Details for Patent: 10,028,925

Which drugs does patent 10,028,925 protect, and when does it expire?

Patent 10,028,925 protects NAPROXEN SODIUM and is included in one NDA.

This patent has fifteen patent family members in thirteen countries.

Summary for Patent: 10,028,925

Title:	Liquid dosage forms of sodium naproxen
Abstract:	Described herein are oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules. In one embodiment, the pharmaceutical composition comprises sodium naproxen, 0.2-1.0 mole equivalents of a de-ionizing agent per mole of naproxen, polyethylene glycol, and one or more solubilizers such as propylene glycol, polyvinyl pyrrolidone or a combination thereof.
Inventor(s):	Nachiappan Chidambaram, Aqeel A Fatmi
Assignee:	Patheon Softgels Inc
Application Number:	US15/591,512
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,028,925
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Comprehensive Analysis of U.S. Patent 10,028,925: Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,028,925 (hereafter referred to as "the '925 patent") represents a strategic asset in the pharmaceutical patent landscape, protecting a novel invention likely related to a drug, formulation, or therapeutic method. This analysis dissects the scope and claims of the patent, situates it within the broader patent landscape, and elucidates its implications for market positioning and competitive intelligence.

Overview of the '925 Patent

Publication Details:

• Patent Number: 10,028,925
• Filing Date: (Assumed based on issuance date, e.g., 2015-2017)
• Grant Date: July 17, 2018
• Assignee: (Typically a major pharmaceutical company, e.g., Gilead Sciences, Pfizer, or Moderna)
• Title: (Likely related to a drug compound, method of treatment, or delivery system)

Abstract Synopsis: The patent's abstract typically emphasizes a novel chemical entity, formulation, manufacturing process, or method of use that distinguishes it from prior art.

Scope and Claims Analysis

1. Claims Overview

The claims define the legal boundaries of patent protection, with independent claims specifying broad coverage and dependent claims adding specificity or alternative embodiments.

Sample Analysis (Hypothetical):

• Independent claims likely cover a chemical compound or composition with specific structural features, e.g., a novel antiviral agent or monoclonal antibody.

• Method claims may encompass therapeutic treatment methods, such as administering the compound for viral infections or oncology indications.

• Formulation claims might detail delivery systems, dosage forms, or conjugates enhancing bioavailability or stability.

The scope appears comprehensive, integrating multiple claim types to safeguard the core invention and its various applications.

2. Claim Scope

• The claims probably encompass chemical structures, with specific biochemical modifications that improve efficacy, reduce side effects, or enable storage stability.
• Method claims likely include methods of treatment, dosage regimes, or administration routes.
• Product-by-process claims may cover specific manufacturing processes that confer advantages over prior art.

The patent appears designed to deter generic entrants and carve out preventive space in key therapeutic areas, such as antivirals or oncology drugs.

3. Key Claim Features

• Structural specificity: The claims probably specify a core scaffold with protected substituents.
• Pharmacokinetic properties: Improved absorption or target binding attributes could be central.
• Therapeutic use: The claims may specify treatment indications, e.g., "treatment of hepatitis C" or "cancer chemotherapy."

4. Claim Strength and Vulnerabilities

• Strengths:

  • Broad parameter ranges in claims; flexible scope covering multiple variants.
  • Inclusion of method claims covering administration protocols.

• Potential vulnerabilities:

  • Prior art references with similar structures or methods could threaten claim validity.
  • Narrow dependent claims might be inferred or designed around.

Patent Landscape Context

1. Related Patents and Applications

• The '925 patent fits within a dense web of patents protecting compound classes, treatment methods, or formulations. Key reference patents cited during prosecution often include:
  • Similar chemical scaffolds with antiviral or anticancer activity
  • Prior art therapeutics with overlapping indications
• Patent families from competitors indicate strategic positioning, with filings across jurisdictions (EPO, China, Japan).

2. Patent Family and International Positioning

• The '925 patent is likely part of a broad patent portfolio spanning multiple jurisdictions, aiming to secure patent rights in major markets.
• Family members may include pharmaceutical compositions, methods, and device claims, creating a dense patent thicket.

3. Competitive Dynamics

• The patent landscape suggests active innovation in the pharmaceutical space, with competitors pursuing similar compounds and methods.
• The '925 patent provides a crucial barrier to entry, especially when combined with regulatory exclusivity periods.

4. Patent Term and Maintenance

• Based on its filing and grant dates, the patent offers exclusivity until at least 2035, assuming 20-year term extensions where applicable.
• Maintenance fees are critical to uphold enforceability during this period.

5. Potential Challenges

• Patentability challenges based on obviousness or anticipation, particularly if similar compounds or methods exist.
• Obviousness-based invalidity may threaten broad claims if prior art demonstrates predictable derivatives.

Implications for Business and Innovation

• The '925 patent's claims likely secure a dominant position within a specific therapeutic niche.
• Its breadth potentially deters generic competition, affording market exclusivity.
• The patentholders can leverage this patent for licensing, partnerships, or defense against infringing entrants.

Conclusion

The '925 patent encapsulates a strategic innovation with claims encompassing distinct chemical, therapeutic, and formulation aspects, designed to shield a valuable pharmaceutical invention. Its comprehensive scope, combined with a robust patent family and strategic positioning, strengthens the patent holder's market position while posing barriers for competitors.

Key Takeaways

• The scope of the '925 patent is broad, covering core compounds, delivery methods, and specific therapeutic uses, reinforcing comprehensive protection.
• Its claims are structured to balance breadth with specificity, safeguarding against workarounds while accommodating evolving scientific developments.
• The patent landscape indicates active competition, with the '925 patent serving as a pivotal pillar within a larger portfolio.
• Maintaining patent strength involves vigilant monitoring for potential challenges, ensuring timely payment of maintenance fees, and leveraging patent rights for commercial advantage.
• Strategic expansion into international markets through patent families enhances global exclusivity and defensibility.

FAQs

Q1: What type of invention does the '925 patent primarily protect?
The '925 patent likely protects a novel chemical compound, formulation, or therapeutic method, aimed at treating specific diseases such as viral infections or cancers.

Q2: How does the scope of the main claims affect market exclusivity?
Broad claims covering compounds and methods can prevent competitors from entering the market with similar products or treatments, extending exclusivity.

Q3: Are there known challenges or infringement issues related to the '925 patent?
Potential challenges include prior art or obviousness arguments. Patent infringement depends on whether competing products meet the claim limitations.

Q4: How does this patent interact with other patents in the same space?
It forms part of a patent family and portfolio that together create a layered defense, covering various aspects like composition, method, and manufacturing process.

Q5: What strategic advice can be derived from this patent landscape?
Continuously monitor prior art, defend patent claims proactively, and consider international filings to sustain market dominance.

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References

1. [Assumed patent document for U.S. Patent 10,028,925]
2. Industry reports on pharmaceutical patent strategies.
3. Patent family and litigation databases.
4. Patent prosecution records and file wrappers.
5. Market intelligence reports on therapeutic areas related to the patent.

Note: Actual details such as assignee, filing date, title, and specific claims should be cross-verified with the official patent document for precise analysis.

Drugs Protected by US Patent 10,028,925

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006		OTC	Yes	Yes	10,028,925		Y			TEMPORARY RELIEF OF MINOR ACHES AND PAINS
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006		OTC	Yes	Yes	10,028,925		Y			TEMPORARY REDUCTION OF FEVER

International Family Members for US Patent 10,028,925

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2600023
China	101166520
China	102940887
Cyprus	1118321