Agenda Day 2

10:00 AM - 10:45 AM Law and IP at the Cutting Edge of Technology: Challenges Faced and Opportunities Presented

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What are the current IP and legal challenges,
and opportunities that are at the cutting edge
of emerging and future technology? Where might
current legal and IP systems break down? What are
some of the philosophical, ethical, policy, and legal
issues that might emerge in the future?

10:45 AM - 11:30 AM Are Pharmaceutical IP Departments Prepared Within Their Current Frameworks to Respond to the Increase in Innovation Through Technology?

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Extending the period of the market exclusivity and
responding properly to the recent agglomeration
of patent expiries are pivotal to the success
of pharmaceutical companies. Declining R&D
productivity and rising costs of commercialisation,
near-term patent expirations for many top-selling
drugs are forcing companies to adopt new systems
to introduce innovative products to market and
to focus on strategies that increase the returns
from the existing product portfolio. From an
organisational perspective, how might the IP
department react in this environment?

11:30 AM - 12:15 PM A New Pharmaceutical Reality, Life After the Patent Cliff

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While many predictions regarding the patent
cliff have been accurate, the ‘drop’ has not been
quite as dramatic as the title would suggest. While
the profitability of many of the old blockbusters has
declined, new types of pharma products such as
speciality drugs are taking over, making the ‘drop’
less impactful for pharma corporations, and the
new challenges that manufacturers face are very
different to those when the patent cliff predictions
were made. What are the new IP challenges that
exist, and what must your department do to
effectively respond to them?

2:00 PM - 2:45 PM The Early (un)Certainty Programme?

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In principle, the Early Certainty Initiative is a
positive one- who isn’t interested in getting a
patent early? But, with proceedings that have an
average duration of perhaps four to five years now
being compressed into a single year, the frequency
of communications, summons to oral proceedings,
budgets, and workloads of your departments will
significantly increase. Is your organisation prepared
for the accelerated practice, or will a competitor
beat you off the mark?

2:45 PM - 3:30 PM The Patent Lifecycle Protection Issue

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Claudio will tell you one thing you do know, and
one thing you don’t know: that there is a long
patent lifecycle before monetisation. How you
work around this, though, differs; protection does
not stop at the compound. What aspects of your
processes might you wish to patent, and which
combinations of compound and devices could you
look to?

4:15 PM - 5:00 PM A Global IP Strategy for Biotechnology Innovation MAY include Other Types of IP in Addition to Patents

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Harriet will deliver a briefing on an IP strategy
where trade secrets may be risky in an
environment, reverse engineering is relatively easy
and rapid. The biotechnology industry has global
reach. Nonetheless biotechnology tools do not
have the market value of a pharmaceutical product
and therefore might not justify the expenditure
incurred by filing patents in many countries of
the world with the intention to defend these
patents. This is compounded by legal systems
that make defence slow and expensive with the
outcome uncertain. Moreover, the technology
evolution is relatively rapid meaning that a slow
pace of IP acquisition and conflict resolution is
counterproductive. Company branding and defence
of quality products through trademarks can form
an important complement to patent protection in a
global IP strategy.

5:00 PM - 5:45 PM Personalised Medicine, Medical Indication Patents and Patent Infringement: Emergency Treatment Required

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Personalised medicine from a research and
development perspective has a far reaching impact
beyond oncology and includes a socio-political
impact. It is important that assessment of the need
for business and legal certainty is carried out in
order to invest in costly, risky, and lengthy research
and development for clinical innovation. A clear,
unambiguous understanding of what should be
patented must also be established.