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Pre-Conference Workshop
Monday, October 16
*Separate Registration Required
7:30 am
Registration and Continental Breakfast
8:30 am - 11:30 am Market Protection for Repositioned Drug Candidates
The main goal of this workshop is to explore several approaches that may be utilized to obtain effective market protection for
repositioned drug compounds that carry a patent history for their original indications. This can be accomplished through:
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A review of U.S. and European patent and regulatory considerations surrounding the protection of new drugs
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An examination of intellectual property protection options for repositioned compounds
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An interactive discussion around optimizing IP and regulatory strategies for maximizing business objectives in
multiple world markets
8:30 How to Protect Repositioned Drugs in the U.S.
Kate H. Murashige, Partner, Pharmaceutical & Healthcare, Morrison & Foerster LLP |
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Patents can be obtained to protect repositioned pharmaceuticals, but some strategic approaches are needed to be successful.
Earlier disclosures relating to the new indication are often found, either by coincidence or because a patent on
the drug itself contains a "laundry list" of indications. These can often be circumvented by including diagnostic steps,
undisclosed symptomologies, new associated effects, or surprising results. Formulations that are critical for success can
also be protected. In sum, patents on new molecules are straightforward and powerful, but method of use patents can
serve to protect new indications just as effectively. |
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9:30 Integrating International Patent, Regulatory and Product Life Cycle Strategies to Maximize
Market Protection
Herwig von Morzé, Ph.D., International Patent Consultant |
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The market for repurposed and repositioned drugs is a global one, and pharmaceutical companies must consider international
practices and rules. Repositioned drug candidates, as well as drugs with impending expirations, can benefit from
optimizing IP strategy. This IP strategy should be closely integrated with the regulatory and product life cycle strategies
and aligned with business goals. The discussion will focus on:
International IP strategy for repurposed drugs and drugs with impending patent expirations
Maximizing strength, duration and international geography of protection (patent, utility model, patent term extension
opportunities, supplementary protection certificates and regulatory exclusivity) with international IP tools
Pluses and minuses of international market or exclusivity protection compared with United States protection
Mandatory integration of international patent, regulatory and product life cycle strategies to achieve business objectives |
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10:30 Regulatory Issues Relating to New Uses--Market Protection for Approved Uses and Risks from
Unapproved Uses
Donald O. Beers, Partner, Arnold & Porter LLP |
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New uses
for existing drugs can be the subject of market and
patent protection, but there are significant
limitations on the value of such protections. This
talk will discuss the available options and the
limitations. Sometimes new uses do not
lead to FDA approval, but are simply adopted by the
physician community based on available data. But
significant offlabel uses lead to risks to
pharmaceutical companies. The risks, and steps to
control those risks, will be discussed. |
11:30-1:00pm Lunch on Your Own
11:30-1:00pm
Summit Registration
*Separate Registration Required
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