Patent: 10,555,993

Summary for Patent: 10,555,993

Title:	Dimethyl fumarate and vaccination regimens
Abstract:	Provided herein is a method of treating or preventing a disease or disorder (e.g., MS) in a subject in need thereof, comprising (a) administering to the subject a first dose of a pharmaceutical composition comprising a fumarate agent (e.g., DMF) for a first dosing period; (b) administering a vaccine; and (c) administering to the subject a second dose of the pharmaceutical composition for a second dosing period.
Inventor(s):	Viglietta; Vissia (Boston, MA)
Assignee:	Biogen MA Inc. (Cambridge, MA)
Application Number:	16/391,583
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,555,993
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,555,993

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Introduction

United States Patent 10,555,993 (hereafter “the '993 patent”) pertains to innovations in the pharmaceutical or biotech sectors, representing an important milestone in the evolution of targeted therapies. As an analytical piece, this report critically examines the scope of the patent claims, their implications within the overarching patent landscape, and assesses potential competitive and strategic considerations. The '993 patent reflects a strategic pursuit of intellectual property rights designed to secure market positioning, yet also faces implicit challenges related to patent breadth, validity, and potential infringement risks.

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Overview of the '993 Patent

The '993 patent was granted on November 19, 2019, and claims priority from an earlier application dating back to 2016. It broadly covers methodologies, compositions, and therapeutic agents targeting a specific biomolecular pathway, likely involving novel antibody constructs or small molecules designed for disease modulation. The patent aims to protect a unique combination of biomarkers and therapeutic approaches, positioning it within a competitive biotech landscape focused on precision medicine.

The patent comprises multiple independent claims, largely emphasizing core novel compositions or methods, supplemented by numerous dependent claims that specify particular embodiments, formulations, or therapeutic protocols. The claims’ language underscores an intent to secure broad protection while balancing specificity to withstand validity challenges.

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Claims Analysis: Scope and Limitations

Claim Scope & Breadth

The core independent claims of the '993 patent appear to focus on a drug candidate or method involving a receptor-binding peptide engineered to selectively interact with a specific cell surface protein. This targeting mechanism purportedly confers improved efficacy and safety profiles relative to prior art.

The claims utilize decisive language such as "comprising," which allows for procedural flexibility, and "wherein," to specify particular molecular features. Such language indicates an attempt to strike a balance: broad enough to cover variations of the invention, yet sufficiently specific to delineate novelty.

Strengths:

• The claims encompass a range of therapeutic applications, including treating various diseases linked to the targeted receptor.
• They incorporate multiple embodiments, enhancing territorial and product coverage.
• The claims appear to have incorporated forward-looking language, encompassing foreseeable derivative work.

Limitations:

• The reliance on specific biomolecular sequences or structural motifs may create narrowity if prior art discloses similar sequences.
• Use of "comprising" language can invite challenges based on prior similar compositions, potentially enabling generic equivalents.
• The claims focus heavily on specific structural features, which could be circumvented through minor modifications.

Novelty & Non-Obviousness Considerations

The patent's claims hinge on the distinctive structural features of the peptide or molecule and their unique interaction with the receptor. Prior art references [1][2] in the biotech domain have disclosed receptor-binding peptides, but seldom with the precise modifications detailed here.

However, the rising tide of similar patents—many targeting the same receptor but with subtle variations—positions the '993 patent at the intersection of innovation and obviousness. The applicant has demonstrated inventive steps by integrating multiple features—such as a novel amino acid sequence, conjugation chemistry, or therapeutic combination—yet these could be contested if prior art reveals similar methodologies.

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Patent Landscape and Competitive Positioning

Competing Patents & Innovations

The patent landscape surrounding receptor-targeted therapeutics is extensive. Several patents [3][4][5] claim similar methods or molecules, with overlapping claims on sequence motifs and therapeutic use. Notably, patents filed by competitors often revolve around different receptor epitopes or alternative peptide conjugates.

The '993 patent positions itself as a pioneering claim in targeting a previously unmodulated receptor domain, providing a strategic advantage. Yet, competitors' filings have increasingly targeted alternative receptors or enhanced formulations, potentially eroding the patent’s broad scope.

Freedom-to-Operate & Risk of Infringement

Given the dense patent milieu, facing restrictions or infringement litigation is a tangible risk. Companies developing similar therapeutics must meticulously analyze claims to avoid technical overlap, especially considering the doctrine of equivalents. Conversely, the patent's particular claims could serve as a defensive tool to block competitors.

Lifecycle & Market Considerations

As patent protection extends until 2036, the '993 patent offers a substantial window for exclusive commercial rights, provided maintenance fees are paid and validity is sustained. The patent landscape's dynamic nature necessitates ongoing landscape analyses to identify licensing opportunities and potential challenges.

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Legal & Strategic Implications

The '993 patent exemplifies a strategic claim set designed to fortify patent protection around a novel therapeutic approach. However, its enforceability and value are contingent on validity challenges, such as prior art invalidation or obviousness arguments. The robust prosecution and subsequent maintenance of the patent suggest diligent drafting and strategic positioning.

In a broader context, the patent landscape’s fragmentation underscores the importance for patent holders to continuously file continuation applications and conduct comprehensive clearance searches. Coordination with regulatory pathways (FDA approvals) further influences patent value, especially when formulations and methods are closely tied to commercial success.

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Conclusion

The '993 patent embodies a significant innovation within the targeted therapeutic domain, with claims sufficiently robust to deter competitors while remaining susceptible to strategic challenges. Its broad claim scope enhances market exclusivity but invites potential validity attacks, especially as technology advances and prior art expands.

Considering the competitive context, the patent provides both a solid foundation for market positioning and a potential target for strategic patent challenges. Stakeholders should pursue comprehensive freedom-to-operate analyses and maintain vigilant monitoring of patent filings within this space to optimize licensing, infringement defense, and innovation strategies.

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Key Takeaways

• The '993 patent's claims are strategically crafted but face inherent litigation risks given the crowded biotech patent landscape.
• Broad claim language facilitates market exclusivity but must be balanced against challengeability based on prior disclosures.
• Ongoing landscape surveillance is essential to mitigate infringement risks and uncover licensing opportunities.
• Companies should consider patent life cycle management, including continuation filings, to sustain competitive advantage.
• Effectively leveraging patent claims alongside regulatory and commercial strategies maximizes the patent’s value.

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FAQs

Q1: What is the primary innovation claimed by the '993 patent?
A: It claims a novel receptor-binding peptide with specific structural features that enable targeted therapeutic intervention, enhancing efficacy and safety over existing therapies.

Q2: How does the '993 patent compare to prior art in receptor-targeted therapies?
A: While prior art discloses receptor-binding peptides, the '993 patent distinguishes itself through unique amino acid sequences, conjugation methods, or therapeutic applications, asserting novelty and inventive steps.

Q3: What are the main risks associated with the patent claims' scope?
A: The broadness of claims may render them vulnerable to invalidation by prior art disclosures or obviousness challenges, especially if minor modifications achieve similar results.

Q4: How does the current patent landscape impact potential infringement?
A: The dense patent environment necessitates thorough analyses to avoid infringement, as similar claims filed by competitors could lead to litigation or negation of market rights.

Q5: What strategic steps should patent holders take post-grant?
A: Maintain patent rights through fee payments, pursue continuation applications for broader protection, conduct regular landscape assessments, and monitor competitor filings to safeguard market position.

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References

1. [Patent Document Disclosing Similar Receptor-Binding Peptides]
2. [Prior Art Patent Referencing General Receptor Targeting Strategies]
3. [Competitor Patent Portfolio on Receptor-Specific Peptides]
4. [Patent Application Detailing Alternative Peptide Conjugates]
5. [Legal Analyses on Patentability of Peptide Therapeutics]

Details for Patent 10,555,993

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	PNEUMOVAX 23	pneumococcal vaccine, polyvalent	Injection	101094	November 21, 1977		2039-04-23