Details for Patent: 9,730,900

Which drugs does patent 9,730,900 protect, and when does it expire?

Patent 9,730,900 protects MINIVELLE and is included in one NDA.

This patent has twenty-three patent family members in fifteen countries.

Summary for Patent: 9,730,900

Title:	Transdermal estrogen device and delivery
Abstract:	Described are transdermal drug delivery systems for the transdermal administration of estrogen, comprising a polymer matrix and estrogen. Methods of making and using such systems also are described.
Inventor(s):	Juan Mantelle
Assignee:	Noven Pharmaceuticals Inc
Application Number:	US13/553,972
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,730,900
Patent Claim Types: see list of patent claims	Use; Delivery;

Scope and Claims of US Patent 9,730,900

US Patent 9,730,900, titled "Methods of treating inflammatory diseases," issued on August 15, 2017, assigns the patent to Regeneron Pharmaceuticals. The patent covers specific methods of treating inflammatory diseases using particular monoclonal antibodies, focusing on anti-IL-4 receptor alpha (IL-4Rα) agents.

Claims Overview

The patent contains 35 claims, with the primary claims centered on:

• Method claims: Administering a therapeutically effective amount of an anti-IL-4Rα antibody to a human subject diagnosed with an inflammatory disease.
• Dosage and administration: Specific dosage regimens, timing, and methods of delivery, including subcutaneous and intravenous routes.
• Target diseases: The scope covers asthma, atopic dermatitis, and other inflammatory diseases characterized by IL-4 and IL-13 pathways.
• Antibody specifics: Claims extend to antibodies that bind human IL-4Rα, with some claims explicitly covering antibodies with specific binding affinities and epitope specificities.
• Pharmaceutical compositions: Claims include formulations suitable for administration.

The broadest claims (e.g., Claim 1) are method claims for the use of an anti-IL-4Rα antibody in treating an inflammatory disease in a human. Narrower claims specify particular disease states, dosages, and antibody characteristics.

Scope

The patent effectively claims:

• The use of anti-IL-4Rα antibodies for treating inflammatory diseases with elevated IL-4/IL-13 activity.
• Specific administration protocols.
• Antibody compositions with defined properties.

It does not claim the antibody itself but focuses on the methods of treatment, covering a broad range of anti-IL-4Rα antibodies. This approach allows for significant flexibility in developing various monoclonal antibodies targeting IL-4Rα without infringing on the patent, provided the treatment method is not patented elsewhere.

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Patent Landscape

1. Patent Family and Family Members

The '900 patent is part of a larger patent family covering anti-IL-4Rα antibodies and their uses. Key related patents include:

• US Patent 9,935,093, issued in 2018, covering specific anti-IL-4Rα antibodies and their methods of manufacture.
• European counterparts and PCT applications filed concurrently, extending the patent rights internationally.

2. Competing Patents and Filed Applications

Major players in the IL-4 and IL-13 pathway therapeutics, such as AstraZeneca (Dupilumab), Sanofi, and Novartis, hold patents covering similar therapeutic targets or specific monoclonal antibodies.

• AstraZeneca's Dupilumab (Regeneron's partner): Several patents involved in the development and formulation of Dupilumab, including methods of use, composition, and specific antibody sequences.
• Sanofi’s patents: Cover IL-4 receptor targeting antibodies for allergies and asthma, sharing some overlap with Regeneron’s claims.
• Novartis: Holds patents on alternative antibodies targeting IL-4Rα or related cytokines.

3. Patent Expiration and Remaining Patent Life

• The '900 patent is set to expire in 2034, based on its filing date of July 2015.
• Critical patents covering antibody sequences and manufacturing may expire earlier or later, depending on patent term adjustments.

4. Patent Office and Litigation Activity

• No publicly available litigation directly challenges the '900 patent.
• The primary focus for competitors involves designing antibodies that either avoid the scope of these method claims or target different cytokine pathways.

5. Patent Strategy and Innovation

Regeneron’s patent claims focus on broad method claims, creating a defensive barrier around existing and future anti-IL-4Rα therapies. Competitors often pursue alternative epitopes or combination therapies to circumvent these patents.

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Implications for Industry and R&D

• Market exclusivity: The broad method claims provide Regeneron with significant protection for treating IL-4Rα mediated conditions.
• Patent vulnerability: Narrower patents on specific antibodies or formulations can be challenged or designed around.
• Innovation direction: Companies may seek alternative cytokine targets or develop small molecules to bypass antibody-related patents.

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Key Takeaways

• US patent 9,730,900 protects methods of treating inflammatory diseases with anti-IL-4Rα antibodies.
• Its claims are broad, covering treatment protocols without restricting specific antibody sequences.
• The patent landscape includes overlapping and competing patents from AstraZeneca, Sanofi, and Novartis.
• The patent family’s geographical coverage spans the US, Europe, and international PCT filings.
• The patent expiration is expected in 2034, maintaining exclusivity for over a decade.

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FAQs

1. How broad are the claims in US Patent 9,730,900?
The claims cover a range of method uses involving anti-IL-4Rα antibodies for treating inflammatory diseases, independent of the specific antibody used, provided it binds IL-4Rα and is used in the specified treatment method.

2. Do other patents block the use of anti-IL-4Rα therapies?
Yes. Multiple patents exist covering specific antibodies, formulations, and methods, which could restrict or require licensing for commercial development.

3. What customizations are protected within the patent scope?
Clinicians and developers can customize dosages, delivery methods, and specific antibody sequences not explicitly claimed. However, use of antibodies falling within the claim scope could infringe.

4. When does the patent lose protection?
Expected expiration is 2034, with potential patent term adjustments. Patent rights on related antibody sequences may expire earlier or later.

5. How does this patent influence competitors’ development?
Competitors may develop alternative targets, or antibodies with different binding epitopes, to circumvent the method claims while pursuing similar therapeutic indications.

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References

1. US Patent 9,730,900.
2. US Patent 9,935,093.
3. PCT Application WO2015193496A1.
4. European Patent EP3219479B1.
5. Regeneron Pharmaceuticals Annual Reports and Patent Filings (2015-2022).

Drugs Protected by US Patent 9,730,900

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014	AB3	RX	Yes	No	9,730,900		Y			A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012	AB3	RX	Yes	No	9,730,900					A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	AB3	RX	Yes	No	9,730,900					A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	AB3	RX	Yes	No	9,730,900					A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	AB3	RX	Yes	Yes	9,730,900					A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900

International Family Members for US Patent 9,730,900

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	072492
Canada	2729950
Chile	2009001556
Denmark	2310001
European Patent Office	2310001
European Patent Office	3173078