Who holds the patent for Albumin?

Introduction to Albumin

Definition and Biological Role 
Albumin is a naturally occurring plasma protein that plays an essential role in maintaining oncotic pressure and serving as a carrier for various endogenous and exogenous molecules. It is produced primarily in the liver and is the most abundant protein in human plasma. Beyond its classical function in fluid balance, albumin has numerous additional roles that include binding hormones, fatty acids, drugs, and metal ions, and even participating in antioxidant defense mechanisms. In biotechnology, albumin’s stability, biocompatibility, and multifunctionality have made it an attractive molecule in drug formulation and delivery systems, as well as in regenerative medicine and as a scaffold for nanocomposite structures.

Applications in Medicine and Industry 
Due to its diverse and well‐understood properties, albumin has found a wide array of applications in both clinical and industrial settings. In medicine, albumin is used as a volume expander and as a carrier molecule for drugs that require improved pharmacokinetic profiles. Therapeutic formulations that incorporate albumin—whether in its native form or as engineered variants—are employed to enhance drug stability, reduce toxicity, and extend circulation times. In the industry, albumin is utilized not only as a therapeutic agent but also as a biomaterial in regenerative medicine, serving as an attractive coating for implants, scaffolds to support cell growth, or as a component in nanocomposite structures that can deliver cargo in a controlled manner.

Patent Landscape of Albumin

Overview of Patent Types Related to Albumin 
It is important to recognize that albumin, being a naturally existing protein, is not patentable as such under many jurisdictions. However, modifications, engineered variants, novel formulations, and the use of albumin as a carrier in inventive therapeutic or diagnostic compositions are all patentable. Various patents cover multiple aspects including:

- Albumin Derivatives and Variants: These include engineered albumins with improved binding properties (e.g., strengthened FcRn binding for longer half-life) or altered pharmacokinetics.
- Albumin-Based Drug Delivery Systems: Patents here describe nanoformulations (such as albumin nanoparticles and nano microspheres) that encapsulate drugs, facilitating slow-release and target-specific delivery.
- Albumin Binding Technologies: Several patents focus on engineered binder molecules (such as single variable domains or improved serum albumin binders) that target albumin. Such innovations serve to exploit albumin’s long circulation half-life or enhance the stability of therapeutic molecules by tethering to albumin.

- Albumin Nanocomposite Structures: These patents detail composite structures where albumin forms a molecular shell or a binding matrix that offers enhanced biocompatibility and versatility in drug formulation and medical devices.

Key Patent Holders 
Given the broad scope of these patents, multiple institutions and companies have contributed to this evolving landscape. Based on the synapse-sourced materials and external website reports, some of the key players include:

- National Nano Science Center: For example, Patent describes “A kind of albumin nanocomposite structure and its preparation method and application” with the current assignee being National Nano Science Center. This patent focuses on innovative albumin-based nanostructures that can encapsulate therapeutic agents.

- Fudan University Affiliated Huashan Hospital: Patent relates to the preparation of gemcitabine‐albumin nano microspheres intended for chemotherapy and is held by this institution. This technology leverages albumin as a carrier to enhance tumor targeting and the slow-release of gemcitabine.

- Tsinghua University: Patent provides a method for preparing stable albumin nanoparticles. The assignee is Tsinghua University, which has contributed to technology enabling albumin nanoparticles to serve as drug delivery systems that release their cargo in response to redox conditions.

- ABLYNX NV: Two filings, referenced as (Improved serum albumin binders), list ABLYNX NV as the applicant. These patents cover engineered immunoglobulin single variable domains capable of binding serum albumin. While not albumin itself, these technologies are integral to modifying the pharmacokinetic profiles of drugs by exploiting albumin binding.

- Other Holders and Applicants: In patents such as, albumin is used as a component in nano drug carriers developed by JINING NO.1 PEOPLE’S HOSPITAL, while from TECHNION RESEARCH & DEVELOPMENT FOUNDATION LIMITED describes compositions that may incorporate albumin as a plasma protein to enhance drug solubility. Additionally, patent mention variants of albumin that exhibit improved binding to FcRn, though the assignee information for these is not explicitly disclosed in the provided excerpts, they nonetheless represent key technological developments in the albumin field.

It is clear that no single entity holds “the patent for Albumin” in its entirety. Instead, the patent landscape is divided among several institutions and companies, each holding patents on specific aspects, modifications, and applications of albumin-based technology. This multidimensional protection strategy reflects the complex nature of albumin’s importance as a therapeutic and industrial protein.

Analysis of Patent Information

Patent Scope and Claims 
The scope of albumin-related patents is broad and diverse. Several patents focus on specific technological improvements while still jointly relying on the natural properties of albumin. For example:

- Patents like those from ABLYNX NV are directed toward developing small binder domains that specifically target serum albumin. The claims in these patents concentrate on novel amino acid sequences that can bind to serum albumin, and thereby, extend the serum half-life of attached therapeutic molecules. Such claims play an important role in drug design, particularly for biologics with otherwise rapid clearance rates.

- In contrast, patents propose methods to formulate albumin-based delivery systems, including nanocomposites, nano microspheres, and stable nanoparticles. Claims in these patents are oriented toward the composition of matter, the method of preparation, and the controlled release of encapsulated drugs. These innovative formulations are especially impactful in the field of targeted cancer therapy and other chronic diseases requiring sustained therapeutic levels.

- Patents that describe engineered albumin variants focus on improving specific properties such as binding affinity for the neonatal Fc receptor (FcRn). Enhanced binding typically translates into prolonged circulation time and improved therapeutic efficiency. The claims in such patents often relate to modified albumin sequences, conjugated forms, or fusion proteins that maintain binding functionalities while extending in vivo half-life.

In all these cases, the patents work to protect inventions that build upon a naturally abundant molecule by making it more effective as a carrier or therapeutic agent. The protective scope of these patents encompasses not only the specific chemical or biological compositions but also the methods of manufacturing and employing the albumin-based products.

Geographic Distribution of Patents 
The patent landscape for albumin and its related technologies is global. For instance, by ABLYNX NV show an international filing strategy under the Patent Cooperation Treaty (PCT); designated states include key markets in Europe, North America, Asia, and beyond. This wide geographic protection underscores the commercial importance of albumin modifications, ensuring that innovations can be commercially exploited in various regions.

The geographic spread of these patents is not uniform but is instead tailored to the strategic interests of each holder. Companies such as ABLYNX NV have pursued extensive international protection given the broad applicability of their binding technologies, while research institutes may file in markets that are relevant to their collaborative or domestic interests. This diversity not only emphasizes varied strategic goals but also indicates that albumin, as a multifunctional protein, has significant commercial relevance across multiple territories.

Implications and Future Directions

Impact on Research and Development 
The current patent landscape has considerable implications for both research and development (R&D) and clinical applications. By securing broad protection over albumin modifications and usages, the patent holders help drive innovation through their R&D investments. For instance:

- The development of albumin-based drug delivery systems has made it possible to formulate new therapies with enhanced stability, targeted delivery, and improved pharmacokinetic profiles. The patents held by institutions like Fudan University Affiliated Huashan Hospital and Tsinghua University provide evidence that academic and research institutions are playing a key role in pushing forward these innovations.

- In parallel, patents on engineered binders and albumin variants, such as those covered by ABLYNX NV, facilitate collaboration between biotechnology companies and research organizations. Such arrangements may lead to license agreements that further drive the clinical development of albumin-based therapies. The licensing strategies discussed in external annual reports also show how collaborative models are used to commercialize albumin binding technology.

- The existence of multiple patents ensuring protection in different geographic regions helps mitigate the risk associated with R&D investments. Companies and research organizations are more likely to innovate if they have confidence in intellectual property protection, knowing that their modified albumin formulations, binder technologies, or novel delivery systems are shielded from competitive encroachment.

Future Trends in Albumin Patents 
Looking forward, the patent landscape for albumin is likely to evolve along with advancements in biotechnology. Based on the current trends, future directions might include:

- Enhanced Albumin Variants: With an increasing focus on improving in vivo stability and half-life, further modifications of albumin are anticipated. Future patents may involve even more precise engineering of albumin for improved binding to FcRn or for use in targeted drug delivery systems.

- Integration with Other Modalities: As emerging therapeutic areas such as gene therapy, cell therapy, and personalized medicine advance, albumin’s role as a delivery vehicle may expand. New patents might focus on conjugating albumin with nucleic acids, nanoparticles, or even CRISPR-based delivery systems, thereby diversifying its applications.

- Advanced Manufacturing and Formulation Methods: Patent filings like those for albumin nanoparticles suggest that innovations in the manufacturing process are key. Future developments may lead to more stable, scalable, and reproducible methods for producing albumin-based formulations, thereby lowering costs and expanding accessibility.

- Broader Geographic Strategies: As demonstrated by ABLYNX NV’s comprehensive international filing and similar strategies by other key holders, future patents are likely to be even more globally oriented in order to capture emerging markets in Asia, Latin America, and other regions where demand for advanced biopharmaceuticals is growing.

- Collaborative and Licensing Activities: The trend toward licensing, as highlighted in reports from companies like Werewolf Therapeutics, highlights how inter-company collaborations will remain central. Such models encourage further innovation by allowing new players to access protected albumin binding technologies, thereby stimulating the overall ecosystem for albumin-based therapeutics.

Conclusion

In summary, the question “Who holds the patent for Albumin?” does not have a single answer because the patent landscape is multifaceted. Numerous patents address the various aspects of albumin—from its application as a drug carrier to the engineering of albumin variants with improved properties. Key patent holders in this field include National Nano Science Center, Fudan University Affiliated Huashan Hospital, Tsinghua University, and ABLYNX NV, among others. These organizations have secured patents that cover diverse facets such as albumin nanocomposite structures, albumin nano microspheres and nanoparticles, as well as innovative binder domains designed to improve the pharmacokinetics of therapeutics.

The scope of these patents spans method claims, composition claims, and process technology, with protection strategies deployed across many regions worldwide including the United States, Europe, China, and other key markets. The diversity in patent types and the broad geographic filing strategies underscore the high commercial value of albumin-based technologies in both medicine and biotechnology.

Looking ahead, as R&D intensifies, further innovations are expected in albumin engineering and its integration with novel therapeutic modalities. This will likely lead to an even more complex patent landscape, with enhanced variants, innovative delivery systems, and global collaborations driving new patent filings. Ultimately, the continued evolution of albumin-based technologies will have a significant impact on the development of next-generation therapeutics, ensuring sustained interest from both academic and industrial sectors.

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