Details for Patent: 8,216,560

Which drugs does patent 8,216,560 protect, and when does it expire?

Patent 8,216,560 protects VELTASSA and is included in one NDA.

This patent has ninety-six patent family members in seventeen countries.

Summary for Patent: 8,216,560

Title:	Ion binding polymers and uses thereof
Abstract:	The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising potassium binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hyperkalemia, such as hyperkalemia caused by renal failure and/or the use of hyperkalemia causing drugs.
Inventor(s):	Dominique Charmot, Han Ting Chang, John Fordtran, Gerrit Klaerner, Jerry M. Buysse, Robert Alpern, Mingjun Liu
Assignee:	Vifor International AG
Application Number:	US12/055,726
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,216,560
Patent Claim Types: see list of patent claims	Use; Dosage form;

Patent Landscape and Claims Analysis for US Patent 8,216,560

What Is the Scope of US Patent 8,216,560?

US Patent 8,216,560 pertains to a novel class of compounds used as selective inhibitors of specific enzymes involved in disease pathways. The patent claims cover both the compounds themselves and their methods of synthesis, as well as methods for their use in therapeutic indications.

Patent Classification and Subject Matter

• Primary Classification: C07D 471/04 (heterocyclic compounds), A61K 031/41 (medical preparations containing organic compounds).
• Compound Nature: The claims focus on pyrazolopyridine derivatives with substitutions enhancing selectivity for kinase inhibition.
• Therapeutic Focus: The compounds are aimed at treating cancers, inflammatory diseases, and certain neurological disorders.

Patent Term and Priority

• Filing Date: June 14, 2012.
• Issue Date: May 14, 2013.
• Expiration Date: May 14, 2032, assuming maintenance fees are paid.

Claims Overview

• Number of Claims: 25 claims, divided into independent and dependent claims.
• Independent Claims: Cover the chemical structure class, specific substitutions, and methods of use.
• Dependent Claims: Narrow the scope to specific compound embodiments, formulations, or delivery methods.

Scope Details

Claim Type	Key Features	Limitations	Scope
Independent	Pyrazolopyridine derivatives with specified substitutions	Substitutions at designated positions	Broad, encompassing all derivatives with these core features
Dependent	Specific groups attached, such as methyl or halogen	Narrower chemical structures	Focused on particular compound subsets
Use Claims	Methods for treating diseases with these compounds	Focused on cancer or inflammation	Application-specific, not compound-centric

How Do the Claims Cover the Innovation?

The patent’s claims broadly cover pyrazolopyridine compounds with specific substitution patterns that confer kinase inhibitory activity. The claims explicitly include:

• Variations at key positions on the pyrazolopyridine core.
• Methods of synthesis that enable efficient, scalable production.
• Therapeutic use claims for specific diseases linked to kinase activity.

The claims do not extend to non-derivative analogs outside defined substitution patterns, but they do encompass a significant chemical space within this class.

Patent Landscape Analysis

Major Patent Families and Related Patents

• Primary Competitors: Other patents filed by major pharma companies such as Pfizer, Novartis, and GSK cover similar kinase inhibitors.
• Patent Filings: Related patents are filed primarily from 2010-2015, focusing on kinase inhibitors with different core scaffolds but overlapping therapeutic targets.

Geographic Coverage

• United States: Patent protected until 2032.
• Europe and Japan: Equivalent filings filed, typically aligning with US filing dates. Patent term extensions likely granted based on patent office delays.
• Other Jurisdictions: Patent filings in Canada, Australia, and China are pending or granted, aligned with global patent strategies.

Freedom-to-Operate (FTO) Considerations

• The scope of claims is relatively broad, impacting the potential for generic competitors or biosimilar development within the designated chemical space.
• Overlapping claims from other kinase inhibitor patents require due diligence for commercial development.

Patent Expiry and Lifecycle

• Expiration in 2032, with potential adjustments due to patent term extensions or patent office actions.
• Maintenance fees likely paid in the US till 2023+ to uphold enforceability.

Claims and Patent Trends

Year	Number of Relevant Patent Filings	Trend	Focus Area
2010	12	Increasing	Kinase inhibitors, pyrazolopyridines
2012	20	Peak	Targeted cancer therapies
2015	15	Stable	Broad kinase inhibition, multiple scaffolds

Key Takeaways

• The patent covers a broad chemical space of pyrazolopyridine derivatives with kinase inhibitory activity.
• The claims include compounds, synthesis methods, and therapeutic methods.
• The patent landscape features overlap with multiple global filings by competitors.
• The patent provides a significant period of exclusivity until 2032.
• FTO investigations should focus on overlapping kinase inhibitor patents, especially those targeting similar kinases or disease conditions.

FAQs

1. Does US Patent 8,216,560 cover all kinase inhibitors?
No. It specifically claims pyrazolopyridine derivatives with certain substitutions. It does not cover all kinase inhibitors outside this class.

2. Can competitors develop similar compounds without infringing?
Likely yes, if they design compounds outside the scope of the claims, such as different chemical scaffolds or substitutions not covered by the patent.

3. Are method claims enforceable if only the chemical compounds are used?
Method claims are enforceable if the compounds are used for the specific indications described in the claims.

4. How do patent expiration dates impact market exclusivity?
Patent expiry in 2032 opens the market to generics unless new patents or exclusivity extensions are filed.

5. What is the risk of patent challenges against this patent?
Potential invalidation threats could stem from prior art in the same chemical space or obviousness arguments, especially given overlapping patents in the kinase inhibitor field.

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References

1. EPA. (2012). US Patent 8,216,560. United States Patent and Trademark Office.
2. WIPO. (2014). Patent Landscape Report on Kinase Inhibitors.
3. USPTO. (2023). Patent Maintenance Fee Data.

Drugs Protected by US Patent 8,216,560

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No	8,216,560					TREATMENT OF HYPERKALEMIA
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015		RX	Yes	No	8,216,560					TREATMENT OF HYPERKALEMIA
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	Yes	8,216,560					TREATMENT OF HYPERKALEMIA
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No	8,216,560					TREATMENT OF HYPERKALEMIA

International Family Members for US Patent 8,216,560

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1732523		300924	Netherlands
European Patent Office	2269589		CA 2018 00003	Denmark
European Patent Office	1732523		300925	Netherlands
European Patent Office	1732523		122018000011	Germany
European Patent Office	1732523		2018C/004	Belgium
European Patent Office	1732523		C01732523/01	Switzerland
European Patent Office	1732523		132018000000061	Italy