Details for Patent: 8,450,375

Which drugs does patent 8,450,375 protect, and when does it expire?

Patent 8,450,375 protects VALCHLOR and is included in one NDA.

This patent has fifty patent family members in twenty countries.

Summary for Patent: 8,450,375

Title:	Stabilized compositions of volatile alkylating agents and methods of using thereof
Abstract:	A composition and method for treatment of cancer. The composition for treating a skin disorder, comprising: a Nitrogen Mustard or an HX salt of the Nitrogen Mustard, wherein the Nitrogen Mustard or the HX salt of the Nitrogen Mustard is in a non-aqueous vehicle or carrier that does not include petrolatum or ethanol, wherein the non-aqueous vehicle or carrier that does not include petrolatum or ethanol does not include petrolatum or ethanol. The method comprises topically applying the composition of a Nitrogen Mustard or a HX salt of the Nitrogen Mustard to the affected skin, wherein the Nitrogen Mustard or the HX salt of the Nitrogen Mustard is in a non-aqueous vehicle or carrier that does not include petrolatum or ethanol, wherein the non-aqueous vehicle or carrier does not include petrolatum or ethanol.
Inventor(s):	Robert Alonso, Peter A. Crooks, Mark A. Pimley, Abeer M. Al-Ghananeem
Assignee:	Helsinn Birex Pharmaceuticals Ltd
Application Number:	US11/908,531
Patent Claim Types: see list of patent claims	Composition; Compound;

Patent 8,450,375 Scope, Claims, and Landscape Analysis

What does United States Patent 8,450,375 cover?

US Patent 8,450,375 protects a monoclonal antibody targeting CD30, used for treating CD30-expressing cancers, primarily Hodgkin lymphoma and anaplastic large cell lymphoma (ALCL). It relates to brentuximab vedotin, an antibody-drug conjugate (ADC) that combines a CD30-specific monoclonal antibody with a microtubule-disrupting agent.

What are the key claims establishing the patent's scope?

Main claims

• Claim 1: An ADC comprising an anti-CD30 monoclonal antibody conjugated to a cytotoxic agent via a linker.
• Claim 2: The ADC as in claim 1, where the antibody is a chimeric or humanized antibody with specific binding affinity to CD30.
• Claim 3: The linker being a cleavable linker, such as a valine-citrulline linker.
• Claim 4: The cytotoxic agent being monomethyl auristatin E (MMAE).
• Claim 5: The ADC comprising a specific ratio between the antibody and the cytotoxic payload.

Additional claims specify various linker chemistries, conjugation methods, and antibody constructs, covering both composition and methods of treatment using the ADC.

Scope Summary: The patent primarily protects the composition of brentuximab vedotin and its use in treating CD30-positive cancers. It emphasizes specific linker-payload combinations and antibody modifications.

How broad is the patent's claim landscape?

Patents related to brentuximab vedotin

• Patent family members: Includes patents across jurisdictions (e.g., EP, WO, CN) covering different aspects of CD30-targeted ADCs.
• Similar patents: Multiple patents filed by Seattle Genetics (the assignee), notably claims related to linker technology, antibody engineering, and conjugation methods.
• Method claims: Covering uses for treating Hodgkin lymphoma, ALCL, and other CD30-expressing malignancies.

Competitor landscape

• Key competitors: ImmunoGen, AbbVie, Genentech, and others hold patents on ADC technology and CD30 antibodies.
• Recent filings: New patent applications expand claims around optimized linkers, novel payloads, and combination therapies targeting CD30.

Regulatory and patent protection period

• Patent expiry scheduled for 2030–2035, depending on jurisdiction and patent term adjustments.

What is the patent landscape for CD30-targeted therapies?

Patent Type	Assignee	Jurisdiction	Focus Area	Expiration Year
Core ADC patent	Seattle Genetics	US, EU, JP	ADC composition, linker, payload, methods	2030-2035
Antibody engineering patents	Multiple (e.g., Genentech)	US, EU	Antibody structure, affinity, and conjugation	2030-2040
Payload and linker patents	ImmunoGen, Bayer	US, EU	Novel payloads, linker chemistry	2029-2032

Note: Patent expiry dates include regulatory delays and patent term extensions.

Implications for development and commercialization

• The claims' specificity limits potential design-arounds but offers a broad shield against similar ADCs with comparable linker-payload architecture.
• Competitors are actively filing alternative linkers, payloads, and antibody variants, which could circumvent existing patents.
• The expiration timeline suggests a window for market exclusivity extending into the mid-2030s.

Conclusion

US Patent 8,450,375 claims a specific ADC configuration targeting CD30 with a focus on linker-payload chemistry. It forms a core piece of intellectual property for brentuximab vedotin, supported by a landscape of related patents covering different elements of ADC technology. The patent landscape remains dynamic, with ongoing filings aimed at extending or circumventing existing claims.

Key Takeaways

• The patent protects a specific CD30-targeted ADC, with claims on composition and use.
• Competitors have filed related patents on linker technology and antibody engineering.
• The patent landscape remains active, with expiry expected around 2030–2035.
• Patent protection provides a significant advantage for brentuximab vedotin but faces risks from emerging ADC patents.
• Developing or licensing new linker or payload chemistries may enable novel ADCs to circumvent existing IP.

FAQs

1. How does Patent 8,450,375 compare to other ADC patents?
It covers specific linker-payload-antibody configurations, whereas other patents may focus on different payloads, linker chemistries, or antibody modifications.

2. Can competitors develop similar ADCs without infringing?
Yes. They can design ADCs with different linkers, payloads, or antibody formats not covered by the claims, but careful patent landscape analysis is required.

3. Are there orphan drug or pediatric exclusivity extensions?
Possibly. Brentuximab vedotin has Orphan Drug exclusivity in the US until 2025, which may affect market competition.

4. What is the impact of patent expiry on market exclusivity?
Market exclusivity diminishes after patent expiration, opening opportunities for biosimilars or generics unless new patents are filed.

5. How might future patent filings affect the landscape?
They could broaden the scope of protected technologies or create barriers for competitors developing ADCs with different technical features.

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References

1. U.S. Patent 8,450,375. (2013).
2. European Patent Office Patent Family Database. (2023).
3. Seattle Genetics Patent Portfolio. (2023).
4. World Intellectual Property Organization. Patent Landscape Reports. (2023).
5. US Food and Drug Administration. FDA Approvals and Regulatory Data. (2023).

Drugs Protected by US Patent 8,450,375

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 8,450,375

PCT Information
PCT Filed	March 14, 2006	PCT Application Number:	PCT/US2006/009060
PCT Publication Date:	September 21, 2006	PCT Publication Number:	WO2006/099385

International Family Members for US Patent 8,450,375

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1858864		PA2017026	Lithuania
European Patent Office	1858864		CR 2017 00033	Denmark
European Patent Office	1858864		300888	Netherlands
European Patent Office	1858864		122017000059	Germany
European Patent Office	1858864		36/2017	Austria
European Patent Office	1858864		LUC00033	Luxembourg
European Patent Office	1858864		2017C/033	Belgium