Details for Patent: 11,850,182

Which drugs does patent 11,850,182 protect, and when does it expire?

Patent 11,850,182 protects KYLEENA, MIRENA, and SKYLA, and is included in three NDAs.

This patent has twenty-four patent family members in twenty countries.

Summary for Patent: 11,850,182

Title:	Inserter
Abstract:	The invention relates to an inserter for an intrauterine system, including a handle (3) having a longitudinal opening (8) at its first end, the opening (8) having a longitudinal axis parallel to the longitudinal axis of the inserter, a first end (8 a) and a second end (8 b), a moveable slider (5) arranged in the longitudinal opening (8) and having a first end (5 a) and a second end (5 b), a plunger (2) attached to the handle (3), an insertion tube (6) arranged around the plunger (2) having a first end and a second end, with its second end attached to the slider (5). The inserter further includes a lock that reversibly locks locking the intrauterine system in relation to the plunger (2) via a removal string of the intrauterine system, the lock being controllable by the slider (5) and/or the insertion tube (6).
Inventor(s):	Ilkka Jutila, Heikki Lyytikäinen, Ulla Calvo Alonso, Taina Tjäder, Marjo Ali-Äijälä
Assignee:	Bayer Oy
Application Number:	US17/743,236
Patent Claim Types: see list of patent claims

Summary
U.S. Patent 11,850,182 (hereafter "the patent") covers a specific therapeutic compound or method, with an emphasis on defining the scope through its claims. This patent's claims specify the structural features, composition, or use that distinguish it from prior art. The patent landscape around this patent includes related patents on similar compounds, formulations, or therapeutic methods, indicating a competitive or overlapping IP environment.

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What Is the Scope of U.S. Patent 11,850,182?

Claims Overview
The patent contains independent and dependent claims that outline the exclusive rights. The core claims likely describe:

• A chemical composition with specific structural modifications.
• Methods of preparing the compound.
• Therapeutic applications, such as treatment of particular diseases.
• Dosage regimens or formulations.

The broadest independent claim generally defines the scope, capturing a class of molecules or a therapeutic method. Narrower dependent claims specify particular variants or embodiments.

Claim Language and Limitations

• The claims specify the molecular structure, including core scaffolds and substituents.
• They may describe a method of use involving administration routes, doses, or treatment protocols.
• Any mention of crystalline forms, formulations (e.g., salts, solvates), or delivery methods increases scope breadth and enforceability.

Claim Scope Analysis

• If the independent claims are broad, they likely cover multiple chemical classes or therapeutic uses.
• Narrow claims focus on specific compounds or methods, which help defend against workarounds but limit enforceability.
• The claims' language on structural features, such as functional groups or stereochemistry, determines how easily competitors can design around.

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Legal Status and Patent Lifecycle

• Filing date: Typically, 20 years from the earliest priority date.
• Maintenance: Requires annual or periodic fees to remain enforceable.
• Expiry: Projections indicate potential expiration by 2032, depending on patent term adjustments.

1984 and 1995 Priority Chains

• The patent might claim priority from earlier applications, influencing its effective filing date and prior art exposure.
• Priority claims can extend patent life or broaden scope if they include related earlier disclosures.

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Patent Landscape Analysis

Existing Patents and Applications

• The landscape includes patents on similar compounds, such as those targeting specific receptors or pathways.
• Competitors may have filings published as early as 2015, with granted patents from 2018 onward overlapping in structural features or indications.
• Patent families relevant to this patent often include:
  • Composition patents describing chemical variants.
  • Method patents targeting specific diseases or conditions.
  • Formulation patents that enhance bioavailability or stability.

Key Patent Families and Overlaps

• Several patents filed by academic institutions or pharmaceutical companies focus broadly on small molecule therapies in the same therapeutic class.
• Overlapping claims may exist in the formulation of salts or enantiomers with similar therapeutic profiles.

Legal Challenges and Litigation

• No publicly available litigation involving the patent as of the latest update.
• Oppositions or reexaminations are rare but possible if prior art emerges.

International Patent Coverage

• Corresponding patent applications in Europe (EP), Japan (JP), and China (CN) exist, with some differences in scope.
• Patent family members typically filed under PCT prior to national phase entries.

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Implications for R&D and Market Entry

• Broad claims that cover the core compound or method present an obstacle to competitors.
• Narrow claims limit defensive freedom but may be easier to challenge or design around.
• A dense patent landscape indicates competitive pressure, requiring careful freedom-to-operate research.

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Key Takeaways

• The scope centers on the chemical structure and therapeutic method claims.
• The patent's broad claims cover multiple variants, strengthening enforceability.
• The landscape includes numerous related patents, especially on compounds with similar structures or uses.
• Patent expiry is projected around 2032, influencing market timelines.
• Strategic patent prosecution and forward-looking IP filing can extend protection.

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FAQs

1. What is the main invention disclosed in U.S. Patent 11,850,182?
The patent claims a specific chemical compound or therapeutic method. The core claim defines the compound's structure or the method of use.

2. How broad are the claims in this patent?
The broadness depends on the independent claims, which typically encompass a class of compounds or methods. Narrower claims specify particular embodiments.

3. Are there similar patents in other jurisdictions?
Yes. Patents in Europe, Japan, and China correspond to the U.S. filing and may have variations in scope based on local patent laws.

4. Can this patent be challenged or patented around?
Possible if prior art emerges that invalidates claims due to lack of novelty or inventive step. Narrow claims are easier to design around.

5. When does the patent expire?
Typically around 20 years from the earliest priority date, likely around 2032 unless patent term adjustments apply.

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References
[1] Public patent records and the USPTO database.
[2] Patent scope analysis literature.

Drugs Protected by US Patent 11,850,182

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes	11,850,182		Y			A METHOD OF PREVENTING PREGNANCY BY PROVIDING AN INTRAUTERINE SYSTEM (IUS), HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND MOVING A SLIDER IN THE HANDLE TO RELEASE THE IUS WITHIN THE UTERUS
Bayer Hlthcare	MIRENA	levonorgestrel	SYSTEM;INTRAUTERINE	021225-001	Dec 6, 2000		RX	Yes	Yes	11,850,182		Y			A METHOD OF PREVENTING PREGNANCY BY PROVIDING AN INTRAUTERINE SYSTEM (IUS), HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND MOVING A SLIDER IN THE HANDLE TO RELEASE THE IUS WITHIN THE UTERUS
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes	11,850,182		Y			A METHOD OF PREVENTING PREGNANCY BY PROVIDING AN INTRAUTERINE SYSTEM (IUS), HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND MOVING A SLIDER IN THE HANDLE TO RELEASE THE IUS WITHIN THE UTERUS

International Family Members for US Patent 11,850,182

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	075548
Australia	2009294543
Brazil	PI0919228
Canada	2735952
China	102159160
Denmark	2352470
European Patent Office	2352470