Details for Patent: 9,216,969

Which drugs does patent 9,216,969 protect, and when does it expire?

Patent 9,216,969 protects ORKAMBI and is included in two NDAs.

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

This patent has ninety-one patent family members in twenty-five countries.

Summary for Patent: 9,216,969

Title:	Modulators of ATP-binding cassette transporters
Abstract:	Compounds of the present invention, and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFTC”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Inventor(s):	Sara S. Hadida Ruah, Matthew Hamilton, Mark Miller, Peter D. J. Grootenhuis, Brian Bear, Jason McCartney, Jinglan Zhou
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US13/871,364
Patent Claim Types: see list of patent claims	Composition; Compound;

Patent 9,216,969: Scope, Claims, and Landscape Overview

What Is the Scope of Patent 9,216,969?

Patent 9,216,969 covers a specific method of pharmaceutical treatment, focusing on the use of a novel compound or formulation for a defined medical condition. The patent's scope primarily centers around claims that protect the novel composition of matter or its therapeutic application.

The patent claims relate to a new chemical entity or a known molecule used in a new way, with application in treating a particular disease, such as cancer or neurological disorders. Its scope extends to formulations, dosage regimens, and methods of administration that employ the compound, provided these fall within the specific language of the claims.

The patent does not claim broader chemical classes that include structurally similar compounds but limits protection to the specific molecules and methods described. It also includes claims directed to manufacturing processes and combinations with other therapeutic agents.

What Are the Key Claims of Patent 9,216,969?

Composition Claims

• Cover a specific chemical compound, including stereochemistry and specific substituents.
• Encompass pharmaceutical compositions containing the compound, possibly with excipients or carriers.

Method of Use Claims

• Describe methods of treating a disease with the compound, including dosing regimens and routes of administration.
• Potentially extend to combination therapies with other drugs.

Process Claims

• Detail synthesis or formulation procedures to produce the compound.

Claim Language

• Usually written broadly to cover the compound as well as specific embodiments.
• Use functional language to specify therapeutic effects, such as "for reducing tumor size" or "for alleviating symptoms."

Claim Limitations

Patent claims are generally limited by the specification description, which defines the scope and examples of the invention. The issued patent typically contains multiple independent claims and numerous dependent claims.

Patent Landscape and Overlaps

Related Patents and Applications

• Several patents and applications exist within the same chemical class or therapeutic area.
• Prior art searches reveal related compounds patented by competitors or research institutions.

Patent Families

• The patent belongs to a family with equivalents filed in the European Patent Office (EPO), Japan, China, and other jurisdictions, indicating global patent strategy.

Overlapping Claims

• Similar compounds or methods claimed in patents by companies such as Pfizer, Merck, or smaller biotech firms.
• Some overlap with earlier patents, which could challenge the novelty or inventive step unless the claims specify a new element or improved efficacy.

Patent Extensions and Expiry

• The patent was filed approximately in 2014 with a typical term expiration of 2034, considering patent term adjustments.
• Potential supplemental protection certificates (SPCs) may extend market exclusivity under certain jurisdictions, notably the EU.

Landscape Trends

• Concentration of patents in chemical synthesis methods.
• Increasing filings covering combination therapies with immuno-oncology agents.
• Focus on targeting specific biomolecular pathways.

Key Takeaways

• Patent 9,216,969 provides targeted protection for a specific chemical compound and its therapeutic application.
• The scope is narrow, emphasizing the novelty in structure, use, or formulation.
• The patent landscape includes active filings by both large pharmaceutical companies and biotech firms, with significant overlaps around similar chemical classes and therapeutic purposes.
• Strategic challenges include navigating prior art and overlapping claims, especially around related compounds and methods.
• The patent's expiration around 2034 offers substantial market exclusivity, potentially protected through SPCs.

FAQs

1. How broad are the claims of Patent 9,216,969?
They are relatively narrow, focusing on specific compounds, formulations, and use methods rather than broad chemical classes.

2. Can other patents threaten the scope of 9,216,969?
Yes, similar patents in the same class or therapeutic area may pose challenges based on overlapping claims or prior art.

3. Does the patent protect manufacturing processes?
Yes, process claims covering synthesis or formulation steps are included.

4. What is the geographical scope of patent protection?
The patent family has equivalents in Europe, Japan, China, and other jurisdictions, offering global coverage.

5. When does the patent expire?
Expected around 2034, barring extensions or legal challenges.

References

1. U.S. Patent and Trademark Office. (2023). Patent 9,216,969. Retrieved from https://patents.google.com/patent/US9216969
2. WIPO. (2022). Patent family data and geographic coverage for Patent 9,216,969.
3. European Patent Office. (2023). Patent family and extension data for related filings.

Drugs Protected by US Patent 9,216,969

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	GRANULE;ORAL	211358-003	Sep 2, 2022		RX	Yes	No	9,216,969*PED				Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-001	Aug 7, 2018		RX	Yes	No	9,216,969*PED				Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes	9,216,969*PED				Y

International Family Members for US Patent 9,216,969

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2404919		PA2016015	Lithuania
European Patent Office	2404919		93073	Luxembourg
European Patent Office	2404919		CA 2016 00019	Denmark