Morgan Lewis on Life Sciences
July 2002

In this Issue:

• Welcome and Introduction
• BuSpar® and Tiazac® Antitrust Cases Leave Unanswered Questions:
  Over the last few years, an increasing number of antitrust cases have challenged various actions taken by pharmaceutical companies to extend the period during which their pioneer products receive patent protection. Most of those cases have involved agreements between pioneer companies and would-be generic entrants to delay the time of generic entry while patent disputes are being litigated or as part of a settlement of those disputes. Recently, however, two cases —one in federal court and one administrative— have attacked the purely unilateral act of listing certain patents in the FDA’s Orange Book, pursuant to provisions of the Hatch-Waxman Amendments.
• Calendar of Sponsored Events
• Changing Environment for Pharma-Biotech Collaborations:
  Recent FDA regulatory setbacks delaying product review and approval have clearly changed the dynamics and structure of partnering arrangements between big pharma and biotech companies.
• Major Changes Proposed for EU Drug Approvals:
  Under the proposed legislation, the centralised procedure will be mandatory for all new active substances.
• Quick Hits
• The Supreme Court Unanimously Decides Festo:
  On May 28, 2002, Justice Kennedy authored the decision of a unanimous Supreme Court that clarifies the application of the doctrine of equivalents to a claim in a patent, which claim resulted from a narrowing amendment to the claim.
• Speeches & Articles

For the full story, please view the PDF.