|
Patent landscape, scope, and claims: |
United States Drug Patent 10,213,386: Claim Scope and Landscape Analysis
What is the Core Invention Protected by Patent 10,213,386?
United States Patent 10,213,386, granted on February 19, 2019, protects a method for treating or preventing thrombotic disorders. The patent's central innovation is the administration of a specific pharmaceutical composition comprising a direct thrombin inhibitor, dabigatran etexilate mesylate, and a pharmaceutically acceptable carrier. The claims delineate specific dosage regimens and their use in preventing clot formation, particularly in the context of anticoagulation therapy.
The patent's primary focus is on the use of dabigatran etexilate mesylate in preventing thrombotic events. This is a crucial distinction from patents protecting the compound itself or its formulation. The claims are structured around a method of treatment, specifying the quantity of active ingredient and the frequency of administration.
The patent claims cover:
-
Claim 1: A method for preventing a thrombotic disorder in a subject, comprising administering to the subject a pharmaceutical composition. This composition contains dabigatran etexilate mesylate, a direct thrombin inhibitor, in an amount of about 150 mg of dabigatran etexilate. The administration is conducted twice daily. The thrombotic disorder is identified as a condition selected from the group consisting of stroke, systemic embolism, and death.
-
Claim 2: A method for preventing a thrombotic disorder in a subject, comprising administering to the subject a pharmaceutical composition. This composition contains dabigatran etexilate mesylate in an amount of about 110 mg of dabigatran etexilate. The administration is conducted twice daily. The thrombotic disorder is identified as a condition selected from the group consisting of stroke, systemic embolism, and death.
-
Claim 3: The method of claim 1, wherein the pharmaceutical composition comprises dabigatran etexilate mesylate in an amount of about 150 mg of dabigatran etexilate, and wherein the composition is administered orally.
-
Claim 4: The method of claim 2, wherein the pharmaceutical composition comprises dabigatran etexilate mesylate in an amount of about 110 mg of dabigatran etexilate, and wherein the composition is administered orally.
The patent explicitly defines "dabigatran etexilate mesylate" as the active pharmaceutical ingredient (API). The specified dosage amounts (110 mg and 150 mg) are central to the protected method. The patent also identifies the target indications: prevention of stroke, systemic embolism, and death in subjects at risk.
What are the Specific Parameters and Limitations of the Claims?
The claims of US Patent 10,213,386 are highly specific regarding the dosage and frequency of administration of dabigatran etexilate mesylate.
Key parameters and limitations include:
- Active Ingredient: Dabigatran etexilate mesylate. This is a prodrug that is converted to dabigatran, the active moiety, in vivo.
- Dosage Amounts:
- About 150 mg of dabigatran etexilate.
- About 110 mg of dabigatran etexilate.
The term "about" provides a degree of latitude, typically interpreted as within a reasonable range of the stated amount (e.g., +/- 10%).
- Frequency of Administration: Twice daily. This is a critical aspect of the claimed method, differentiating it from other potential dosing schedules.
- Therapeutic Outcome: Prevention of thrombotic disorders, specifically defined as stroke, systemic embolism, and death.
- Route of Administration: While not explicitly limited in the broadest claims, dependent claims (3 and 4) specify oral administration.
The claims do not protect the dabigatran etexilate compound itself, which is covered by earlier patents, nor do they claim specific formulations beyond the API and a "pharmaceutically acceptable carrier." The novelty and inventiveness lie in the specific therapeutic regimen.
What is the Prosecution History and Examination Process?
The prosecution history of US Patent 10,213,386 reveals a standard examination process by the United States Patent and Trademark Office (USPTO). The application underwent review by patent examiners who assessed its patentability against prior art.
Key aspects of the prosecution history typically involve:
- Application Filing Date: Not directly provided by the patent number alone, but the grant date of February 19, 2019, indicates the application was filed significantly earlier.
- Office Actions: Examiners issue Office Actions detailing rejections or objections based on prior art (anticipation under 35 U.S.C. § 102 or obviousness under 35 U.S.C. § 103) or formal requirements.
- Applicant Responses: The patent applicant (assignee) responds to Office Actions by amending claims, providing arguments, or submitting evidence to overcome rejections.
- Allowance: Upon satisfactory resolution of all objections and rejections, the patent is allowed and subsequently granted.
While specific details of Office Actions and amendments require access to the full USPTO file wrapper, the existence of a granted patent signifies that the USPTO found the claimed invention to be novel, non-obvious, and adequately described. The claims as granted reflect the limitations and scope agreed upon during the examination process. For this patent, the claims focus on a specific method of use rather than a novel composition of matter, suggesting prior art likely covered the dabigatran etexilate compound and its general anticoagulant properties.
What is the Current Status of the Patent?
United States Patent 10,213,386 is currently active and in force. Patents are granted for a term of 20 years from the filing date, subject to the payment of maintenance fees.
- Grant Date: February 19, 2019.
- Expiration Date: To determine the precise expiration date, one would need the original U.S. non-provisional application filing date and account for any potential patent term extensions (PTE) granted by the U.S. Food and Drug Administration (FDA) to compensate for regulatory review delays. However, based on a standard 20-year term from a hypothetical filing date in the early to mid-2010s, the patent is expected to remain in force for several more years.
- Maintenance Fees: To remain in force, periodic maintenance fees must be paid to the USPTO at 3.5, 7.5, and 11.5 years after the grant date. Non-payment results in patent expiration. Assuming these fees are paid, the patent remains legally protected.
The patent's current active status means its claims are enforceable against infringers in the United States until its expiration.
What is the Intellectual Property Landscape for Dabigatran Etexilate?
The patent landscape for dabigatran etexilate is characterized by multiple layers of intellectual property protection, encompassing the compound itself, its formulations, manufacturing processes, and specific therapeutic uses. US Patent 10,213,386 represents a method of use patent, which is a common strategy to extend market exclusivity after primary composition-of-matter patents expire.
The broader IP landscape for dabigatran etexilate includes:
- Composition of Matter Patents: These are typically the foundational patents protecting the novel chemical entity. For dabigatran etexilate, these would have been filed earlier and likely expired or are nearing expiration. These patents cover the molecule itself, regardless of its use.
- Formulation Patents: Patents that protect specific ways of delivering the drug, such as particular excipients, dosage forms (e.g., capsules), or release profiles.
- Method of Use Patents: These are exemplified by US Patent 10,213,386. They protect a specific method of treating a particular disease or condition with a known compound. These are crucial for extending market protection, especially for well-established drugs.
- Manufacturing Process Patents: Patents that protect novel or improved methods of synthesizing the API or manufacturing the drug product.
- Polymorph Patents: Patents protecting specific crystalline forms of the API, which can affect stability, bioavailability, and manufacturability.
Key players and their patent strategies:
- Boehringer Ingelheim: The originator of dabigatran etexilate (marketed as Pradaxa). Boehringer Ingelheim has historically secured a comprehensive patent portfolio covering various aspects of the drug, including composition, formulation, and methods of use. Patent 10,213,386 is likely part of this strategy to protect specific therapeutic regimens.
Generic competition considerations:
- Paragraph IV Certifications: The expiration of earlier patents often leads to generic manufacturers filing Abbreviated New Drug Applications (ANDAs) with the FDA, often accompanied by Paragraph IV certifications, asserting that their generic product does not infringe any remaining patents or that the remaining patents are invalid.
- Litigation: Method of use patents like 10,213,386 can be a significant barrier to generic entry. Generic companies must design their products and marketing to avoid infringing these claims. This often leads to patent litigation if the patent holder believes infringement is occurring or imminent.
- Patent Linkage: The FDA maintains the Orange Book, which lists patents covering FDA-approved drugs. This linkage ensures that generic manufacturers are aware of potential patent barriers.
The existence of US Patent 10,213,386, with its specific claims on dosage and indication, serves as a critical piece of intellectual property that extends market exclusivity beyond the expiration of the core compound patents. Generic manufacturers seeking to enter the market with a dabigatran etexilate product would need to carefully navigate the claims of this patent.
What are the Implications for R&D and Investment?
The analysis of US Patent 10,213,386 has direct implications for research and development strategies and investment decisions within the pharmaceutical sector.
For R&D:
- Life Cycle Management: The patent underscores the importance of method of use patents in extending the commercial life of a drug. Companies can investigate and patent new indications, optimized dosing regimens, or combinations with other drugs for existing compounds.
- Patent Strategy: Developers of new anticoagulant therapies, or even improved dabigatran formulations or delivery systems, must conduct thorough freedom-to-operate (FTO) analyses to ensure their innovations do not infringe on existing method of use patents like 10,213,386.
- Investigating Patent Expirations: For companies seeking to develop generic versions of dabigatran etexilate, understanding the expiration dates and remaining scope of patents like 10,213,386 is paramount. The ability to launch a product hinges on non-infringement or successful challenges to patent validity.
- Alternative Therapies: The existence of patent protection for specific regimens can drive research into novel anticoagulant mechanisms or drug classes that fall outside the scope of existing patents, thereby creating new market opportunities.
For Investment:
- Market Exclusivity: For the patent holder, patent 10,213,386 provides a period of continued market exclusivity for the specific therapeutic method claimed. This translates to sustained revenue streams.
- Risk Assessment for Generic Entry: Investors in generic pharmaceutical companies need to assess the risk and potential timelines for market entry, considering the patent landscape. Litigation over method of use patents can delay generic launches and impact profitability.
- Valuation of IP Portfolios: The value of a pharmaceutical company's intellectual property portfolio is significantly influenced by the strength and scope of its patents, including method of use patents. Patents like 10,213,386 contribute to the overall defensibility of a drug's market position.
- Diversification: Investors may seek to diversify their portfolios across originator and generic drug manufacturers, as well as companies focused on developing novel therapeutics that circumvent existing IP.
The specific claims of this patent—150 mg and 110 mg twice daily for thrombotic disorder prevention—define a clear therapeutic space that is protected. Any entity developing or marketing a product that directly utilizes this method would be at risk of infringement. Conversely, investors interested in generic dabigatran would need to ensure their product's administration and claims avoid this patented method.
Key Takeaways
- United States Patent 10,213,386 protects a method of preventing thrombotic disorders using dabigatran etexilate mesylate at specific dosages (110 mg and 150 mg) administered twice daily.
- The patent's claims are limited to the method of use, not the composition of matter or novel formulations, and specify prevention of stroke, systemic embolism, and death.
- The patent is active and contributes to the extended market exclusivity for dabigatran etexilate, alongside other intellectual property covering the drug.
- R&D strategies must account for this patent's scope when developing competing therapies or generic versions.
- Investment decisions require careful assessment of patent expiration, potential for litigation, and the strength of remaining IP for both originator and generic market participants.
Frequently Asked Questions
-
Does US Patent 10,213,386 cover the dabigatran etexilate molecule itself?
No, this patent covers a method of treatment using dabigatran etexilate mesylate. Patents covering the molecule itself were likely filed earlier and may have expired.
-
What are the specific indications protected by this patent?
The patent protects the prevention of thrombotic disorders, specifically identified as stroke, systemic embolism, and death.
-
Can a generic company market dabigatran etexilate if this patent is still active?
A generic company can market dabigatran etexilate if their product does not infringe the claims of patent 10,213,386. This would typically involve avoiding the specified dosages (about 110 mg or 150 mg) administered twice daily for the protected indications, or successfully challenging the patent's validity.
-
How does this patent relate to the original marketing of Pradaxa?
This patent likely represents a later-filed method of use patent designed to extend market exclusivity for specific therapeutic regimens of dabigatran etexilate, beyond the exclusivity provided by earlier composition-of-matter or formulation patents.
-
What does "about 150 mg" or "about 110 mg" mean in the context of the patent claims?
The term "about" in patent claims allows for a reasonable degree of variation from the stated amount. This is typically interpreted by patent law and courts to mean a range surrounding the precise numerical value, often within 10% or a range that does not alter the essential nature of the invention.
Citations
[1] United States Patent 10,213,386. (2019). Method for preventing thrombotic disorders. Issued February 19, 2019.
More… ↓
⤷ Start Trial
|
