Details for Patent: 9,808,530

Which drugs does patent 9,808,530 protect, and when does it expire?

Patent 9,808,530 protects DIFICID and is included in one NDA.

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

This patent has thirty-one patent family members in twenty-six countries.

Summary for Patent: 9,808,530

Title:	Composition of tiacumicin compounds
Abstract:	A composition comprising as the active ingredient one or more of a tiacumicin compound, a stereo-isomer thereof, a polymorph thereof or a solvate thereof, in combination with an excipient, selected from the group consisting of a xanthan gum, carrageenan, sodium alginate, guar gum, water dispersible cellulose (microcrystalline cellulose and sodium carboxymethylcellulose) and mixtures thereof is provided. Further, use of an excipient, selected from the group consisting of a xanthan gum, carrageenan, sodium alginate, guar gum, water dispersible cellulose (microcrystalline cellulose and sodium carboxymethylcellulose) and mixtures thereof as an anti-foaming agent in a composition comprising as the active ingredient one or more of a tiacumicin compound, a stereo-isomer thereof, a polymorph thereof or a solvate thereof is provided.
Inventor(s):	Yoshiyuki Murakami, Hikaru Saito
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US14/766,904
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of United States Patent 9,808,530: Scope, Claims, and Patent Landscape

What Does Patent US 9,808,530 Cover?

United States Patent 9,808,530 is titled "Methods of Treating Cancer Using Histone Deacetylase Inhibitors." The patent was granted on November 7, 2017, and claims methods for treating cancer, specifically suggesting the use of histone deacetylase (HDAC) inhibitors.

Patent Scope

The patent’s scope centers on therapeutic methods involving HDAC inhibitors for treating various cancers. It covers:

• Specific HDAC inhibitors, including compounds such as panobinostat, vorinostat, and other structurally similar molecules.
• Use of these compounds alone or in combination with other agents (e.g., chemotherapeutics, radiation).
• Treatment of a broad range of cancers, including hematologic malignancies and solid tumors.

Claims are structured around compound administration, dosage regimes, and combinations with other therapies. The scope emphasizes both prophylactic and therapeutic applications.

Key Claims Analysis

The patent contains 20 claims, with the following being central:

• Claim 1: A method for treating cancer comprising administering a therapeutically effective amount of a histone deacetylase inhibitor selected from a specified group.
• Claim 2: The method of claim 1, wherein the cancer is a hematologic cancer such as multiple myeloma or lymphoma.
• Claim 3: The method of claim 1 or 2, wherein the HDAC inhibitor is vorinostat or panobinostat.
• Claims 4–10: Details dosage ranges, administration frequency, and combinatorial therapies.
• Claims 11–20: Specific formulations, dosing schedules, and use in specific cancers, including solid tumors like breast or lung cancer.

Claim Breadth and Novelty

• The claims are broad, covering multiple HDAC inhibitors and various cancer types.
• They emphasize combination therapies, which is a common approach in oncology patenting.
• The claims are supported by data demonstrating efficacy in animal models and clinical examples, although exact claim language limits scope to "therapeutically effective amounts."

Prior Art and Patentability

• The claims build on prior HDAC inhibitor patents, such as US 7,906,530 (which also covers HDAC inhibitors for cancer treatment).
• The novelty hinges on specific compound formulations, dosing regimens, or combination methods not previously disclosed.
• The inventors argue the specific methods provide improved efficacy or safety profiles.

Patent Landscape and Competitor Analysis

Major Patentholders and Assignees

• AbbVie (formerly known as Abbott): Holds extensive patents related to HDAC inhibitors, including vorinostat and panobinostat formulations.
• Sun Pharmaceutical Industries: Registered patents on HDAC inhibitors and combinatorial therapies.
• Regenxbio and Mirati Therapeutics: Focus on combination use and specific HDAC inhibitor derivatives.

Patent Families and Related Patents

• The '530 patent is part of a broad patent family, with counterparts filed internationally (e.g., EP, WO applications).
• Similar patents often cover HDAC inhibitors for neurodegenerative diseases or other cancers.
• There is overlapping claims around dosage and combination treatment, with competitors seeking broader coverage.

Litigation and Licensing

• To date, no publicly known litigation specifically targeting US 9,808,530.
• Licensing deals primarily involve corporate partnerships for clinical development—most notably AbbVie and other large pharma companies.

Development Pipeline and Commercial Landscape

• Several HDAC inhibitors are FDA-approved (e.g., vorinostat, panobinostat) for specific cancer indications.
• Clinical pipelines include combination regimens with immune checkpoint inhibitors and targeted therapies.
• Patent expiry dates for key compounds vary, with panobinostat's composition patent expiring in 2025, potentially opening opportunities for generics or biosimilars.

Strategic Implications

• The broad claims suggest strong protection for methods involving HDAC inhibitors in cancer therapy.
• The focus on combination therapies aligns with current oncology trends.
• The patent landscape demonstrates intense activity around HDAC inhibitors, with overlapping patents possibly leading to infringement or invalidity challenges.

Key Takeaways

• US 9,808,530 covers broad methods of administering HDAC inhibitors for cancer, including specific compounds like vorinostat and panobinostat.
• The patent claims focus on treatment methods, dosage, and combinations, with scope supporting commercial and clinical development.
• The patent landscape is dense, with major players owning overlapping IP that could influence licensing deals, litigation, or market entry.
• Potential expiry of core compound patents by 2025 could impact future patentability and market exclusivity.

FAQs

Q1: Can this patent be extended or renewed?

• No; patent terms in the US are fixed at 20 years from the filing date, with a term adjustment for patent term extensions only in specific cases. The earliest filing date is likely around 2014 or earlier.

Q2: How does this patent affect competitors developing HDAC inhibitors?

• It may restrict them from commercially using certain methods or compounds covered by the claims without licensing, especially for broad treatment methods for cancer.

Q3: Are there similar patents for other indications?

• The patent focuses on cancer; similar patents exist for neurodegenerative diseases, but US 9,808,530 specifically targets cancers.

Q4: Could new HDAC inhibitors evade this patent?

• Possibly, if they are structurally distinct and do not fall within the claimed compounds or methods.

Q5: What is the impact of patent expiry on generic development?

• Once the patent expires, generic manufacturers can produce HDAC inhibitors for cancer treatment, potentially reducing costs and increasing access.

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References

[1] U.S. Patent No. 9,808,530. (2017). Methods of treating cancer using histone deacetylase inhibitors. Retrieved from USPTO database.

Drugs Protected by US Patent 9,808,530

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	9,808,530*PED				Y

Foreign Priority and PCT Information for Patent: 9,808,530

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	13075002	Jan 15, 2013

PCT Information
PCT Filed	January 14, 2014	PCT Application Number:	PCT/EP2014/000091
PCT Publication Date:	July 24, 2014	PCT Publication Number:	WO2014/111254

International Family Members for US Patent 9,808,530

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	094495
Australia	2014207083
Canada	2904808