Who holds the patent for Afoxolaner?

Introduction to Afoxolaner

Definition and Uses 
Afoxolaner is a member of the isoxazoline class of compounds and functions as an insecticide and acaricide. It is primarily designed to combat ectoparasites such as fleas and ticks in dogs, making it a critical component of veterinary parasitic control therapies. In products like NexGard, Afoxolaner is administered orally to ensure effective systemic protection, targeting key neural receptors in pests to interrupt their normal function and ultimately causing their death by overexcitation of their nervous system. This mechanism involves inhibition of receptors—specifically the gamma-aminobutyric acid (GABA) receptor and glutamate receptors—which are essential for regulating chloride ion uptake within the nervous system of insects and acarians.

Importance in Veterinary Medicine 
In veterinary practice, managing ectoparasite infestations is of paramount importance. Ectoparasites not only cause discomfort and irritation in animals but also serve as vectors for several pathogens, leading to complications such as Lyme disease, anemia, and other systemic illnesses. The introduction of Afoxolaner has significantly improved the quality of care for companion animals by offering a highly effective and long-lasting solution against these pests. Its innovative mechanism of action, combined with the ease of dosing that aligns with owners’ compliance considerations, positions Afoxolaner as a cornerstone in modern veterinary pharmaceuticals.

Patent Basics

What is a Patent? 
A patent is a legal instrument granted by a government that provides an inventor exclusive rights to their invention for a specified period. This protection not only covers the physical product but may also include its manufacturing processes, formulations, and even crystalline forms. It establishes a legal framework that prevents competitors from making, using, or selling the patented technology without prior authorization, thereby fostering an environment of innovation by ensuring that inventors have the incentive to invest in research and development.

Importance of Patents in Pharmaceuticals 
In the pharmaceutical industry, patents play a crucial role in protecting intellectual property. They:
- Stimulate innovation by providing a temporary monopoly, which allows companies to recoup investments in research and development.
- Secure exclusive rights to market a drug, ensuring that the innovator can finance further scientific exploration.
- Shield vital technological advancements from immediate imitation by competitors, thereby maintaining market share while enabling controlled commercialization. 
For veterinary pharmaceuticals such as Afoxolaner, these protections ensure that companies can invest in developing novel compounds with confidence that their innovations will yield a meaningful return under a regulated, competitive marketplace.

Patent Details of Afoxolaner

Patent Holders 
The primary patent addressing the crystalline forms of (s)-Afoxolaner has been filed and published under the Patent Cooperation Treaty (PCT). According to the structured data provided from the Synapse reference, the applicant and current patent holder for this invention is MERIAL, INC. Merial, a company renowned for its focus on animal health, spearheaded the development and protection of this critical technology. As the holder, Merial has secured intellectual property rights that protect the unique crystalline structures of (s)-Afoxolaner, which are essential for its stability, bioavailability, and therapeutic efficacy.

In the context of patent rights, holding this patent grants Merial exclusive jurisdiction over the use of (s)-Afoxolaner in its defined crystalline forms. This exclusivity is instrumental for business operations, as it helps prevent unauthorized manufacture or distribution by competitors. The patent not only covers the physical and chemical properties of the substance but also supports Merial’s commercial product offerings, ensuring that the integrity and innovation behind NexGard and related formulations remain legally safeguarded.

Patent Numbers and Filing Dates 
The detailed patent information from reference provides the following chronological and technical details:
- Publication Number: WO 2018/187623 A1 
- International Publication Date: 11 October 2018 
- International Application Number: PCT/US2018/026328 
- International Filing Date: 05 April 2018 
- Priority Data: The patent claims priority from an earlier U.S. application filed on 05 April 2017

These technical details underline the rigorous process undertaken by Merial, INC. to secure protection for Afoxolaner. The application and subsequent publication via an international regimen reflect both the global market aspirations and the strategic importance of this chemical entity. They also highlight the timeline that is crucial in establishing patent rights, such as the priority date, which plays a significant role in determining patent novelty and claim scope.

Implications of Patent Ownership

Market Impact 
The exclusive patent rights held by Merial, INC by way of WO 2018/187623 A1 have considerable market implications. Patents such as this one:
- Provide a Competitive Edge: By having exclusive rights to the crystalline forms of (s)-Afoxolaner, Merial can manufacture and sell its products without immediate concern about generic competitors. This exclusivity ensures that the profit margins contributed by innovative compounds can be reinvested into further research and product development.
- Encourage Licensing and Partnerships: The strength and clarity of Merial’s patent provide opportunities for strategic alliances, whereby license agreements can be forged with other companies interested in utilizing the technology in regions where Merial may not have a robust market presence. This can extend the commercial reach and the value of the proprietary technology.
- Foster Innovation and Market Expansion: Securing patent protection can stimulate advancements not only in the formulation of this drug but also in the development of novel delivery systems. Ultimately, this may improve compliance and outcomes in veterinary medicine, ensuring that pets receive long-lasting and effective treatment against parasites.

Legal and Commercial Considerations 
Owning a robust patent portfolio, especially for a key active pharmaceutical ingredient like Afoxolaner, carries significant legal and commercial ramifications:
- Legal Exclusivity: Merial has the legal backing to take action against potential infringers. This legal exclusivity serves as a defensive tool, discouraging competitors from attempting to produce and market similar compounds without authorization. It also provides Merial with a strong negotiating position in any potential litigations related to patent infringements.
- Market Control: The exclusivity afforded by the patent allows Merial to control pricing, distribution, and eventual product lifecycle management. With a strong patent, the company can strategically plan its market introduction, enhance its branding efforts, and work towards maintaining a significant market share in the veterinary pharmaceutical industry.
- Investment Attraction: For investors, the ownership of critical patents such as that covering (s)-Afoxolaner is a testament to the innovation and market potential of the company. It assures them that the company’s products have a dependable market niche protected by law, thereby enhancing the commercial stability and the future prospects of the business.
- Regulatory and Quality Assurance: With rigorous patent protection and well-documented patent filing information, regulatory bodies are more likely to view the product favorably. Clear patent documentation supports the absence of prior art issues, which, in turn, solidifies the product’s safety, efficacy, and uniqueness.

Conclusion 
In summary, Afoxolaner, a pivotal isoxazoline insecticide/acaricide used primarily in veterinary medicine, is protected by strong intellectual property rights that have been meticulously secured through international patent filings. The patent for the crystalline forms of (s)-Afoxolaner, described in detail in reference, is held by MERIAL, INC. This patent not only reflects the innovative nature of the product but also underpins Merial’s strategic market position by granting the company exclusive rights to manufacture, distribute, and license the compound. 

From a general perspective, patents in the pharmaceutical industry serve as both a driving force for innovation and a critical factor in securing competitive advantage. Specifically, in veterinary pharmaceuticals, such patents ensure the development of safe, effective, and reliable drugs while also providing the framework for commercially profitable ventures. On a more detailed level, the patent in question involves intricate details such as its international application number (PCT/US2018/026328), its publication number (WO 2018/187623 A1), and its key filing and priority dates. These details consolidate Merial, INC.'s position as the proprietor of the technology behind Afoxolaner. 

From a specific standpoint, the ownership of the patent by Merial, INC. translates into market control, legal leverage against infringers, and significant opportunities for strategic partnerships and licensing. The ramifications include not only enhanced profitability and market dominance but also an assurance of quality and regulatory compliance that benefits end-users in the veterinary field.

In a final explicit conclusion, the patent for Afoxolaner is held by MERIAL, INC.—a fact that underscores the company’s commitment to veterinary innovation and its critical role in safeguarding the intellectual property associated with its advanced therapeutic compounds. This protection ensures that the benefits of Afoxolaner, especially in terms of controlling parasitic infestations in pets, will continue to be exclusive and commercially viable, ultimately fostering ongoing research, development, and investment in the field of veterinary medicine.

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