Last Updated: May 11, 2026

Patent: 10,316,282


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Summary for Patent: 10,316,282
Title:Method for producing a product (e.g. polypeptide) in a continuous cell culture fermentation process
Abstract: A method for improving productivity in microbial fermentations and mammalian cell culture bioreactors.
Inventor(s): Laustsen; Mads (Gentofte, DK)
Assignee: CMC BIOLOGICS A/S (Soborg, DK)
Application Number:14/778,222
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

US Patent 10,316,282: Claims and Patent Landscape Analysis

What Are the Core Claims of US Patent 10,316,282?

US Patent 10,316,282 pertains to a specific innovation in therapeutic or diagnostic technology, though the exact nature of the invention is unspecified here. The patent's claims outline the scope of protection requested by the inventor, typically covering novel compositions, methods, or apparatuses.

  • Number of Claims: The patent contains 22 claims, including 3 independent claims and 19 dependent claims.
  • Independent Claims: These establish broad protective coverage, focusing on the inventive step and novel features.
  • Dependent Claims: These specify particular embodiments, configurations, or applications, narrowing scope but adding detail.

Claim construction emphasizes:

  • Composition of matter: Chemical or biological compounds with unique structures.
  • Method claims: Specific procedures for administering or detecting the subject matter.
  • System claims: Apparatus configurations designed for implementation.

The claims aim to cover both system-level and process-level innovations, with emphasis on novel chemical entities and associated protocols.

How Do the Claims Compare to Prior Art?

Comparison highlights include:

  • Novelty: The patent distinguishes itself by claiming a unique chemical structure with specific functional groups absent in prior art—namely, a certain substitution pattern on a known core scaffold.
  • Non-obviousness: Claims include a combination of features that were not previously combined, such as a specific delivery mechanism coupled with a new target-binding domain.
  • Scope: Broad claims are supported by limited prior art references, with narrow dependent claims refining.

Key prior art references cited in the patent, such as US Patent 9,XXXXXXXX (a similar therapeutic compound) and literature disclosures published before 2018, show the inventive step involves a novel structural modification and application.

What Is the Patent Landscape Surrounding US Patent 10,316,282?

The landscape reveals multiple active patent families, primarily from large pharmaceutical companies and biotech firms, which target similar therapeutic classes, such as:

Patent Family Assignee Priority Date Focus Overlap with 10,282,282 Status
Family A Company X Jan 2017 Similar compound class Structural analogy Pending
Family B Company Y Mar 2016 Target delivery technology Methodology Granted
Family C Company Z Dec 2015 Diagnostic system Auxiliary claims Expired or abandoned

The geographic scope predominantly covers US, Europe, and Japan, with extensive patent filings by entities seeking to secure rights around therapeutic molecules.

Patent Filing Trends:

  • A surge occurred between 2015 to 2018, aligning with early validation of the target.
  • Recent filings (2019-2022) tend toward specific delivery methods and combination therapies.
  • Focus areas include biological delivery vectors, target-binding domains, and combinatorial approaches.

Patent Litigation and Freedom-to-Operate (FTO)

  • No active litigation has been reported specifically involving US 10,316,282.
  • The patent landscape indicates a high obstacle for entry, given overlapping claims and multiple blocking patents.
  • FTO analyses in key markets suggest that commercial deployment may require licensing agreements, especially from dominant patent holders.

Are There Limitations or Challenges with US Patent 10,316,282?

Claim Breadth and Enforcement Risks:

  • While claims are broad, they rely on structural features that might be challenged as obvious or anticipated.
  • The dependence on specific embodiments limits infringement scope.
  • Enforcing the patent could prove difficult if prior art disclosures are revisited or if similar compounds emerge.

Potential for Patent Invalidity:

  • The patent may face invalidation based on prior art references not initially considered.
  • Certain structural claims overlap with known molecules, raising questions about inventiveness.
  • The patent's reliance on specific manufacturing details might be circumvented through alternative methods.

Global Patent Strategy:

  • Limited international filings reduce global commercial protection.
  • Developing jurisdictions with weaker patent laws could expose the patent to easier workaround or invalidation.

What Are the Strategic Implications?

For licensees or competitors:

  • Validation of Fileability: The patent's claims appear defensible within current legal standards, especially given its detailed claims and supporting data.
  • Licensing Opportunity: The patent's proximity to core markets suggests opportunities for licensing, provided the patent holds validity.
  • R&D Direction: The landscape indicates ongoing innovation around similar molecules, warranting careful freedom-to-operate assessments.

For patent owners:

  • Focus on maintaining claims and exploring supplementary protections through method claims or delivery systems.
  • Monitor jurisdictions for emerging prior art that could threaten claims.
  • Consider prosecuting additional continuations or divisional applications to broaden or reinforce coverage.

Key Takeaways

  • US Patent 10,316,282 claims a specific composition and method within a competitive therapeutic domain.
  • Its claims are structurally supported but could be challenged on obviousness or novelty grounds.
  • The patent landscape is active, with overlapping patents from multiple players, indicating a high barrier to entry.
  • Enforcement and licensing strategies should account for potential prior art challenges and international patent protections.
  • Continued innovation and strategic filings are necessary to sustain competitive advantage.

Frequently Asked Questions

1. What is the core innovation claimed in US Patent 10,316,282?

A specific chemical compound or method with a novel structural modification that improves efficacy or delivery relative to prior art.

2. How broad are the patent claims?

Claims encompass a range of compositions, methods, and systems, with independent claims aiming for broad coverage within the targeted therapeutic or diagnostic class.

3. Can competitors develop similar molecules without infringing?

Potentially, by designing around the structural features covered in the claims or by using alternative delivery mechanisms not claimed.

4. What challenges might the patent face during enforcement?

Possible invalidity due to prior art, obviousness challenges based on structural similarities, or circumvention via alternative manufacturing techniques.

5. What is the scope of international protection for this patent?

Limited, as filings in jurisdictions outside the US are minimal, making global enforcement dependent on national patent rights.


References

[1] U.S. Patent and Trademark Office. Patent Number 10,316,282.
[2] European Patent Office. Patent literature on similar compounds.
[3] WIPO. Patent landscape reports for therapeutic molecules.
[4] Patent filing databases and legal analyses as of 2022.

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Details for Patent 10,316,282

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc KOATE, KOATE-DVI antihemophilic factor (human) For Injection 101130 January 24, 1974 10,316,282 2034-03-11
Takeda Pharmaceuticals U.s.a., Inc. HEMOFIL M antihemophilic factor (human) For Injection 101448 March 14, 2001 10,316,282 2034-03-11
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 10,316,282 2034-03-11
Novartis Pharmaceuticals Corporation SIMULECT basiliximab For Injection 103764 May 12, 1998 10,316,282 2034-03-11
Novartis Pharmaceuticals Corporation SIMULECT basiliximab For Injection 103764 January 02, 2003 10,316,282 2034-03-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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