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Fish Forum Fish at the Podium

Patent Resources Group (PRG) Hatch-Waxman and Biosimilars: A Total Immersion Course Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal

Thursday, April 16th, 2015, 8:00 am EDT

Fish Forum Fish at the Podium

Patent Resources Group (PRG) Hatch-Waxman and Biosimilars: A Total Immersion Course Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal

Thursday, April 16th, 2015, 8:00 am EDT

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April 16 -18, join the Patent Resources Group (PRG) and principals from Fish & Richardson’s life sciences group for an immersion course on “Hatch-Waxman and Biosimilars: Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal.” Details are included below and also available on the event website.

16 April 2015 – 18 April 2015
Orlando, FL
Course Schedule: 8:15 – 11:30; 1:30 – 4:15 (Days 1-3)

Hatch-Waxman and Biosimilars:
A Total Immersion Course Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal
Register Online | Register by Mail or Fax

Faculty:
Janis Fraser, Fish & Richarsdon
Terry Mahn, Fish & Richarsdon
Chad Shear, Fish & Richarsdon
Dorothy Whelan, Fish & Richarsdon

Projected CLE Credit: 16.5

Hatch-Waxman and Biosimilars Syllabus

Course Highlights
Topics covered by the course include ideas for addressing the new challenge of patenting compositions derived from nature, for ensuring that your claims will survive validity challenges, and for obtaining patents on inventions (such as side effects) discovered after the product is on the market. The lecturers will explain what to expect in a Hatch-Waxman litigation or in the “patent dance” required by the BPCIA, considerations to take into account when settling such a litigation, and strategies for successfully challenging a patent (or surviving a challenge) under the various types of post-grant procedures. The increasing importance of the pharmaceutical label as a way to extend the life cycle of an approved drug is explored and specific strategies proposed.

Course Materials:
Each attendee will receive a detailed set of slides covering all of the topics included in this intensive immersion course.

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