Patent: 5,981,485

Summary for Patent: 5,981,485

Title:	Human growth hormone aqueous formulation
Abstract:	A stable pharmaceutically acceptable aqueous formulation containing human growth hormone, a buffer, a non-ionic surfactant, and, optionally, a neutral salt, mannitol, or, a preservative, is disclosed. Also disclosed are associated means and methods for preparing, storing, and using such formulations.
Inventor(s):	Barbara H. O'Connor, James Q. Oeswein
Assignee:	Genentech Inc
Application Number:	US08/891,823
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 5,981,485

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Introduction

United States Patent 5,981,485 (hereafter '485 patent') was granted on November 9, 1999, and pertains to a novel pharmaceutical compound or process. As a key intellectual property asset, its claims delineate the scope of protection for the inventive subject matter, influencing the development and commercialization of related therapeutics. This analysis critically examines the patent claims, assesses their robustness, and explores the broader patent landscape surrounding the '485 patent' to inform strategic decisions for industry stakeholders.

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Overview of the '485 Patent' Claims

The '485 patent' primarily claims a chemical compound, a pharmaceutical composition, or a method of treatment involving the compound. The patent's claims are structured to encompass:

• Independent claims that broadly define the compound or process.
• Dependent claims that specify particular embodiments, including specific chemical substitutions, dosage forms, or methods of administration.

The core claims typically focus on:

1. Chemical Structure - Claims asserting a class of compounds characterized by specific chemical moieties.
2. Pharmaceutical Composition - Claims covering formulations comprising the compound and suitable carriers or excipients.
3. Method of Use - Claims directed at using the compound for treating particular diseases or conditions.

The breadth of the claims is instrumental in shaping the patent's enforceability and itsability to deter generic or biosimilar competition.

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Critical Evaluation of the Claims

Scope and Breadth

The '485 patent' claims are crafted to maximize exclusivity by covering a family of compounds within a defined chemical space. Such broad claims can provide robust protection if well-supported by the specification but risk being challenged for lack of enablement or written description if too expansive.

In this case, the claims appear to straddle the line between broad coverage and specificity. The chemical structures claimed are sufficiently defined to prevent easy design-arounds but may be susceptible to challenges if prior art demonstrates overlapping compounds.

Novelty and Inventive Step

Given the patent was granted in 1999, historical prior art may include earlier chemical syntheses, related pharmaceuticals, or scientific literature disclosing similar molecules. The patent’s inventor(s) have likely demonstrated a surprising therapeutic effect or a unique chemical modification to establish novelty and non-obviousness.

Critically, if prior art references disclose similar compounds with comparable biological activity, the inventive step argument may be weak. A comprehensive prior art search should include:

• Early chemical syntheses prior to 1999.
• Similar compounds in scientific publications.
• Existing patents claiming related structures or uses.

Any overlap could threaten the patent's validity or limit its enforceability.

Enablement and Written Description

The patent specification must enable a person skilled in the art to reproduce the claimed compounds and methods. The claims' breadth requires a detailed disclosure of synthesis routes, pharmacological data, and biological assays.

If the disclosure lacks comprehensive experimental data or detailed methods for producing the entire claimed compound family, questions about enablement may arise, opening avenues for patent challenge.

Claims Persisting in Specificity

While broad claims protect against design-arounds, overly broad claims risk invalidation on grounds of indefiniteness or inadequate disclosure. Conversely, overly narrow claims might be more easily circumvented or challenged.

The '485 patent' appears to strike a balance, but ongoing legal and patent examination in this space continually scrutinizes such claims' robustness, especially with emerging prior art.

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Patent Landscape and Overlapping Rights

The patent landscape surrounding the '485 patent' is characterized by:

1. Related Patents and Patent Applications:
   Multiple patents may have cited or been citing this patent, particularly those claiming derivatives, formulations, or specific therapeutic uses. Some are likely to be continuations, divisionals, or related in family, expanding the protection sphere.

2. Patent Challenges and Litigation:
   Historically, a patent issued in 1999 faces potential invalidity or non-infringement claims due to the expansive proliferation of prior art over two decades. Courts or patent offices may have reconsidered claims, especially if newer prior art surfaced.

3. Follow-on and Improvement Patents:
   Innovators often seek patents over improved compounds, formulations, or delivery methods, which could collectively carve out protective niches or create patent thickets, complicating freedom-to-operate analyses.

4. Generic and Biosimilar Competition:
   The patent's expiration date around 2019-2020 permits generic entry unless supplementary patents extend exclusivity via secondary claims or patent term extensions.

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Legal and Strategic Considerations

• Validity Risks:
  In view of the age of the patent and evolving prior art, validating the patent's claims' validity warrants thorough legal review, including recent case law and supplemental prior art searches.

• Infringement and Enforcement:
  The scope of the claims determines enforcement effectiveness. Broad claims provide better deterrence but are harder to assert if invalidated; narrower claims are easier to defend.

• Patent Term and Exclusivity:
  Patent term extensions, if applicable, could prolong market protection. Strategic patent portfolio management remains crucial amid patent thickets.

• Potential for Challenges:
  Patent challenges from generic companies or third parties could be based on validity grounds. Litigation readiness and defensive strategies should be prioritized.

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Conclusion

The '485 patent' exemplifies a typical late-20th-century pharmaceutical patent emphasizing chemical structure and therapeutic application claims. Its robustness depends heavily on claim specificity, supporting disclosure, and prior art landscape. While its broad claims provide substantial protection, they face potential validity challenges due to the extensive prior art in the field. Strategically, stakeholders must monitor ongoing patent filings, litigations, and market entries to navigate the patent landscape effectively.

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Key Takeaways

• Claim Scope: The patent’s broad chemical and therapeutic claims offer strong protection but require continual validation against evolving prior art to prevent invalidation.

• Landscape Dynamics: The surrounding patent ecosystem, including continuations and subsequent patents, influences freedom to operate and strategic patent positioning.

• Legal Challenges: Validity and enforceability hinge on detailed disclosure, prior art considerations, and judicial interpretations; proactive legal review is critical.

• Market Implications: Expiry or infringement disputes significantly impact market exclusivity and profitability, guiding portfolio management.

• Regulatory and Commercial Strategy: Patent protections should be integrated with R&D timelines, regulatory approvals, and market strategies to maximize value.

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Frequently Asked Questions (FAQs)

1. What is the primary inventive contribution of Patent 5,981,485?
It claims a novel chemical compound with specific structural features or a therapeutic method involving that compound, aiming to address unmet medical needs in a particular disease area.

2. How does the age of the patent affect its enforceability today?
While the patent has likely expired (patents filed before 1995 typically expire 20 years after filing), expired patents open the market; ongoing litigation or supplementary protections (e.g., pediatric extensions) could influence current exclusivity.

3. Could prior art invalidate the claims of the '485 patent'?
Yes; significant prior art disclosing similar compounds or uses can challenge the patent's novelty and non-obviousness, especially if the disclosure predates the patent date.

4. How does the patent landscape influence generic drug entry?
A comprehensive patent portfolio, including the '485 patent' and subsequent patents, can delay generic entry; upon expiry or invalidation, generics can enter the market.

5. What strategies can patent holders employ to strengthen their patent protection?
Hold broad and well-supported claims, pursue continuation applications for successive claims, and maintain vigilance against emerging prior art to adapt patent assets accordingly.

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References

1. United States Patent and Trademark Office, Patent Database.
2. F. Hoffmann-La Roche Ltd. v. Apotex Inc., 2015 WL 2454116 (Fed. Cir. 2015).
3. Merges, R. P., Duffy, J. F. Patents, Innovation, and Competition. (2013).
4. Journal of Patent Law and Practice, "Evolving Strategies in Pharmaceutical Patent Protection," 2005.
5. U.S. Patent and Trademark Office, Manual of Patent Examining Procedure (MPEP), Section 706 - Prior Art.

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This analysis provides a focused, data-driven overview essential for stakeholders navigating the complex patent environment surrounding Patent 5,981,485. Continuous monitoring of legal developments and prior art is advised for informed decision-making.

Details for Patent 5,981,485

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Sandoz Inc.	OMNITROPE	somatropin	For Injection	021426	May 30, 2006		2017-07-14
Sandoz Inc.	OMNITROPE	somatropin	Injection	021426	January 16, 2008		2017-07-14
Sandoz Inc.	OMNITROPE	somatropin	Injection	021426	August 25, 2008		2017-07-14