By Julie Schmit
USA TODAY
The launch at risk strategy means the generic-drug maker would be liable for damages if it were to lose a patent case. Companies take that chance because of intense competition to be first with generics of blockbuster drugs and their increased confidence of winning patent disputes.
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(Schmit, USA Today, 8/24).
Prescription Drugs Drug Makers Introducing Generic Medications While Patent Claims Still Being Considered in Court
USA Today on Tuesday examined the increasing trend of generic drug companies releasing lower-cost versions of brand-name medicines while "fighting patent claims in court." The "launch at risk" strategy can result in a generic drug maker being liable for damages if it loses a patent case, but companies are accepting the risk because of the "intense competition" in the generic industry and their "increased confidence of winning patent disputes," USA Today reports. Drug companies usually have 20 years to develop and market a medication without facing generic competition, and 30 additional months during patent litigation when they can keep disputed generic drugs off the market. FDA-approved generics can be marketed after the 30-month period, even if the brand-name drugs' patents remain under dispute. The first generic drug launched for a brand-name version can win 70% of the market in the first six months, when other generics are prevented from release, according to USA Today.
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