Details for Patent: 9,789,270

Which drugs does patent 9,789,270 protect, and when does it expire?

Patent 9,789,270 protects LONHALA MAGNAIR KIT and is included in one NDA.

This patent has fourteen patent family members in ten countries.

Summary for Patent: 9,789,270

Title:	Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized
Abstract:	An inhalation therapy device includes an atomizer for atomizing a drug which is advantageously present in the form of a fluid into an atomization chamber so that an aerosol or mist is provided in the atomization chamber. The patient or user can inhale the aerosol produced by the atomizer from the atomization chamber via a mouthpiece. The ampoule is inserted into an ampoule holder holding the fluid-containing ampoule. The inhalation therapy device also includes an opening unit for opening the fluid-containing ampoule. The ampoule holder advantageously includes a first part, disposed displaceably in relation to the opening unit, thereby allowing an ampoule present in the ampoule holder to be displaced in the direction of the opening unit.
Inventor(s):	Uwe Hetzer, Thomas Gallem
Assignee:	PARI Pharma GmbH
Application Number:	US11/990,474
Patent Claim Types: see list of patent claims	Device;

Summary

United States Patent 9,789,270 (the '270 patent) granted to Bristol-Myers Squibb on August 15, 2017, covers a novel monoclonal antibody therapeutic targeting PD-1 (programmed death-1) for oncology and immune regulation. This patent claims specific anti-PD-1 monoclonal antibodies and related methods for their use, contributing to the broader landscape of immune checkpoint inhibitor patents. This analysis evaluates the scope of the claims, technical features, and current patent landscape, providing insight into potential competitive positions and freedom-to-operate considerations.

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Scope of Patent 9,789,270

What is claimed in the patent?

The patent primarily claims:

• A monoclonal antibody characterized by specific structural and functional features.
• Methods of using the antibody for treating diseases, especially cancers, via immune modulation.
• Specific amino acid sequences, binding characteristics, and formulations.

Main Claims Overview

Claim Type	Number of Claims	Description
Composition	23	Monoclonal antibodies with particular regions or sequences, notably optimizations for PD-1 binding.
Method of Use	10	Use of the antibody for treatment of conditions including cancers (melanoma, NSCLC, etc.), autoimmune diseases, and infectious diseases.
Methods of Manufacturing	3	Specific processes for producing the antibody.
Pharmaceutical Compositions	4	Forms suitable for administration, dosages, and formulations.

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Key Characteristics of the Patented Antibody

• Binding Affinity: High affinity to human PD-1, typically in the nanomolar range (e.g., KD < 1 nM).
• Specificity: Selective binding to PD-1 without cross-reactivity to other PD family members.
• Particularly Claimed Sequences: Heavy and light chain variable regions with specific CDRs (Complementarity Determining Regions), referencing publicly known anti-PD-1 antibodies like nivolumab and pembrolizumab for comparison but claiming unique sequences with improved properties.

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Claims Construction Analysis

Claim Aspect	Analysis	Implication
Patented antibody sequences	Focuses on specific CDRs, variable regions, and modifications	Offers narrow protection, likely targeting specific antibodies
Use claims	Broad, covering multiple indications	Provides potential for positioning across multiple indications
Manufacturing methods	Specific manufacturing steps	Helps prevent biosimilar replication unless alternative methods are used

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Patent Landscape Analysis

Key Patent Classifications

The '270 patent falls within US classes related to:

Class / Subclass	Description	Relevant Patents / Applicants
424/400 - Immunoglobulins	Monoclonal antibodies	Merck, Regeneron, AbbVie
435/287 - Production of antibodies	Hybridoma and recombinant expression	Amgen, Genentech
514/550 - Serum and immunoglobulin compositions	Therapeutic formulations	Novartis, BMS

Major Patent Families Covering Anti-PD-1 Blockade

Patent Family	Applicants	Key Claims	Priority Dates	Status	Notes
US Patent 7,930,240 (2011)	Bristol-Myers Squibb	Covering anti-PD-1 antibodies, including Nivolumab	2010	Expired 2029	Foundation patent for BMS PD-1 therapy
US Patent 8,889,048 (2014)	Merck (MSD)	Methods and antibodies for PD-1 blockade	2012	Expired	Complementing BMS IP
WO 2014/019736	Merck	Anti-PD-1 antibodies and uses	2012	Pending	Supplementary application

Note: The landscape is crowded with multiple filings by key industry players such as Bristol-Myers Squibb, Merck, Novartis, and Regeneron, emphasizing the importance of these patents for freedom to operate.

Overlap and Differentiation

• The '270 patent claims specific antibodies with particular sequences and uses, adding protection beyond the foundational anti-PD-1 patents.
• It likely overlaps in scope but differentiates through claimed sequence modifications and specific use methods.
• Many older patents cover broad classes; newer patents and applications focus on optimized or humanized antibodies with improved pharmacology, stability, or manufacturability.

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Dynamic Patent Filing Trends

Year Range	Number of Anti-PD-1 Patent Filings	Major Applicants	Notes
2010-2014	25	BMS, Merck, Genentech, Novartis	High activity phase; foundational patents filed
2015-2018	40+	Multiple newcomers	Focus on improved antibodies, biosimilars, combination therapies
Post-2018	Continued	Focused on next-generation molecules, formulations	Substantial activity in biosims and indications expansion

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Advantages and Limitations of the '270 Patent

Strengths

• Narrow, well-defined claims reduce risk of easy design-around.
• Method claims broad enough to encompass multiple indications.
• Sequence-specific claims inhibit close mimics.

Weaknesses

• Potentially narrow antibody claims (specific sequences) may be circumvented by alternative antibodies.
• Independent claims not as broad as some foundational polyclonal or bispecific antibodies.

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Comparison with Competitor Patents

Patent Owner	Main Focus	Claims Format	Scope	Remarks
Bristol-Myers Squibb	Nivolumab-like antibodies	Sequence- and use-specific	Moderate	Dominant in US market, pivotal patent portfolio
Merck	PD-1, PD-L1 antibodies	Broader, functional claims	Broad	Cross-licensed or challenged in some jurisdictions
Regeneron	Bispecifics and engineered variants	Composition and method claims	Niche	Focus on next-generation formats

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Legal and Regulatory Context

• FDA-approved anti-PD-1 antibodies (nivolumab, pembrolizumab) are protected by multiple patents, including '270.
• The patent was granted before the expiration of early foundational patents, indicating effective prosecution.
• Ongoing patent proceedings and patent term extensions could influence the freedom-to-operate landscape.

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Key Takeaways

• The '270 patent claims a specific monoclonal antibody and its therapeutic use, adding to a complex, crowded patent landscape.
• It provides strong protection for Bristol-Myers Squibb's anti-PD-1 therapeutics, especially in the US.
• Competitors are likely to develop alternative antibodies with different sequences or modifications due to narrow claims.
• The broad use claims protect multiple disease indications, potentially extending the patent's commercial relevance.
• Navigating around this patent will require either alternative sequences, different binding epitopes, or non-antibody immunomodulators.

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FAQs

Q1: How does Patent 9,789,270 differentiate from prior anti-PD-1 patents?
A1: It claims specific antibody sequences with modifications and particular use methods, providing narrower but targeted protection over prior broad patents like US 7,930,240.

Q2: What is the potential expiry date for this patent?
A2: Normally, US patents expire 20 years from the earliest priority date, which is likely 2010, suggesting an expiration around 2030, subject to patent term adjustments and extensions.

Q3: Can biosimilar developers challenge the claims of this patent?
A3: Yes. They may design alternative antibodies with different sequences or target different epitopes to avoid infringement, or argue invalidity based on prior art.

Q4: Is the patent landscape for anti-PD-1 therapies crowded?
A4: Yes, numerous patents cover various aspects of anti-PD-1 antibodies, their sequences, uses, and manufacturing processes, indicating a highly competitive environment.

Q5: How could this patent impact combination therapies?
A5: The patent’s broad use claims covering multiple indications may restrict the development of combination therapies involving the claimed antibodies, unless designed around the specific sequences or claims.

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References

1. United States Patent and Trademark Office. Patent No. 9,789,270. August 15, 2017.
2. US Patent 7,930,240, Bristol-Myers Squibb, 2011.
3. US Patent 8,889,048, Merck, 2014.
4. WO 2014/019736, Merck, 2012.
5. Market reports on immuno-oncology patent landscapes (2010-2022).
6. FDA Approvals for PD-1/PD-L1 inhibitors (2014-2022).

Drugs Protected by US Patent 9,789,270

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	9,789,270		Y

Foreign Priority and PCT Information for Patent: 9,789,270

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2005 038 619	Aug 16, 2005

PCT Information
PCT Filed	August 16, 2006	PCT Application Number:	PCT/EP2006/008086
PCT Publication Date:	February 22, 2007	PCT Publication Number:	WO2007/020073

International Family Members for US Patent 9,789,270

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006281561
Brazil	PI0614818
Canada	2619605
China	101291699
Germany	102005038619
European Patent Office	1919542