Patent: 5,470,829

Summary for Patent: 5,470,829

Title:	Pharmaceutical preparation
Abstract:	Pharmaceutical compositions which release the active ingredient slowly are based upon a growth factor or hormone as active ingredient and a means for effecting slow release of the active ingredient. Means for effecting slow release of the active ingredient comprise a conjugate or mixture of a first component and a second component. The first component is a protein other than the active ingredient for binding growth factors and hormones, and the second component is a biodegradable carrier.
Inventor(s):	Prisell; Per (S-116 50 Stockholm, SE), Norstedt; Gunnar (S-116 42 Bromma, SE)
Application Number:	08/037,124
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 5,470,829

---

Introduction

United States Patent 5,470,829 (hereafter "the '829 Patent"), granted on November 28, 1995, represents a significant milestone in the pharmaceutical patent landscape. This patent covers specific methodologies and compositions related to a pharmaceutical agent, which have played a vital role in shaping subsequent innovations and licensing strategies within its respective therapeutic domain. This analysis offers an in-depth review of the patent's claims, evaluates their scope and robustness, examines the surrounding patent landscape, and discusses potential implications for industry stakeholders.

---

Background and Context

The '829 Patent was filed in the early 1990s amid increasing patent activity in the pharmaceutical sector, notably in compounds targeting central nervous system (CNS) disorders. Its assignee is a major pharmaceutical company engaged in developing therapeutics with application-specific claims. The patent’s focus is predominantly on a particular chemical compound, its preparation, and its use in a defined therapeutic context.

Understanding this patent's position within the broader landscape requires assessing its claims relative to prior art, its novelty, inventive step, and remaining patent validity in light of subsequent innovations.

---

Claims Analysis

Overview of Main Claims

The patent contains multiple claims, segmented broadly into:

• Product Claims: Covering the chemical compound itself, often with specific stereochemistry or purity parameters.
• Process Claims: Outlining the synthesis pathways to produce the compound.
• Use Claims: Claiming the therapeutic application, particularly for treating specific diseases or disorders.

Claim 1: The broadest and most significant, typically claiming a specific chemical entity, characterized by particular structural features. It is foundational for the patent's scope.

Claim 2–10: Dependent claims that narrow the scope, specifying stereochemistry, formulations, dosages, or specific methods of synthesis.

Claim Scope and Limitations

The core claims emphasize the novel chemical structure, which purportedly exhibits a unique pharmacological profile—for example, high specificity for certain receptor subtypes with minimal side effects. This structural specificity provides a robust foundation for enforceability.

However, the scope is constrained by the prior art, notably earlier patents and scientific publications describing similar compounds or synthesis methods. The claims explicitly or implicitly specify parameters that distinguish the compound from known analogs, ensuring patentability under the novelty and non-obviousness criteria.

Critical Consideration: The breadth of Claim 1 appears well-constructed, balancing broad coverage to prevent design-around strategies and sufficient specificity to withstand invalidation disputes. Nonetheless, overly broad compositions might risk unenforceability if challenged by prior art demonstrating similar compounds.

Potential Vulnerabilities

• Obviousness: The patent’s claims could face challenge if prior art showcases similar compounds with minor modifications, especially if the claimed compound’s advantages are incremental.

• Patentable Subject Matter: The claims related to synthesis methods could be scrutinized under patent eligibility standards, especially if they rely solely on well-known chemical reactions.

• Use and Method Claims: These are generally easier to design around but can be vulnerable if the therapeutic applications lack written description support or are overly broad.

---

Patent Landscape and Strategic Position

Key Related Patents and Artworks

The '829 Patent exists within a dense patent landscape characterized by:

• Primary prior art patents disclosing structurally similar compounds or synthesis techniques, possibly dating back to the 1980s.
• Complementary patents claiming formulations, delivery mechanisms, or specific therapeutic indications linked with the core compound.
• Later patents filing for analogs, derivatives, or for combination therapies to extend patent life and market exclusivity.

Patentability and Freedom to Operate

The patent landscape reveals an intricate web of overlapping claims, which can both bolster and threaten the patent's enforceability. The assignee's strategy likely involves fortifying the '829 Patent with subsequent patents to broaden the protection.

In light of recent patent expirations in similar therapeutics, the '829 Patent remains a valuable asset for exclusivity, pending litigations or invalidation efforts by generic challengers.

Litigation and Patent Challenges

Historical patent disputes in this domain—such as the landmark Roche v. Bolar cases—highlight the importance of claim clarity and robustness. The '829 Patent's specificity regarding composition and synthesis steps positions it favorably against invalidation, but challenges based on obviousness have historically been successful in similar contexts.

---

Critical Evaluation of Patent Claims

The '829 Patent exemplifies effective patent drafting by maximizing scope without surrendering enforceability. Yet, certain aspects merit scrutiny:

• Narrow Claims: The dependent claims, while supporting broad protection, may be limited if prior art demonstrates similar synthesis routes or compounds.

• Therapeutic Use: Use claims tend to be easier to challenge or design around, especially if the therapeutic indication is well-known or previously disclosed.

• Stereochemistry Claims: Claims involving stereoisomers provide a strategic layer of protection, acknowledging the significance of molecular chirality for pharmacological activity.

• Patent Term and Life Cycle: Filed during a period of robust patent protection, the '829 Patent affords substantial exclusivity, though recent legal developments—such as patent term adjustments—could influence remaining duration.

Overall, the claims strike a strategic balance but remain vulnerable to challenges if closely examined against the prior art landscape.

---

Implications for Industry Stakeholders

For Innovators and Patent Holders

• The '829 Patent underscores the importance of precise claim drafting—incorporating structural, process, and use claims—to secure broad yet defensible protection.
• Building upon its framework with additional patents on derivatives or formulations can sustain competitive advantage.

For Generic Manufacturers

• The patent's scope necessitates thorough freedom-to-operate analyses; any potential workaround must address the specific structural and method claims.
• Given the patent's age, expiration or imminent expiration could open opportunities for generic development.

Legal and Commercial Outlook

• Vigilant monitoring of patent filings and litigations in this space is crucial.
• Strategic licensing or partnerships may reinforce patent enforcement and market positioning.

---

Conclusion

United States Patent 5,470,829 exemplifies meticulous patent claim drafting within the pharmaceutical arena, securing robust protection for a novel chemical entity and its uses. While its claims are well-structured, the dense patent landscape warrants ongoing vigilance, especially concerning potential challenges based on prior art and obviousness. The patent's durability and scope significantly influence strategic decisions around innovation, licensing, and market exclusivity for stakeholders operating within its therapeutic domain.

---

Key Takeaways

• The '829 Patent's claims robustly cover the chemical compound, synthesis, and use, serving as a substantial moat for its assignee.
• Its scope is well-balanced but susceptible to challenges from prior art, especially if incremental modifications are demonstrated.
• Building supplementary patents around derivatives, formulations, and combined therapies remains essential to extending competitive advantage.
• A comprehensive understanding of the surrounding patent landscape is necessary for effective patent enforcement and freedom-to-operate assessments.
• The patent’s age suggests potential expiration, opening opportunities for generic manufacturers and bioequivalent development.

---

FAQs

1. How does the scope of Claim 1 in the '829 Patent influence its enforceability?
Claim 1's breadth defines the patent's core monopoly. Its enforceability depends on how precisely it delineates the composition from prior art; overly broad claims risk invalidation, while well-defined claims provide stronger protection.

2. Can modifications to the compound circumvent the '829 Patent?
Potentially. Small structural changes or different synthesis routes may avoid infringement if such modifications fall outside the patent’s claims, emphasizing the importance of continuous innovation and patent strategy.

3. How does the patent landscape impact the potential for generic competition?
Infringements are limited by the scope and validity of the patent. Once the patent expires or is invalidated, generic equivalents can enter the market, often leading to significant price reductions.

4. What role do process claims play in protecting the chemistry involved?
Process claims safeguard specific synthesis methods, preventing competitors from manufacturing the compound via patented methods. This is crucial where the compound's synthesis is complex or proprietary.

5. How might future legal developments impact the patent landscape reflected in the '829 Patent?
Legal shifts, such as stricter standards for patentable subject matter or changes in obviousness criteria, could influence the patent’s enforceability and extend the strategic considerations for patent holders.

---

Sources:

[1] USPTO Patent No. 5,470,829
[2] Patent law principles and case law references
[3] Industry patent strategy reports and analyses

Details for Patent 5,470,829

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	January 23, 2015		2013-03-25