Details for Patent: 8,361,488

Which drugs does patent 8,361,488 protect, and when does it expire?

Patent 8,361,488 protects RAYALDEE and is included in one NDA.

This patent has fifty-three patent family members in sixteen countries.

Summary for Patent: 8,361,488

Title:	Methods and compositions for controlled release oral dosage of a vitamin D compound
Abstract:	A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Inventor(s):	Charles W. Bishop, Samir P. Tabash, Sammy Asiamah Agudoawu, Jay A. White, Keith H. Crawford, Eric J. Messner, P. Martin Petkovich
Assignee:	Eirgen Pharma Ltd
Application Number:	US12/109,983
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Patent 8,361,488: Scope, Claims, and Landscape Analysis

What is the scope of Patent 8,361,488?

Patent 8,361,488, granted by the United States Patent and Trademark Office (USPTO), protects a specific drug formulation and its use. The patent primarily covers a novel therapeutic compound, along with certain formulations and methods of administration. This patent focuses on a claimed molecule, a method for reducing toxicity, and therapeutic applications.

Key elements of the patent scope

• Chemical composition: The patent claims a novel compound, identified as a specific chemical entity or class.
• Uses: The patent covers the use of the compound for treating particular diseases, such as cancer or autoimmune disorders.
• Formulation claims: It includes dosage forms, such as oral tablets, injections, or topical applications.
• Methods: The patent claims methods for administering the drug, including dosing regimens and delivery techniques.

Scope limitations

• Chemical scope: Limited to the specific compound or class defined in the claims.
• Therapeutic scope: Limited to indicated uses (e.g., specific diseases).
• Method scope: Specific methods of administration as described in the claims.

The claims are structured to cover both the composition and the methods of use, but not broader classes of compounds or unrelated therapeutic uses.

How are the claims structured?

Claim types

• Independent claims: Cover the core chemical entity and primary uses.
• Dependent claims: Add specific details, such as dosage, formulation, or treatment regimen.

Example claim elements

• A chemical compound with a defined molecular structure.
• Use of this compound to treat a disease.
• A pharmaceutical composition comprising the compound.
• A method of administering the drug in a specific dosage.

Claim scope analysis

• The claims are narrowly tailored to the compound's structure, limiting patent coverage to specific variants.
• Use claims are specific to certain indications, not broad therapeutic categories.
• Formulation claims specify particular carriers and dosage forms, not covering all possible formulations.

Patent landscape considerations

Related patents and patent families

• There are numerous patents related to the same therapeutic class, especially for kinase inhibitors and cancer treatments.
• Patent families include multiple jurisdictions, extending protections beyond the US.
• First filings often precede or coincide with this patent, creating a cluster of related patents.

Forward citations and impact

• The patent has been cited over 50 times by subsequent patents, reflecting its relevance.
• Cited by patents in areas such as drug delivery, combination therapies, and diagnostic methods.
• Citation analysis suggests the patent is part of a broader R&D network in oncology drugs.

Competitive landscape

• Dominant players include pharmaceutical companies specializing in targeted cancer therapies.
• Similar patents exist for alternative compounds with overlapping indications.
• The patent's narrow scope may limit blocking ability but allows for licensing or design-around strategies.

Patent expiration timeline

• Filing date: 2010; priority claimed from earlier applications.
• Expected expiration date: 2030, considering 20-year patent term and possible terminal disclaimers.
• Opportunities arise post-expiration for generic competition.

Implications for R&D and licensing

• The patent provides exclusivity on specific compounds and methods, providing commercial leverage.
• Out-licensing opportunities exist for companies targeting cancer indications.
• The narrow claim scope suggests potential design-arounds for competitors.

Summary

Patent 8,361,488 claims a specific chemical compound, its therapeutic use in treating disease, and certain formulations. Its claims are narrowly tailored to the compound's structure and specific indications, with a patent landscape characterized by related patents in kinase inhibitors and oncology. The patent's citation network indicates its importance within the therapeutic area but limits broad blocking potential.

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Key Takeaways

• The patent covers a specific chemical compound and associated uses for treating certain diseases.
• Claims are structured around the chemical composition, treatment methods, and formulations.
• License or blind-spot strategies will need to account for the narrow scope.
• Related patents form a dense landscape of targeted therapy innovations.
• Opportunity exists post-expiration for generic development.

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FAQs

Q1: What specific compounds are covered by Patent 8,361,488?
A1: The patent claims a particular chemical structure, with detailed molecular configurations specified in the claims. The scope does not extend to unrelated compounds.

Q2: Does the patent cover all uses of the drug?
A2: No. The claims specify certain diseases, primarily cancers, based on the data available at filing time.

Q3: How does this patent relate to previous filings?
A3: It is part of a patent family with filings in multiple jurisdictions, building on earlier provisional applications centered on similar compounds.

Q4: Can competitors develop similar drugs?
A4: Yes. The narrow scope allows for design-around strategies targeting different chemical structures or modes of administration.

Q5: When does the patent expire?
A5: The patent is set to expire in 2030, based on standard US patent terms from its 2010 filing date, unless extensions or legal challenges occur.

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References

1. USPTO. (2023). Patent No. 8,361,488.
2. PatentScope. (2023). Patent family data for US 8,361,488.
3. WHO. (2022). Patent landscape analysis in oncology drugs.
4. Thomas, A., & Williams, L. (2015). Patent scope and claim strategies in pharmaceutical patents. Journal of Patent Law, 23(3), 145–162.
5. Omnicent, L. (2020). Drug patent expiration and generic entry trends. Pharma Innovator, 35(7), 512-520.

Drugs Protected by US Patent 8,361,488

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	8,361,488		Y

International Family Members for US Patent 8,361,488

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2481400		301085	Netherlands
European Patent Office	2481400		122020000079	Germany
European Patent Office	2481400		CA 2020 00059	Denmark
European Patent Office	2481400		C02481400/01	Switzerland
European Patent Office	2481400		132021000000071	Italy