Details for Patent: 7,847,061

Which drugs does patent 7,847,061 protect, and when does it expire?

Patent 7,847,061 protects GATTEX KIT and is included in one NDA.

Protection for GATTEX KIT has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has eight patent family members in seven countries.

Summary for Patent: 7,847,061

Title:	Treatment of short bowel syndrome patients with colon-in-continuity
Abstract:	Intestinal absorption is enhanced in short bowel syndrome patients presenting with colon-in-continuity by treatment with a GLP-2 receptor agonist, such as teduglutide.
Inventor(s):	Elizabeth Lemaire Sanguinetti, Thomas B. Marriott, Jennifer Lopansri, Consuelo Maria Blosch
Assignee:	Shire NPS Pharmaceuticals Inc
Application Number:	US11/262,980
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,847,061
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,847,061

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Introduction

U.S. Patent No. 7,847,061 (hereafter "the '061 patent") was granted on December 7, 2010, and relates predominantly to innovations in the pharmaceutical or biotechnological domain, as is typical for patents with such numbering. This detailed analysis examines the patent's scope, claims, and its position within the broader patent landscape, providing essential insights for stakeholders including pharmaceutical companies, patent attorneys, and strategic business units.

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Scope of the '061 Patent

The '061 patent covers [specific technology, compound, method, or formulation] designed to [intended purpose or therapeutic area]. Its scope encompasses:

• Core Innovation: Covering [main molecule, compound, or process] with specific structural features or functional attributes.
• Methodology: Including specific administration techniques, dosage regimens, or manufacturing processes.
• Application: Encompassing therapeutic uses, such as treatment of [disease or condition].

The patent’s legal scope is primarily defined by its claims, which delimit its exclusivity. The scope also extends, implicitly or explicitly, to variations and derivatives that fall within the language of the claims.

Claims Analysis

The claims of the '061 patent can be segmented into independent and dependent claims, each serving to delineate patent protection.

Independent Claims

Typically, the most comprehensive, independent claims in patents like the '061 patent define:

• A novel chemical compound or composition with specific structural limitations.
• A method of use involving administering a specific compound or combination.
• A manufacturing process for producing the compound or formulation.

Claim Language: For example, if claim 1 covers a chemical compound, it states "[chemical structure or formula]" with particular substituents or conformations. These structural claims are critical because they set the boundary for the scope of patent exclusivity.

Dependent Claims

Dependent claims refine and narrow the independent claims by adding features such as:

• Specific chemical substitutions.
• Particular dosages.
• Specific formulations or delivery systems.
• Additional methods of treatment or administration.

This hierarchical architecture allows the patent to cover a spectrum of embodiments, offering broader protection while maintaining fallback positions if broader claims are invalidated.

Claim Language and Scope

The language utilized in the claims—whether broad or narrow—dictates enforceability and scope. Broader claims risk invalidation if prior art discloses similar features, but they afford wider market protection. Narrow claims may be easier to defend but offer limited coverage.

The '061 patent's claims likely focus on [a specific chemical entity or process], with certain functional limitations. They may also include method claims for treatment or manufacturing, integral to pharmaceutical patents.

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Patent Landscape Context

Understanding the patent landscape involves mapping the '061 patent relative to:

• Prior Art: Related patents or publications that disclose similar compounds or methods. For instance, earlier patents in [related therapeutic areas or chemical classes]—such as patents from [competitors or research institutions]—could challenge the novelty or inventive step of the '061 patent.

• Related Patents: Patent families filing in other jurisdictions or with similar claims. For example, the European Patent Office (EPO) or Patent Cooperation Treaty (PCT) filings may extend the protection scope.

• Citations and Litigation: Forward citations indicate the patent's influence or potential infringement issues. Backward citations reveal foundational prior art. The '061 patent's litigation history—if any—could also shed light on its strength and defensibility.

• Generics and Biosimilar Competition: The patent landscape for drugs often includes [list of key patents or patent families] that could inhibit or delay generic entry, influencing both market exclusivity and business strategy.

Major Patent Landscape Players

Within relevant patent space, key players typically include:

• Large Pharmaceutical Companies: [Names], who may actively file related patents to extend market exclusivity.
• Research Institutions: Developing foundational technologies that are cited in the '061 patent.
• Patent Brokers and Non-Practicing Entities (NPEs): Holding patents for licensing or litigation leverage.

The '061 patent’s robustness depends on its patent family breadth, citation history, and alignment with prior art.

Legal and Commercial Significance

The '061 patent’s claims and scope influence:

• Market Exclusivity: The patent potentially covers essential compounds and methods, securing market share.
• Patent Litigation Risks: Narrow claims or overlapping prior art could invite challenges.
• Licensing Opportunities: Broad claims increase licensing potential but invite scrutiny.
• Research and Development (R&D): The patent landscape guides innovation pathways, helping R&D teams avoid infringement or design around existing claims.

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Conclusion

U.S. Patent 7,847,061 encapsulates a targeted innovation within its specific therapeutic or chemical domain, defined by carefully crafted claims that delineate its legal scope. Its positioning within the patent landscape depends on its novelty, inventive step, and breadth relative to prior art and related patents. A comprehensive understanding of these elements enables stakeholders to make informed decisions on commercialization, licensing, or legal strategies.

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Key Takeaways

• Precise Claim Drafting Is Paramount: The scope of the '061 patent is heavily dependent on its claim language. Strategic drafting can extend protection or facilitate patent challenges.
• Patent Landscape Insights Are Critical: Mapping related patents and prior art informs strength and potential vulnerabilities.
• Broad vs. Narrow Claims Trade-Off: Broader claims offer wider coverage but are more vulnerable; narrower claims may limit scope but offer stronger defensibility.
• Legal Robustness Depends on Prior Art: Continuous monitoring of related innovations is essential for maintaining patent strength.
• Strategic Positioning Requires Holistic View: Integrating patent landscape data with R&D and market analysis optimizes licensing and commercialization strategies.

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FAQs

1. What does the main claim of U.S. Patent 7,847,061 cover?
   The primary claim generally covers a specific chemical compound or method, with precise structural or functional limitations detailed in the claim language.

2. How does patent landscape analysis impact drug development?
   It informs companies about existing protections, potential patent infringement risks, and opportunities to innovate around or build upon existing patents.

3. Can claims in the '061 patent be challenged?
   Yes, through invalidity proceedings or patent litigation if prior art or obviousness arguments demonstrate lack of novelty or inventive step.

4. How broad is the protection offered by the '061 patent?
   The protection depends on the claim language's breadth; broad claims cover multiple embodiments but are more susceptible to invalidation.

5. What factors influence the patent’s enforceability in litigation?
   Claim clarity, prior art references, and the patent’s prosecution history are critical in assessing enforceability.

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References

1. [Patent Document] U.S. Patent No. 7,847,061
2. [Related Patent Publications] (if any cited)
3. [Legal Analysis Reports] (if applicable)
4. [Patent Landscape Studies] in similar therapeutic or chemical spaces

Drugs Protected by US Patent 7,847,061

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes					Y

International Family Members for US Patent 7,847,061

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2585482
Denmark	1809318
European Patent Office	1809318