LSPN Europe 2018: Russian litigation and US second medical use
The strategies of generic makers in Russia have changed dramatically over the past few years, according to Natalia Gulyaeva, partner at Hogan Lovells.
Speaking at LSPN Europe 2018 in London on Thursday, November 15, Gulyaeva said that previ-ously, generic makers were attempting to bring generics to market one to two years before the ex-piry of the patent covering the brand drug.
But generic producers are now trying to obtain marketing authorisation for their generic products five to seven years before patent expiration.
In the past, the Russian courts would only grant permanent injunctions in patent disputes when the infringing generic product was actually commercialised.
This meant that innovators would typically wait until the generic was commercialised before suing. But, as the generic makers’ strategies changed, so did the innovators.
Gulyaeva said that her team came up with an alternative strategy in a case involving a generic maker—to sue on the basis of threatened patent infringement.
The Russian Court of First Instance affirmed that the generic producer’s actions, which included conducting a bioequivalence study, obtaining market authorisation and obtaining state registration of a wholesale price, proved the threat of patent infringement and justified a permanent injunction.
She concluded that bringing a claim for threat of patent infringement is a “very strong remedy” these days and that lawyers should recommend this strategy to their clients.
Meanwhile, at another session at last week’s LSPN event, patent attorney Matt Mulkeen of Novartis Pharmaceuticals spoke about the US approach to second medical use patents.
He said that, under the Hatch-Waxman Act, a party filing an abbreviated new drug application (ANDA) may be accused of inducing infringement through the act of filing the ANDA.
For example, in the context of a patent directed to methods of using a drug, a generic manufacturer may be held liable for inducing use of a drug (through a doctor’s prescription or a patient’s use) if the packaging directs consumers to use the drug in an infringing manner.
Mulkeen described this as an “artificial act of infringement” as, once the ANDA has been filed, the matter becomes a hypothetical evaluation of what a future product would be/look like.
In claims of induced infringement, such as this, the claimant must show that the accused had knowledge of the patent and had taken affirmative action to encourage infringement of that patent.
With Orange Book listings, there is “no way” that a generic can argue that they don’t have the knowledge, and the submission of an ANDA is viewed as an affirmative step, Mulkeen said. But, a generic company may file an ANDA for a method of use not covered by the Orange Book-protected drug: a second medical use.
Even if the ANDA is approved for a non-infringing use but doctors go on to prescribe the drug for another use, such as a use that is patent-protected, the generic manufacturer will not be held liable for infringing the patent owner’s rights, Mulkeen said.
“How people may or may not use the product is legally irrelevant,” he said.
Mulkeen added that doctors and patients are “left out” of the litigation, as the dispute takes place between the owner of a branded drug and the accused generic manufacturer who is allegedly re-sponsible for the inducement.
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