After the Supreme Court's decision regarding eBay, the grant of an injunction to enforce a valid and infringed patent is no longer assured. Citing the public interest prong of the four-part injunction test, district courts are beginning to consider alternative remedies for infringement of patents on therapeutic drugs and biologics, including the imposition of a compulsory license. This issue was litigated at length in the U.S. District Court for the District of Massachusetts in Amgen v. F. Hoffmann- La Roche, a case in which the district court initially considered, but ultimately rejected, the grant of an "injunction on terms," which would have permitted the defendant to introduce a competing product found to infringe valid patents, subject to payment of a royalty and court supervision of pricing. Driven by similar policy considerations aimed at encouraging price competition in the market for biologics, Congress is now poised to create a special regulatory framework for litigating biotechnology patents under an abbreviated approval pathway for follow-on biologics that may restrict the availability of injunctive relief and otherwise limit remedies for infringement. On this panel, experts will evaluate the business implications of these developments from the perspective of innovator companies and their investors and discuss these developments in the context of proposed follow-on biologics legislation.

• Review the evolving legal landscape, including increasing judicial acceptance of "injunctions on terms" and compulsory licenses in the wake of eBay
• Evaluate the implications of these developments for the exclusivity business model
• Offer strategies to maximize the chances of obtaining injunctions to enforce patents on biologics