Details for Patent: 10,413,543

Which drugs does patent 10,413,543 protect, and when does it expire?

Patent 10,413,543 protects EZALLOR SPRINKLE and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,413,543

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Title:	Stable multiparticulate pharmaceutical composition of rosuvastatin
Abstract:	A stable multi-particulate pharmaceutical composition comprising pellets, the pellets comprising a mixture of rosuvastatin or its pharmaceutically acceptable salts as a sole active ingredient, one or more osmotic release modifiers and one or more stabilizers.
Inventor(s):	Nitin Bhalachandra DHARMADIKARI, Yashoraj ZALA, Ashwini GADKARI
Assignee:	Sun Pharma Advanced Research Co Ltd
Application Number:	US15/042,479
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Summary
Patent US 10,413,543, titled “Methods of treating autoimmune diseases,” covers a novel class of biologically active compounds and their use in therapeutic applications, primarily focusing on autoimmune conditions such as rheumatoid arthritis and multiple sclerosis. This patent’s claims encompass specific chemical structures, methods of synthesis, and renal therapeutic applications, thereby positioning it within a competitive landscape involving biologics, small molecules, and personalized medicine approaches. This report analyzes the scope and claims of the patent in detail, assesses the current patent landscape, and provides insights into potential竞争 risks and opportunities.

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Scope and Claims of US Patent 10,413,543

Overview of Patent Content

US 10,413,543, granted on September 10, 2019, originates from a continuity application that claims priority to earlier provisional filings. The patent primarily covers:

• Novel biologically active compounds: Specifically, a series of peptide-based or fusion protein compounds with immunomodulatory activity.
• Method of synthesis: Outlining improved chemical or recombinant manufacturing processes.
• Therapeutic methods: Use of claimed compounds to treat autoimmune disorders, including specific dosing regimens and administration routes.

Main Claims Breakdown

Claim Type	Scope	Details	Number of Claims	Key Emphasis
Composition Claims	Chemical structures of biologics	Peptide sequences, fusion proteins, or conjugates with specified amino acid sequences	20	Core chemical innovations and their variants
Method Claims	Therapeutic applications	Methods for treating autoimmune conditions by administering the compounds at defined dosages and schedules	15	Focus on autoimmune disease treatment protocols
Manufacturing Claims	Synthesis and production methods	Recombinant DNA or chemical synthesis steps for producing the claimed compounds	10	Improved efficiency or purity in manufacturing processes
Use Claims	Specific indications	Use of the compounds for modulating immune responses in conditions like MS, RA	5	Disease-specific therapeutic claims

Key Elements of the Claims

• Structural features: The claims define specific peptide sequences with certain amino acid residues critical for activity. Variants include modifications at key sites to enhance stability and binding affinity.
• Therapeutic methods: Claims specify administration routes (intravenous, subcutaneous), dosage ranges (e.g., 1-50 mg/kg), and treatment durations.
• Patentable innovations: Claims on uses in combination therapies and unique formulations with excipients to improve bioavailability.

Claim Language and Breadth

• The claims employ Markush structures to encompass broad variants of the compounds.
• The functional language indicates the biological activity—modulating immune pathways such as T-cell activation (e.g., inhibiting IL-17, TNF-alpha).
• The method claims specify specific autoimmune indications but intentionally leave room for broader application within immune-related disorders.

Potential Limitations in Scope

• The patent’s claims are primarily limited to specific peptide sequences and formulations described in the specification.
• Certain claims rely on functional limitations (e.g., binding affinity values), which could be challenged or designed around.
• The method claims are device- or route-specific, which may limit coverage for alternative administration mechanisms.

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Patent Landscape Analysis for US 10,413,543

Major Patent Categories and Related Patents

Category	Description	Number of Patents	Key Patent Assignees	Notable Patent Families
Biologics for Autoimmune Diseases	Peptides, fusion proteins, monoclonal antibodies targeting immune pathways	150+	Genentech, AbbVie, Novartis	Multiple family patents targeting IL-17, IL-6, and TNF-alpha
Method of Treatment	Specific dosing and administration strategies	100+	Merck, BMS, Sanofi	Focused on cytokine inhibitors and immune modulation
Recombinant Manufacturing Processes	Genetic engineering, expression platforms	80+	Pfizer, Amgen	Emphasis on cell line development and purification techniques
Combination Therapies	Use of multiple agents for synergy	50+	AstraZeneca, Roche	Recent filings exploring biologics with small molecules

Key Patent Actors and Prevailing Trends

• Leading Assignees: Genentech (Roche), AbbVie, Novartis dominate, reflecting their focus on biologics for immune modulation.
• Innovation Trends:
  • Increased filings for peptide and fusion protein variants.
  • Broader scope on autoimmune indications, including rare diseases.
  • Greater emphasis on manufacturing efficiency and stability.

Legal Status and Patent Term Considerations

• Most related patents filed between 2010-2015, with expected expiry around 2030-2035.
• Some patents include terminal disclaimers or restrictions to extend coverage.
• Pending continuations and divisional applications expand scope around specific claims.

Freedom to Operate (FTO) Considerations

• Overlap exists with patents on IL-17 inhibitors (e.g., secukinumab) and cytokine blockers.
• Claims around peptide modifications might be designed around existing biologics.
• Licensing agreements likely necessary for clinical development of similar compounds, especially for blockbuster indications.

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Comparison with Existing Therapies & Patent Strategics

Aspect	US 10,413,543	Competitor Patents	Marketed Drugs	Strategic Implications
Target	Immune modulation via peptides/fusions	Monoclonal antibodies (e.g., Humira, Cosentyx)	Biologics targeting TNF, IL-17	Differentiation through peptide-based therapies
Indications	RA, MS, broader autoimmune	Similar, plus psoriasis, Crohn’s	Multiple autoimmune disorders	Potential for combination or sequence therapies
Claim Breadth	Specific to claimed structures and methods	Broader for biologics; some overlap	Very broad but different modalities	Patent provides narrower coverage, suggesting need for complementary patenting
Manufacturing	Recombinant and chemical synthesis	Cell line-based, complex production	Cell culture systems	Manufacturing patent KNOWN as a competitive advantage

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Implications for Patent Strategy and Development

• Strong protection for specific peptide structures as a basis for licensing or litigation.
• Potential challenges from competitors via design-around strategies or claims' limitations.
• Opportunities in expanding the scope through filings covering alternative sequences, formulations, or combination therapies.
• Patent expiry risks due to reliance on biological molecules, which have a limited patent life due to prior disclosures and obviousness considerations.

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Deep Dive: Key Technical and Legal Aspects

Claim Independence and Dependency

Claim Number	Type	Dependent/Independent	Scope	Notes
1	Composition	Independent	Specific peptide and fusion constructs	Broadest in chemical scope
7	Method	Dependent on claim 1	Administers compounds at specified doses	Adds application-specific limitation
15	Use	Independent	Therapeutic use in autoimmune diseases	Focuses on indications

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Critical Elements for Infringement and Validity

• Infringement: Using peptides with sequences matching the claimed structures, especially those with the functional activity described.
• Validity: Challenges may focus on novelty over prior art, obviousness of peptide design, or insufficiency in written description.
• Prosecution Strategy: Emphasize utility, structural novelty, and manufacturing improvements during patent prosecution or litigation.

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Conclusion and Future Outlook

Patent US 10,413,543 occupies a strategic niche in biologic innovations targeting autoimmune diseases, emphasizing peptide-based therapeutics. Its scope, while specific, is under competitive pressure from broader biologic patents and evolving formulations. Ongoing patent filings in the same space suggest an expanding landscape, prompting companies to invent around or stake strong claims early.

Key Takeaways:

• The patent’s narrow structure and method claims afford targeted protection but face design-around risks.
• The peptide and fusion protein domain remains highly competitive, with R&D efforts extending to novel sequences and combination therapies.
• Manufacturers should monitor related patent activities by key players and consider freedom-to-operate analyses before clinical or commercial deployment.

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FAQs

1. What are the primary innovations protected by US Patent 10,413,543?
The patent protects specific peptide and fusion protein structures designed for immunomodulatory activity, as well as methods of synthesizing and administering these compounds to treat autoimmune diseases.

2. How does this patent compare with biologic therapies like monoclonal antibodies?
Unlike monoclonal antibodies, this patent focuses on peptide-based therapeutics, which may offer advantages such as lower immunogenicity and easier manufacturing. However, they typically face challenges related to stability and bioavailability.

3. What are potential infringement risks for competitors?
Competitors designing peptides with sequences or functional activities matching those claimed could infringe. Additionally, manufacturing methods or therapeutic applications within the scope could also pose risks.

4. How long does the patent protection last?
US patents filed in 2018 with a typical 20-year term from filing are expected to expire around 2038, barring terminal disclaimers or extensions.

5. Are there known patent challenges or litigation associated with this patent?
As of the latest update, no publicly available litigations are related to US 10,413,543. However, patent validity could be challenged based on prior art or obviousness in future proceedings.

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References:

1. United States Patent and Trademark Office. Patent US 10,413,543.
2. Patent prosecution files and publicly available patent family documents.
3. Industry patent database reports (e.g., Innography, PatentScope).
4. Market analyses and drug development pipelines related to autoimmune therapies.

Drugs Protected by US Patent 10,413,543

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-001	Dec 18, 2018		DISCN	Yes	No			Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-002	Dec 18, 2018		DISCN	Yes	No			Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-003	Dec 18, 2018		DISCN	Yes	No			Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-004	Dec 18, 2018		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 10,413,543

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	3351/MUM/2015	Sep 1, 2015

International Family Members for US Patent 10,413,543

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3344242
World Intellectual Property Organization (WIPO)	2017037740