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Last Updated: December 22, 2024

Details for Patent: 10,596,178


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Which drugs does patent 10,596,178 protect, and when does it expire?

Patent 10,596,178 protects TABRECTA and is included in one NDA.

This patent has forty-nine patent family members in thirty-one countries.

Summary for Patent: 10,596,178
Title:Tablet formulation of 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl) imidazo [1,2-B] [1,2,4] triazin-2-yl] benzamide
Abstract: The present invention is related to tablets comprising of 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,-2-b][1,2,4]triazin- -2-yl]benzamide, processes for the production thereof, and uses in the treatment of certain cancers.
Inventor(s): Goncalves; Elisabete (Basel, CH), Tauchmann; Christin (Sankt Florianweg, GE), Yen; Shau-Fong (Basel, CH), Vippagunta; Sudha (Morris Plains, NJ), Zong; Zhixin (Franklin Park, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:16/134,162
Patent Claim Types:
see list of patent claims
Compound; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of U.S. Patent 10,596,178: A Comprehensive Analysis

Introduction

When analyzing a patent, particularly one like U.S. Patent 10,596,178, it is crucial to delve into the scope and claims of the patent, as well as the broader patent landscape. This analysis will help in understanding the patent's validity, potential for litigation, and its impact on the industry.

Patent Scope and Claims

Definition and Importance

Patent scope refers to the breadth and depth of protection granted by a patent, which is defined by the claims of the patent. The claims are the most critical part of a patent application, as they delineate what is protected and what is not[3][5].

Metrics for Measuring Patent Scope

To evaluate the scope of U.S. Patent 10,596,178, metrics such as independent claim length and independent claim count can be used. These metrics have been validated to have explanatory power for several correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes[3][5].

  • Independent Claim Length: Longer independent claims often indicate a narrower scope, as they provide more detailed descriptions of the invention. Conversely, shorter claims may suggest broader scope but could also lack clarity.
  • Independent Claim Count: A higher number of independent claims can indicate a broader scope, but it may also complicate the patent and increase the risk of litigation.

Claim Language and Clarity

The language used in the claims is vital for determining the patent's scope and clarity. Clear and specific claims reduce the risk of litigation and ensure that the patent is more likely to be granted and maintained.

  • Functional Claiming: Patents, especially in software and technology fields, often face criticism for using functional claiming language, which can be overly broad and unclear. This type of language can impede innovation and increase litigation costs[5].

Patent Examination Process

The examination process at the U.S. Patent and Trademark Office (USPTO) plays a significant role in shaping the scope of patent claims.

  • Narrowing of Claims: The examination process tends to narrow the scope of patent claims, both in terms of claim length and claim count. This narrowing is more significant when the duration of examination is longer[5].
  • Probability of Grant: Patents with narrower claims at publication are associated with a higher probability of grant and a shorter examination process compared to those with broader claims[5].

Continuation Applications and Their Impact

Continuation applications are a common practice in the U.S. patent system, allowing applicants to keep a patent application alive and potentially secure a better patent in the future.

  • Frequency and Abuse: Continuations are widely used, with about 23% of all patents granted from 1976 through 2000 claiming priority to one or more previously-filed applications. This practice can significantly extend the prosecution time and increase the likelihood of litigation[2].
  • Impact on Patent Scope: Continuations can affect the scope of the patent by allowing applicants to refine and narrow their claims over time, potentially leading to stronger, more defensible patents.

Patent Term Adjustment (PTA) and Patent Term Extension (PTE)

Understanding the patent term is crucial for determining the lifespan of the patent and its impact on the market.

  • PTA and PTE: Patent Term Adjustment (PTA) and Patent Term Extension (PTE) can extend the life of a patent beyond its statutory term. However, these extensions are treated differently under the doctrine of obviousness-type double patenting (ODP). PTA is calculated after the grant, while PTE is based on the original expiration date or disclaimed date[1].
  • ODP Considerations: ODP prevents applicants from obtaining an unjustified extension of patent term by ensuring that later-expiring patents are not obvious variants of earlier-expiring patents. This doctrine is critical in calculating expiration dates and determining potential unpatentability[1].

Litigation and Enforcement

Patents that issue from continuation applications are more likely to be litigated due to their often broader scope and the extensive prosecution process.

  • Litigation Statistics: Patents based on continuation applications represent about 52% of all litigated patents, despite constituting only about 23% of all patents granted. This indicates that continuation patents are more valuable but also more contentious[2].
  • Enforcement Challenges: The clarity and scope of the claims can significantly impact the enforceability of the patent. Broader, less clear claims may face more challenges in litigation, while narrower, clearer claims are generally more defensible.

Industry Impact

The scope and claims of U.S. Patent 10,596,178 can have significant implications for the industry in which it operates.

  • Innovation Incentives: Patents with clear and narrow claims can incentivize innovation by providing clear boundaries and reducing litigation costs. Conversely, overly broad or unclear patents can stifle innovation by creating uncertainty and increasing licensing and litigation costs[5].
  • Market Domination: A well-crafted patent with a clear scope can help a company dominate the market by protecting its inventions and preventing competitors from entering the same space.

Key Takeaways

  • Patent Scope Metrics: Independent claim length and count are crucial metrics for evaluating patent scope.
  • Claim Clarity: Clear and specific claim language is essential for reducing litigation risks and ensuring patent validity.
  • Continuation Applications: These applications can extend prosecution time and increase the likelihood of litigation but can also lead to stronger patents.
  • PTA and PTE: Understanding the differences between PTA and PTE is vital for calculating patent expiration dates and determining ODP.
  • Litigation Risks: Patents from continuation applications are more likely to be litigated, emphasizing the need for clear and narrow claims.

FAQs

  1. What are the key metrics for measuring patent scope?

    • Independent claim length and independent claim count are two validated metrics for measuring patent scope[3][5].
  2. How does the patent examination process affect patent claims?

    • The examination process tends to narrow the scope of patent claims, both in terms of claim length and claim count, especially when the duration of examination is longer[5].
  3. What is the impact of continuation applications on patent scope and litigation?

    • Continuation applications can extend prosecution time, increase the likelihood of litigation, but also lead to stronger, more defensible patents[2].
  4. How are PTA and PTE treated differently under ODP?

    • PTA is calculated after the grant, while PTE is based on the original expiration date or disclaimed date. ODP can cut off granted PTA but not PTE[1].
  5. Why are patents from continuation applications more likely to be litigated?

    • Patents from continuation applications are more valuable and have undergone extensive prosecution, making them more contentious and likely to be litigated[2].

Sources

  1. Duanemorris.com - Patent Term Adjustment and Patent Term Extension Analyzed Differently...
  2. Duke Law School - test - Duke Law School
  3. SSRN - Patent Claims and Patent Scope
  4. Court of Appeals for the Federal Circuit - 04-1522.pdf
  5. Hoover Institution - Patent Claims and Patent Scope

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Drugs Protected by US Patent 10,596,178

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-001 May 6, 2020 RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-002 May 6, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,596,178

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3172209 ⤷  Subscribe 301208 Netherlands ⤷  Subscribe
European Patent Office 3172209 ⤷  Subscribe CA 2022 00056 Denmark ⤷  Subscribe
European Patent Office 3172209 ⤷  Subscribe 2022C/558 Belgium ⤷  Subscribe
European Patent Office 3172209 ⤷  Subscribe 122022000076 Germany ⤷  Subscribe
European Patent Office 3172209 ⤷  Subscribe 51/2022 Austria ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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