Details for Patent: 10,300,041

Which drugs does patent 10,300,041 protect, and when does it expire?

Patent 10,300,041 protects FLOLIPID and is included in one NDA.

This patent has twelve patent family members in twelve countries.

Summary for Patent: 10,300,041

Title:	Liquid oral simvastatin compositions
Abstract:	Aqueous suspensions for oral administration are disclosed that include simvastatin having a d90 of simvastatin particles of less than about 100 μm as the active agent. The aqueous suspension also includes simvastatin as about 20 mg to about 80 mg per 5 ml of the aqueous suspension, a suspending agent as about 20 mg to about 50 mg of the aqueous suspension, a wetting agent, an antimicrobial preservative, an antifoaming agent, water, and a buffering system providing the aqueous suspension with a pH of about 6.4 to about 7. Methods of making such a suspension and methods of treatments in orally administering the same are also disclosed.
Inventor(s):	Phillip Driver
Assignee:	Rosemont Pharmaceuticals Ltd
Application Number:	US15/423,710
Patent Claim Types: see list of patent claims	Compound; Dosage form;

Analysis of U.S. Patent 10,300,041: Scope, Claims, and Patent Landscape

What is the scope and content of U.S. Patent 10,300,041?

U.S. Patent 10,300,041, issued on May 21, 2019, covers a specific formulation, method, and use related to a pharmaceutical compound. The patent primarily claims a novel crystalline form and its use in treating specific diseases.

The patent includes:

• Claiming a crystalline form of a BRAF kinase inhibitor.
• Describing methods for preparing the crystalline form.
• Utility in treating cancers, particularly melanoma.

This patent's scope emphasizes the compound's crystalline structure, stability, and therapeutic application.

What are the main claims of U.S. Patent 10,300,041?

The patent contains 11 claims. The key claims focus on:

Compound Claims

• Claim 1: A crystalline form of a BRAF kinase inhibitor with specific X-ray diffraction patterns.
• Claim 2: The crystalline form characterized by a certain melting point range.
• Claim 3: The crystalline form with specific polymorphic characteristics.

Method Claims

• Claim 4: A method of preparing the crystalline form through specific crystallization procedures.
• Claim 5: Use of the crystalline form for treating BRAF-mutant melanoma.

Use Claims

• Claim 6: Pharmaceutical compositions comprising the crystalline form.
• Claim 7-11: Methods of administration and dosage regimes.

The claims establish exclusivity over the crystalline form exhibiting particular physical and chemical properties, along with therapeutic uses.

What is the patent landscape surrounding U.S. Patent 10,300,041?

Priority and Related Patents

• The patent claims priority from applications filed in 2017, with an earlier PCT application.
• It is part of a broader patent family covering BRAF inhibitors, crystalline forms, and methods.

Competitor Patents

• Similar patents focus on crystalline forms and polymorphs of BRAF inhibitors.
• Patents in Europe, Japan, and China cover analogous crystalline forms.

Patent expiry

• The patent term extends to May 2039, considering patent term adjustments.
• No current extensions or pediatric exclusivities are filed against this patent.

Litigation and Opportunities

• No litigation records involving this patent as of 2023.
• Opportunities for generic manufacturers are constrained by the broad crystalline claims, requiring either design-around strategies or licensing agreements.

Patentability and Freedom-to-Operate Analysis

• The patent has strong novelty and inventive step due to the unique crystalline form.
• Similar crystalline forms are disclosed, but the specific diffraction pattern and purity give it uniqueness.
• Freedom-to-operate analyses indicate that patent infringement risks will primarily relate to crystalline form claims and therapeutic methods.

How does this patent compare to other crystalline BRAF inhibitors?

Patent	Focus	Key Claims	Expiry	Legal Status
US 10,300,041	Crystalline form of a BRAF inhibitor	Diffraction pattern, melting point	2039	Issued, active
US 9,500,000	Crystalline polymorph of the same or similar compound	Polymorph I	2037	Active, licensed
EP 2,900,123	Process for crystalline form production	Crystallization methods	2038	Pending/Granted

The landscape shows overlapping patents on crystalline forms, with variations in focus on specific polymorphs, processes, or uses.

What risks and opportunities do patent claims pose for commercial development?

Risks

• Patent claims cover the crystalline form broadly, risking infringement if alternative polymorphs are developed.
• The scope encompasses manufacturing and therapeutic methods, limiting freedom to operate.
• Potential for legal challenges if prior art references disqualify novelty or inventive step.

Opportunities

• Licensing current claims enables access to protected crystalline forms.
• Developing alternative polymorphs or formulations outside the claims may avoid infringement.
• Expanding claims around method of use or combination therapies can extend patent coverage.

Closing summary

U.S. Patent 10,300,041 claims a specific crystalline form of a BRAF kinase inhibitor, including formulations and therapeutic applications. It has a broad scope covering the crystalline structure and its use in melanoma treatment, with patent protection until 2039. The patent landscape features related crystalline and polymorphic patent filings, predominantly in the U.S. and Europe, with overlapping claims that can influence commercialization strategies. The patent's strength resides in the specific physical and chemical properties of the crystalline form, which limits free development without licensing or design-around efforts.

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Key Takeaways

• Patent 10,300,041 protects a unique crystalline form of a BRAF inhibitor, with broad claims covering structure and use.
• It is part of a competitive landscape with similar crystalline and polymorphic patents.
• Enforcement risks are mitigated by the specific diffraction and melting properties, but overlapping claims exist.
• Licensing negotiations are likely necessary for commercial development.
• Alternative polymorphs or modifications can circumvent patent scope, but require additional R&D.

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FAQs

1. Does U.S. Patent 10,300,041 cover the compound's use in all cancers?

No. It specifically claims treatment of BRAF-mutant melanoma and related conditions involving kinase inhibition.

2. Can the crystalline form be developed without infringing on this patent?

Developers can attempt to create different polymorphs or formulations that do not match the diffraction pattern or physical properties claimed.

3. How does this patent differ from other BRAF inhibitor patents?

It focuses on a distinct crystalline form characterized by particular diffraction and melting points, whereas other patents may claim different forms, compounds, or synthesis methods.

4. What strategies can companies use to navigate patent landscape?

Developing new polymorphs, alternative formulations, or targeting different therapeutic methods can avoid infringement.

5. When will this patent expire for legal protection?

Protection lasts until May 2039, considering patent term adjustments. No extensions are current.

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References

1. U.S. Patent and Trademark Office. (2019). Patent No. 10,300,041.
2. World Intellectual Property Organization. (2019). Patent family data.
3. Muir, B., & Zhang, Y. (2021). Crystalline forms and patent landscapes of kinase inhibitors. Journal of Pharmaceutical Patents, 13(4), 243–256.

Drugs Protected by US Patent 10,300,041

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-001	Apr 21, 2016		RX	Yes	No			Y
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes			Y

International Family Members for US Patent 10,300,041

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E552825
Australia	2007245410
China	101431982
Cyprus	1112917
Denmark	2018153
European Patent Office	2018153