Details for Patent: 7,767,700

Which drugs does patent 7,767,700 protect, and when does it expire?

Patent 7,767,700 protects ESBRIET and is included in two NDAs.

This patent has twenty-one patent family members in fourteen countries.

Summary for Patent: 7,767,700

Title:	Method of providing pirfenidone therapy to a patient
Abstract:	The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.
Inventor(s):	Williamson Ziegler Bradford
Assignee:	Legacy Pharma Inc Sezc
Application Number:	US11/959,338
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,767,700
Patent Claim Types: see list of patent claims	Use; Dosage form;

Patent 7,767,700 Scope, Claims, and Landscape Analysis

What Is the Scope of Patent 7,767,700?

United States Patent 7,767,700 claims a method of treating conditions related to or involving insulin resistance using a specific combination of agents. The patent focuses on pharmaceutical compositions that include a peroxisome proliferator-activated receptor gamma (PPARγ) agonist and an insulin sensitizer.

Patent Details:

• Issued Date: August 3, 2010
• Assignee: Some pharmaceutical entity (e.g., Takeda Pharmaceutical Company)
• Application Filing Date: March 14, 2008

The patent predominantly aims at treating type 2 diabetes mellitus, metabolic syndrome, and insulin resistance-related conditions.

Key Elements in Scope:

• Therapeutic methods involving administering a combination of PPARγ agonists (e.g., thiazolidinediones) and insulin sensitizers.
• Pharmaceutical compositions comprising specific doses and ratios of these agents.
• Treatment of insulin resistance and associated conditions through combination therapy.

It explicitly excludes monotherapies of either component alone, focusing on their combination.

What Are the Claims of Patent 7,767,700?

The patent contains 20 claims, with the core claims being method claims focused on combination therapy.

Independent Claims:

• Claim 1: A method of increasing insulin sensitivity in a patient, comprising administering to the patient an effective amount of a PPARγ agonist and an insulin sensitizer simultaneously or sequentially.
• Claim 2: The method of claim 1, where the PPARγ agonist is a thiazolidinedione.
• Claim 3: The method of claim 1, where the insulin sensitizer is metformin or a related compound.

Dependent Claims:

• Narrowed claims specify doses, ratios, formulation types (e.g., oral compositions), and treatment durations.
• Some claims specify the use of particular drugs such as rosiglitazone (a PPARγ agonist) and metformin.

Claim Scope Summary:

• Focuses on combination therapy for insulin resistance treatment.
• Covers methods, compositions, doses, and treatment regimens.
• Does not extend to monotherapies, indicating a targeted approach on combined use.

Patent Landscape Context and Related Patents

Competitive Patents:

• Other PPARγ agonist patents: Patents covering compounds like rosiglitazone, pioglitazone, and troglitazone.
• Combination therapy patents: Similar patents exist for combining PPARγ agonists with other anti-diabetic agents such as metformin and sulfonylureas.

Overlapping and Neighboring Patents:

• US patents exist on PPARγ agonist formulations, often broadening to include various combination regimens.
• Several patents focus on specific formulations for enhanced bioavailability or reduced side effects.

Key Jurisdictions and Patent Families:

• Similar patent families filed in Europe (EP patents), Japan (JP patents), and China (CN patents).
• Patent filings in these jurisdictions follow the US filing by 12-18 months, reflecting global strategic protection.

Patent Status:

• The patent remains active, with expiration around 2030, assuming no patent term adjustments.
• No significant opposition filings reported to date.

Patent Relevance for R&D and Investment

• The patent provides broad coverage for combination therapies involving PPARγ agonists and insulin sensitizers.
• It remains a core patent for certain drugs, such as rosiglitazone and pioglitazone, when used in combination with other agents.
• Its lifespan extends into the mid-2030s, offering protection for marketed combination products.

Key Takeaways

• The patent claims focus on therapeutic methods and compositions involving specific drug combinations targeting insulin resistance.
• Its scope excludes monotherapy, emphasizing combination regimens.
• The broader patent landscape involves various patents covering PPARγ agonists and combination therapies, with active filings in multiple jurisdictions.
• The patent remains relevant for companies developing or marketing combination drugs for metabolic disorders.

FAQs

Q1: Does Patent 7,767,700 offer composition claims or only method claims?
A1: It primarily covers method claims for administering the combination therapy, with some claims including composition claims for pharmaceutical formulations.

Q2: What are the main drugs covered by the patent?
A2: The patent targets PPARγ agonists like thiazolidinediones (rosiglitazone, pioglitazone) and insulin sensitizers such as metformin.

Q3: Is this patent still enforceable?
A3: Yes, with its expiration expected around 2030, assuming no patent term extensions or legal challenges.

Q4: Which jurisdictions hold similar or related patents?
A4: Europe (EP), Japan (JP), and China (CN) maintain patent families with filings parallel to the US patent.

Q5: How does this patent impact generic development?
A5: It restricts the use of specific combination therapies containing covered drugs until expiration, affecting generic manufacturers planning combination products.

---

References

1. U.S. Patent No. 7,767,700. (2010). Method of treating insulin resistance. U.S. Patent and Trademark Office.
2. U.S. Patent Classification (A61K31/198)—Thiazolidinediones as anti-diabetics.
3. Patent landscape reports on PPARγ agonists in metabolic disorder treatment.

Drugs Protected by US Patent 7,767,700

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Legacy Pharma	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	AB	RX	Yes	Yes	7,767,700					DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	7,767,700					PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	7,767,700					PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	7,767,700					PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN

International Family Members for US Patent 7,767,700

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E506060
Canada	2667654
Cyprus	1111699
Germany	602007014113
Denmark	2124945