Who holds the patent for Paclitaxel Protein Bound?
Introduction to Paclitaxel Protein Bound
Definition and Mechanism of Action
Paclitaxel Protein Bound refers to a formulation of the anticancer drug paclitaxel in which the hydrophobic drug is associated with a carrier protein, typically albumin. This approach overcomes paclitaxel’s poor water solubility by allowing albumin to stabilize and solubilize the drug as it circulates in the bloodstream. The protein-bound formulation leverages albumin’s natural transport properties and receptor-mediated uptake by tumor cells, which enhances drug delivery while reducing the toxicity associated with conventional solvents. As a result, the aggregation of paclitaxel with albumin leads to a safer and more efficient therapy against various cancers by promoting a more targeted accumulation in the tumor and an enhanced pharmacokinetic profile.
Clinical Uses and Benefits
Clinically, paclitaxel protein-bound formulations have been indicated for the treatment of several cancers including metastatic breast cancer, non-small-cell lung cancer (NSCLC), and pancreatic adenocarcinoma. The albumin-bound format improves drug distribution, minimizes adverse side effects, and enables a shorter infusion schedule. In comparison to conventional paclitaxel formulations, the protein-bound version has demonstrated improved tolerability as well as better penetration into solid tumors, thereby offering significant benefits in patient management and therapeutic outcomes.
Patent Landscape
Overview of Patent System in Pharmaceuticals
The patent system in the pharmaceutical industry is designed to protect the significant research and development investments behind new drug innovations. Patents grant the innovators market exclusivity for a predetermined period, allowing them to recoup R&D costs and generate revenues without immediate competition. Over time, as multiple patents can be filed on various aspects of a drug—ranging from formulation techniques to manufacturing processes and even diagnostic methods—the landscape becomes complex, with overlapping claims and a dynamic interplay between originator companies and generic competitors.
Historically, the evolution of patent protection has driven the progression of more refined drug delivery systems. With the introduction of formulations such as paclitaxel protein bound, companies have filed patents not only covering the drug compound but also the methods of its formulation, the composition of the nanomedicines that carry it, and the techniques used in its administration. This has opened up an environment where multiple patents by different assignees may coexist, each covering a unique aspect of the overall treatment modality.
Historical Patents and Developments
Since the original discovery and development of paclitaxel, various patents have been filed to cover improvements and new formulations. Early efforts focused on overcoming the hydrophobicity of paclitaxel through the use of solubilizing agents and formulation techniques. As research advanced, the concept of binding paclitaxel to serum albumin emerged, leading to the development of albumin-bound paclitaxel formulations.
For example, patents describe nanomedicine approaches that involve loading paclitaxel onto copper-doped layered double hydroxide matrices or stabilizing suspended particles with proteins. Over time, these innovations were refined to produce more uniform nanoparticles with optimal dimensions (around 100 nm), enhanced stability, and superior drug delivery characteristics. Such developments represent significant advancements in enabling a drug’s effective clinical use while mitigating side effects and improving overall treatment efficacy.
Current Patent Holders
Identification of Patent Holders
The patent landscape for paclitaxel protein-bound formulations is notably complex due to the multiple aspects covered by different patents. There are several patent holders globally who have contributed to various aspects of this technology. Key players include:
- ABRAXIS BIOSCIENCE, LLC
Patents focus on methods of treating cancer (e.g., NSCLC, prostate cancer) by administering nanoparticles comprising paclitaxel bound with albumin. These patents clearly designate ABRAXIS BIOSCIENCE, LLC as the current assignee. This set of patents underscores their pioneering work in the development of what many know commercially as an albumin-bound paclitaxel formulation (often represented by the brand name Abraxane). The strategic approach adopted in these patents leverages the unique properties of albumin to enhance paclitaxel’s solubility and tumor-targeting ability.
- AbraCos Biosciences Co., Ltd.
Other patents describe the creation of nanoparticle formulations that include a hydrophobic drug (such as paclitaxel), an albumin, and a bioactive polypeptide as components. These patents indicate that AbraCos Biosciences is actively involved in the development and protection of nanoparticle-based delivery systems which involve protein binding. The patents hold significant promise in bringing forward diversification in the design of protein-bound paclitaxel formulations.
- Chengdu Peilong Biomedical Technology Co., Ltd.
Patent related to “Albumin-bound paclitaxel sustained release preparation and preparation method thereof” is attributed to Chengdu Peilong Biomedical Technology. This patent focuses on achieving sustained release of paclitaxel from albumin-bound formulations using specific carriers, such as medicinal-grade chitosan, to enhance release stability and prolong therapeutic effect. This strategic improvement demonstrates how formulation innovations can further modify the clinical profile and safety of the drug.
- Sichuan Huiyu Pharmaceutical Co., Ltd. and Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd.
Patent, “Preparation method of albumin-bound paclitaxel nanoparticles,” lists these two companies as the current assignees. Their patented methods provide streamlined approaches for producing albumin-bound paclitaxel nanoparticles, where the process parameters (e.g., temperature, solvent selection, mixing conditions) are optimized to reduce production cost and time while ensuring consistent product quality. Such innovations bolster manufacturing efficiency and offer an alternative pathway for large-scale production.
- Other Patent Holders in China
Additionally, a patent filed by The First Affiliated Hospital of the Hainan Medical College and Hainan Affiliated Hospital of Hainan Medical University details a nanomedicine formulation incorporating albumin-bound paclitaxel for breast cancer treatment. This indicates that academic and clinical institutions in China are also active in patenting novel drug delivery concepts that involve albumin binding.
Details of Patent Claims
The primary claims encompassed in these patents range from the specific formulation strategies—doping metal hydroxides and coating with serum albumin—to the clinical application methods such as targeted delivery coupled with light irradiation for tumor ablation. In the case of ABRAXIS BIOSCIENCE, LLC’s patents, the claims are centered on the combination of paclitaxel and albumin forming nanoparticles that can be co-administered with platinum-based agents for enhanced treatment of solid tumors. The claims of these patents are significant not only for their therapeutic implications but also for the manufacturing processes that ensure the uniformity and stability of the nanoscale particles.
Similarly, the patents by AbraCos Biosciences emphasize innovative compositions that integrate hydrophobic drugs, albumin, and bioactive polypeptides into stable nanoparticle suspensions without conventional surfactants. The uniqueness of these compositions is claimed by the combined use of high-shear methods and specific solvent ratios, which has been an essential breakthrough in the production method.
The patents held by Chengdu Peilong Biomedical Technology further distinguish themselves by focusing on sustained release mechanisms, employing carriers such as chitosan gels to modulate drug release kinetics. This provides a balance of efficacy and safety over an extended period following administration.
Moreover, the production method patented by Sichuan Huiyu Pharmaceutical Co., Ltd. and Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd. illustrates a simplified route for forming albumin-bound paclitaxel nanoparticles. Their claims elaborate on a precise method involving the heating of the albumin aqueous phase, the mixing of the paclitaxel organic solution with this phase, and subsequent steps like emulsification, filtration, and freeze-drying. This not only shortens the production time but also ensures cost-effective manufacturing, which is critical for commercial viability.
Implications of Patent Ownership
Impact on Market Competition
The attribution of these patents to different entities has several implications for market competition. From a competitive intelligence standpoint, the fact that ABRAXIS BIOSCIENCE, LLC holds key patents on paclitaxel protein-bound formulations in the United States provides a strong market exclusivity edge. Such exclusivity not only deters immediate generic competition in the U.S. market but also establishes a benchmark for safety and efficacy that competitors must meet before entering the market with alternative formulations.
On the other hand, the presence of multiple patents held by various Chinese entities indicates a robust domestic focus on innovation in drug delivery systems within the Chinese market. These companies are positioning themselves not only against international players but also in anticipation of broader market needs as production capacities and regulatory frameworks evolve in emerging markets.
This multi-patent scenario underscores a decentralization of technological authority where different aspects of the formulation (from sustained release to manufacturing process efficiency) are protected by various stakeholders. As a result, market competition in the albumin-bound paclitaxel segment is influenced by the overlapped patent territories, which can lead to both cooperative licensing arrangements and contentious patent disputes.
Influence on Drug Pricing and Accessibility
Patent protection typically enables the patent-holding companies to keep prices elevated during the period of exclusivity, as they have the legal authority to prevent competitors from producing cheaper generic versions. For a drug like paclitaxel protein-bound, which offers significant improvements in terms of safety and efficacy, this patent-induced exclusivity often translates into higher drug prices due to limited competition. However, as seen in multiple studies, the eventual entry of generics—post-patent expiry—can lead to steep price reductions and significantly improved drug accessibility.
For instance, the patents held by ABRAXIS BIOSCIENCE, LLC provide market exclusivity that allows them to command premium pricing, which is a common occurrence in pharmaceutical products with novel delivery systems. Conversely, once patents expire or if challenges to patent validity arise, the price can drop dramatically due to generic competition. In markets where multiple patent holders protect different aspects of the formulation, the landscape becomes even more nuanced, with price competition emerging from various fronts. Thus, the influence of patent ownership on drug pricing is twofold: it ensures initial market protection and high pricing, but also sets the stage for eventual price declines when the exclusivity wanes.
Future Considerations
Patent Expiry and Generic Entry
Looking ahead, the expiration of these patents is a critical factor that will reshape the competitive dynamics. Patent cliffs are a well-documented phenomenon within the pharmaceutical industry, where the loss of market exclusivity is associated with substantial revenue declines for innovator companies. For paclitaxel protein-bound formulations, the timing of patent expiry will be decisive. In regions where key patents held by ABRAXIS BIOSCIENCE, LLC and other significant entities expire, generic manufacturers may swiftly enter the market by introducing biosimilar products that replicate the albumin-bound technology. This would not only reduce the cost of treatment but also force the original patent holders to innovate further or engage in strategic licensing deals to sustain their market position.
Innovations and New Formulations
In anticipation of patent expiry and increasing generic competition, many companies are already investing in next-generation innovations and alternative formulations. The current patent holders, including ABRAXIS BIOSCIENCE, LLC, AbraCos Biosciences, and the Chinese entities mentioned earlier, are exploring improvements such as sustained release formulations, methods for improving particle size uniformity, and novel nanomedicine strategies to further enhance the therapeutic index of paclitaxel. These innovations not only extend the life-cycle of the original product but also create opportunities for new patents that define separate technological territories, thereby maintaining a competitive edge despite impending generic challenges.
Additionally, collaborations between pharmaceutical companies, biotechnology firms, and academic institutions are increasingly common. Such partnerships are key to developing derivative products or combination therapies that incorporate paclitaxel protein-bound formulations with other therapeutic agents to address complex disease mechanisms more effectively. These strategic moves will likely lead to a continuous evolution in the patent landscape and further diversification of product portfolios across geographies.
Conclusion
In summary, the patent for paclitaxel protein bound is not held by a single entity but is instead part of a complex, multifaceted patent landscape. The consolidated evidence from the synapse-provided references reveals that several key players are active in protecting different aspects of this technology:
• In the United States, the principal patents covering methods of treatment using paclitaxel protein-bound nanoparticles are held by ABRAXIS BIOSCIENCE, LLC. This company’s patents protect the innovative methods of formulating and administering albumin-bound paclitaxel, which is widely recognized in the market under the Abraxane brand.
• In China, a number of entities contribute to the innovation and protection of this technology. The First Affiliated Hospital of the Hainan Medical College and Hainan Affiliated Hospital of Hainan Medical University have patented nanomedicine formulations that incorporate albumin-bound paclitaxel.AbraCos Biosciences has secured patents covering innovative nanoparticle formulations. Additionally, Chengdu Peilong Biomedical Technology and the combined forces of Sichuan Huiyu Pharmaceutical Co., Ltd. and Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd. hold patents focusing on sustained release and efficient production methods.
Each of these patents addresses specific aspects of the formulation, production, and clinical application of paclitaxel protein-bound products, contributing to the overall robustness of the patent portfolio in this therapeutic area. The existence of multiple patents across different jurisdictions underscores the importance of a diversified protection strategy in modern pharmaceuticals, where each patent may cover unique technical innovations ranging from composition and method of manufacturing to clinical administration protocols.
From a general perspective, such a diversified patent landscape secures a competitive advantage for the original formulators by ensuring sufficient market exclusivity. From a specific standpoint, the lead role played by ABRAXIS BIOSCIENCE, LLC in the US market, along with strong contributions from innovative Chinese entities, clearly delineate the key stakeholders in this arena. Finally, on a general note, the interplay of these patents will significantly impact market pricing, accessibility of paclitaxel protein-bound formulations, and the future evolution of anticancer therapies as patents expire and generic versions emerge.
For an experience with the large-scale biopharmaceutical model Hiro-LS, please click here for a quick and free trial of its features！
