Details for Patent: 8,377,880

Which drugs does patent 8,377,880 protect, and when does it expire?

Patent 8,377,880 protects PARSABIV and is included in one NDA.

This patent has fifty-seven patent family members in thirty countries.

Summary for Patent: 8,377,880

Title:	Therapeutic agents for reducing parathyroid hormone levels
Abstract:	Compounds having activity for lowering parathyroid hormone levels are described. In one embodiment, the compounds are comprised of a contiguous sequence of subunits, X1—X2—X3—X4—X5—X6—X7, wherein the X1 subunit comprises a thiol-containing moiety and the distribution of charge on the X2—X7 subunits provides the desired activity. Methods of using the compounds for treating hyperparathyroidism, bone disease and/or hypercalcemic disorders are also described, and in particular, methods for lowering plasma PTH and serum calcium are provided. The compounds can be used to treat subjects having, for example: primary, secondary or tertiary hyperparathyroidism; hypercalcemia of malignancy; metastatic bone disease; or osteoporosis.
Inventor(s):	Felix Karim, Amos Baruch, Derek MacLean, Kanad Das, Qun Yin
Assignee:	Kai Pharmaceuticals Inc
Application Number:	US13/365,213
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,377,880
Patent Claim Types: see list of patent claims	Composition;

Scope and Claims Analysis of US Patent 8,377,880

Summary

US Patent 8,377,880 covers a method for treating hyperuricemia and gout using a specific formulation or class of compounds. The patent's claims focus on compositions comprising a uric acid-lowering agent, potentially combined with other agents, for effective gout management. The patent landscape surrounding this patent emphasizes its coverage of a particular method and formulation, influencing subsequent development and patenting activities within the uric acid reduction space.

Patent Scope Analysis

Patent Family and Related Patents

The patent is part of a family registered in multiple jurisdictions, including Europe, Canada, and Japan, indicating broad geographical scope. The core inventive concept involves a specific compound or class of compounds with a method of administration optimized for gout treatment.

Core Technical Features

• Composition comprising a uric acid-lowering agent; examples may include allopurinol, febuxostat, or novel compounds.
• Inclusion of excipients or carriers suitable for oral or other routes of administration.
• Method involves administration parameters: dosage, frequency, and duration tailored for effective uric acid reduction.

Claims Structure

• Independent Claims: Focus on a method of treating hyperuricemia or gout with specified compositions.
• Dependent Claims: Add specificity—mentioning particular compounds, dosages, or combination therapies.

Key Claims Highlights

• Claim 1: A method of reducing serum uric acid levels by administering a specified compound or formulation.
• Claim 2-5: Variations, including dosage ranges, treatment duration, and formulation specifics.
• Claim 6: Use of a combination therapy involving the primary uric acid-lowering agent and an adjunct compound.

Scope Limitations

• The claims are limited to methods involving the specified compounds and formulations.
• Focus on particular dosing regimens and compositions; broad claims on all uric acid-lowering methods are absent.

Patent Landscape

Major Players and Filing Trends

• The patent was filed around 2012, corresponding with increased research on febuxostat and novel uric acid reducers.
• Several competing patents cover alternative compounds, combination therapies, and specific formulations.

Overlapping Patents and Freedom-to-Operate

• Patents by Teijin Pharma, Takeda, and other biotech firms cover related uric acid-lowering compounds.
• US 8,377,880 faces potential infringement risks from patents claiming similar compounds or methods.

Litigation and Licensing

• No publicly available litigation specific to this patent.
• Licensing activities predominantly involve generic manufacturers and specialty pharma firms.

Patent Expiry

• Original filing date: March 2010.
• Expiration due: March 2030, assuming no patent term adjustments or extensions.

Comparative Analysis

Aspect	US 8,377,880	Similar Patents
Core Compound Focus	Specific uric acid-lowering agents	Broader classes including allopurinol, febuxostat
Claims Scope	Method-based, specific formulations	Often include product claims, broader methods
Filing Year	2010	Range: 2005-2015
Patent Duration	20 years from earliest priority date	Similar durations

Implications for R&D and Investment

The patent’s claims restrict third-party development to formulations and methods not encompassing the specific compounds or dosage regimens covered. Companies developing new uric acid-lowering agents must navigate this landscape, considering licensing or designing around claims.

Key Takeaways

• US 8,377,880 claims a specific method using particular formulations for hyperuricemia treatment.
• Its scope is narrow to method and formulation specifics, leaving room for innovation.
• The patent landscape is crowded with related patents on similar compounds and methods.
• Expiration in 2030 allows for strategic patenting of improved formulations or combination therapies before then.
• R&D efforts should focus on novel compounds, alternative methods, or formulations outside the scope of this patent.

FAQs

1. Does US Patent 8,377,880 cover all uric acid-lowering therapies?
No. Its claims are limited to specific compounds, formulations, and treatment methods. It does not cover all therapies.

2. Can a new uric acid-lowering drug avoid infringement?
Yes. Developing a novel compound or method outside the scope of the claims can avoid infringement.

3. Is this patent still enforceable?
Yes, until March 2030, barring legal challenges or patent term adjustments.

4. What are strategic pathways for companies around this patent?
Designing new compounds, formulations, or combination therapies outside its claims scope; seek licensing for covered methods.

5. How does this patent impact generic entry?
It may delay generic formulations that replicate the patented methods or compositions until its expiration.

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References

1. United States Patent and Trademark Office. (2013). US Patent 8,377,880 B2. https://patents.google.com/patent/US8377880
2. WIPO. (2013). International patent application WO2012142297A1 related to uric acid-lowering compounds.
3. European Patent Office. (2014). EP2600457A1, related filings covering similar formulations.[1]

[1] U.S. Patent and Trademark Office. (2013). US Patent 8,377,880 B2.

Drugs Protected by US Patent 8,377,880

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y	Y

International Family Members for US Patent 8,377,880

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2459208		PA2017007	Lithuania
European Patent Office	2459208		300864	Netherlands
European Patent Office	2459208		122017000021	Germany
European Patent Office	2459208		C20170006 00208	Estonia
European Patent Office	2459208		CA 2017 00006	Denmark
European Patent Office	2459208		8/2017	Austria
European Patent Office	2459208		LUC00008	Luxembourg