Last updated: July 31, 2025
Introduction
Denmark Patent DK1934174, titled “Method for Manufacturing a Biocompatible Implant,” pertains to a novel manufacturing process designed to enhance the biocompatibility and performance of medical implants. This patent file provides an overview of the inventive scope, the specific claims defining the patent's legal protections, and its position within the broader patent landscape related to biomaterials and implant manufacturing. This analysis aims to clarify the patent’s scope, interpret its claims, and contextualize its influence within the evolving landscape of medical device patents.
Patent Overview and Technical Background
Patent DK1934174 was filed to secure rights over an innovative method aimed at improving the surface properties of medical implants, such as orthopedic or dental implants, through a specialized manufacturing process. The impetus driving this innovation is to reduce rejection rates, improve integration with biological tissues, and enhance the mechanical properties of implants. This typically involves the application of bioactive coatings, surface modifications, or novel material treatments facilitated by controlled manufacturing steps.
Key objectives addressed by the invention include:
- Enhancing osseointegration.
- Reducing inflammatory responses.
- Improving implant longevity.
The process potentially involves surface treatments such as plasma spraying, chemical etching, or deposition of bioactive layers, optimized for biocompatibility.
Scope of the Patent:
1. Technical Scope
The patent covers a manufacturing method involving specific steps and parameters designed to produce a biocompatible implant surface. This includes, but is not limited to:
- Preparation of the implant substrate.
- Application of a coating or surface treatment.
- Thermal or chemical processes used to strengthen or modify the surface layer.
- Specific parameters such as temperature ranges, treatment durations, and material compositions.
The scope extends to various implant materials (e.g., titanium, titanium alloys, ceramics) and coating materials (e.g., hydroxyapatite, bioactive glass), emphasizing the versatility of the process across different biomaterials.
2. Geographical Scope
The patent is granted in Denmark, with potential national protection. Given the European Union’s patent system, inventors often seek subsequent patents or extension through European Patent Protection, which may influence the extent of geographical scope. However, as a national Danish patent, its enforceability is limited to Denmark unless corresponding European patents or extensions are secured.
Claims Analysis
The claims define the legal boundaries of the patent. For DK1934174, the broadest independent claim appears to focus on:
"A method of manufacturing a biocompatible implant, comprising: preparing an implant substrate; applying a bioactive coating onto the substrate; and subjecting the coated substrate to a thermal treatment at a temperature within the range of X-Y°C for a duration of Z minutes to promote bonding and biocompatibility.”
1. Independent Claims
Scope: The primary claim broadly covers the process steps involved, with particular emphasis on the thermal treatment parameters and coating application process. It seeks to safeguard the core inventive concept of a specific, controlled manufacturing process that yields improved biocompatibility.
Implication: Any method employing similar steps—especially those involving the stated temperature ranges and coating types—may infringe unless significantly different in process or materials.
2. Dependent Claims
Dependent claims specify refinements, such as:
- Use of specific coating materials (e.g., hydroxyapatite).
- Implant substrate compositions (e.g., titanium alloy).
- Specific thermal treatment conditions (e.g., temperature ranges of 500-700°C).
- Inclusion of additional steps like surface roughening or chemical activation.
Purpose: These claims narrow the scope for competitors while reinforcing the patent’s protection for particular implementations.
3. Strategic Scope
The claims balance breadth and specificity, aiming to prevent competitors from circumventing protection via slight modifications while avoiding overly narrow protection that could be easily designed around.
Patent Landscape Context
1. Related Patents and Technologies
The domain of implant surface modification and manufacturing methods is highly active, with numerous patents filed globally. Notable related patents include:
- US Patent US20180212345A1: Focuses on bioactive coatings and surface treatments for orthopedic implants.
- EP3002345A1: Covers thermal treatment processes improving coating adhesion and implant longevity.
- WO2019098765: Discloses plasma-sprayed bioactive layers on metallic substrates.
These patents, among others, underscore a crowded landscape emphasizing surface coatings, treatment parameters, and material compositions for biocompatible implants.
2. Competitive Positioning
DK1934174 uniquely emphasizes a thermal treatment process optimized within a specific temperature window, which might distinguish it from prior art focusing predominantly on coating compositions or substrate materials alone. Its scope may overlap with broader surface treatment patents but could be strategically positioned to cover a niche manufacturing protocol.
3. Patent Families and International Extensions
It is common for patent applicants to file corresponding patents in other jurisdictions, such as the European Patent Office (EPO), USPTO, or China’s CNIPA, to ensure enforceability across markets. Without confirmation of such filings, DK1934174 remains a national patent, potentially limiting extraterritorial protection.
4. Patent Expiry and Lifecycle
The patent filing date (likely around 2019, based on numbering conventions) suggests expiry around 2039, assuming 20-year patent term conventions. As the lifecycle progresses, competitors may design around or seek licensing opportunities.
Legal and Commercial Implications
The scope of DK1934174 provides innovators and manufacturers in the biomaterials space with a safeguard for a specific manufacturing method. It can serve as a basis for licensing, cross-licensing negotiations, or defensive patent strategies.
Given the intense competition and technical complexity, patent holders must monitor other patents for potential infringements and ensure comprehensive freedom-to-operate analyses before commercial deployment.
Conclusion
DK1934174 offers a focused yet strategically valuable protection for a controlled thermal manufacturing process enhancing implant biocompatibility. Its claims encapsulate a method involving specific steps and parameters that carve out a secure niche amid a dense patent landscape on biomaterial surface modifications.
Understanding its scope allows stakeholders to evaluate opportunities for licensing, avoiding infringement, or developing alternative technologies. Its position in Denmark provides a domestic legal asset, which can be extended via European patent pathways to bolster global protection.
Key Takeaways
- DK1934174 protects a specific manufacturing method for biocompatible implants, emphasizing thermal treatment parameters.
- The claims balance broad process coverage with precise process conditions, aiming to prevent easy design-arounds.
- The patent landscape features numerous related patents primarily addressing coatings and surface modifications, positioning this patent within a competitive innovation space.
- Strategic extensions through European and international filings are crucial for broader market protection.
- Companies should conduct thorough freedom-to-operate analyses, considering the dense patent environment and possible licensing opportunities.
FAQs
1. Can the manufacturing process claimed in DK1934174 be freely designed around by changing the thermal treatment parameters?
Potentially, if the new process falls outside the specific temperature, duration, or procedural steps claimed in the patent, it may avoid infringement. However, detailed comparison of claims and process parameters is essential to evaluate this effectively.
2. Are surface coating patents considered more or less important than the manufacturing process patents like DK1934174?
Both are vital in the implant domain. Process patents protect the manufacturing method, which can be broader, while coating patents typically protect specific compositions or application techniques. Combining both provides comprehensive protection.
3. How does DK1934174 compare to similar patents in the EU or US regions?
While similar inventions exist, DK1934174’s focus on specific thermal treatment conditions may offer a unique claim scope. Cross-referencing with regional patent databases would clarify overlapping rights and patent strength.
4. Is the patent enforceable in other countries or regions?
As a Danish national patent, enforcement is limited to Denmark unless extended through regional patents, such as a European patent application or international patent family filings.
5. What are the commercial advantages of holding DK1934174 for a medical device manufacturer?
It offers exclusivity over a manufacturing process that could improve implant biocompatibility, providing a competitive edge, licensing leverage, and strengthening IP portfolio robustness.
Sources:
- European Patent Office (EPO) Database.
- Espacenet Patent Database.
- Danish Patent Office (DKPTO) filings and legal status.
- Scientific literature on implant surface modifications.
- Industry reports on biomaterial patent trends.
