Post-Grant for Practitioners: A monthly series of webinars focusing on developments in post-grant proceedings and related practice tips.
Since September 16, 2012, patent practitioners have been paying close attention to post-grant proceedings – methods of challenging patent validity at the United States Patent and Trademark Office. Fish & Richardson is one of the most active firms in filing and advising on post-grant matters, and on February 13, 2013, kicked-off a monthly webinar series designed to share practice tips, nuances, observations, and strategy. Information on previous webinars in this series is included below, with the most recent appearing first.
2016 WEBINAR SERIES:
The number of IPR petitions filed against biopharma patents at the Patent Trial and Appeal Board continues to steadily increase. Join us for a discussion on Significant PTAB Decisions in BioPharma on November 9, 2016. Fish’s Dorothy Whelan and Tasha Francis provided an update on the most recent biopharma PTAB statistics and decisions. They also discussed the implications of these decisions on the industry and the future impact on biopharma patents.
As the popularity of biosimilars continues to grow in the United States, biosimilar and biologics manufacturers have begun testing the bounds of the BPCIA statute in district court litigation. In addition, biosimilar manufacturers have also turned to IPR proceedings to challenge patents covering biologic drugs.
- Recent district court cases and their impact on the biosimilars industry
- IPRs challenging biologic patents
- Strategies for biologics litigation
While inter partes review (IPR) petitions of design patents are rare (less than 1%), it is expected that the numbers will steadily increase with the growing popularity of design patents generally. Fish attorneys Jim Babineau (Austin) and Craig Deutsch (Twin Cities) discussed issues in the inter partes review (IPR) of design patents and the Patent Trial and Appeal Board’s (PTAB) procedures for challenging design patents. Jim and Craig reviewed:
- Statistics and recent trends at the PTAB
- Claim construction
- Obviousness analysis applied to design patents
Recent statistics from the USPTO show that still more post-grant review (PGR) proceedings have been filed. As more patents issue under the America Invents Act (AIA), are PGR proceedings a favorable option as a counterpart to inter partes review?
Post-grant review is available immediately after patent issuance and it is designed to allow proceedings to conclude quickly. Fish & Richardson attorneys Joshua Griswold and Dan Smith discussed the requirements for PGR and estoppel, and took a closer look at how practitioners are using PGR proceedings as part of their patent strategy. They also took a closer look at recent PGR filings and the first PGR decisions from the Patent Trial and Appeal Board, providing best practices and strategic considerations.
On July 13th, we had a midyear review and discussion of the latest Patent Trial and Appeal Board decisions in 2016. Fish attorneys Dorothy Whelan and Stuart Nelson offered insights and best practices based on their experience, and projected what’s ahead for the second half of 2016. Topics included:
- Recent cases the PTAB identified as precedential
- Latest developments in biopharma IPRs
Fish Principals John Adkisson (District Court trial lawyer experienced in PTAB Trials), Stephen Schaefer (PTAB practitioner), and Thomas Rozylowicz (PTAB practitioner), continued our recent discussion of evidentiary trends at the Patent Trial and Appeal Board (PTAB), focusing on “paper” witness testimony. Witness testimony in a PTAB trial is presented on the papers instead of through live witness testimony. Our speakers provided best practices and practical tips for post-grant practitioners to consider in light of this. Topics included:
- How the PTAB treats issues of bias and credibility
- Expert witness competence, and Daubert Standards in PTAB trials
- Strategy considerations given witness testimony is on the papers
- Exceptions when live testimony may be permitted
Fish attorneys Thomas Rozylowicz, Stephen Schaefer, and David Holt discussed evidentiary trends at the Patent Trial and Appeal Board (PTAB) and provided practical insights for practitioners on how to prepare and submit evidence to support either a petitioner or patent owner position. Topics included:
- Evidentiary objections – evidence weight and admissibility
- Evidence strategy and PTAB evidence procedures
- Timing of evidence submitted and limitations for both petitioners and patent owners
We continued our discussion from March on multiple parties and multiple petitioners. Our speakers took a closer look at redundancy and 325(d) and how they influence strategy in post-grant proceedings. They addressed a number of hypothetical situations involving filings at the PTAB and address the issues that petitioners and patent owners face.
Last year, the FDA approved the first biosimilar drug under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and the courts have recently rendered some important statutory interpretations. This represents the dawn of a new era in the approval and marketing of biologic products. As the popularity of biosimilars grows, biosimilars manufacturers have turned to IPR proceedings to challenge patents covering biologic drugs.
Fish attorneys Dorothy Whelan and Brian Coggio presented for our third presentation in this series. (Replays of the first and second webinars are available here.) This presentation discussed recent developments, including:
- A review of biosimilars IPR filings and PTAB decisions to date
- Multiple filer/multiple petitions issues and related timing considerations
- Tips for both challengers and patent owners
Fish Principals Dorothy Whelan and Karl Renner discussed multiple parties and multiple petitions in post-grant proceedings, and offered practical tips for both patent owners and petitioners. To date, these issues have arisen primarily in the tech area. However, they will become increasingly important in the life sciences, particularly in biosimilars. Topics included:
- Multiple parties filing a single petition vs. individual petitions
- Real party in interest and privity issues
- Joinder and consolidation issues
- Timing issues where there are multiple potential filers
- Redundancy when filing multiple petitions
2015 brought the first wave of Federal Circuit decisions in appeals from final written decisions in inter partes review and covered business method proceedings. In its first 55 post-grant appeals, the Federal Circuit affirmed or dismissed 89%, with most being summary affirmances without opinion.
Fish Principals John Dragseth and Craig Countryman, discussed the Federal Circuit’s record on PTAB post-grant appeals and the fundamental legal issues that will impact post-grant cases in the future. Topics included:
- Challenges to the PTAB’s decision to institute
- Claim construction
- Procedural issues
2015 was a busy year for Post-Grant proceedings at the PTO. Fish Principals and Post-Grant Co-Chairs, Karl Renner and Dorothy Whelan, discussed significant developments in IPR practice during the year, including:
- AIA Patent Trials: The New Proposed Rules
- Bass and Bio-Pharma Developments
- Estoppel, Broadest Reasonable Interpretation, and Appeals of Institution Decisions
- NPEs, Strong Patents Act & the Revised Innovation Act
Additional topics discussed were: the implications that these issues may have on your business and patent strategy and the issues to watch for in 2016.