We have extensive experience in Hatch-Waxman cases and have been involved in over a dozen such lawsuits. Our work has involved every aspect of providing representation to proprietary pharmaceutical companies, from early assessment of patent portfolios covering products that may be subject to generic challenge to advising clients on how potential problems can be corrected before litigation begins to trying the cases.
We also help clients develop viable strategies based on our knowledge and understanding of the regulatory principles of the Food and Drug Act. Our lawyers draw on their knowledge and experience in advising clients on new and supplemental drug exclusivity provisions, orphan drug exclusivity, pediatric exclusivity and operation and use of patent term extension rights. We also counsel clients on patent listing issues, based on the experience we have gained in assessing patents for this purpose. And, of course, all of these variables are contemplated in conjunction with the planning for and execution of an effective patent litigation strategy in response to ANDA filings containing paragraph IV notifications.
A significant strength of Sidley is that the Food, Drug and Medical Device Regulatory group works closely with the intellectual property lawyers on Hatch-Waxman litigation matters. The Hatch-Waxman Act provides a complex approval scheme for generic drugs that integrates both patent and regulatory issues. Often, Hatch-Waxman litigation involves unique issues regarding whether a patent may be listed in FDA’s Orange Book, patent certification requirements for the generic applicant, the scope of market exclusivity periods and the 30-month stay of approval against the generic applicant. There also may be issues regarding the approval requirements governing the generic application, including bioequivalence, labeling and formulations issues. The FDA Regulatory group has extensive experience with the Hatch-Waxman Act and agency administrative proceedings, such as citizen petitions, letters and meetings.
We have also handled many pharmaceutical cases outside the Hatch-Waxman context, often on behalf of pharmaceutical companies sued by patent holders claiming that successful products infringe their patents. We find that the same patent litigation experience of lawyers who have worked on Hatch-Waxman cases can be brought to bear in these disputes.