BIO International Convention 2014 Preview -- Part III: Post-Grant Patent Challenges and Biosimilar Regulatory Pathways

BIO International ConventionThe 2014 BIO International Convention has already begun in San Diego, but most of the sessions and forums get underway beginning on Tuesday, June 24, 2014.  Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention.  For example, today, we focus on issues surrounding post-grant challenges of patents, both in the U.S. and Europe, and on the issues surrounding the regulatory approval of biosimilars.  Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth to discuss these sessions (or whatever other topic is of interest to you) (#1337).

Today we highlight two distinct topics that may be of interest to readers of this blog.  The first involves the ability to challenge issued patents at the U.S. Patent Office or EPO instead of in the court system.  Many detractors of the U.S. patent system have blamed the Patent Office for issuing too many vague or allegedly invalid patents.  The AIA set up new and improved mechanisms allowing potential or alleged infringers to request another look by the Office.  Of course, EPO has already had a lot of experience with opposition proceedings.  A couple of panels will look at the challenges and considerations involving these mechanisms.  The second topic does not necessarily implicate intellectual property, but patent attorneys are certainly paying close attention to regulatory approval pathways for biosimilars.  All eyes have been focused on the FDA, but so far the mechanisms established for the approval of biosimiars have not been sufficiently utilized.  It is therefore useful to look at the scientific and regulatory issues faced by countries outside the U.S.

With regard to post-grant challenges, we first note that Donald Zuhn of Patent Docs fame will be moderating a panel on opposition proceedings at the European Patent Office on Wednesday, June 25, at 4:15 PM to 5:15 PM.  The title of this session is "'Chairman, That Patent Should be Revoked!' -- Join the EPO Opposition Mock Workshop and Help Argue the Case."  As the name suggests, representatives of the EPO are scheduled to conduct a realistic opposition proceeding to decide the fate of a contested illustrative patent.  Both the proprietor and defendant will be represented by European patent attorneys, but attendees are invited to join either party and help debate the case.  The session promises to elucidate how opposition proceedings are conducted within the EPO, explore how the validity of patents are determined, and compare the differences with comparable proceedings in the U.S.  The speakers for this session are Siobhán Yeats, Director of Biotechnology at the European Patent Office; Reuben Jacob, partner at RGC Jenkins & Co.; and Aylsa Williams, Partner at D Young & Co LLP.

In addition to hearing the comparisons between the EPO and US systems in the previous session, attendees will also be able to hear an in-depth presentation on post-issuance challenges at the United States Patent Office.  On Wednesday, June 25, at 10:15 AM to 11:30 AM, the Intellectual Property track will be feature "Navigating Patent Challenges Under the America Invents Act."  Biotechnology and pharmaceutical companies are not immune to such challenges, so it is important to understand the intricacies of these relevantly new procedures.  Moreover, the Federal Circuit's Fresenius v. Baxter International decision has made the timing of such a challenge an important consideration.  Of course, which process is used and how it is defended can affect not only whether suitable patent protection can be maintained, but can limit or expand defenses available either in court or at the Office.  This session will assess the risks and benefits associated with the available actions for challenging patent validity at the Office, in the courts, and at the International Trade Commission.  The speakers for this session will be Lead Administrative Patent Judge Michael Tierney, Patent Trial and Appeal Board; Judge Dana Sabraw, U.S. District Court for the Southern District of California; and Cliff Ford, Executive Director and Senior Patent Counsel at Isis Pharmaceuticals, Inc.  The session will be moderated by Meaghan Kent from Venable LLP.

With regard to the two sessions we are highlighting with regard to the regulation of biosimilars, unfortunately their times overlap (likely because they are in different tracks/forums).  First, the Regulatory Review & Approval track will present "Ensuring the Safety and Commercial Success of Biosimilars in the United States" on Tuesday at 1:45 PM to 2:45 PM.  The description of the session notes that there is a debate over what approach the FDA and the industry should take to ensure patient safety on one hand, and promoting market competition and continued biomedical innovation on the other.  The session promises to explore several critical issues related to safety, naming and traceability, substitution, product drift, and comparability and similarity.  There will be a focus on the lessons learned from Europe in the launch of the new class of biosimilar monoclonal antibodies.  With regard to issues of naming products, the "unknown" differences between an approved treatment with known process histories and a new product being studied for biosimilarity will be discussed.  The speakers for the session are Marcia Horn, President and CEO of ICAN (the International Cancer Advocacy Network), Phillip Schneider, Associate Dean and Professor at the University of Arizona College of Pharmacy; and Robert Yapundich, Board Certified Neurologist with the Neurology Associates, P.A.

At about the same (1:30 PM to 3:30 PM on June 24), the Emerging Opportunities in Global Markets Forum will present "Biosimilars Regulations: A Perspective from Influential Global Regulators."  This session will feature regulatory agency officials from around the globe to discuss both scientific and regulatory issues for biosimilars, especially with regard to the WHO draft guidelines.  For example, the discussion of approval requirements will address clinical trials, extrapolation of data, and immunogenicity, among other topics.  The session promises to also address issues surrounding naming, labeling, and pharmacovigilance.  The panel will include Lic. Mikel Arriola, Commissioner at COFEPRIS; and Dirceu Barbano, President of ANVISA; and will be moderated by Christian Lopez-Silva, Partner with Baker & McKenzie, S.C. in Mexico.

We look forward to seeing you at BIO 2014!


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McDonnell Boehnen Hulbert & Berghoff LLP on:

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