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Patent landscape, scope, and claims: |
Understanding the Scope and Claims of United States Patent 8,906,851
Introduction
The United States Patent 8,906,851 is one of the many patents that are part of the complex patent landscape surrounding pharmaceuticals, particularly those involved in the generic and biosimilar market. To analyze this patent, we need to delve into its specifics, the context in which it was granted, and its implications.
Patent Overview
- Patent Number: 8,906,851
- Expiration Date: August 18, 2026[2][5]
- Assignee: The patent is associated with pharmaceutical companies, although the specific assignee is not explicitly mentioned in the provided sources.
Patent Claims
Patent claims are the heart of any patent, defining the scope of the invention and what is protected.
- Method-of-Use Patents: This patent, like several others in the pharmaceutical sector, may involve method-of-use claims. These claims cover specific uses of a drug rather than the drug itself. For example, a patent might cover the use of a drug for treating a particular condition, even if the drug's original patent has expired[2][5].
Patent Scope
The scope of a patent is crucial in determining its impact on the market and competition.
- Claim Language: The scope can be measured by metrics such as independent claim length and independent claim count. Narrower claims tend to have a higher probability of grant and a shorter examination process[3].
- Patent Expiration: The patent expires on August 18, 2026, which means that after this date, the protected methods or uses will enter the public domain, allowing for generic or biosimilar competition[2][5].
Context in Pharmaceutical Patent Landscape
The pharmaceutical industry is notorious for its complex and often contentious patent landscape.
- Evergreening Practices: Companies often engage in "evergreening" practices, where they obtain patents on minor or obvious variations of existing drugs to extend their market exclusivity. This can include patenting methods of screening patients or new uses for existing drugs[1].
- Impact on Generic and Biosimilar Competition: Patents like 8,906,851 can delay the entry of generic and biosimilar drugs into the market. For instance, the analysis on drugs selected for Medicare price negotiation reveals that patent abuses and evergreening tactics have resulted in significant financial losses for taxpayers due to the absence of lower-cost alternatives[1].
Specific Examples and Cases
- Johnson & Johnson’s Stelara: A similar case involves Johnson & Johnson’s Stelara (ustekinumab), where the company obtained a secondary patent expiring in 2039 by claiming a previously disclosed use of the drug. This extended the market exclusivity and delayed biosimilar entry[1].
- Dapagliflozin Tablets: Another example is the series of patents associated with Dapagliflozin Tablets, where multiple patents with different expiration dates protect various aspects of the drug, including its use and manufacturing processes[2][5].
Challenges and Controversies
The patent landscape is not without its challenges and controversies.
- PTAB Proceedings: The Patent Trial and Appeal Board (PTAB) is an administrative forum that allows for the challenge of problematic patents. However, legislative proposals like the PREVAIL Act could make it harder to invalidate such patents, potentially reducing access to lower-cost alternatives[1].
- Economic Impact: The economic impact of these patents is significant. For example, the analysis suggests that taxpayers will lose between $4.9 and $5.4 billion by January 1, 2026, due to patenting practices that delay access to generic and biosimilar drugs[1].
Conclusion
The United States Patent 8,906,851 is part of a broader landscape of pharmaceutical patents that often involve complex strategies to extend market exclusivity. Understanding the scope and claims of such patents is crucial for navigating the legal and economic implications they carry.
Key Takeaways
- Patent Expiration: The patent expires on August 18, 2026.
- Method-of-Use Claims: The patent may involve method-of-use claims that protect specific uses of a drug.
- Evergreening Practices: Companies use evergreening tactics to extend market exclusivity.
- Impact on Competition: These patents can delay the entry of generic and biosimilar drugs.
- Economic Impact: Patent abuses can result in significant financial losses for taxpayers.
FAQs
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What is the expiration date of the United States Patent 8,906,851?
- The patent expires on August 18, 2026[2][5].
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What are method-of-use patents in the pharmaceutical sector?
- Method-of-use patents cover specific uses of a drug rather than the drug itself, often extending market exclusivity beyond the original patent's expiration[2][5].
-
How do evergreening practices affect the pharmaceutical market?
- Evergreening practices involve obtaining patents on minor or obvious variations of existing drugs, delaying the entry of generic and biosimilar competition and extending market exclusivity[1].
-
What is the role of the Patent Trial and Appeal Board (PTAB) in challenging pharmaceutical patents?
- The PTAB provides a forum for challenging problematic patents, but legislative proposals like the PREVAIL Act could make it harder to invalidate such patents[1].
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What is the estimated economic impact of patent abuses on Medicare?
- Taxpayers are estimated to lose between $4.9 and $5.4 billion by January 1, 2026, due to patenting practices that delay access to generic and biosimilar drugs[1].
Sources
- Using the Inflation Reduction Act to Rein in Patenting ... - Citizen.org
- ANDA 211414 - U.S. Food & Drug Administration
- Patent Claims and Patent Scope - SSRN
- Patent No.: US 10,993,992 B2 - Google APIs
- Dapagliflozin Tablets - U.S. Food & Drug Administration
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