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What is the hottest issue now with respect to pharmaceutical patents?
The Hatch Waxman Act and the many antitrust lawsuits alleging sham litigation in connection with the 30 month delay in FDA approval of generic drugs when a patent lawsuit is filed based on a generic company's FDA filing. While some of these antitrust cases have been dismissed, others have been settled for large sums and others are headed for trial. Meanwhile, Congress is considering whether and how to amend the law to speed generic approvals. Companies should focus R&D and patenting on value-added improvements that may be listed in the FDA's Orange Book to minimize their antitrust risk.
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