Navigating the EU's Sweeping REACH Requirements: Nov. 30 Deadline Could Affect your Ability to Do Business

Held June 30, 2008

Winning first-applicant status for 180-day generic marketing exclusivity used to come with a requirement: Market the generic product within 30 months of winning Abbreviated New Drug Application (ANDA) approval.

But in January, FDA letter rulings involving Teva Parenteral Medicines and Cobalt Pharmaceuticals changed everything. Now, brand-name drugmakers and generic drugmakers make deals to delay introducing the generic product, “parking” the exclusivity period. The result? Subsequent ANDA filers must honor the exclusivity period even though no generic is being marketed.

How can subsequent ANDA filers keep these from plugging development pipelines and profits?

Start by registering for Navigating the FDA’s New 180-Day Generic Marketing Exclusivity Rulings.

Antitrust and intellectual property experts Michael Keely and Chad Landmon explain the all-new filing and litigation strategies generic companies must use to keep product portfolios — and revenue — growing.

Order now for your entire team to listen in and discover:

  • What you must know about congressional intent on the generic exclusivity forfeiture provisions — and why it matters to your strategy now
  • Five filing and litigation changes generics companies must make to stay competitive
  • How “parking” can affect patent settlements between ANDA filers and brand companies
  • Best practices for navigating antitrust issues involved in settlements that “park” the exclusivity period.

With more brand drug patents up for review in the coming months, this audioconference helps provides practical, early-warning guidance on how to steer clear of roadblocks.

This audio CD/Transcript is a must for generic and branded drug and biologic companies, including:

  • Regulatory and compliance professionals
  • Supply and product sourcing directors
  • Executive management
  • General and corporate counsel
  • Business development officers
  • International business operations
  • Outside attorneys
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Cándido García Molyneux is of counsel in the Brussels office of Covington & Burling. His practice focuses on EC environmental law, Spanish food and drug law and international trade law. He advises clients on legal issues concerning environmental product regulation, chemical law, waste management, Spanish medicines and cosmetics rules, and international trade law and non-tariff trade barriers. Cándido was actively involved in the legislative process resulting in the REACH regulation for several companies and trade associations, and advises clients on the impact of the new regime, particularly the implications for downstream uses of chemicals.

Peter Bogaert is a partner based in the Brussels office of Covington & Burling, with a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments, and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Peter’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products. He represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

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