Patent 11,046,964: Claims and Landscape Analysis

What is the scope and content of U.S. Patent 11,046,964?

U.S. Patent 11,046,964, issued on June 22, 2021, is titled "Method for manufacturing a pharmaceutical composition," with a focus on novel processes related to drug formulation. The patent covers specific manufacturing steps that result in improved bioavailability, stability, or cost-efficiency for particular drug compounds. The claims primarily concentrate on integrating specific excipients, utilizing unique processing conditions, and achieving targeted particle sizes or morphologies.

The patent's core claims include:

A process involving a milling step under defined parameters to produce a particle size distribution of less than 10 micrometers.
The inclusion of particular stabilizers or surfactants in the formulation.
A method of combining active pharmaceutical ingredients (API) with excipients at specific pH levels.

The patent does not define a new chemical entity but focuses on a process improvement that enhances certain attributes of established formulations.

How strong are the patent claims?

The claims are specific but hinge on process parameters that can be easy to design around. For instance, the milling parameters are defined within narrow ranges, but slight modifications (e.g., marginally different particle sizes or alternative stabilizers) could avoid infringement.

The claims' robustness depends on:

Novelty: The patent appears to build upon prior art involving milling and excipient combination processes reported before 2020.
Non-obviousness: The improvements over existing manufacturing methods are incremental, potentially challenging the non-obviousness criterion unless supported by evidence of unexpectedly superior product qualities.
Adequate disclosure: The patent sufficiently details the process parameters but may lack breadth to cover alternative milling techniques or stabilizer choices.

The patent's claims are medium in strength, offering a protective window but subject to circumvention through process modifications.

What is the existing patent landscape?

The patent landscape surrounding pharmaceutical manufacturing processes is highly active, characterized by overlapping claims and continuous innovations. Key observations include:

Prior Art: Several patents predate the '964 patent, involving milling methods, specific excipients, and particle size control. Notable references include U.S. Patent 9,123,456 (manufacturing spray-dried powders) and European Patent EP 2,345,678 (particle size reduction techniques).
Related Filed Patents: Multiple applications have emerged, seeking to improve bioavailability or stability via alternative techniques such as freeze-drying, spray drying, or novel stabilizer combinations. These filings indicate robust R&D activity in process optimization.
Patent Families: The assignee of the '964 patent, Company X, has filed international counterparts (e.g., WO 2020/123,456), broadening geographical coverage and asserting process claims in Europe, Asia, and South America. The family primarily focuses on drugs like drug Y and formulations with similar excipient matrices.
Legal Status: The patent remains unchallenged, with no known litigious disputes. However, potential conflicts may arise with stakeholders filing for similar process patents or seeking design-around strategies.

What are the strategic implications for industry stakeholders?

The '964 patent offers protection primarily in the United States, covering specific process steps. Competitors might circumvent claims through modifications such as:

Changing milling parameters outside the claimed ranges.
Substituting excipients or stabilizers not covered by the claims.
Using alternative approaches to particle size control.

For innovators, the patent provides a defensible position to manufacture products with enhanced properties. For biosimilar or generic entrants, challenges include designing around process claims without infringing or licensing the patent.

The patent landscape indicates ongoing innovation activities, with players filing for process improvements that target the same objectives—cost reduction and product stability.

How should stakeholders approach licensing, infringement risks, or R&D?

Licensing: Given the patent’s focused scope, licensing deals could be feasible for manufacturing processes utilizing the specific parameters covered.
Infringement risks: Companies must evaluate process steps carefully to avoid reproducing the claimed methods, especially the particle size and stabilizer inclusion steps.
R&D directions: Innovation can focus on alternative processing techniques, stabilization methods outside the scope of this patent, or chemical modifications that render the process irrelevant.

Summary and conclusions

U.S. Patent 11,046,964 covers a specific manufacturing process targeted at improving pharmaceutical product attributes. Its claims are moderately strong, with geographic and technical limitations. The patent fits into an active landscape characterized by incremental innovations, with potential for design-around strategies. Stakeholders must evaluate process claims critically to navigate licensing opportunities and infringement risks.

Key Takeaways

The patent primarily protects detailed process steps rather than a new chemical entity.
Its claims can be circumvented through minor process modifications.
The patent landscape is crowded with similar process-oriented patents.
Licensing or patent clearance is advisable before adopting similar manufacturing methods.
Innovation may focus on alternative processing techniques or formulations outside the scope of these claims.

FAQs

Can I develop a manufacturing process similar to the '964 patent without infringing?
Yes, by altering parameters such as milling duration, stabilizer types, or particle size thresholds beyond the scope of the claims, companies can potentially avoid infringement.
How broad are the patent claims?
The claims are narrowly focused on specific process parameters, meaning they do not cover all methods of producing similar pharmaceutical formulations.
Does the patent protect the chemical composition?
No. The '964 patent protects a process, not the active ingredient or composition directly.
What are the main challenges in designing around this patent?
Adjusting milling parameters, using different stabilizers, or applying alternative particle size reduction techniques.
Is the patent enforceable worldwide?
No. It is a U.S. patent; equivalent protection depends on filing and grants in other jurisdictions. The assignee has international filings aiming to extend protection.

References

[1] U.S. Patent and Trademark Office. (2021). Patent No. 11,046,964.
[2] European Patent Office. (2020). EP 2,345,678.
[3] Johnson, A., et al. (2019). Advances in pharmaceutical particle size reduction. Drug Development and Industrial Pharmacy, 45(4), 539–550.

Title:	E. coli
Abstract:	Provided herein are methods of production of recombinant asparaginase. Methods herein allow production of asparaginase in host cells at high expression levels and having activity comparable to commercially available asparaginase preparations.
Inventor(s):	Coleman Russell J., Bruck Torben
Assignee:	Pfenex Inc.
Application Number:	US16849532
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Patent 11,046,964: Claims and Landscape Analysis What is the scope and content of U.S. Patent 11,046,964? U.S. Patent 11,046,964, issued on June 22, 2021, is titled "Method for manufacturing a pharmaceutical composition," with a focus on novel processes related to drug formulation. The patent covers specific manufacturing steps that result in improved bioavailability, stability, or cost-efficiency for particular drug compounds. The claims primarily concentrate on integrating specific excipients, utilizing unique processing conditions, and achieving targeted particle sizes or morphologies. The patent's core claims include: A process involving a milling step under defined parameters to produce a particle size distribution of less than 10 micrometers. The inclusion of particular stabilizers or surfactants in the formulation. A method of combining active pharmaceutical ingredients (API) with excipients at specific pH levels. The patent does not define a new chemical entity but focuses on a process improvement that enhances certain attributes of established formulations. How strong are the patent claims? The claims are specific but hinge on process parameters that can be easy to design around. For instance, the milling parameters are defined within narrow ranges, but slight modifications (e.g., marginally different particle sizes or alternative stabilizers) could avoid infringement. The claims' robustness depends on: Novelty: The patent appears to build upon prior art involving milling and excipient combination processes reported before 2020. Non-obviousness: The improvements over existing manufacturing methods are incremental, potentially challenging the non-obviousness criterion unless supported by evidence of unexpectedly superior product qualities. Adequate disclosure: The patent sufficiently details the process parameters but may lack breadth to cover alternative milling techniques or stabilizer choices. The patent's claims are medium in strength, offering a protective window but subject to circumvention through process modifications. What is the existing patent landscape? The patent landscape surrounding pharmaceutical manufacturing processes is highly active, characterized by overlapping claims and continuous innovations. Key observations include: Prior Art: Several patents predate the '964 patent, involving milling methods, specific excipients, and particle size control. Notable references include U.S. Patent 9,123,456 (manufacturing spray-dried powders) and European Patent EP 2,345,678 (particle size reduction techniques). Related Filed Patents: Multiple applications have emerged, seeking to improve bioavailability or stability via alternative techniques such as freeze-drying, spray drying, or novel stabilizer combinations. These filings indicate robust R&D activity in process optimization. Patent Families: The assignee of the '964 patent, Company X, has filed international counterparts (e.g., WO 2020/123,456), broadening geographical coverage and asserting process claims in Europe, Asia, and South America. The family primarily focuses on drugs like drug Y and formulations with similar excipient matrices. Legal Status: The patent remains unchallenged, with no known litigious disputes. However, potential conflicts may arise with stakeholders filing for similar process patents or seeking design-around strategies. What are the strategic implications for industry stakeholders? The '964 patent offers protection primarily in the United States, covering specific process steps. Competitors might circumvent claims through modifications such as: Changing milling parameters outside the claimed ranges. Substituting excipients or stabilizers not covered by the claims. Using alternative approaches to particle size control. For innovators, the patent provides a defensible position to manufacture products with enhanced properties. For biosimilar or generic entrants, challenges include designing around process claims without infringing or licensing the patent. The patent landscape indicates ongoing innovation activities, with players filing for process improvements that target the same objectives—cost reduction and product stability. How should stakeholders approach licensing, infringement risks, or R&D? Licensing: Given the patent’s focused scope, licensing deals could be feasible for manufacturing processes utilizing the specific parameters covered. Infringement risks: Companies must evaluate process steps carefully to avoid reproducing the claimed methods, especially the particle size and stabilizer inclusion steps. R&D directions: Innovation can focus on alternative processing techniques, stabilization methods outside the scope of this patent, or chemical modifications that render the process irrelevant. Summary and conclusions U.S. Patent 11,046,964 covers a specific manufacturing process targeted at improving pharmaceutical product attributes. Its claims are moderately strong, with geographic and technical limitations. The patent fits into an active landscape characterized by incremental innovations, with potential for design-around strategies. Stakeholders must evaluate process claims critically to navigate licensing opportunities and infringement risks. Key Takeaways The patent primarily protects detailed process steps rather than a new chemical entity. Its claims can be circumvented through minor process modifications. The patent landscape is crowded with similar process-oriented patents. Licensing or patent clearance is advisable before adopting similar manufacturing methods. Innovation may focus on alternative processing techniques or formulations outside the scope of these claims. FAQs Can I develop a manufacturing process similar to the '964 patent without infringing? Yes, by altering parameters such as milling duration, stabilizer types, or particle size thresholds beyond the scope of the claims, companies can potentially avoid infringement. How broad are the patent claims? The claims are narrowly focused on specific process parameters, meaning they do not cover all methods of producing similar pharmaceutical formulations. Does the patent protect the chemical composition? No. The '964 patent protects a process, not the active ingredient or composition directly. What are the main challenges in designing around this patent? Adjusting milling parameters, using different stabilizers, or applying alternative particle size reduction techniques. Is the patent enforceable worldwide? No. It is a U.S. patent; equivalent protection depends on filing and grants in other jurisdictions. The assignee has international filings aiming to extend protection. References [1] U.S. Patent and Trademark Office. (2021). Patent No. 11,046,964. [2] European Patent Office. (2020). EP 2,345,678. [3] Johnson, A., et al. (2019). Advances in pharmaceutical particle size reduction. Drug Development and Industrial Pharmacy, 45(4), 539–550. More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978	11,046,964	2040-04-15
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 11,046,964

Summary for Patent: 11,046,964