patents against generic manufacturers seeking to enter the market.
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How can patent analytics tools help in managing pharmaceutical patents?
- Patent analytics tools, such as Claim Coverage Matrix, help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities.
Sources
- Hemphill, C. S., & Sampat, B. N. (2012). An Empirical Analysis of “Secondary” Pharmaceutical Patents. PLOS ONE, 7(10), e49470. doi: 10.1371/journal.pone.0049470
- Patent Docs. (2020). Court Report - Patent Docs.
- Schwegman, Lundberg & Woessner, P.A. Patent Analytics | Intellectual Property Law.
- United States Court of Appeals for the Federal Circuit. (2023). H. Lundbeck.
- Robins Kaplan. (2019). ANDA Litigation Settlements | Resources - Robins Kaplan.
