Morgan Lewis on Life Sciences
January/February 2003

In this Issue:

• A Shift in the Hatch-Waxman Balance: FDA's Proposed Rule:
  The Hatch-Waxman Act, which created today’s generic drug system, was premised on balancing two divergent interests — facilitating the approval of generic drugs, and providing adequate incentives for the development of new pioneer drugs.
• Managing Pre- and Post-Acquisition Pharmaceutical Patent Due Diligence:
  Pharmaceutical product acquisitions are not daily occurrences. Because pharmaceutical product approvals are precious, most companies are reluctant to part with approved products or even with late-stage development compounds.
• Patent Reexamination Standards Liberalized:
  Legislation enacted in November 2002 liberalized the standard for instituting patent reexamination, overruling prior case law, In re Portola Packaging, 110 F.3d 786 (Fed. Cir. 1997), that precluded the U.S. Patent and Trademark Office (“PTO”) from considering, during reexamination, prior art references that had previously been cited during the original examination of the patent.
• Medical Device User Fee and Modernization Act:
  On October 26, 2002 important new legislation was enacted that significantly affects the regulation of medical devices and combination products. While the impetus for the legislation, the Medical Device User Fee and Modernization Act (MDUFMA), was the imposition of device user fees, the MDUFMA also covers establishment of a new office ofcombination products, third-party inspections, and pre-market review of certain reprocessed devices.

For the full story, please view the PDF.