Who holds the patent for Goserelin?
Introduction to Goserelin
Definition and Uses
Goserelin is a synthetic decapeptide and a gonadotropin-releasing hormone (GnRH) agonist that is primarily used in the treatment of hormone-responsive cancers, such as prostate cancer in men and breast cancer in premenopausal women, as well as in conditions like endometriosis and uterine fibroids. Due to its pharmacological action, it is effective in suppressing the secretion of sex hormones, which is critical in managing these conditions. The molecule works through a reversible downregulation of the GnRH receptors when administered in controlled-release formulations, leading to a dramatic reduction in circulating estrogen and testosterone levels.
Overview of Goserelin in Medical Treatment
In medical practice, goserelin is administered either as an implant or in a depot formulation; these applications ensure a continuous delivery over a period that may vary between one to several months depending on the therapeutic regimen. Its role in treating hormone-dependent conditions leverages its ability to effectively reduce the hormonal drive that fuels disease progression, making it a vital therapeutic agent in oncology and gynecology. Moreover, various novel formulations, including sustained-release microspheres and implant preparations, have been developed to optimize its delivery, improve patient compliance, and enhance treatment outcomes.
Patent Information on Goserelin
Current Patent Holder
Goserelin has been the subject of extensive intellectual property protection, with several patents issued covering its synthesis, formulation, and delivery systems. It is important to note that there is no single patent encapsulating all aspects of goserelin; rather, multiple patents are held by different entities for various components of the development and manufacture of the drug.
One of the key patents related to the synthetic process of goserelin is Patent CN106589072B a synthetic method specifically designed to improve yield and purity through a series of solid-phase and liquid-phase synthesis steps. This particular patent is assigned to Sinopep-Allsino Bio Pharmaceutical. In addition to this, another patent describing a fragment method synthesis for goserelin, Patent CN111233980B, Nanjing Liwei Biomedical, emphasizing a method that shortens synthesis time and enables high-yield, cost-effective industrial-scale preparation. Furthermore, Chinese Peptide holds a patent, CN108383896B,relates to a fragment method for synthesizing goserelin with notable improvements in purity and production efficiency.
Thus, when asked “Who holds the patent for Goserelin?”, it becomes clear that the intellectual property landscape for goserelin is segmented. While Sinopep-Allsino Bio Pharmaceutical holds a critical patent for its synthetic procedure, other aspects of its production are protected by patents held by Nanjing Liwei Biomedical and Chinese Peptide. Additionally, other patents relate to specific formulations and delivery technologies, such as sustained-release microspheres, which are held by companies like SHANDONG LUYE PHARMACEUTICAL CO. LTD and Beijing Bo'Ente Pharmaceutical, among others.
Patent Details and Scope
The scope of these patents can be analyzed from several perspectives:
1. Synthetic Methods:
- Patent CN106589072B delineates a robust synthetic method for goserelin. The strategy involves a sequence of five pentapeptides synthesized via solid-phase methods, followed by convergence via liquid-phase coupling, resulting in a goserelin crude product that is of high yield and purity. This method does not require catalytic reduction and is well-suited for industrial production.
- Patent CN111233980B similarly covers a fragment method that leverages both solid-phase and liquid-phase synthesis. It emphasizes the ease of synthesis and high purity of individual fragments and ultimately of the final goserelin formulation, thereby reducing production time and cost.
- Patent CN108383896B also focuses on a fragment synthesis method where key fragments, once synthesized separately, are coupled under optimal conditions to yield pure goserelin. The process underlines simplicity, cost-effectiveness, and scalability.
2. Formulation Technologies:
- Several patents focus on the formulation aspects of goserelin, including its sustained-release properties. For instance, Patent IN413889B by Shandong Luye Pharmaceutical discusses the development of goserelin sustained-release microspheres that maximize bioavailability while achieving entrapment efficiencies over 90%.
- Patent CN109394705B, held by Shenyang Pharmaceutical University, a freeze-dried powder form of goserelin sustained-release microspheres. This invention relies on a dual-layer release system (a temperature-sensitive gel core within a biodegradable shell), which ensures a controlled goserelin release profile.
- Another formulation-related patent, CN114209807A, by Anggu Pharmaceutical, addresses a goserelin implant preparation that provides a long-acting sustained-release effect with low solvent residues and a smooth drug release curve.
- Patent CN114569564B, from Zhejiang Sundoc Pharmaceutical, details the composition and manufacturing of goserelin sustained-release microsphere compositions, aiming for improved drug encapsulation and safety by reducing auxiliary materials.
3. Equipment and Analytical Methods:
- Beyond the core synthesis and formulation patents, there are patents that cover specialized production equipment for goserelin implant manufacturing. Patent CN114367229A, held by Anggu Pharmaceutical, describes production equipment specifically designed for goserelin implants, addressing aspects like the stirring mechanism, positioning, and material handling used during production.
- Additionally, analytical methods such as those for measuring the dissolution rate of goserelin acetate sustained-release implants have been patented. For instance, Patent CN110954491B by Beijing Bo'Ente Pharmaceutical covers a method for in vitro dissolution rate measurement that aids in rapid evaluation of drug release characteristics. Patent CN113945535B by Zhejiang Peptites Biotech provides a similar method to accelerate evaluation and ensure consistent quality control.
These patents, collectively, provide a multifaceted protection strategy that covers almost every aspect of goserelin—from its initial synthesis and fragment assembly to the final formulation and production methodologies. The variety of patents reflects the complexity of the therapeutic product and the strategic importance of securing intellectual property rights across different stages of its development and commercialization.
Legal and Commercial Implications
Impact of Patent on Market
The intellectual property (IP) rights surrounding goserelin play a pivotal role in its market exclusivity and commercial success. Given that multiple patents cover different aspects of goserelin, the market benefits from a robust protection strategy that discourages generic competition during the active period of these patents. This multipronged IP protection ensures that various elements—from synthesis to sustained-release formulation—are shielded, thereby providing the patent holders with significant leverage in pricing and market positioning.
When patents such as those held by Sinopep-Allsino Bio Pharmaceutical, Nanjing Liwei Biomedical, and Chinese Peptide are in force, generic competitors are restricted from employing the same processes or replicating the exact formulations. This, in turn, prolongs the period during which the original manufacturers can recover their investment in research and development (R&D) and enjoy higher profit margins. Additionally, patents on advanced formulations, such as sustained-release systems, offer extended protection by differentiating the product's performance and therapeutic efficacy, ultimately influencing prescribing practices among clinicians.
Licensing and Legal Considerations
The complexity of the goserelin patent landscape also gives rise to several legal and licensing considerations. Given that different companies hold patents for different processes or product innovations, there may be cross-licensing agreements or collaborative arrangements in certain markets. For example, a company seeking to manufacture a generic version of goserelin may need to navigate not only the core synthesis patents but also those associated with specific delivery mechanisms like implants or microsphere formulations.
The breadth of the patent protection necessitates comprehensive freedom-to-operate analyses before any generic or follow-on product is introduced into the market. Companies must ensure that their manufacturing processes and formulations do not infringe upon any active patents, which might otherwise result in costly litigation or injunctions. In some instances, generic manufacturers might secure compulsory licenses or enter into licensing agreements with the patent holders in exchange for royalties, as seen in other sectors of the pharmaceutical industry. Licensing terms and collaborative strategies become critical tools for mitigating legal risks while ensuring that innovative processes are appropriately licensed and maintained under patent law.
Future Prospects and Developments
Patent Expiry and Generic Drugs
The expiry of patents is a critical milestone in the life cycle of any pharmaceutical product, including goserelin. Each of the patents mentioned above has a distinct expiry date, and once the core patents expire, it opens the door for generic manufacturers to enter the market with follow-on products. This can lead to a significant decrease in the price of the drug, increased market competition, and ultimately, improved accessibility for patients.
For instance, once the synthetic process patent CN106589072B or any formulation-related patent expires, generic manufacturers can potentially develop biosimilars or generics that are therapeutically equivalent to goserelin. This dynamic was observed in other drug markets, where post-patent competition contributed not only to lower prices but also to increased investment in next-generation formulations and improved drug delivery systems. Manufacturers may also explore strategies such as obtaining new dosage patents, which extend the market exclusivity of the therapeutic antibody beyond the expiry of the original compound patent.
Research and Development Directions
Moving forward, research and development in goserelin is likely to focus on optimizing its formulation for improved patient outcomes and enhanced therapeutic efficacy. The current patent portfolio illustrates several areas of R&D interest, including novel synthesis methods that reduce production costs, advanced sustained-release delivery systems that ensure smooth and prolonged drug release, and innovative implant technologies that simplify administration and improve patient compliance.
The continued evolution of analytical methodologies, such as in vitro dissolution rate measurement techniques (as seen in patents CN110954491B and CN113945535B), will be crucial for ensuring that new formulations meet rigorous quality standards and regulatory requirements. Additionally, the potential repurposing of goserelin for alternative indications, such as its novel use for treating virus-related conditions as explored by SANSKRITI UNIVERSITY, presents further avenues for R&D investment. These multifaceted research directions ensure that, despite the eventual expiry of some patents, the overall intellectual property ecosystem remains dynamic and conducive to continuous innovation.
Moreover, the ongoing competition between generic manufacturers and brand-name companies will drive further technological advancements, as companies might invest in developing improved formulations that offer tangible benefits over the original product. This includes better bioavailability, reduced side effects, and more patient-friendly dosing regimens. As the generic versions enter the market, incumbent companies holding earlier patents may need to innovate rapidly to maintain their market share and continue to justify premium pricing.
Conclusion
In summary, the intellectual property landscape for goserelin is characterized by a diversified array of patents held by multiple companies. The synthetic method for goserelin is prominently protected by Patent CN106589072B, held by Sinopep-Allsino Bio Pharmaceutical. Complementary patents addressing fragment synthesis methods are held by Nanjing Liwei Biomedical with Patent CN111233980B and by Chinese Peptide with Patent CN108383896B. Furthermore, various patents related to sustained-release formulations and implant technologies are distributed among other entities such as SHANDONG LUYE PHARMACEUTICAL CO. LTD and Beijing Bo'Ente Pharmaceutical, which highlight the extensive nature of patent protection in this area.
From a market and legal standpoint, the robust patent protection underpins a competitive commercial landscape by securing market exclusivity, supporting the recovery of R&D investments, and setting the stage for strategic licensing and collaborative agreements. The expiry of these patents is anticipated to usher in a new era of generic competition, which will enhance drug accessibility and potentially lower prices, while also stimulating further innovation in drug formulation and delivery systems.
In conclusion, there is no single holder of the patent for goserelin; instead, the IP rights are distributed among several companies, each safeguarding different aspects of the drug’s synthesis, formulation, and product delivery. This diversified patent profile not only reflects the complexity and multi-dimensionality of goserelin as a therapeutic agent but also underscores the dynamic interplay of science, technology, and law in the biopharmaceutical field. The continuous evolution of both patent strategies and formulation technologies will ensure that goserelin remains at the forefront of therapeutic innovation while balancing the interests of innovation with broader public health considerations.
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