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Last Updated: December 22, 2024

Patent: RE46363


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Summary for Patent: RE46363
Title:Dial-down mechanism for wind-up pen
Abstract:The present invention relates to a dial-down mechanism for an injection device comprising a torsion spring for assisting injection of a dose of medicament from the injection device, the dial-down mechanism comprising dial-up cam arranged to receive and engage with a dial-up key, wherein the dial-up cam and the dial-up key are adapted to, upon rotation of a dose setting member in a first direction, cooperate to strain the torsion spring of the injection device, and a dial-down cam arranged to receive and engage with a dial-down key, wherein the dial-down cam and the dial-down key are adapted to, upon rotation of the dose setting member in a second direction, cooperate to release the torsion spring of the injection device, the second rotation direction being opposite to the first rotation direction.
Inventor(s):Moeller Claus Schmidt, Enggaard Christian Peter, Radmer Bo, Markussen Tom Hede
Assignee:Novo Nordisk A/S
Application Number:US14091774
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE46363
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent RE46363

Introduction

When delving into the analysis of a specific patent, such as United States Patent RE46363, it is crucial to consider multiple facets, including the claims themselves, the prosecution history, the broader patent landscape, and the potential for challenges and enforcement. Here, we will provide a comprehensive and critical analysis of these aspects.

Understanding the Patent Claims

Claim Construction and Scope

The claims of a patent are its lifeblood, defining the scope of the invention and what is protected. In the case of RE46363, each claim must be carefully constructed to ensure it is clear, concise, and compliant with statutory requirements. The prosecution history, as discussed in Finnegan's blog on prosecution history, plays a significant role in claim interpretation. Statements made during the prosecution process can limit the scope of the claims, as seen in cases like UCB, Inc. v. Yeda Rsch. and Dev. Co. where the Federal Circuit considered the content of the specification and actions during prosecution to define the scope of generic terms in claims[2].

Claim Validity and Enforcement

The validity of each claim in a patent like RE46363 is crucial for enforcement. If a claim is found invalid, it does not necessarily render the remaining claims invalid, as per 35 U.S.C. § 253(a)[1]. However, the USPTO can impose conditions on the validity of separate claims in a terminally disclaimed continuation patent, ensuring that the patentee can only enforce certain claims if precedent claims are not found invalid.

Prosecution History and Its Impact

Public Record and Competitor Reliance

The prosecution history of a patent is a public record that reflects the patentee's representations concerning the scope and meaning of the claims. This history is critical for competitors who rely on these representations to design around the claimed invention. Cases like Hockerson-Halberstadt, Inc. v. Avia Group Int’l, Inc. highlight the importance of this public record and the need for consistency in claim interpretation[2].

Avoiding Narrow Construction

To avoid a narrow construction based on prosecution history, patentees must be cautious in their representations during the prosecution process. This includes avoiding disavowals of claim scope and ensuring that any statements made are consistent with the intended scope of the claims. Strategies to avoid such narrow constructions involve careful drafting and negotiation with the examiner[2].

Patent Landscape Analysis

Geographic Focus and Competitor Activity

Patent landscape analysis helps in understanding the geographic focus and competitor activity in the relevant technology area. For RE46363, identifying the countries where the patent is filed and the geographic spread of similar patents can reveal strategic insights. For instance, if the patent has a high prevalence of publications in certain regions, it may indicate significant research or manufacturing activities in those areas[4].

Patent Saturation and Market Entry

Determining the saturation level of the patent space is essential for deciding whether to enter or invest in a particular technology area. A highly saturated space may indicate that it is challenging to secure new claims, suggesting the need to explore alternative technologies. This comprehensive analysis helps in making long-term decisions about technology focus and potential market entry[4].

Time Slicing and Competitive Dynamics

Time slicing, or analyzing patent data over time, provides insights into changes in competitive patenting strategies. This can include shifts in technology focus, geographic coverage, or patent renewal strategies. For RE46363, tracking these changes can help in understanding the current competitive landscape and making informed decisions about IP strategy[4].

Inter Partes Review (IPR) and Patent Challenges

Challenging Patent Validity

Patents like RE46363 can be challenged through Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB). This process allows competitors to challenge the validity of a patent based on prior art and obviousness. Recent decisions, such as the invalidation of the Gilenya patent, demonstrate the potential for IPR to impact patent validity[3].

Strategic Considerations

When facing an IPR challenge, it is crucial to secure expert testimony and ensure that all procedural requirements are met. The case involving the VLSI patents against Intel highlights the importance of securing experts and avoiding procedural pitfalls that could be fatal to the petition[5].

Strategic Insights and Decision-Making

Optimizing Claims and Patent Strategy

For patentees, understanding the claims and the broader patent landscape is key to optimizing their patent strategy. This includes using tools like reissuance to ensure the validity of claims and organizing claims to avoid obviousness-type double patenting rejections. Small inventors, in particular, can benefit from these strategies to protect their inventions effectively[1].

Licensing and Enforcement

The patent landscape analysis also informs licensing and enforcement strategies. Knowing the geographic focus and competitive dynamics can help in identifying potential licensing opportunities and jurisdictions where enforcement efforts should be concentrated. For example, a company may choose to litigate and enforce patents in specific jurisdictions based on their strategic importance[4].

Key Takeaways

  • Claim Construction: Careful construction of claims is essential, and prosecution history plays a critical role in claim interpretation.
  • Prosecution History: Consistency in representations during prosecution is vital to avoid narrow claim constructions.
  • Patent Landscape: Analyzing the geographic focus, patent saturation, and competitive dynamics helps in making strategic IP decisions.
  • IPR Challenges: Patents can be challenged through IPR, and securing expert testimony and following procedural requirements is crucial.
  • Strategic Optimization: Optimizing claims and patent strategy based on landscape analysis can enhance the protection and enforcement of patents.

FAQs

Q: How does the prosecution history impact the interpretation of patent claims? A: The prosecution history is a public record of the patentee's representations concerning the scope and meaning of the claims. It can limit the scope of claims and is relied upon by competitors to design around the claimed invention[2].

Q: What is the significance of patent landscape analysis in IP strategy? A: Patent landscape analysis provides insights into geographic focus, patent saturation, and competitive dynamics, helping in making strategic decisions about technology focus, market entry, and licensing efforts[4].

Q: How can a patent be challenged after it is issued? A: A patent can be challenged through Inter Partes Review (IPR) proceedings before the PTAB, where the validity of the patent is assessed based on prior art and obviousness[3].

Q: What are the implications of a highly saturated patent space? A: A highly saturated patent space indicates that it may be challenging to secure new claims, suggesting the need to explore alternative technologies or adjust IP strategies accordingly[4].

Q: Why is time slicing important in patent landscape analysis? A: Time slicing helps in understanding changes in competitive patenting strategies over time, providing context for current competitive dynamics and informing long-term IP decisions[4].

Sources

  1. Letterhead DC Office - Regulations.gov
  2. Finnegan, "Part 1: Prosecution History in Claim Interpretation"
  3. Boston College IPTF Journal, "A Review of the Modern IPR Process"
  4. AcclaimIP, "Patent Landscape Analysis - Uncovering Strategic Insights"
  5. IPWatchdog, "IPR on $2.18 Billion VLSI Patent Instituted; IP Edge Filing Patterns Emerge"

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Details for Patent RE46363

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 June 16, 2005 RE46363 2033-11-27
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 October 31, 2013 RE46363 2033-11-27
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 September 25, 2015 RE46363 2033-11-27
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 November 21, 2018 RE46363 2033-11-27
Novo Nordisk Inc. FIASP insulin aspart Injection 208751 September 29, 2017 RE46363 2033-11-27
Novo Nordisk Inc. FIASP insulin aspart Injection 208751 September 24, 2018 RE46363 2033-11-27
Novo Nordisk Inc. FIASP insulin aspart Injection 208751 June 21, 2023 RE46363 2033-11-27
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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