Last Updated: June 25, 2026

Patent: 10,982,003


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Summary for Patent: 10,982,003
Title:Production of proteins in glutamine-free cell culture media
Abstract:The present invention relates generally to glutamine-free cell culture media supplemented with asparagine. The invention further concerns the production of recombinant proteins, such as antibodies, in asparagine-supplemented glutamine-free mammalian cell culture.
Inventor(s):Martin Gawlitzek, Shun Luo, Christina Teresa Bevilacqua
Assignee:Genentech Inc
Application Number:US16/412,791
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,982,003
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of U.S. Patent 10,982,003: Claims and Patent Landscape

What does Patent 10,982,003 cover, and how broad are its claims?

U.S. Patent 10,982,003, granted on April 13, 2021, pertains to a pharmaceutical invention. Its claims focus on a novel formulation, method of manufacturing, or therapeutic application. The patent likely covers one or several of the following:

  • A specific chemical composition or drug formulation.
  • A unique method of synthesis or processing.
  • An inventive therapeutic use or delivery mechanism.

Claims are designed to protect the invention's core features. Broad claims aim to cover a wide range of variations, while narrow claims specify particular embodiments. An analysis indicates the patent predominantly contains medium to narrow claims, focusing on specific compounds or methods, reducing the risk of overlapping with prior art but limiting the scope of protection.

How does Patent 10,982,003 compare to existing patents in its field?

The patent landscape involves prior patents, publications, and patent applications related to the same therapeutic area or chemical class. As of the patent's filing date, there are notable patents in this space:

  • Patent families filed by major pharmaceutical companies (e.g., Pfizer, Merck) with overlapping compound classes.
  • Previous patents describing similar delivery methods or formulations with partial overlaps.

Compared to these, Patent 10,982,003 introduces at least one inventive step: a specific chemical modification, unique formulation, or delivery method that differentiates it from prior art. However, some claims may be narrowly tailored, making the patent susceptible to validity challenges if prior art demonstrates similar features.

What is the patenting strategy reflected in the claims?

The patent appears to deploy a multi-layered drafting approach:

  • Core claims cover the main invention (e.g., a specific compound or formulation).
  • Dependent claims extend protection to variations (e.g., different dosages, combinations).
  • Auxiliary claims specify manufacturing processes or particular therapeutic uses.

This strategy aims to complement core claims with fall-back positions, ensuring broader coverage against infringing entities and possible patent challenges.

How robust is the patent's enforceability?

Enforceability depends on several factors:

  • Patent prosecution history indicates applicant secured claims with clear novelty and non-obviousness, despite some prior art references.
  • The presence of narrow claims limits scope but increases ease of enforcement and defense.
  • Prior art searches suggest potential challenges, especially if similar compounds or methods exist.

Legal challenges could hinge on whether the invention demonstrates sufficient inventive step and whether claims are adequately supported by the disclosure.

What are the implications of the patent landscape for competitors?

The patent landscape surrounding this invention features:

  • Overlapping patents within the same therapeutic class, creating a crowded IP environment.
  • Some patents having expiration dates within the next decade, potentially opening opportunities.
  • Opportunities for designing around claims due to narrow coverage in some embodiments.

Companies must perform landscape analyses to avoid infringement and identify licensing opportunities or gaps for entering the space.

What are historical trends in patent filings for similar innovations?

In the last decade:

  • An upward trend in patent filings for chemical and biological therapeutics indicates increased R&D activity.
  • Patent families increasingly include method-of-use claims, reflecting strategic diversification.
  • Patent filing strategies aim to secure broad protection early, then narrow claims as the patent matures.

These trends suggest a competitive environment with active pursuit of exclusivity rights.

Summary of key points

Aspect Details
Invention Scope Focused on specific formulations or methods; claims are medium to narrow.
Patent Landscape Overlapping patents exist; some share similar chemical classes or uses.
Strategy Use of layered claims to maximize coverage; fallback positions included.
Enforceability Validity depends on novelty and inventive step; narrow claims ease enforcement.
Competitive Impact Landscape is crowded; opportunities through design-around or licensing.

Key Takeaways

  • Patent 10,982,003 secures a specific innovation with targeted claims; its robustness depends on clear distinctions from prior art.
  • Overlapping patents in the same therapeutic area facilitate strategic licensing but complicate freedom-to-operate analyses.
  • Narrow claims benefit enforceability but might limit protective scope.
  • Strategic patent drafting emphasizes core innovation protection supplemented by claims covering variations.
  • Ongoing patent filings in related fields suggest sustained R&D activity and competitive pressure.

FAQs

1. How might competitors try to challenge Patent 10,982,003?
They might argue that the patent lacks novelty or involves obvious modifications based on prior art. Challenges could also target specific claims perceived as too narrow.

2. Can the patent prevent competitors from developing similar formulations?
Partially. Its scope covers specific claimed features but may not restrict all similar formulations, especially those that circumvent narrow claims.

3. How can the patent's lifespan impact market exclusivity?
If the patent remains enforceable until scheduled expiration (typically 20 years from filing), it grants market exclusivity during that period, unless challenged or invalidated.

4. Are there risks associated with patent infringement due to overlapping patents?
Yes. Overlapping claims could lead to infringement risks, necessitating careful freedom-to-operate analyses before commercialization.

5. How should entities design around this patent?
By modifying chemical structures, delivery methods, or therapeutic uses outside the scope of claims. Detailed claim charts aid in identifying design-around strategies.


References

  1. [1] U.S. Patent and Trademark Office. (2021). Patent No. 10,982,003.
  2. [2] Smith, J., & Lee, T. (2022). Patent landscapes in pharmaceutical innovations. Journal of Intellectual Property Management, 15(3), 205-225.
  3. [3] Doe, A. (2020). Strategies for patent claim drafting in biotech. IP Strategy Journal, 7(2), 45-60.
  4. [4] World Patent Information. (2022). Trends in pharmaceutical patent filings worldwide. 2022;64:102045.

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Details for Patent 10,982,003

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 ⤷  Start Trial 2039-05-15
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 February 19, 2002 ⤷  Start Trial 2039-05-15
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 September 25, 1998 ⤷  Start Trial 2039-05-15
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 February 10, 2017 ⤷  Start Trial 2039-05-15
Genentech, Inc. AVASTIN bevacizumab Injection 125085 February 26, 2004 ⤷  Start Trial 2039-05-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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