PATENT PROTECTION
To improve their chances of winning, brands typically file in one of two district courts: Delaware
and New Jersey. Sometimes, they
also file in New York’s southern district court. Jonathan Singer, principal at law firm Fish & Richardson LLP, says drug companies have traditionally been clustered in these areas and, as a result, judges have become familiar with the subject matter at hand, embedding a sense of trust and security within the brands. “If you file in an unfamiliar place, what you risk is the prevalence of
the common attitude of people
who like and need drugs rather than the merits of the case,” he says. “In those three courts, you tend to get what we call a ‘fair shake’. You win or lose on the merits, as opposed to losing because generic drugs are seen as being good for society.”
Trying to improve their own chances of success, generics commonly ‘gang up’ on brand owners. Generics typically have fewer resources than brands, so they pool them together to pile on the pressure. Tey combine money and lawyers, and split up responsibility for handling different aspects of the case. “Tis allows them collectively to devote more attorneys and expenses than the innovator company can individually,” says Monroe. While it is a sensible approach for
“AIMING TO CONSOLIDATE AS MANY CASES IN ONE COURT BY FILING AGAINST MULTIPLE GENERICS SIMULTANEOUSLY, THEY CAN KEEP THEIR OWN COSTS DOWN.”
patent covering a molecule, can force brands to find other approaches to litigation. As they move towards the ‘weaker’ patents—on method and formulation—brands are more willing to settle for “shortened terms”, adds Singer. “Te brand might say ‘we’ll make enough money in 10 years so we’ll let the generic company on the market aſter that time period, and forfeit the remaining years of patent exclusivity’. Tey basically say: ‘let’s split the difference’.”
The 30-month stay
generics, brands try to adopt an equally efficient strategy for litigating. Aiming to consolidate as many cases in one court by filing against multiple generics simultaneously, they can keep their own costs down and more easily keep track of what can be a very complex process.
But brands don’t have it easy. Tis sustained attack from generics and, possibly, the lack of a ‘strong’
Turning to the second major strategy—delaying the entry of generics to the market—Monroe says he is unconvinced of its effectiveness. Under US patent legislation, if a company sues within 45 days of receiving a notice from a generic wanting to produce its drugs, it is automatically entitled—in most cases—to a ‘30-month stay’. Tis stay prevents the FDA from finally approving a generic product for the first 30 months of the litigation.
“But there is a lot of rhetoric about the 30-month stay,” says Monroe. “Te bottom line is that two things are happening: courts are trying to ensure that these cases are resolved within the 30-month period and before preliminary FDA approval, ie,
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