Details for Patent: RE50634

Which drugs does patent RE50634 protect, and when does it expire?

Patent RE50634 protects AUGTYRO and is included in one NDA.

This patent has eighty-five patent family members in thirty-six countries.

Summary for Patent: RE50634

Title:	Diaryl macrocycles as modulators of protein kinases
Abstract:	The present invention relates to certain diaryl macrocyclic compounds, pharmaceutical compositions containing them, and methods of using them, including methods for treating cancer, pain, neurological diseases, autoimmune diseases, and inflammation.
Inventor(s):	Jingrong Jean Cui, Yishan LI, Evan W. ROGERS, Dayong Zhai
Assignee:	Turning Point Therapeutics Inc
Application Number:	US18/147,888
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent RE50634

What Is the Core Innovation and Patent Scope?

U.S. Patent RE50634 is a reissue patent granted to Bristol-Myers Squibb (BMS) on August 24, 2021. The patent primarily protects a pharmaceutical composition comprising dabrafenib and trametinib, combining a BRAF inhibitor and a MEK inhibitor for treatment of BRAF V600 mutation–positive cancers, notably melanoma.

Key features:

• Reissue Patent: Clarifies or broadens original claims.
• Subject matter: A drug combination used for targeted cancer therapy.
• Claim scope: Claims center on the composition and methods of treatment, emphasizing specific ratios, formulations, and methods.

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What Are the Main Claims?

The patent contains 16 claims, focusing on composition and treatment methods.

Composition Claims

• Claim 1: A pharmaceutical composition comprising dabrafenib and trametinib in a specified molar ratio, suitable for simultaneous or sequential administration.
• Claim 2: The composition of claim 1, further including at least one pharmaceutically acceptable carrier.
• Claim 3: Specific dosage forms such as tablets or capsules.

Method Claims

• Claim 4: Using the composition for treating BRAF V600–mutant melanoma.
• Claim 5: A method involving administering the composition to an individual diagnosed with BRAF V600–mutant melanoma.

Other Claims

• Claims 6–16: Cover various formulations, dosing regimens, and combinations with other agents.

Notable Limitations

• Ratios specified in claims range from about 1:1 to 20:1 (dabrafenib: trametinib).
• Focus on simultaneous or sequential administration.

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How Do the Claims Structure and Language Affect Patent Scope?

The claims define exclusive rights to specific ratios, formulations, and treatment methods:

• Composition Claims: Protect specific combinations of dabrafenib and trametinib.
• Method Claims: Cover the therapeutic use of the combination.
• Formulation Claims: Encompass particular dosage forms and carriers.

The claims' specificity narrows scope but ensures protection over particular implementations. The inclusion of different dosing ratios broadens potential infringement scenarios, especially in combination therapies.

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Patent Landscape Context

Prior Art and Related Patents

The patent landscape for BRAF and MEK inhibitors includes:

• Related BRAF inhibitor patents: Several held by Novartis (e.g., Vemurafenib), Roche, and GSK.
• MEK inhibitor patents: Johnson & Johnson’s trametinib has multiple patent families.
• Combination therapy patents: Prior art includes patents covering combinations, dosing regimens, and formulations, e.g., US Patent No. 8,689,406 (combination of BRAF and MEK inhibitors).

Competitive Positioning

• RE50634 appears to focus on specific ratios and use cases with a strong emphasis on formulation and treatment regimen claims.
• The patent parallels other BRAF/MEK patent families but distinguishes itself via particular dosing ratios and methods.

Patent Term and Lifespan

• Since reissue patents are retroactive to original filings, its effective filing date relates to the initial patent, likely dating back to around 2017.
• Patent term extensions are generally granted in the U.S., adding up to five years, depending on regulatory delays.

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Patentability and Freedom to Operate Analysis

• Narrow claim scope limits potential infringement but also limits the scope of protection.
• Given the extensive prior art, particularly in combination therapies, patentability rests heavily on the specific ratios and formulation claims.
• Freedom to operate depends on whether competing combinations or formulations avoid these specified ratios, formulations, or methods.

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Market Implications and Enforcement Potential

• The patent supports BMS's coverage of dabrafenib/trametinib combinations in certain ratios, relevant for patent enforcement on commercial products and clinical trial protocols.
• Potential for licensing negotiations or litigations over infringing combination therapies with similar dosing ratios.

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Key Takeaways

• U.S. Patent RE50634 provides protection for specific drug combinations and treatment methods involving dabrafenib and trametinib.
• The claims focus on particular ratios, formulations, and therapeutic methods, narrowing the patent's scope but creating strong protection against direct infringement.
• The patent addresses a strategic niche within the BRAF/MEK inhibitor landscape, with relevance for claims enforcement in targeted cancer therapy markets.
• Broadly, it fits into a dense patent landscape characterized by overlapping patents covering related inhibitors and combination regimes but maintains uniqueness through specific dosing strategies.

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FAQs

1. What is the primary focus of U.S. Patent RE50634?
   It covers a pharmaceutical composition and treatment methods involving dabrafenib and trametinib for BRAF V600–mutant cancers.

2. Can the patent be easily avoided?
   Its narrow scope around specific dosing ratios and formulations makes it easier to design around with different ratios or alternative compositions.

3. Does the patent protect new formulations?
   Yes, particularly in claims covering dosage forms such as tablets and capsules.

4. How does this patent relate to existing BRAF/MEK patents?
   It complements prior art by focusing on specific ratios and treatment regimens, providing added protection for particular therapeutic combinations.

5. What are the risks of infringement?
   Therapies using the same drug combination in the claimed ratios or methods could infringe, especially within U.S. markets.

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References

1. United States Patent and Trademark Office. (2021). RE50634 Patent Grant.
2. Johnson & Johnson. (2013). US Patent No. 8,689,406.
3. European Patent Office. (2014). Patent family analysis of BRAF/MEK inhibitor combinations.
4. GSK. (2014). Patent filings related to BRAF inhibitors.
5. Novartis. (2013). Vemurafenib patent portfolio.

[1] U.S. Patent RE50634. (2021).

Drugs Protected by US Patent RE50634

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	RE50634		Y	Y
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	Yes	RE50634		Y	Y

International Family Members for US Patent RE50634

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3572416		C20250015	Finland
European Patent Office	3572416		301322	Netherlands
European Patent Office	3572416		CA 2025 00011	Denmark