Government's obligation
As illustrated by the Sandoz lawsuit against the FDA, any policy changes would probably result in legal action. The FDA is, most likely, waiting for Congressional action before setting regulatory policy, but Congress itself seems reluctant to do so. No mention was made in Congress of bio-pharmaceutical drugs in the recently amended Hatch-Waxman Act, and little movement in this market is predicted for the immediate future.
Legal recourse is a long approach and it also costs a lot of money. It is also difficult to predict what the courts may decide. Rulings in patent infringement lawsuits have provided little in the way of definitive answers. For example, in Scripps Clinic vs. Genentech (1991), a federal circuit court determined that the end product, not the process, was patent protected.
In another federal case, Atlanta Thermoplastics vs. Faytex (1992), a circuit court reached the opposite conclusion (Herrera 2004). Although a case-by-case resolution will take time and involve substantial cost, it may be the best answer in this highly contentious field. As more scientific information is published, informed judgments about market entry will be less difficult to achieve.
In addition, information from those countries that have allowed the market entry of generic bio-pharmaceutical drugs will be available for review. The prices of bio-pharmaceutical drugs will encourage more efforts in research and development. The prospect of longer-term monopoly power will add to that incentive, and high prices will induce third-party payers to impose pre-certification and other requirements to try to control their costs.
At some point, the development of improved second-generation bio-pharmaceutical drugs may encourage pioneer companies to support expedited approval based on clinical trials conducted for the original drugs. These companies would have to balance the gains achieved from preventing follow-on drug entry against the lower cost of obtaining approval for second-generation medications (Chamberlain 2004).
