The structure of the pharmaceutical industry almost invariably leads to antitrust issues. Patent protection is strong. The patentee, prior to generic entry, usually has a monopoly over the particular pharmaceutical dosage, but often not as to a therapeutic category. The patent-based monopoly can lead to large profits—sometimes more than a billion dollars per year for blockbuster drugs. When a generic product is introduced to the market, the substitution for the patentee product is rapid, often above 90% in the first six months, and virtually guaranteed, given healthcare and insurance policies.
Thus, antitrust issues that follow abbreviated new drug application (ANDA) disputes arise in two main ways: (1) accusations that settlements between the patentee and the generic allow the brand to extend its patent based monopoly; and (2) accusations that the patentee engaged in some form of anticompetitive behavior to keep the generic out of the market, such as sham patent litigation or patent litigation based on a fraudulently acquired patent.
Educational Objectives:
- Become aware of potential litigation risks to be aware of brand-generic ANDA settlements
- Learn strategies for successfully prosecuting and defending antitrust claims involving generic drugs
- Find out about up-to-date discussion of court decisions regarding ANDA antitrust issues
Who would benefit from attending the program?
In-house and outside counsel for brand and generic drug companies responsible for (1) patent litigation; (2) negotiation of settlements, including transactional lawyers; (3) general litigation.