You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 24, 2025

Patent: 10,058,589


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,058,589
Title:Stable pharmaceutical composition of Etanercept in a phosphate citrate buffer with glycine as an anti-aggregating agent
Abstract: The present invention relates to the stable pharmaceutical compositions comprising tumor necrosis factor receptor Fc fusion protein (TNFR:Fc). More particularly, it relates to the stable pharmaceutical compositions comprising tumor necrosis factor receptor Fc fusion protein (TNFR:Fc), phosphate-citrate buffer. It also relates to the methods of manufacturing the composition, method of administration and kits containing the same.
Inventor(s): Apte-Deshpande; Anjali Deepak (Maharashtra, IN), Deokar; Vaibhav Dyaneshwar (Maharashtra, IN), Mody; Rustom Sorab (Maharashtra, IN)
Assignee: LUPIN LIMITED (Mumbai, Maharashtra, IN)
Application Number:14/438,404
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,058,589

Introduction

Understanding the intricacies of a patent, particularly the claims and the broader patent landscape, is crucial for inventors, patent holders, and legal professionals. This analysis will delve into the key aspects of United States Patent 10,058,589, focusing on the determination of inventorship, the drafting of patent claims, and the broader patent landscape influenced by recent legislative and judicial developments.

Determining Inventorship

Inventorship is a critical aspect of patent law, as it determines who is entitled to a patent. According to U.S. patent law, the true inventor must be identified, and this identification focuses almost exclusively on the conception step of the invention process[1].

  • Conception Definition: Conception is defined as the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention. This idea must be sufficient to permit one with ordinary skill in the field to reduce it to practice without undue experimentation[1].
  • Collaborative Efforts: Inventorship can involve two or more persons who collaborate to produce the invention through aggregate efforts. However, contributions such as reducing an invention to practice or performing experiments do not qualify someone as an inventor unless they contributed to the conception of the invention[1].

Drafting Patent Claims

The drafting of patent claims is a delicate process that can significantly impact the validity and enforceability of a patent.

  • Specificity and Clarity: Claims must be drafted with specificity and clarity. For example, using vague terms like "control means" without disclosing specific structures or algorithms can lead to invalid claims, as seen in the case of Aristocrat Technologies, Inc. v. International Game Technology[2].
  • Claim Limitations: Carefully drafting claim limitations is essential. The case of Kustom Signals, Inc. v. Applied Concepts, Inc. highlights the importance of precise language, where the use of "or" instead of "and/or" led to a ruling of noninfringement[2].

Patent Claims Analysis for US Patent 10,058,589

To analyze the claims of US Patent 10,058,589, one must carefully review the patent specification and the claims themselves.

  • Claim Scope: Determine the exact subject matter of the patent claims. This involves identifying each feature of the invention claimed and ensuring that the claims are supported by the specification[1].
  • Claim Language: Examine the language used in the claims. Ensure that the terms are specific and clear, avoiding ambiguities that could lead to challenges or invalidation[2].

Patent Landscape and Recent Developments

The patent landscape in the United States has been significantly influenced by recent legislative and judicial developments.

  • Leahy-Smith America Invents Act (AIA): The AIA introduced the Patent Trial and Appeal Board (PTAB) and new administrative challenges such as Inter Partes Review (IPR) and Post-Grant Review (PGR). These mechanisms allow for faster and less expensive challenges to patent validity compared to judicial proceedings[3].
  • Patent Subject Matter Eligibility: The USPTO has issued guidelines for determining whether a patent application seeks to claim ineligible subject matter, such as laws of nature, natural phenomena, or abstract ideas. The Alice/Mayo test is used to determine if the patent claims have an "inventive concept" that transforms the ineligible subject matter into a patent-eligible application[3].

Novelty and Nonobviousness Requirements

For a patent to be granted, the claimed invention must meet the requirements of novelty and nonobviousness.

  • Novelty: The claimed invention must not have been patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention[3].
  • Nonobviousness: The invention must be significantly different from existing knowledge (prior art) and not obvious to a person with ordinary skill in the field[3].

Advanced Patent Searching Techniques

When analyzing a patent like US Patent 10,058,589, it is important to use advanced patent searching techniques to identify related patents and prior art.

  • Claims Variation: During the prosecution process, claims may be amended or narrowed. Therefore, it is crucial to review the entire patent family and any amendments made during prosecution[4].
  • Comprehensive Searches: Leveraging tools and strategies to conduct comprehensive searches can provide better patent insights and help in identifying potential challenges to the patent[4].

Quality of Patents

The quality of patents is a recurring concern, with various recommendations aimed at improving it.

  • GAO Recommendations: The Government Accountability Office (GAO) has recommended that the USPTO more consistently define patent quality and articulate this definition in agency documents and guidance. This includes reassessing the time allotted for examination and analyzing the effects of incentives on patent quality[5].

Practical Considerations and Strategies

When dealing with patents, several practical considerations and strategies can help in drafting strong and broad patent claims.

  • Do's and Don'ts: Following a list of "do's and don'ts" can help in avoiding common pitfalls. For example, disclosing specific structures, materials, or acts in the specification can strengthen the claims[2].
  • Legal Counsel: Ensuring thorough invention disclosure and accurate identification of inventors can help in maintaining the enforceability of the patent, even in the face of later challenges[1].

Key Takeaways

  • Inventorship: Accurate determination of inventorship is crucial and focuses on the conception step of the invention process.
  • Claim Drafting: Claims must be specific, clear, and supported by the patent specification.
  • Patent Landscape: Recent legislative and judicial developments, such as the AIA and PTAB, have significantly impacted the patent landscape.
  • Novelty and Nonobviousness: These requirements must be met for a patent to be granted.
  • Advanced Searching: Comprehensive searches and analysis of the entire patent family are essential.
  • Patent Quality: Ensuring high-quality patents through clear definitions and consistent examination processes is vital.

FAQs

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

    • Conception is the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention. It is the key step in determining who is an inventor[1].
  2. How can vague claim terms affect the validity of a patent?

    • Vague terms, such as "control means" without specific disclosure, can lead to invalid claims due to lack of clarity and specificity[2].
  3. What is the role of the Patent Trial and Appeal Board (PTAB) in challenging patents?

    • PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents, such as IPR and PGR, which can be faster and less expensive than judicial proceedings[3].
  4. Why is it important to conduct comprehensive patent searches?

    • Comprehensive searches help in identifying related patents, prior art, and any amendments made during the prosecution process, providing better patent insights and helping to avoid potential challenges[4].
  5. How does the GAO recommend improving patent quality?

    • The GAO recommends that the USPTO define patent quality consistently, reassess examination times, and analyze the effects of incentives on patent quality to improve overall patent quality[5].

Sources

  1. Determining Inventorship for US Patent Applications - Oregon State University
  2. Practical Considerations and Strategies in Drafting U.S. Patent Applications - Finnegan
  3. The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service
  4. Advanced Patent Searching Techniques - CAS.org
  5. Intellectual Property: Patent Office Should Define Quality, Reassess Examination Time - GAO

More… ↓

⤷  Try for Free

Details for Patent 10,058,589

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Immunex Corporation ENBREL etanercept For Injection 103795 November 02, 1998 ⤷  Try for Free 2032-10-26
Immunex Corporation ENBREL etanercept For Injection 103795 May 27, 1999 ⤷  Try for Free 2032-10-26
Immunex Corporation ENBREL etanercept Injection 103795 September 27, 2004 ⤷  Try for Free 2032-10-26
Immunex Corporation ENBREL etanercept Injection 103795 February 01, 2007 ⤷  Try for Free 2032-10-26
Immunex Corporation ENBREL MINI etanercept Injection 103795 September 14, 2017 ⤷  Try for Free 2032-10-26
Immunex Corporation ENBREL etanercept Injection 103795 ⤷  Try for Free 2032-10-26
Immunex Corporation ENBREL etanercept Injection 103795 March 05, 2020 ⤷  Try for Free 2032-10-26
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 7 of 7 entries

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.