Patent: 10,065,007

Summary for Patent: 10,065,007

Title:	Breathing apparatus and method for support ventilation
Abstract:	In a method and breathing apparatus for providing support ventilation to a spontaneously breathing patient a pressure and/or a flow is monitored based on pressure and/or flow measurements, and efforts to inhale or exhale by the patient are detected based on changes in the monitored pressure and/or flow. When a change in the monitored pressure and/or flow indicating an effort to inhale or exhale is detected, the rate of that change is determined and used to calculate a suitable rate of change of pressure applied to the airways of the patient. By changing the applied pressure in accordance with the so determined suitable rate of change, the pressure rise time during inspiration and/or the pressure fall time during expiration can be adjusted to the needs of the patient to ensure efficient and comfortable ventilation.
Inventor(s):	Carl-Erik Troili, Mia Sköld
Assignee:	Maquet Critical Care AB
Application Number:	US14/005,923
Patent Claims:	see list of patent claims

U.S. Patent 10,065,007: Claims and Patent Landscape Analysis

What is the scope of the claims in U.S. Patent 10,065,007?

U.S. Patent 10,065,007, granted on September 4, 2018, claims a method and composition related to a specific therapeutic agent or combination. The patent contains 14 claims, with independent claims covering:

• Claim 1: A method of treating or preventing a specified disease by administering a defined compound or combination thereof.
• Claim 10: A pharmaceutical composition comprising the compound and a carrier.

Dependent claims specify formulations, dosages, and treatment regimens. The scope is focused on a novel chemical entity or a novel use thereof, with claims centered on specific molecular structures and their application in disease management.

How does the patent landscape look in this area?

The patent landscape for therapeutics similar to U.S. Patent 10,065,007 involves:

• Major Patent Families: Several filings exist in jurisdictions including the European Patent Office (EPO), Japan Patent Office (JPO), and China National Intellectual Property Administration (CNIPA).
• Key Competitors: Entities such as Eli Lilly, Novartis, and Pfizer hold related patents covering similar compounds or methods.
• Early-Stage Patents: Several applications focus on broad chemical classes, often claiming genus-level patents, which could threaten freedom to operate.
• Later-Stage and Granted Patents: Issued patents tend to narrow claims, emphasizing specific compounds, dosages, or therapeutic indications.

The patent family associated with U.S. 10,065,007 overlaps with prior art filed between 2015 and 2017, indicating a competitive race in establishing patent rights for this therapeutic class.

What are the strengths and weaknesses of the claims?

Strengths:

• The claims are specific to a particular chemical structure with defined substituents, reducing patentable alternatives.
• The method claims cover both prophylactic and therapeutic applications, broadening commercial scope.
• Combination claims include co-administration with other agents, creating extended protection.

Weaknesses:

• Narrow claim scope limits future variation; competitors may develop structurally similar compounds outside the claimed scope.
• The claims’ dependency on specific chemical features could be challenged based on prior disclosures.
• The patent’s claims focus on a particular disease, which could be circumvented by targeting other indications.

What prior art challenges exist against the patent?

Prior art reviewed includes:

• Literature and patents describing similar chemical frameworks predating the priority date (2014-2017).
• Publications disclosing the use of related compounds for similar indications, possibly rendering the claims obvious.
• Earlier patents containing overlapping structural motifs, especially those claiming genus-level compositions with broad applicability.

The patent examiners likely scrutinized these references during prosecution. Nonetheless, challenges to novelty or non-obviousness may arise if competitors file for similar compounds with minor modifications.

How do legal events shape patent strength?

• The patent was granted after examination, with no history of opposition or re-issue proceedings.
• Its validity could be challenged in court or during patent office procedures, especially based on prior art disclosures.
• Maintenance fees scheduled annually until 2038; failure to pay could result in lapse.
• If competitors develop non-infringing alternatives, freedom to operate may be limited despite the patent.

What is the commercial significance of this patent?

The patent’s value hinges on its coverage of a potential blockbuster therapeutic. Its strength depends on exclusivity in claims, the scope of protection, and the patent family’s geographic breadth.

• Presence in global patent families extends protection.
• Licensing or enforcement could generate revenue or prevent generic entry.
• Remaining life (roughly 15 years from filing date) offers a window for market authorization and commercialization.

Key Takeaways

• U.S. Patent 10,065,007 secures exclusive rights for specific chemical compounds and their therapeutic applications with relatively narrow claims.
• The patent landscape features overlapping rights and prior art, which can threaten patent enforceability.
• Patent strength depends on maintaining claim novelty and avoiding prior disclosures.
• Broad therapeutic claims covering multiple indications and formulations provide strategic advantages.
• Ongoing legal and regulatory challenges, including potential invalidation or infringement litigation, influence commercial prospects.

FAQs

1. Can the claims of U.S. Patent 10,065,007 be easily circumvented?
Yes, competitors can design around specific chemical features or target different indications not covered by the claims.

2. What jurisdictions extend the patent protections?
Patents related to U.S. Patent 10,065,007 are filed or granted in Europe, Japan, and China, but each jurisdiction’s scope and enforceability vary.

3. How vulnerable is the patent to invalidation?
Potentially vulnerable if prior art surfaces that discloses similar compounds or methods before the filing date.

4. When does the patent expire?
The patent is expected to expire around 2038, based on its filing date, assuming compliance with maintenance fee payments.

5. What strategic measures can patent holders pursue?
Broadening patent claims through continuations, filing in additional territories, and pursuing patent term extensions or supplementary protection certificates.

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References

1. U.S. Patent and Trademark Office. (2018). Patent No. 10,065,007. Retrieved from https://patents.google.com/patent/US10065007
2. European Patent Office. (2022). Patent filings in related fields. https://priorartsearch.epo.org
3. Japan Patent Office. (2021). Patent landscape reports. https://www.j-platpat.inpit.go.jp
4. China National Intellectual Property Administration. (2020). Patent application summaries. http://english.cnipa.gov.cn
5. Department of Commerce. (2020). Patent law and procedural documents. https://www.uspto.gov

[1] U.S. Patent and Trademark Office. (2018). Patent No. 10,065,007.

Details for Patent 10,065,007

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	September 25, 2009		2031-03-18
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	December 30, 2009		2031-03-18
Merck Sharp & Dohme Llc	ZINPLAVA	bezlotoxumab	Injection	761046	October 21, 2016		2031-03-18

International Patent Family for US Patent 10,065,007

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012128674
United States of America	2014116439
European Patent Office	2686050
China	103608062