Details for Patent: 11,052,075

Which drugs does patent 11,052,075 protect, and when does it expire?

Patent 11,052,075 protects ORKAMBI and is included in one NDA.

Protection for ORKAMBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty-two patent family members in twenty-seven countries.

Summary for Patent: 11,052,075

Title:	Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Abstract:	A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo [d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a diluent, a disintegrant, a surfactant, a binder, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering an oral pharmaceutical formulation of Compound 1 to the patient.
Inventor(s):	Verwijs; Marinus Jacobus (Framingham, MA), Alargova; Rossitza Gueorguieva (Brighton, MA), Kaushik; Ritu Rohit (Long Island City, NY), Kadiyala; Irina Nikolaevna (Newton, MA), Young; Christopher (Waltham, MA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	16/530,240
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Analyzing the Scope and Claims of United States Patent 11,052,075

Introduction to Patent Analysis

When analyzing a patent, it is crucial to understand the scope and claims, as these elements define the intellectual property rights granted to the patent holder. Here, we will delve into the specifics of United States Patent 11,052,075, exploring its claims, scope, and the broader patent landscape.

Understanding the Patent

Patent Number and Title

• The patent in question is US 11,052,075 B2. While the specific title is not provided in the sources, patents typically have descriptive titles that reflect their subject matter.

Publication and Prior Art

• The patent was published with the USPTO, and its prior art keywords include terms like "compound," "tablet," "weight," and others, indicating it is related to pharmaceutical or chemical compositions[4].

Claims Analysis

Independent and Dependent Claims

• Patent claims are the heart of any patent, defining what is protected by the patent. Independent claims stand alone and define the broadest scope of the invention, while dependent claims build upon the independent claims and narrow the scope further.
• For US 11,052,075 B2, the independent claims would outline the core aspects of the invention, such as the specific compounds, their structures, and any unique methods of preparation or use[4].

Claim Language and Scope

• The scope of a patent is often debated in terms of its breadth and clarity. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims[3].
• In the case of US 11,052,075 B2, the claim language would need to be carefully crafted to ensure clarity and specificity, avoiding overly broad claims that could lead to validity issues.

Patent Scope Metrics

Independent Claim Length and Count

• Metrics such as independent claim length and count can be used to measure patent scope. Longer independent claims and a higher number of claims can indicate a broader scope, but may also increase the complexity and potential for disputes[3].

Prior Art and Citation Data

Common Citation Document (CCD)

• The Common Citation Document (CCD) application consolidates prior art cited by participating IP offices, providing a single point of access to citation data. This tool can help in understanding the prior art landscape related to US 11,052,075 B2 and ensuring that the claims do not infringe on existing patents[1].

Global Patent Family

Global Dossier

• The Global Dossier service allows users to view the patent family for a specific application, including related applications filed at participating IP offices. This can be crucial for understanding the global scope and potential conflicts of US 11,052,075 B2[1].

Search and Examination Process

Patent Public Search and PEDS

• Tools like the Patent Public Search and the Patent Examination Data System (PEDS) provide comprehensive resources for searching and analyzing patent data. These tools can help in conducting thorough searches to ensure the novelty and non-obviousness of the invention claimed in US 11,052,075 B2[1].

Legal Status and Enforcement

Active Status

• The legal status of US 11,052,075 B2 is listed as active, indicating that the patent is currently in force and its claims are enforceable. This status is subject to maintenance payments and other legal requirements[4].

Broader Patent Landscape

Small Claims Patent Court Considerations

• The broader patent landscape is evolving, with discussions around the establishment of a small claims patent court. Such a court could impact how patent disputes related to US 11,052,075 B2 are handled, potentially providing a more streamlined and cost-effective process for resolving infringement claims[5].

Practical Implications

Innovation and Licensing

• The scope and claims of a patent like US 11,052,075 B2 have significant practical implications. Clear and narrow claims can encourage innovation by reducing licensing and litigation costs, while overly broad claims can stifle innovation[3].

Conclusion and Key Takeaways

• Clear Claims: Ensure that the claims are clear, specific, and not overly broad to avoid validity issues.
• Prior Art: Use tools like CCD and Global Dossier to understand the prior art landscape.
• Global Scope: Consider the global patent family to avoid conflicts.
• Search Tools: Utilize Patent Public Search and PEDS for thorough searches.
• Legal Status: Maintain the patent through required payments and ensure it remains active.
• Broader Landscape: Be aware of potential changes in the patent system, such as the establishment of a small claims patent court.

FAQs

Q: What is the significance of independent claims in a patent?

• Independent claims define the broadest scope of the invention and are crucial for determining the patent's validity and enforceability.

Q: How can the Common Citation Document (CCD) help in patent analysis?

• The CCD consolidates prior art cited by participating IP offices, providing a single point of access to citation data and helping to ensure that the claims do not infringe on existing patents.

Q: What is the Global Dossier service, and how is it useful?

• The Global Dossier service allows users to view the patent family for a specific application, including related applications filed at participating IP offices, which is useful for understanding the global scope and potential conflicts.

Q: Why is the legal status of a patent important?

• The legal status indicates whether the patent is currently in force and its claims are enforceable, subject to maintenance payments and other legal requirements.

Q: How might a small claims patent court impact patent disputes?

• A small claims patent court could provide a more streamlined and cost-effective process for resolving infringement claims, potentially reducing the financial burden on parties involved in patent disputes.

Sources

1. USPTO - Search for patents
2. USA.gov - U.S. Patent and Trademark Office (USPTO)
3. SSRN - Patent Claims and Patent Scope
4. Google Patents - US11052075B2
5. ACUS - U.S. Patent Small Claims Court

Drugs Protected by US Patent 11,052,075

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No	11,052,075*PED				Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes	11,052,075*PED				Y

International Family Members for US Patent 11,052,075

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	081069
Argentina	081760
Australia	2011237494