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Last Updated: January 7, 2025

Patent: 8,404,809


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Summary for Patent: 8,404,809
Title:Glycopegylated factor IX
Abstract:Conjugates between Factor IX and PEG moieties are disclosed in the present application. The conjugates are linked via a glycosyl linking group interposed between and covalently attached to the peptide and the modifying group. Conjugates are formed from glycosylated peptides by the action of a glycosyltransferase. The glycosyltransferase ligates a modified sugar moiety onto a glycosyl residue on the peptide. Also provided are methods for preparing the conjugates, methods for treating various disease conditions with the conjugates, and pharmaceutical formulations including the conjugates.
Inventor(s):DeFrees Shawn, Bayer Robert J., Bowe Caryn L., Panneerselvam Krishnasamy
Assignee:Novo Nordisk A/S
Application Number:US12605028
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Claims and Patent Landscape of United States Patent 8,404,809

Introduction

When analyzing a patent, particularly one like United States Patent 8,404,809, it is crucial to delve into the specifics of the claims, the inventors, and the broader patent landscape. This analysis will cover the key aspects of patent claims, inventorship, patent validity challenges, and the overall patent term and its implications.

Patent Claims: Definition and Importance

Patent claims are the heart of any patent application, defining the scope of the invention for which protection is sought. For a claim to be valid, it must meet several criteria, including novelty, nonobviousness, and subject matter eligibility[2].

  • Novelty Requirement: The claimed invention must be new and not previously disclosed in the prior art. This means that every element of the claimed invention must not be identically disclosed in any public source before the effective filing date of the patent application[2].
  • Nonobviousness Requirement: The invention must be significantly different from existing technology and not obvious to a person with ordinary skill in the relevant field. This ensures that the invention is an advancement over what is already known[2].
  • Subject Matter Eligibility: The invention must fall within a category of subject matter that is eligible for patent protection. This excludes laws of nature, natural phenomena, and abstract ideas unless the claims contain an inventive concept that transforms the nature of the claim[2].

Inventorship Determination

Inventorship is a critical aspect of patent law, focusing almost exclusively on the conception step. An inventor is someone who conceives the subject matter of at least one claim of the patent. This can include individuals who collaborate to produce the invention through aggregate efforts[1].

  • Conception: This is defined as the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention. It must be sufficiently definite and permanent to permit one with ordinary skill in the field to reduce it to practice without undue experimentation[1].
  • Contributions: Only those who contribute to the conception of the invention are considered inventors. Reducing an invention to practice or performing experiments does not qualify someone as an inventor unless they also contributed to the conception[1].

Challenges to Patent Validity

The Leahy-Smith America Invents Act (AIA) introduced significant changes to U.S. patent law, including the creation of the Patent Trial and Appeal Board (PTAB) and new administrative challenges such as inter partes review (IPR) and post-grant review (PGR)[2].

  • Inter Partes Review (IPR): This allows a party to challenge the validity of an already-issued patent in an administrative forum. IPR is often faster and less expensive than judicial proceedings and requires a lower burden of proof to invalidate patents[2].
  • Post-Grant Review (PGR): Similar to IPR but available only for patents issued from applications filed on or after March 16, 2013. PGR allows for a broader range of challenges, including subject matter eligibility and written description requirements[2].

Patent Term and Expiration

The term of a patent is a critical factor in understanding its lifespan and the period during which the patent holder can enforce their rights.

  • Utility Patents: Generally, utility patents have a term of 20 years from the filing date of the earliest application for which a benefit is claimed. This applies to patents filed on or after June 8, 1995[3].
  • Design Patents: Design patents have a term of 14 years from the date of grant[3].
  • Terminal Disclaimers: These can affect the patent term by disclaiming the terminal portion of the patent term that would extend beyond the expiration date of an earlier issued patent[3].

Impact of PTAB on Patent Validity

The PTAB plays a significant role in challenging the validity of patents. Decisions by the PTAB can significantly impact the enforceability of a patent.

  • Estoppel Standards: The PTAB has regulations that prevent patent owners from obtaining claims that are not patentably distinct from claims invalidated by the PTAB. This can limit the ability to maintain or amend claims during IPR proceedings[5].
  • Administrative Efficiency: PTAB processes are generally faster and less expensive than judicial proceedings, making them a preferred route for challenging patent validity[2].

Case Studies and Examples

To illustrate the complexities, consider the case of Frank’s Casing Crew v. PMR Technologies. Here, a patent was issued to individuals who were not the true inventors, and the court found the patent unenforceable due to deceptive intent. This highlights the importance of accurate inventorship determination[1].

Industry Trends and Litigation

The patent landscape is dynamic, with trends in litigation and enforcement evolving over time.

  • NPE Filings: Non-practicing entities (NPEs) continue to play a significant role in patent litigation, with filings increasing in recent quarters. This can impact the strategy of patent holders and accused infringers alike[5].

Key Takeaways

  • Accurate Inventorship: Proper determination of inventorship is crucial to avoid invalidation of the patent.
  • Claim Construction: Careful drafting of patent claims is essential to ensure they meet the criteria for novelty, nonobviousness, and subject matter eligibility.
  • PTAB Challenges: Understanding the role of PTAB and the processes of IPR and PGR is vital for both patent holders and challengers.
  • Patent Term Management: Managing the patent term, including any terminal disclaimers or extensions, is critical for maximizing the protection period.

FAQs

  1. What is the significance of the conception step in determining inventorship?

    • The conception step is crucial as it defines the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention[1].
  2. How do IPR and PGR differ from judicial proceedings in challenging patent validity?

    • IPR and PGR are administrative processes that are generally faster and less expensive, with a lower burden of proof to invalidate patents compared to judicial proceedings[2].
  3. What is the impact of terminal disclaimers on the patent term?

    • Terminal disclaimers can reduce the patent term by disclaiming the portion that would extend beyond the expiration date of an earlier issued patent[3].
  4. Why is accurate inventorship determination important?

    • Accurate inventorship is essential to avoid the invalidation of the patent due to deceptive intent or incorrect naming of inventors[1].
  5. How do PTAB decisions affect patent enforceability?

    • PTAB decisions can render a patent unenforceable if the claims are found to be invalid or if there was deceptive intent in the patent application process[2].

Cited Sources

  1. Determining Inventorship for US Patent Applications - Oregon State University[1]
  2. The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service[2]
  3. Patent Term - USPTO[3]

More… ↓

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Details for Patent 8,404,809

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. REBINYN coagulation factor ix (recombinant), glycopegylated For Injection 125611 May 31, 2017 8,404,809 2029-10-23
Novo Nordisk Inc. REBINYN coagulation factor ix (recombinant), glycopegylated For Injection 125611 August 11, 2022 8,404,809 2029-10-23
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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