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Last Updated: December 25, 2024

Patent: 10,293,030


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Summary for Patent: 10,293,030
Title:Lyophilised pharmaceutical formulation and its use
Abstract: A pharmaceutical formulation in a lyophilised form, which comprises pharmacologically effective amount of interferon beta-1a as an active ingredient, disaccharides as a bulking agent and a non-ionic surfactant. After reconstitution, the composition can be administered intravenously.
Inventor(s): Jalkanen; Markku (Piispanristi, FI), Maksimow; Mikael (Turku, FI), Piippo; Ilse (Parainen, FI)
Assignee: Faron Pharmaceuticals Oy (Turku, FI)
Application Number:15/355,691
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Patent Landscape: A Comprehensive Analysis of US Patent 10,293,030

Introduction

Patent law and the process of obtaining a patent in the United States are complex and multifaceted. This article will delve into a comprehensive analysis of the claims and the patent landscape surrounding US Patent 10,293,030, highlighting key aspects of patent law, the examination process, and strategies for overcoming common hurdles.

The Patent Examination Process

The journey to securing a US patent involves a rigorous examination process. The USPTO calculates several types of patent allowance rates, including the first-action allowance rate, progenitor allowance rate, and family allowance rate. These rates help in understanding the likelihood of a patent application being granted, considering factors like continuations and the overall application family[1].

Continuations and Their Impact

Continuations are a critical aspect of the patent examination process. They allow applicants to file new applications that are closely related to the original (progenitor) application. These can include continuation-in-part (CIP) applications, divisional applications, and requests for continued examination (RCEs). Continuations can significantly complicate the calculation of allowance rates but are essential for applicants seeking to refine or expand their claims[1].

Subject Matter Eligibility Under 35 U.S.C. ยง 101

One of the most challenging hurdles in the patent examination process is overcoming section 101 rejections. The USPTO's two-pronged framework, as outlined in the 2024 Guidance Update, is crucial here. Prong Two, in particular, requires demonstrating that the claims are directed to a specific, concrete technological advancement or solution to a technical problem. This involves crafting a compelling narrative that highlights the practical utility and real-world impact of the invention[2].

Crafting Effective Arguments Under Prong Two

To overcome section 101 rejections, it is essential to build a strong argument under Prong Two. This involves:

  • Identifying Technical Improvements: Show that the claimed invention improves the functioning of a computer or another technology or technical field.
  • Narrative and Specification: Develop a clear and logical narrative supported by the specification, guiding the examiner through the technical problem and the claimed innovation.
  • Practical Utility: Emphasize the practical utility and real-world impact of the invention to distinguish it from mere abstract ideas or conventional practices[2].

Patent Term and Expiration

Understanding the patent term is vital for managing intellectual property. Patents generally have a term of 20 years from the filing date of the application. However, this can be affected by terminal disclaimers, patent term adjustments, and extensions. For instance, terminal disclaimers can limit the patent term to avoid conflicts with earlier issued patents, and patent term adjustments can extend the term due to USPTO delays[3].

Director Review and Appeal Processes

In cases where patent applicants disagree with the decisions of the Patent Trial and Appeal Board (PTAB), they can seek Director Review. This process, revised in 2023, allows for an independent Delegated Review Panel (DRP) to review fact-intensive issues. The DRP can issue a decision, remand the case for further proceedings, or request additional briefing. This mechanism provides an additional layer of oversight and potential relief for patent applicants[5].

Case Studies: Overcoming Examination Hurdles

DK Crown Holdings and SynAffix B.V.

In cases like DK Crown Holdings and SynAffix B.V., the Director Review process has been instrumental in addressing fact-intensive issues and alleged abuses of discretion by the PTAB. These cases highlight the importance of meticulous argumentation and the need for independent review in complex patent disputes[5].

Strategies for Success in Patent Applications

Understanding Examiner Perspectives

Patent examiners apply the subject matter eligibility framework differently, influenced by their understanding and productivity requirements. Applicants must craft arguments that are persuasive and concise, focusing on the most critical aspects of their invention[2].

Leveraging Continuations

Continuations can be a powerful tool for refining claims and addressing examiner concerns. However, they must be used strategically to avoid unnecessary delays and complications in the examination process[1].

Building a Compelling Narrative

A well-crafted narrative that highlights the innovative value and practical utility of the invention is crucial for overcoming section 101 rejections. This narrative should be supported by the specification and guide the examiner through the technical problem and the claimed solution[2].

Key Takeaways

  • Understanding Allowance Rates: Recognize the different types of allowance rates and how continuations impact these rates.
  • Overcoming Section 101 Rejections: Focus on Prong Two of the subject matter eligibility analysis, highlighting technological improvements and practical utility.
  • Managing Patent Term: Be aware of the patent term, terminal disclaimers, and potential adjustments or extensions.
  • Utilizing Director Review: Know the process and benefits of seeking Director Review for fact-intensive issues.
  • Strategic Use of Continuations: Use continuations to refine claims and address examiner concerns effectively.

FAQs

What are the different types of patent allowance rates calculated by the USPTO?

The USPTO calculates the first-action allowance rate, progenitor allowance rate, and family allowance rate to assess the likelihood of a patent application being granted[1].

How do continuations affect the patent examination process?

Continuations allow applicants to file new applications related to the original, which can complicate allowance rate calculations but provide opportunities to refine or expand claims[1].

What is the significance of Prong Two in overcoming section 101 rejections?

Prong Two requires demonstrating that the claims are directed to a specific, concrete technological advancement or solution to a technical problem, emphasizing practical utility and real-world impact[2].

How does the Director Review process work?

The Director Review process involves an independent Delegated Review Panel reviewing fact-intensive issues, which can lead to a decision, remand, or additional briefing[5].

What is the typical term of a US patent?

A US patent generally has a term of 20 years from the filing date of the application, subject to adjustments and extensions[3].

Sources

  1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
  2. Baker Botts. (2024, August 26). The Importance of Prong Two of Step 2A for AI Inventions. Retrieved from https://www.bakerbotts.com/thought-leadership/publications/2024/september/the-importance-of-prong-two-of-step-2a-for-ai-inventions
  3. USPTO. (n.d.). 2701-Patent Term. Retrieved from https://www.uspto.gov/web/offices/pac/mpep/s2701.html
  4. NCBI. (n.d.). A lyophilised pharmaceutical formulation and its use - Patent WO-2017149199-A1. Retrieved from https://pubchem.ncbi.nlm.nih.gov/patent/WO-2017149199-A1
  5. Sterne Kessler. (2024, February 8). 2023 Changes in Director Review. Retrieved from https://www.sternekessler.com/news-insights/publications/2023-changes-director-review/

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Details for Patent 10,293,030

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Biogen Inc. AVONEX interferon beta-1a For Injection 103628 May 17, 1996 ⤷  Subscribe 2036-02-29
Biogen Inc. AVONEX interferon beta-1a Injection 103628 May 28, 2003 ⤷  Subscribe 2036-02-29
Biogen Inc. AVONEX interferon beta-1a Injection 103628 February 27, 2012 ⤷  Subscribe 2036-02-29
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 March 07, 2002 ⤷  Subscribe 2036-02-29
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 December 17, 2004 ⤷  Subscribe 2036-02-29
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 December 21, 2012 ⤷  Subscribe 2036-02-29
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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