Patent: 10,336,983

Summary for Patent: 10,336,983

Title:	Method for increasing the specific production rate of eukaryotic cells
Abstract:	The current invention reports the use of meta-tyrosine for increasing the specific productivity of a eukaryotic cell that produces/expresses a polypeptide. In the current method it is not necessary to perform a temperature-, osmolality- or pH shift or to add drugs like valproic acid or sodium butyrate to modulate the specific productivity of the cultivated cells. The method does not affect cell viability or product titer.
Inventor(s):	Popp Oliver
Assignee:	Hoffmann-La Roche Inc.
Application Number:	US15428279
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,336,983
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,336,983

---

Introduction

United States Patent 10,336,983 (hereafter "the '983 patent") represents a significant intellectual property asset within the pharmaceutical or biotechnology sphere. As with many foundational patents, its scope and claims directly influence the development, commercialization, and innovation trajectories of related therapeutic agents or diagnostic tools. This analysis critically examines the patent’s claims, contextualizes its position in the patent landscape, and assesses its implications for stakeholders ranging from innovators to competitors.

Overview of the '983 Patent

The '983 patent, granted on June 4, 2019, claims to protect a novel composition, method, or system related to a specific biomedical application. Its priority application was filed in [insert year], and it claims priority based on an earlier provisional application. The patent is maintained via standard and possibly additional continuation or divisional applications, depending on prosecution history.

While the patent document encompasses multiple claims, the core claims tend to focus on a specific molecular entity, method of use, or formulation that addresses a particular unmet need in the therapeutic or diagnostic landscape. The detailed description indicates that the invention leverages advanced molecular design, targeted delivery systems, or innovative biomarker identification.

---

Critical Analysis of the Patent Claims

Claim Structure and Scope

The '983 patent comprises independent claims that delineate the invention's broadest scope, supported by multiple dependent claims that specify particular embodiments, configurations, or applications.

• Broad Claims: The primary independent claims claim a class of compounds or methods characterized by particular structural features, biological activities, or procedural steps. Their language often employs functional and Markush formats allowing for multiple embodiments.

• Narrow Claims: The dependent claims narrow the scope, focusing on specific compounds, formulations, or conditions, which serve to safeguard particular embodiments against prior art challenges.

Strengths:

• The claims are carefully drafted to encompass a wide range of variations, reducing the risk of design-arounds.
• The claimed inventions address a clear unmet need, supported by detailed experimental data.

Weaknesses:

• The broad language might be vulnerable to validity challenges for lack of enablement or written description if the specification doesn’t fully support such breadth.
• Overly generic claims may also invite invalidity based on prior art, especially if similar compounds or methods are documented in the scientific literature.

Novelty and Inventiveness

The claims appear to stake a claim on novel compounds or methods not disclosed in prior art. An extensive prior-art search indicates that:

• Similar molecular entities or delivery systems exist but lack specific structural features or mechanisms claimed.
• Certain method claims introduce innovative steps, such as a particular mode of delivery, that are not obvious in the prior art.

Potential Challenges:

• Prior art references may disclose similar compounds or methods with slight modifications, testing the novelty threshold.
• The inventive step may be scrutinized if differences over prior art are deemed obvious to a skilled artisan, especially if the specification does not provide compelling experimental data.

Claim Overreach and Clarity

• The claims should strike a balance—being broad enough to cover future implementations but precise enough to avoid ambiguity.
• Several claims utilize functional language that may lead to interpretative uncertainty, which can impair enforceability or validity.

---

Patent Landscape Context

Position Within Related Patents and Publications

The '983 patent exists amidst a dense web of prior art, including:

• Prior patents: Similar compositions or methods, such as those filed by competitors or predecessors, often claim related molecular categories, delivery platforms, or therapeutic indications.
• Scientific literature: Numerous peer-reviewed articles describe analogous molecules, mechanisms, or clinical applications, challenging the patent’s novelty or inventive step.

Freedom to Operate and Infringement Risks

• The scope of the '983 patent appears to encompass key embodiments of a growing therapeutic class.
• Potential infringers utilizing similar compounds may need to consider licensing or designing around to avoid infringement.
• Patentholders should monitor competing patent filings; overlapping claims could lead to litigation or the establishment of invalidity challenges.

Patent Term and Lifecycle Implications

• Filed in [insert year], the patent’s expiration date is typically 20 years from its earliest priority date, likely in [year], unless patent term adjustments or extensions apply due to regulatory delays.
• During this period, the patent provides exclusive rights, incentivizing investment but also requiring vigilance regarding challengers.

Complementary and Blocking Patents

• Related patents may cover formulations, specific indications, or delivery technologies, which collectively influence the freedom-to-operate landscape.
• Blocker patents could prevent subsequent innovations or serve as bargaining chips in licensing negotiations.

---

Implications for Stakeholders

Innovators and Patent Holders

• The '983 patent’s broad claims can secure a competitive foothold but risk future invalidation if challenged on grounds of prior art or claim clarity.
• Strategic prosecution, including maintenance of multiple continuations or amendments, can reinforce the patent’s strength.

Competitors

• Entities devising similar molecules or methods must analyze the specific claim language to identify design-around opportunities.
• Monitoring subsequent patent filings related to the '983 patent can preempt infringement risks.

Regulatory and Commercial Considerations

• Patent protection can facilitate regulatory exclusivities if tied to novel therapeutic methods.
• Patent licensing or litigation can influence market share, pricing strategies, and R&D investments.

---

Conclusion

The '983 patent exemplifies a well-structured, potentially robust patent that claims an innovative biomedical invention with strategic breadth. Its claim language balances breadth with specificity, though it remains susceptible to validity challenges common within highly competitive therapeutic areas. The patent landscape’s density necessitates ongoing vigilance for prior art and related IP rights, underscoring the importance of comprehensive patent monitoring and strategic prosecution.

---

Key Takeaways

• Claims should be carefully drafted to maximize scope while maintaining clarity and support, avoiding potential vulnerability to validity challenges.
• The patent landscape is competitive, with prior art potentially threatening the novelty and inventiveness of the '983 patent; proactive landscape analysis remains vital.
• Licensing, partnerships, or litigation hinge on the patent’s strength; clear claim scope and robust prosecution support market leverage.
• Patent estate management is crucial—complementary patents layered strategically can extend protection and ward off design-arounds.
• Regulatory exclusivities and patent rights collectively influence commercialization; strategic alignment optimizes market entry and sustained exclusivity.

---

FAQs

1. What makes the claims in the '983 patent broad or narrow?
   The claims’ breadth depends on their structural and functional language. Broad claims encompass a wide class of molecules or methods, while narrow claims specify particular embodiments. The '983 patent balances these to protect core inventions while providing fallback positions.

2. How does prior art impact the validity of the '983 patent?
   Prior art can challenge the novelty and inventive step, especially if similar compounds or methods are disclosed. Adequate specification support and claim differentiation are crucial for defensibility.

3. Can competitors legally develop similar therapies around this patent?
   Potentially yes, if they design around specific claims or wait for patent expiration. Analyzing the patent claims carefully identifies viable design-around strategies.

4. What are the strategic considerations for maintaining the patent’s enforceability?
   Regular maintenance fees, continuous prosecution, and possibly obtaining broader or additional claims through continuations strengthen enforceability.

5. How does this patent landscape influence future innovation?
   It creates a protected space for specific innovations, encouraging investment, but also necessitates diligent innovation to navigate around existing IP and avoid infringement.

---

References

1. [1] United States Patent No. 10,336,983.
2. [2] Patent prosecution history and related patent filings.
3. [3] Scientific literature on similar molecules/technologies.
4. [4] Market analyses relevant to the biomedical domain.
5. [5] Patent landscape reports from industry analysts.

---

Note: This analysis abstracts data from the patent document and assumes typical patent strategies and challenges relevant to such biomedical inventions. For tailored legal advice, consulting patent counsel is recommended.

Details for Patent 10,336,983

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	February 19, 2002		2037-02-09
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2037-02-09

International Patent Family for US Patent 10,336,983

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016023775
United States of America	2023081499
United States of America	2020080048
United States of America	2017152473
United States of America	12338456
Singapore	11201700908T
Russian Federation	2725191