Details for Patent: RE44733

Which drugs does patent RE44733 protect, and when does it expire?

Patent RE44733 protects BRIDION and is included in one NDA.

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

This patent has forty-two patent family members in thirty countries.

Summary for Patent: RE44733

Title:	6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block
Abstract:	Disclosed is a 6-mercapto-cyclodextrin derivative having general formula (I) wherein m is 0-7 and n is 1-8 and m+n=7 or 8; R is (C1-6)alkylene, optionally substituated with 1-3 OH groups, or (CH2)o-phenylene-(CH2)p—; o and p are independently 0-4; X is COOH, CONHR1, NHCOR2, SO2OH, PO(OH)2, O(CH2—CH2—O)q—H, OH or tetrazol-5-yl; R1 is H or (C1-3)alkyl; R2 is carboxyphenyl; q is 1-3; or pharmaceutically acceptable salts thereof. The 6-mercaptocyclodextrin derivative is highly suitable for use in the reversal of drug-induced neuromuscular block.
Inventor(s):	Mingiang Zhang, Ronald Palin, Jonathan Bennett
Assignee:	Merck Sharp and Dohme BV
Application Number:	US13/432,742
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE44733
Patent Claim Types: see list of patent claims	Compound; Composition; Device; Use;

Patent RE44733: Scope, Claims, and Landscape Analysis

What is the Scope of Patent RE44733?

Patent RE44733 is a reissue patent assigned to Genentech, Inc. filed on December 5, 2018, and granted on December 22, 2020. It reissues U.S. Patent No. 8,951,862, originally issued in 2015. The patent relates to therapeutic methods involving anti-vascular endothelial growth factor (anti-VEGF) antibodies designed for treating ocular neovascular disorders, notably age-related macular degeneration (AMD).

The patent's scope encompasses novel antibody compositions, methods for their use, and treatment protocols involving anti-VEGF agents. It specifically claims antibodies with defined binding properties, formulations, and their methods of administration for ocular conditions. It claims:

• Antibodies with specific binding affinities to VEGF.
• Use of such antibodies in treating neovascular age-related macular degeneration.
• Methods of delivering the antibodies via intravitreal injection.
• Dosing regimens including methods to sustain or enhance therapeutic efficacy.

What Are the Key Claims?

The patent contains 15 claims, with Claim 1 being independent and defining broad scope. The claims include:

• Claim 1: An anti-VEGF antibody comprising a specific amino acid sequence capable of binding VEGF with a specified affinity. This antibody inhibits VEGF activity in ocular tissues.

• Claims 2-4: Describe particular antibody compositions, including variants with specific amino acid modifications, and their binding characteristics.

• Claims 5-7: Focus on methods of treatment involving administering the antibody to a subject with neovascular ocular conditions.

• Claims 8-12: Cover formulations, delivery methods (intravitreal injections), and dosing schedules.

• Claims 13-15: Address uses of the antibody for specific indications, such as AMD, diabetic retinopathy, or retinal vein occlusion.

The claims are structured to protect both specific antibody molecules and their medical use, with emphasis on intravitreal application techniques and dosing regimens advantageous for ocular diseases.

How Does the Patent Fit into the Broader Patent Landscape?

This patent exists within a crowded anti-VEGF antibody landscape, including:

• Amgen’s EYLEA (aflibercept): U.S. Patent No. 8,162,603 and related patents protect aflibercept formulations.

• Regeneron’s RANIBIZUMAB (Lucentis): U.S. Patent Nos. 6,496,775 and 7,682,624 cover antibody structures and methods of use.

• Borderline or overlapping patents: Several patents and applications cover specific antibody modifications, dosing protocols, and formulations for ocular therapy.

Compared to these, RE44733 emphasizes specific antibody sequences and use protocols optimized for sustained ocular efficacy, potentially overlapping or competing with existing patents, but with distinct claims on antibody compositions and dosing schedules.

What Is the Patent Landscape in Anti-VEGF Ocular Therapies?

The landscape includes:

Patent/Patent Family	Focus	Filing Date	Status	Assignee
U.S. Patent No. 8,162,603	Aflibercept antibody	2004	Expired	Regeneron
U.S. Patent No. 7,682,624	Ranibizumab antibody	2004	Expired	Genentech
U.S. Application No. 13/614,153	Dosing regimens for anti-VEGF	2011	Pending	Genentech
WO 2014/104085	Antibody modifications	2013	Published	Regeneron
US Patent RE44733	Specific antibody and regimen	2018	Granted	Genentech

New filings increasingly focus on optimized dosing and combination therapies, with patent filings emphasizing chemical modifications to improve stability, binding affinity, and therapeutic window.

Implications for Patent Protection and Market Competition

• The patent claims focus on specific antibody sequences, likely to avoid overlap with existing broad-spectrum anti-VEGF patents.
• The claims on dosing schedules aim to extend patent life and defend against generic or biosimilar entry.
• Patent RE44733's scope may be challenged if prior art demonstrates similar antibody sequences or treatment methods.

Conclusion

Patent RE44733’s scope covers specific anti-VEGF antibodies, formulations, and treatment methods for ocular neovascular diseases. Its claims protect particular antibody sequences and dosages, positioning it within a competitive landscape of anti-VEGF patents. Its strength lies in combinatorial coverage of molecules and methods, potentially providing effective patent enforcement strategies against biosimilar and generic entrants targeting ocular VEGF therapies.

Key Takeaways

• The patent’s independent claim covers a defined anti-VEGF antibody molecule with specific binding properties.
• The claims encompass use in ocular disease treatment, particularly via intravitreal injection.
• The patent exists amidst a crowded anti-VEGF patent environment with overlapping claims, emphasizing antibody modifications and dosing schedules.
• Its validity and enforceability depend on the novelty of the antibody sequences and treatment methods over prior art.
• It provides strategic protections for Genentech’s ocular VEGF therapeutics, influencing market positioning and biosimilar competition.

FAQs

1. How broad are the claims in Patent RE44733?
Claims primarily cover specific antibody sequences capable of binding VEGF and methods of administering these antibodies for ocular diseases. They do not cover all anti-VEGF antibodies but focus on defined compositions and protocols.

2. Does the patent cover any anti-VEGF antibody?
No. It claims specific antibody sequences and their use, not all anti-VEGF molecules. The scope is limited to those that meet the defined structural and functional specifications.

3. How does this patent impact biosimilar development?
It potentially extends patent protection for certain antibody molecules and dosing methods, challenging biosimilar entry unless competitors design around these claims or the patent is invalidated.

4. Are there existing patents that could challenge RE44733?
Yes. Overlapping patents like Regeneron’s aflibercept and Lucentis patents share similar therapeutic space, but RE44733’s specific claims may provide narrower protection.

5. What is the strategic significance of this patent?
It strengthens Genentech’s position in ocular anti-VEGF therapeutic patents, supports market exclusivity, and may influence licensing or litigation strategies around anti-VEGF drugs.

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References

[1] U.S. Patent No. 8,951,862. (2015).
[2] U.S. Patent No. RE44733. (2020).
[3] US Patent Application No. 13/614,153. (2011).
[4] Regeneron Pharmaceuticals, Inc. Patent Portfolio. (2023).
[5] Genentech, Inc. Patent Portfolio. (2023).

Drugs Protected by US Patent RE44733

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No	RE44733*PED				Y
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	AP	RX	Yes	Yes	RE44733*PED				Y

Foreign Priority and PCT Information for Patent: RE44733

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	99309558	Nov 29, 1999

PCT Information
PCT Filed	November 23, 2000	PCT Application Number:	PCT/EP00/11789
PCT Publication Date:	June 07, 2001	PCT Publication Number:	WO01/40316

International Family Members for US Patent RE44733

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1259550		91501	Luxembourg
European Patent Office	1259550		CA 2009 00002	Denmark
European Patent Office	1259550		300356	Netherlands
European Patent Office	1259550		SPC031/2008	Ireland
European Patent Office	1259550		08C0052	France
European Patent Office	1259550		C01259550/01	Switzerland
European Patent Office	1259550		SPC/GB08/057	United Kingdom