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Last Updated: January 7, 2025

Details for Patent: 10,385,078


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Which drugs does patent 10,385,078 protect, and when does it expire?

Patent 10,385,078 protects ALUNBRIG and is included in one NDA.

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

Summary for Patent: 10,385,078
Title:Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl)phenyl]-N2-{2-methoxy-4-[4-(4-methylp- iperazin-1-YL) piperidin-1-YL]phenyl}pyrimidine-2,4-diamine
Abstract: Crystalline forms of brigatinib, pharmaceutical compositions comprising the same, and methods of their preparation and use of the same are disclosed herein.
Inventor(s): Rozamus; Leonard W. (Andover, MA), Sharma; Pradeep (Westford, MA)
Assignee: ARIAD PHARMACEUTICALS, INC. (Cambridge, MA)
Application Number:15/520,694
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,385,078

To delve into the specifics of the United States Patent 10,385,078, it is crucial to analyze several key aspects, including the patent's claims, scope, and the broader patent landscape.

Patent Overview

United States Patent 10,385,078, while not explicitly detailed in the provided sources, can be analyzed through general principles of patent law and the structure of patent documents.

Claims Analysis

Independent and Dependent Claims

Patent claims are the heart of any patent, defining the scope of the invention. Independent claims stand alone and define the invention without reference to other claims, while dependent claims refer back to and further limit the independent claims[3].

  • Independent Claim Length (ICL) and Count (ICC): Research suggests that the length and number of independent claims can be significant metrics for measuring patent scope. Shorter independent claims and fewer overall claims often indicate a narrower, more focused patent scope, which can be associated with a higher probability of grant and a shorter examination process[3].

Claim Clarity and Scope

  • Claim Clarity: Clear and specific claims are essential for maintaining patent quality. Unclear or overly broad claims can lead to litigation and licensing issues, potentially hindering innovation[3].
  • Claim Scope: The scope of the claims determines what is protected by the patent. Narrower claims are generally easier to defend and less likely to be challenged, while broader claims may face more scrutiny during the examination process[3].

Patent Scope

Metrics for Measuring Scope

  • Patent Maintenance Payments: The cost of maintaining a patent can be an indicator of its scope. Broader patents might require more maintenance fees over their lifetime[3].
  • Forward Citations: The number of forward citations (citations by later patents) can indicate the novelty and breadth of the patent. Patents with many forward citations are often seen as more influential and broader in scope[3].

Examination Process

  • The examination process at the USPTO tends to narrow the scope of patent claims. Longer examination durations often result in more significant reductions in claim length and count, reflecting a more refined and specific patent scope[3].

Patent Landscape

Industry and Technological Context

Understanding the technological and industry context in which the patent is filed is crucial. For example, patents in highly competitive fields like pharmaceuticals or software may face more stringent examination and have narrower scopes due to the existing body of prior art[4].

International Patent Cooperation

The patent landscape is also influenced by international agreements and practices. For instance, the Patent Cooperation Treaty (PCT) allows for the filing of international patent applications, which can be examined by various International Searching Authorities (ISAs) without restrictions on subject matter, as of recent updates[2].

Maintenance and Fees

  • Patents like 10,385,078 require regular maintenance fees to remain in force. These fees are due at 3.5, 7.5, and 11.5 years after the patent's grant date. Failure to pay these fees can result in the patent expiring prematurely[2].

Litigation and Enforcement

  • The quality and scope of patent claims can significantly impact litigation outcomes. Clear and narrowly defined claims are generally easier to enforce and less likely to be challenged in court[3].

Expert Insights

Industry experts often emphasize the importance of well-crafted patent claims. For example, Alan C. Marco and his colleagues note that the clarity and breadth of claims are critical factors in determining patent quality and the incentives for innovation[3].

Illustrative Statistics

  • A study by Marco et al. found that patents with narrower claims at publication had a higher probability of grant and a shorter examination process. This underscores the importance of focused and clear claim drafting[3].

Examples and Case Studies

  • In the pharmaceutical industry, drug patents often have very specific claims to protect the unique aspects of the drug or its manufacturing process. For instance, patents expiring in 2030, such as those listed by GreyB, highlight the importance of precise claim drafting to maintain market exclusivity[4].

Key Takeaways

  • Clear and Narrow Claims: These are associated with a higher probability of grant and shorter examination processes.
  • Patent Scope Metrics: Independent claim length and count are useful metrics for measuring patent scope.
  • Maintenance Fees: Regular fees are necessary to keep the patent in force.
  • International Cooperation: The PCT and ISAs play a significant role in the global patent landscape.
  • Litigation Impact: Clear and narrow claims are easier to enforce and less likely to be challenged.

FAQs

What are the key metrics for measuring patent scope?

Independent claim length (ICL) and the total number of independent claims (ICC) are significant metrics for measuring patent scope[3].

Why is claim clarity important?

Claim clarity is crucial because unclear or overly broad claims can lead to litigation and licensing issues, potentially hindering innovation[3].

How does the examination process affect patent claims?

The examination process tends to narrow the scope of patent claims, with longer examination durations resulting in more significant reductions in claim length and count[3].

What happens if maintenance fees are not paid?

Failure to pay maintenance fees can result in the patent expiring prematurely[2].

How do international agreements impact patent filings?

International agreements like the PCT allow for the filing of international patent applications, which can be examined by various ISAs without restrictions on subject matter[2].

Cited Sources:

  1. US Patent and Trademark Office, "Patent and Trademark Office Notices" - https://www.uspto.gov/web/offices/com/sol/og/2023/week04/TOC.htm
  2. Hoover Institution, "Patent Claims and Patent Scope" - https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
  3. GreyB, "List - 29 Drug Patents Expiring in 2030" - https://www.greyb.com/blog/drug-patents-expiring-2030/

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Drugs Protected by US Patent 10,385,078

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-001 Apr 28, 2017 RX Yes No 10,385,078 ⤷  Subscribe Y Y TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) ⤷  Subscribe
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-002 Apr 28, 2017 RX Yes No 10,385,078 ⤷  Subscribe Y Y TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) ⤷  Subscribe
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 RX Yes Yes 10,385,078 ⤷  Subscribe Y Y TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) ⤷  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

Foreign Priority and PCT Information for Patent: 10,385,078

PCT Information
PCT FiledOctober 21, 2015PCT Application Number:PCT/US2015/056701
PCT Publication Date:April 28, 2016PCT Publication Number: WO2016/065028

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