United States Patent 9,827,191: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 9,827,191, titled "Compositions and methods for ophthalmic and/or other applications," was issued on November 28, 2017. This patent is part of a broader series of inventions related to the development of compositions and methods that facilitate the efficient transport of pharmaceutical agents through mucus barriers in the body.
Inventors and Assignees
The patent was invented by a team of researchers including Alexey Popov, Elizabeth M. Enlow, Hongming Chen, and James Bourassa, among others. The assignee for this patent is The Johns Hopkins University, reflecting the academic and research origins of the invention[2][5].
Patent Scope and Claims
Composition and Methods
The patent describes compositions and methods designed to overcome the challenges posed by mucus barriers in delivering pharmaceutical agents. These compositions typically involve the use of nanocrystals, microcapsules, or nanoparticles that are engineered to penetrate and traverse mucus layers efficiently. The methods outlined include the preparation and application of these compositions for ophthalmic and other medical uses[1][5].
Key Components
- Nanocrystals and Nanoparticles: The patent details the use of nanocrystals and nanoparticles as key components for enhancing the transport of pharmaceutical agents through mucus. These particles are often coated with specific materials to improve their mucus-penetrating capabilities[1][5].
- Microcapsules and Microparticles: The invention also includes microcapsules and microparticles surrounded by distinct coating layers. These coatings can be made from various organic macromolecular compounds, such as polyethylene glycol or poly(lactide-co-glycolide)[1].
Applications
The patent covers a wide range of applications, primarily focusing on ophthalmic uses but also extending to other medical fields. For example:
- Ophthalmic Applications: The compositions are particularly useful for treating conditions such as allergic conjunctivitis and post-surgical inflammation and pain in the eye. Drugs like loteprednol etabonate, which is used to treat allergic reactions and post-surgical inflammation, could benefit from these delivery methods[4].
- Other Medical Applications: The technology is not limited to ophthalmic use and can be adapted for other medical applications where mucus barriers hinder drug delivery.
Patent Claims
Specific Claims
The patent includes several specific claims that define the scope of the invention:
- Claim 1: This claim typically describes the composition comprising particles of a pharmaceutical agent and a mucus-penetrating coating.
- Claim 2: This might include methods for preparing these compositions, such as the process of coating the particles.
- Claim 3: This could involve the application of these compositions in ophthalmic or other medical contexts[1].
Genus Claims
The patent also includes genus claims, which are broader and cover a class of items rather than specific embodiments. These claims are critical in capturing the full scope of the invention but must be supported by a detailed written description to satisfy the enablement and written description requirements under 35 U.S.C. § 112(a)[3].
Patent Landscape
Related Patents
The patent is part of a series of related patents issued to The Johns Hopkins University, all focusing on similar technologies:
- Patent 9,056,057: Issued on June 16, 2015, this patent also deals with nanocrystals and methods that aid particle transport in mucus.
- Patent 9,737,491: Issued on August 22, 2017, this patent covers similar compositions and methods.
- Patent 10,058,511: Issued on August 28, 2018, this patent continues the development of these technologies[2][5].
Expiration Dates
The patent is set to expire on May 3, 2033, which is consistent with the expiration dates of other related patents in this series[2][5].
Legal and Regulatory Considerations
Enablement and Written Description
The patent claims must comply with the enablement and written description requirements of 35 U.S.C. § 112(a). This means the specification must provide a clear, concise, and exact description of the invention and how to make and use it, enabling any person skilled in the art to replicate the invention[3].
Jurisprudence Impact
The current jurisprudence on genus claims, as interpreted by the Federal Circuit, has significant implications for pharmaceutical and biotechnology patents. The rigid approach to genus claims can make it challenging for innovators to claim the full scope of their inventions without violating the enablement and written description requirements[3].
Practical Implications
Drug Delivery
The compositions and methods described in this patent have the potential to significantly improve drug delivery in ophthalmic and other medical applications. By enhancing the ability of pharmaceutical agents to penetrate mucus barriers, these technologies can increase the efficacy of treatments and improve patient outcomes.
Competitive Landscape
The absence of generic versions for drugs like Inveltys and Eysuvis, which could potentially benefit from these delivery methods, highlights the competitive advantage that patented technologies like those described in US 9,827,191 can provide[2][5].
Key Takeaways
- Innovative Drug Delivery: The patent introduces novel compositions and methods for enhancing drug delivery through mucus barriers.
- Broad Applications: The technology is applicable in ophthalmic and other medical fields.
- Legal Considerations: The patent must comply with strict legal requirements regarding enablement and written description.
- Competitive Advantage: The patented technologies provide a significant competitive edge in the pharmaceutical and biotechnology industries.
- Expiration Dates: The patent is set to expire on May 3, 2033, along with related patents.
FAQs
What is the primary focus of United States Patent 9,827,191?
The primary focus is on compositions and methods that facilitate the efficient transport of pharmaceutical agents through mucus barriers, particularly for ophthalmic applications.
Who are the inventors and assignees of this patent?
The inventors include Alexey Popov, Elizabeth M. Enlow, Hongming Chen, and James Bourassa, among others. The assignee is The Johns Hopkins University.
What are the key components of the compositions described in the patent?
The key components include nanocrystals, nanoparticles, microcapsules, and microparticles coated with specific materials to enhance mucus penetration.
What are the implications of this patent for drug delivery?
The patent has the potential to significantly improve drug delivery by enhancing the ability of pharmaceutical agents to penetrate mucus barriers, thus increasing treatment efficacy.
When is the patent set to expire?
The patent is set to expire on May 3, 2033.
How does the current jurisprudence on genus claims affect this patent?
The current rigid approach to genus claims can make it challenging for innovators to claim the full scope of their inventions without violating the enablement and written description requirements.
Sources
- US Patent 9,827,191: Compositions and methods for ophthalmic and/or other applications.
- Drugs.com: Generic Inveltys Availability.
- DigitalCommons@NYLS: Eviscerating Patent Scope.
- DrugBank: Loteprednol etabonate.
- Drugs.com: Generic Eysuvis Availability.
