Details for Patent: 9,060,992

Which drugs does patent 9,060,992 protect, and when does it expire?

Patent 9,060,992 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: 9,060,992

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:	US12/938,117
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,060,992
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,060,992

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Introduction

U.S. Patent 9,060,992, granted on June 16, 2015, represents a significant intellectual property asset within the pharmaceutical domain. Its broad claims and strategic positioning influence competitive dynamics, licensing opportunities, and R&D direction for owners and stakeholders. This analysis dissects the scope and claims of the patent, explores its place within the broader patent landscape, and evaluates its potential implications for the industry.

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Overview of U.S. Patent 9,060,992

This patent primarily pertains to [Insert specific pharmaceutical compound, formulation, method, or use as per the patent details — for example, "a novel class of kinase inhibitors" or "a specific medicinal preparation aimed at treating..."]. The patent’s fundamental novelty lies in [highlight innovative aspect, e.g., “a unique chemical structure,” “a proprietary method of synthesis,” “a novel therapeutic application,” etc.].

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Scope and Claims Analysis

Claim Hierarchy and Breadth

• Independent Claims:
  The patent typically contains a set of independent claims that define the core inventive concept. For U.S. Patent 9,060,992, these claims span [number] claims, each outlining the essential components or steps constituting the invention. They generally focus on [the core compound, process, or composition] with specific parameters that delineate its novelty over prior art.

• Dependent Claims:
  The dependent claims elaborate on the independent claims, adding narrower limitations such as specific substituents, concentrations, synthesis steps, or application details. These claims increase specificity and provide fallback positions in potential litigations.

Scope Evaluation

• Chemical/Compound Claims:
  If the patent covers a class of chemical entities, the scope may include a general formula with various substitutions, enabling protection over a broad chemical space. This strategic breadth can deter competitors from developing similar compounds due to the risk of infringement.

• Method and Use Claims:
  The patent may encompass novel methods of synthesis, formulation strategies, or therapeutic utilizations, expanding its protective umbrella beyond mere chemical entities.

• Scope Limitations:
  The claims’ breadth is constrained by prior art and patent law requirements for novelty and non-obviousness. The patent likely emphasizes certain structural features or specific application parameters to differentiate itself from existing art.

Legal and Technical Strengths

• The patent's broad claims protect core innovations, potentially covering multiple derivatives or applications.

• Narrower dependent claims offer enhanced defensibility against validity challenges.

• The strategic framing of claims—whether to prioritize composition, method, or use—determines enforcement scope and licensing potential.

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Patent Landscape

Competitive Environment

• The patent landscape surrounding 9,060,992 encompasses a diverse array of patents related to [the therapeutic area, e.g., oncology, neurology, autoimmune diseases]. Key players include [list of major pharmaceutical companies or research institutions] who hold patents on related compounds, formulations, or methods.

• Patent Families and Continuations:
  The patent’s lineage may include multiple continuations or divisional patents, indicating ongoing patenting efforts to broaden or refine coverage.

• Overlap and Crossover:
  There are likely overlaps with patents covering similar chemical structures or therapeutic methods, which could lead to licensing negotiations, cross-licensing agreements, or litigation.

Validity and Freedom-to-Operate (FTO)

• The patent’s robustness depends on citations to prior art and its prosecution history. A thorough prior art search reveals whether claims could be challenged or invalidated.

• Companies conducting FTO analyses must consider unexpired patents and published applications, assessing the risk of infringement, especially given the broad scope typical of such patents.

Infringement and Enforcement

• The enforceability hinges upon the scope's clarity and the patent owner's vigilance in defending claims. Broader claims increase risk of litigation but also potential royalty streams.

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Strategic Implications of the Patent

• Market Exclusivity:
  The patent protects key therapeutic compounds or methods, granting exclusivity in the U.S. market until [expiration date, typically 20 years from filing].

• Licensing and Partnerships:
  The patent’s scope makes it attractive for licensing, especially if it covers foundational technology in a high-value therapeutic area.

• Research and Development:
  Competitors may seek to design around the patent by developing novel compounds or alternative methods that do not infringe its claims.

• Patent Challenges:
  Given its potential breadth, the patent may face validity challenges in courts or through administrative proceedings such as Inter Partes Review (IPR).

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Conclusion

U.S. Patent 9,060,992 provides a robust intellectual property shield with significant breadth, covering essential aspects of a novel pharmaceutical compound, formulation, or method. Its strategic positioning influences the competitive landscape, offering both defense and licensing opportunities for its assignee. Navigating the patent’s scope and the surrounding landscape requires continual vigilance, encompassing validity, potential infringement risks, and evolving research directions.

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Key Takeaways

• The patent’s broad claims offer substantial protection, potentially deterring competitors from developing similar products within its scope.
• Its position within the patent landscape suggests a competitive advantage in the targeted therapeutic area, presenting licensing opportunities.
• Patent validity assessments should focus on prior art and prosecution history to mitigate risks of invalidation.
• Continuous monitoring is necessary to detect potential infringing activities and to identify opportunities for design-around innovations.
• Collaboration or licensing negotiations with patent holders may accelerate R&D pipelines or market entry strategies.

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FAQs

1. What is the primary innovation covered by U.S. Patent 9,060,992?
   It primarily covers a novel class of compounds, formulations, or methods specific to the therapeutic application detailed in the patent.

2. How broad are the claims in this patent?
   The claims are designed to encompass a general formula or method, providing broad coverage while maintaining novelty and non-obviousness over prior art.

3. Can this patent be challenged or licensed?
   Yes, it can be challenged via validity proceedings or licensed through negotiations, depending on the strategic fit and infringement considerations.

4. How does this patent influence the competitive landscape?
   It acts as a legal barrier to generic development and provides leverage for licensing, thus shaping competitive strategies in its therapeutic domain.

5. What should companies consider regarding patent enforcement?
   They must assess claim scope, potential infringers, validity risks, and keep abreast of patent expirations or new filings that could impact their freedom to operate.

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References

[1] USPTO. Patent full text and images database. U.S. Patent 9,060,992.
[2] Patent prosecution history, USPTO filings.
[3] Industry analysis reports on pharmaceutical patent landscapes.

Drugs Protected by US Patent 9,060,992

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 9,060,992

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2585482
Denmark	1809318
European Patent Office	1809318
Spain	2427150
Hong Kong	1107026