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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Patent

Date & Time
  • event Date

    Thursday, October 3, 2024

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$347.00
CLE
ALL

This CLE course will guide patent counsel through strategies for overcoming Section 101 rejections of biotech patents. The panel will review recent case law and USPTO guidance on Section 101 patent eligibility and offer strategies to address Section 101 rejections.

Faculty

Amanda K. Murphy
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new patent applications, prosecutes U.S. and foreign applications, and represents applicants at appeals and oral hearings before the PTAB. She has experience in prosecuting inter partes and ex partes reexamination applications, reissue applications, and patent term extension applications for approved pharmaceuticals, including obtaining supplemental protection certificates in Europe.

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Paul W. Browning
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

Dr. Browning focuses on patent litigation and appeals. He has led teams as first chair at trial, at Markman proceedings, and on appeal. His litigation experience includes taking and cross examining witnesses at trial, briefing and arguing dispositive motions, drafting appellate briefs, and arguing cases on appeal. He has also managed day-to-day litigation activities in actions involving multiple parties. In addition, he advises clients on patent matters, including coordination of prosecution and U.S. and foreign litigation strategy.

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Sara A. Leiman
Attorney
Finnegan Henderson Farabow Garrett & Dunner LLP

Dr. Leiman prosecutes and provides strategic counseling on U.S. and foreign patent portfolios, provides validity and patentability opinions, and manages and prepares landscape and freedom-to-operate analyses. She has developed global prosecution strategies and prosecuted patent applications in fields spanning the life sciences, including antibodies, complement inhibition, controlled-release formulations, diagnostics and in vitro detection assays, gene editing (e.g., CRISPR), gene therapy, immunology, immuno-oncology, metabolic disease, neuroscience, nucleotide sequencing, protein purification, and recombinant and fusion protein therapeutics. Her work also includes preparing invalidity and infringement contentions for district court litigations in the mechanical and electrical spaces.

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Description

The number of Section 101 rejections over all types of technologies, including biotechnology, has dramatically increased since the Supreme Court's decision in Mayo Collaborative Servs. v. Prometheus Labs. Inc. (U.S. 2012) and Alice Corp. v. CLS Bank (U.S. 2014).

A review of USPTO guidance documents and art unit-specific responses to Section 101 can help practitioners craft a strategy for overcoming subject matter eligibility rejections. The guidance documents attempt to summarize the specific facts and holdings of exemplary 101 cases and suggest analogous fact patterns presented in prosecution to identify eligible and ineligible claims. Case law has not clearly illuminated the line between eligible and ineligible subject matter. Still, it does provide helpful guidance regarding claim types to avoid because they have been found ineligible by the courts.

The panel will discuss these cases and their counterpoints, suggesting potential strategies for eligible patent protection under Section 101.

Section 101 rejections and appeals continue to mount in numbers as examiners and PTAB judges attempt to reconcile inconsistent case law. Applicants should anticipate Section 101 rejections and devise strategies to prevent or mitigate these rejections. Anticipating and properly planning for eligibility rejections can lead to success in avoiding or overcoming these rejections.

Listen as our authoritative panel of patent attorneys discusses the impact of the Mayo and Alice decisions and the USPTO's guidance on Section 101 rejections. The panel will offer best practices for patent counsel to avoid or overcome Section 101 rejections for biotech patents.

Outline

  1. Current guidance
    • How the courts have applied Mayo and Alice and lessons learned from those decisions
    • USPTO guidance
  2. Strategies for avoiding or overcoming 101 rejections in biotech patents
    • Identifying and arguing deficiencies in examiner's characterization
    • Examiner interviews
    • Addressing the rationale behind a rejection
    • Amending claims
    • Improved drafting

Benefits

The panel will review these and other relevant issues:

  • The impact of recent decisions on USPTO and Federal Circuit decisions addressing 101 rejections for biotech patents
  • The reliability of USPTO guidance documents
  • Robust patent specification and claim drafting tips to help avoid 101 rejections
  • Potential strategies to overcome 101 rejections