Teva ‘Skinny Label’ Decision Comes Amid Legislator’s Fight Against Drug Costs
Republican and Democratic lawmakers trying to bring down prescription drug prices may have come at a key in their efforts through a federal appeals court, following a ruling according to legal experts, which will complicate entry into the generic market.
Manufacturers of brand-name drugs often file patents on new uses of old drugs. Generic drug makers trying to enter the market often apply “skinny labels” to their copied versions of drugs that cut out new patented uses of the mark in order to prevent the courts from holding them liable for infringement.
But on Thursday, the United States Court of Appeals for the Federal Circuit may have made it more difficult for generic manufacturers to rely on the practice to evade legal action. By reinstating a $ 235 million patent infringement verdict against
“This will force them to be much more careful,” said Dmitry Kashtedt, law professor at George Washington University. “This notice makes it clear that a label, if not particularly carefully worded, even if it tries to avoid counterfeiting, can still be read as a user manual, which is a classic way to induce a counterfeit. “
The Teva decision comes as government support for lowering prescription drug costs reaches bipartisan heights. Lawmakers on both sides of the aisle and the Biden administration are relying on legislation and government agencies to curb the practices of drug companies that many see as anti-competitive.
“It is unfortunate that this ruling is being made now, when so much emphasis is placed on drug pricing” on Capitol Hill and with the administration, said Scott Lassman, FDA legal and policy attorney at Lassman Law. + Policy. “This is the kind of thing that will be detrimental to that.”
The decision “undermines all efforts to address the drug price problem,” Lassman said.
‘In the dark’
A rendered divided Federal Circuit sign GlaxoSmithKline vs. Tevathe result. The majority called the decision a “close, case-specific review” that will not impact other cases of skinny labels. Dissent has claimed it leaves generics “in the dark about what might expose them to liability.”
GSK’s drug Coreg was initially approved for the treatment of hypertension, but the company later obtained approval and a patent to promote the drug as a way to prevent congestive heart failure. After GSK’s patent on Coreg’s active ingredient expired, Teva began selling a generic with a thin label only mentioning hypertension.
GSK nevertheless sued, alleging that press releases on Teva’s website encouraged doctors to prescribe its generic for heart failure. Thursday’s ruling marks the second time the case has been taken to the Federal Circuit, with the majority writing “substantial evidence supports conclusion that Teva’s partial label was evidence Teva asked doctors to use his carvedilol illegally ”.
Some legal experts say the ruling places more emphasis on using a thin label to determine whether a generic infringes a brand name drug.
“The notice makes it clear that evidence of incitement can come from anywhere, ironically including the skinny label itself,” Karshtedt said. And given the current congressional climate around dropping drug prices, the decision “may prompt further congressional action” to have skinny labeling definitely considered non-infringing.
‘No more bite’
At the end of July, a series of bills backed by both parties aimed at lowering drug prices by reducing allegedly anti-competitive behavior were submitted to the Senate Judiciary Committee.
Among them are bills limiting agreements whereby brand name drug makers compensate generics for waiting to enter the market and prohibiting companies from changing the formulation or delivery of drugs to transfer a patent to a new one. version of a product, or “product break”.
“Congress is interested in medical innovation,” said John Thomas, Georgetown law professor. The Teva decision would “complicate” these efforts, because now patents for “secondary” drugs “may have more teeth.”
Thomas said that for a long time generics have “engaged in a nudge, nudge” situation where they sell products primarily used for the cut indication, given that from a patient perspective. and the doctor, “An old reused drug is the same as a new drug.
Now, “reused drugs can be subject to significant intellectual property rights, which would delay competition for reused drugs,” Thomas said.
“Generically, a lot of people say the sky is falling under scant labeling. On the other side, on the brand side, they argue that this case is an anomaly and the skinny labeling will not be affected negatively, ”Burgy said.
“It’s going to create a lot of ambiguity going forward, and it’s going to create complexity over time,” he added.