United States Patent 10,456,354: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 10,456,354, issued on October 29, 2019, pertains to stable, ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate. This patent is assigned to SLAYBACK PHARMA LLC and was invented by Rahul Dhulaji Bhise, Ajay Kumar Singh, Mahadeo Vasant Mahadik, and Ashish Anilrao Dubewar, among others[4].
Key Components of the Patent
Active Ingredients
The patent focuses on compositions that include neostigmine and glycopyrrolate, which are used to reverse the effects of non-depolarizing neuromuscular blocking agents. Specifically, the preferred composition includes neostigmine methylsulfate and glycopyrronium bromide[4].
Stabilizing Agents
The composition also includes a stabilizing amount of one or more aminopolycarboxylic acids, such as ethylenediaminetetraacetic acid (EDTA), which helps maintain the stability of the active ingredients[4].
Pharmaceutical Vehicle
The patent specifies that the composition is formulated in a pharmaceutically acceptable liquid vehicle, suitable for intravenous administration. This is typically provided in a pre-filled, ready-to-use sealed container, such as a pre-filled syringe[4].
Scope of the Patent Claims
Claim Coverage
The patent claims cover the specific combination of neostigmine and glycopyrrolate, along with the stabilizing agents and the pharmaceutical vehicle. These claims are designed to protect the proprietary formulation and the method of preparing and using these compositions[4].
Methods of Preparation
The patent includes claims related to the methods of making these compositions. This ensures that the process of formulation, including the addition of stabilizing agents and the preparation of the liquid vehicle, is protected under the patent[4].
Methods of Use
The claims also extend to the methods of using these compositions for reversing the effects of non-depolarizing neuromuscular blocking agents. This is crucial for ensuring that the clinical application of the invention is fully protected[4].
Patent Landscape and Exclusivity
Patent Expiration
The patent is set to expire on October 25, 2038, which is 20 years from the date of filing. This period of exclusivity allows the patent holder to have sole rights to manufacture, market, and sell the patented composition without competition from generic versions[4].
Drug Exclusivity
In addition to patent protection, the FDA may grant exclusivity periods that can run concurrently with the patent. However, for this specific patent, the primary protection comes from the patent itself rather than FDA exclusivity[4].
Challenges in Patent Protection
Genus Claims and Enablement
The pharmaceutical industry often faces challenges with genus claims, which involve claiming a broad class of compounds rather than specific embodiments. The Federal Circuit's rigid stance on genus claims under 35 U.S.C. ยง 112(a) requires that the specification must include a written description that enables any person skilled in the art to make and use the claimed invention. This can be particularly challenging for pharmaceuticals, where the scope of the claim must be balanced between being broad enough to protect the invention and narrow enough to avoid invalidation due to lack of enablement[3].
Designing Around Claims
One of the significant challenges in drafting patent claims is ensuring they are not too narrow, which could allow competitors to design around them with minor modifications. Conversely, claims that are too broad may not meet the enablement and written description requirements, leading to potential invalidation[3].
Practical Implications
Clinical Use
The ready-to-use injectable compositions covered by this patent are crucial in clinical settings for quickly and effectively reversing neuromuscular blockade. The stability and convenience of these compositions make them valuable in emergency and surgical procedures[4].
Market Impact
The exclusivity provided by this patent allows SLAYBACK PHARMA LLC to maintain a competitive edge in the market for neuromuscular blocking agent reversal agents. This exclusivity period is critical for recouping the significant investment required to develop and bring such pharmaceuticals to market[3].
Key Takeaways
- Stable Compositions: The patent protects stable, ready-to-use injectable compositions of neostigmine and glycopyrrolate.
- Stabilizing Agents: The use of aminopolycarboxylic acids like EDTA is crucial for maintaining stability.
- Clinical Application: These compositions are used to reverse non-depolarizing neuromuscular blocking agents.
- Patent Exclusivity: The patent expires on October 25, 2038, providing 20 years of exclusivity.
- Challenges in Patent Protection: The patent landscape in pharmaceuticals is complex, with challenges related to genus claims and enablement.
FAQs
What are the primary active ingredients in the compositions protected by this patent?
The primary active ingredients are neostigmine and glycopyrrolate, specifically neostigmine methylsulfate and glycopyrronium bromide[4].
What is the role of EDTA in the patented compositions?
EDTA serves as a stabilizing agent to maintain the stability of the active ingredients in the composition[4].
How are the compositions administered?
The compositions are administered intravenously, typically via a pre-filled syringe[4].
What is the significance of the patent expiration date?
The patent expires on October 25, 2038, marking the end of the 20-year exclusivity period granted to the patent holder[4].
Why is the balance between broad and narrow claims important in pharmaceutical patents?
A balance is necessary to ensure the claims are broad enough to protect the invention but not so broad that they fail to meet the enablement and written description requirements, which could lead to invalidation[3].
Sources
- US10456354B1 - Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate - Google Patents
- Generic Prevduo Availability - Drugs.com
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Methods of administration of glycopyrrolate compositions - Google Patents
