Monday, April 22,
2013 Preview

By Andrew Williams
—

This
week, the 2013 BIO International Convention is in Chicago, home of the Patent
Docs.  If you are planning on attending,
you probably already know that the amount of information and opportunities
available can be daunting.  Therefore, we
would like to provide a preview of some of the sessions or other opportunities
that might be of interest to Patent Docs readers.  This is not, however, meant to be an
exhaustive list of events (far from it), and it is not meant to be an
endorsement of these events over any others in particular.  Instead, we are just highlighting various
events that caught our eye as presented and described in the BIO schedule.  Moreover, 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 (#3684) to discuss any of these sessions,
whether you think Chicago-style pizza is better than Chicago-style Hot Dogs, or
just about any other topic that is of interest to you.

BIO
kicks off on Monday with several breakout sessions that might be of interest to
readers of this blog.  In addition, the
Exhibitor Hall will be open for business.  However, there are no Super Sessions scheduled for Monday, and there is
no keynote luncheon.  In the evening, the
Welcome Reception will occur on Navy Pier between around 7:00 pm to 9:00 pm.

Biotech Patenting and Tech
Transfer Track

The
Biotech Patenting and Tech Transfer breakout session track is one that readers
of this blog usually find interesting, and this year is no exception.  On Monday afternoon, this track is featuring
a couple of sessions that highlight global considerations for patent protection
and procurement.  One of these sessions, The
Unitary Patent: How Will it Affect the Biotech Sector and Your Business, is
moderated by Patent Docs author Donald Zuhn.  This session, which is scheduled on Monday from 3:45 pm to 5:00 pm, will
explore the new unitary patent system that the EU Council recently passed.  Once the system is ratified, these unitary patents will be valid in all of
the participating countries, and a centralized patent court in Paris (with
branches in London and Munich) will handle the litigations related to these
patents.  This session promises to review
the political background of patent systems in Europe, analyze the expected
benefits of this system for the applicants, and devise new strategies to allow
optimal benefit from the new legal framework.  The speakers are Victor Kaas, Director of Biotechnology at the European
Patent Office; Cyra Nargolwalla, Partner at Cabinet Plasseraud; and Alexander
Natz, Director General of EUCOPE.

Former
Undersecretary of Commerce for Intellectual Property and USPTO Director David
J. Kappos will be moderating the other global patent law session in this track
on Monday (2:30 pm to 3:30 pm):  How Much is Enough? Comparing Canadian,
European, Japanese and U.S. Patent Utility Requirements for Biopharmaceutical
Inventions.  As the session
description points out, there have been 18 pharmaceutical patents rendered
invalid or unenforceable in Canada on the grounds of lack of utility.  This session will provide both viewpoints
regarding these developments, Patrick Kierans, Senior Partner at Norton Rose
(Toronto) will argue that Canada's utility requirement runs counter to Canada's
obligations to numerous international trade agreements, and Tim Gilbert,
Partner at Gilberts LLP (Toronto) will argue that these invalidations reflect
flawed patent applications and sound Canadian patent law.  The discussion will also include Bert
Oosting, Partner at Hogan Lovells (Amsterdam); Takashi Fujita, with Akabe,
Ikubo & Katayama (Tokyo); and David Kappos, currently Partner at Cravath
Swain and Moore (New York), all of whom will provide the global context to this
issue.

Personalized Medicine and
Diagnostics Track

Many,
if not all, of the sessions from this breakout track tend to be of interest to
Patent Docs readers.  However, one
highlight will be Monday from 10:15 am to 11:30 am:  How IP Issues Impact
Innovations in Biomarker Diagnostics & Personalized Medicine.  The description of this session explains that
personalized medicine research and development require considerable costs, and
the innovators in the field need to seek enforceable patents to protect their
inventions and investments.  Jan Skouv,
Director IPR of Exiqon A/S, will moderate the session with Simon O’Brien,
Chartered Patent Attorney at D. Young & Co.; John Tessensohn, Board Member
at Shusaku Yamamoto Patent Attorneys; and David Gass, Partner at Marshall
Gerstein & Borun as speakers.  In
addition, to discussing the recent court decisions regarding
patent-eligibility, and the impact they will have on diagnostics, they will
analyze how the U.S., EP, and JP patent offices are examining such
applications, and discuss enforcement issues, such as territoriality and joint
infringement considerations.

Manufacturing of Biologics
and Drugs Track

Perhaps
not on the radar of many readers of this blog, this breakout track has a
session on Monday between 10:15 am and 11:30 am that may be of interest this
week, and may continue to be of interest in the future:  Biosimilars Manufacturing and Supply Chain
Stability: What Does the Current Drug Shortage Crisis Suggest for Biosimilars?  As the description for this session explains,
there is a drug shortage crisis in this country because hundreds of generic
drugs are in short supply, or will soon be.  This has profound implications for both the patients that do not have
access to these drugs, and for the future of drug innovation.  The FDA is trying to prevent any harm from
these shortages, but the extent to which these drug shortages will threaten
public health is unknown.  This is
critical to keep in mind when considering the FDA's implementation of the new
approval pathway for biosimilars.  It
needs to be considered whether such biosimilars will also be at risk for
shortages, and what preventative measures could be taken.  This session will be moderated by Andrew
Spiegel, CEO of the Colon Cancer Alliance, and will include as speakers Kenneth
Getz, Director of Sponsored Research Programs and Research at Tufts Center for
the Study of Drug Development; and Richard Lit, Vice President, Global
Regulatory Affairs, Amgen Inc.