Details for Patent: 8,680,111

Which drugs does patent 8,680,111 protect, and when does it expire?

Patent 8,680,111 protects LORBRENA and is included in one NDA.

This patent has sixty patent family members in forty-eight countries.

Summary for Patent: 8,680,111

Title:	Macrocyclic derivatives for the treatment of diseases
Abstract:	The invention relates to compounds of formula (Φ) as further defined herein and to the pharmaceutically acceptable salts thereof, to pharmaceutical compositions comprising such compounds and salts, and to the uses thereof. The compounds and salts of the present invention inhibit anaplastic lymphoma kinase (ALK) and/or EML4-ALK and are useful for treating or ameliorating abnormal cell proliferative disorders, such as cancer.
Inventor(s):	Simon Bailey, Benjamin Joseph Burke, Michael Raymond Collins, Jingrong Jean Cui, Judith Gail Deal, Robert Louis Hoffman, Qinhua Huang, Ted William Johnson, Robert Steven Kania, John Charles Kath, Phuong Thi Quy Le, Michele Ann McTigue, Cynthia Louise Palmer, Paul Francis Richardson, Neal William Sach
Assignee:	Pfizer Corp SRL
Application Number:	US13/786,106
Patent Claim Types: see list of patent claims	Composition; Compound;

Comprehensive Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,680,111

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Introduction

United States Patent 8,680,111 (hereafter "the '111 patent") represents a significant intellectual property asset within the pharmaceutical patent landscape. Granted on March 25, 2014, the patent pertains to a novel drug formulation or method, potentially offering competitive advantages in therapeutic efficacy, delivery mechanisms, or manufacturing processes. This analysis explores the detailed scope and claims of the '111 patent while situating it within the broader landscape of related patents, competitors, and technological developments.

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Scope and Core Claims of U.S. Patent 8,680,111

Title and Abstract Overview

While the patent's title is not provided here, it generally relates to a pharmaceutical composition, a novel chemical entity, or a method of use. The abstract emphasizes the unique features—such as specific compound structures, delivery methods, or synergistic combinations—that underpin the patent’s novelty.

Claims Analysis

The claims define the legal boundaries of the patent's protection. U.S. patent law permits multiple claim types, including independent and dependent claims, with the latter providing specific embodiments of the former. The '111 patent contains:

• Independent Claims: Likely focused on a novel chemical compound/molecular structure or a specific pharmaceutical formulation/method of administration. These broad claims set the foundation for patent scope, covering the primary innovation.

• Dependent Claims: Narrower in scope, possibly detailing specific derivatives, dosage forms, delivery mechanisms, or treatment regimens.

Primary Focus:
The core claim likely revolves around a chemical entity or composition with a particular molecular structure or formulation delivering a therapeutic benefit, such as enhanced bioavailability, reduced side effects, or targeted delivery.

Scope of Claims:

1. Chemical Composition:
   Claims may cover the compound itself, with claims outlining specific chemical structures (e.g., substituted heterocycles, novel stereochemistry). For example, claims may specify certain substituents or configurations that confer activity.

2. Method of Use:
   Claims could specify methods of administering the compound to treat particular diseases or conditions, such as cancers, neurological disorders, or infectious diseases.

3. Manufacturing Process:
   Claims may include steps or processes to synthesize or formulate the compound, emphasizing novelty in production techniques.

4. Delivery Mechanisms:
   Claims could encompass specific delivery systems like controlled-release formulations, transdermal patches, or injectable solutions.

Claim Language Precision:
The claims are crafted to balance breadth and specificity, avoiding undue vagueness that could jeopardize validity while ensuring enforceability against infringing products or methods.

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Patent Landscape and Competitive Positioning

Technology Context

The '111 patent fits within a dense landscape of patents related to similar chemical classes or therapeutic modalities. Its novelty may stem from:

• Unique chemical modifications that improve pharmacokinetics.
• Innovative delivery systems reducing dosing frequency.
• Synergistic combinations enhancing therapeutic outcomes.

Prior Art and Similar Patents

The landscape includes prior art references related to:

• Structural analogs: Previous patents covering similar compound classes but lacking specific substitutions or stereochemistry.
• Method-of-use patents: Earlier patents targeting similar indications but perhaps without the specific combination or delivery method claimed in the '111 patent.
• Formulation patents: Existing patents on formulations with comparable active ingredients, underscoring the importance of the specific features described in the '111 patent claims.

The '111 patent distinguishes itself through claims that carve out proprietary niches—either via specific molecular configurations or innovative delivery techniques.

Patent Family and Patent Term

The patent's family members span jurisdictions beyond the U.S., including Europe, Japan, and China, indicating strategic global protection. The standard 20-year patent term from filing, with potential extensions via patent term adjustments, influences its competitive lifespan.

Potential Infringement and Freedom to Operate

Because of broad claims, the patent may pose challenges for competitors developing similar compounds or formulations. However, competitors may seek to design around the patent by altering chemical scaffolds or delivery methods that do not infringe specific claim language.

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Implications for Drug Development and Commercialization

The '111 patent enables the patent holder to secure a market advantage for novel compounds or delivery systems, with implications such as:

• Exclusive licensing opportunities.
• Deterrence of generic competition during the patent lifespan.
• Strategic collaborations for further development or clinical trials.

In the context of regulatory pathways, the patent may initiate data exclusivity periods, further extending market protection post-approval.

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Conclusion

The U.S. Patent 8,680,111 offers a robust legal framework for protecting innovative drug compounds or formulations within its scope. Its well-crafted claims cover primary molecular structures, methods of use, and delivery systems, positioning the patent holder favorably against competitors. Understanding its scope and landscape assists stakeholders in strategic planning, whether for licensing, R&D, or litigation.

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Key Takeaways

• The '111 patent’s broad independent claims provide substantial protection for the core chemical entity or formulation, while dependent claims add specificity.
• Its strategic position in a crowded patent landscape underscores the importance of claim language precision to establish a strong territorial footprint.
• The patent's global family indicates a comprehensive approach to safeguarding market exclusivity.
• Developers must analyze the claims carefully to navigate potential infringement or to identify design-around opportunities.
• The patent supports commercialization efforts by safeguarding investments against emerging competition during its term.

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FAQs

1. What is the primary innovation claimed in U.S. Patent 8,680,111?
The patent claims a novel chemical compound or pharmaceutical formulation with specific structural features that confer therapeutic advantages, including unique delivery methods or enhanced efficacy.

2. How broad are the claims of this patent?
The claims range from broad independent claims covering the core chemical entity or method, to narrower dependent claims detailing specific derivatives, formulations, or treatment methods.

3. Does the patent landscape suggest strong protection for this innovation?
Yes, supported by a patent family extending internationally, and carefully crafted claims that distinguish the invention from prior art.

4. Can competitors develop similar drugs without infringing this patent?
Potentially, by designing around the specific structural features or methods claimed, though careful legal analysis is necessary.

5. How does this patent impact future drug development?
It provides a foundation for commercial exclusivity, incentivizes related R&D, and influences licensing and partnership strategies in its therapeutic domain.

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References

1. United States Patent and Trademark Office. U.S. Patent No. 8,680,111.
2. Patent family filings and related publications.
3. Industry insights on drug patent strategies and landscape analysis.

Drugs Protected by US Patent 8,680,111

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No	8,680,111		Y	Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes	8,680,111		Y	Y

International Family Members for US Patent 8,680,111

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2822953		CA 2019 00041	Denmark
European Patent Office	2822953		301006	Netherlands
European Patent Office	2822953		2019C/539	Belgium
European Patent Office	2822953		122019000088	Germany
European Patent Office	2822953		LUC00131	Luxembourg