The U.S. Court of Appeals for the Federal Circuit supported the jury’s 2017 ruling that Teva urged doctors to abandon the use of GlaxoSmithKline’s drug Coreg (carvedilol) to use the drug that is still protected by patent law, and it was decided by a score of 2 to 1. Announced on Thursday.
A company can be held liable by persuading others to “induce” patent infringement, usually through advertisements, instructions for use, or the wording used on the labels discussed in this case.
In their precedent opinions, most people stated that although their verdict was overturned by the district judge, the jury members actually concluded that “part of Teva’s label is that Teva instructs doctors to use its Kawi in an infringing manner. Evidence of Dilo” and against Teva’s loss of US$234 million and another US$1.5 million in royalties due to the loss of GlaxoSmithKline’s sales.
In her dissent, Judge Prost strongly disagreed. She said: “Because reasoning is sometimes laborious and sometimes opaque, most people try their best to support a jury verdict that cannot be supported.”
Teva not so skinny tags
In 2007, Teva launched its generic version of carvedilol, with the label “hollow” or “slimming”, indicating that it can effectively treat hypertension and left ventricular dysfunction after a heart attack, and avoid GlaxoSmithKline still holds a patented indication-the treatment of heart disease. Congestive Heart Failure (CHF)-or so they think.
However, despite this “thin label”, doctors can still prescribe Teva’s generic medicine, and pharmacies can automatically substitute it for any purpose, including the treatment of CHF, thanks to Section 8 of the Hatch-Waxman Act.
Section viii allows generic drug manufacturers to seek FDA approval to sell generic drugs for non-patent purposes, where the reference drug has multiple indications, but not all indications are included in the method of use patent.
If a generic drug applicant takes this route, it must propose to label its products “open up” the use of patents, and only seek approval for methods that have never been protected by patents or whose protection has expired.
Legal history
GlaxoSmithKline first sued Teva in 2014, arguing that Teva infringed its 2008 relicensed patent, which listed a variety of “follow-up” ways you can use the drug, including its use to treat CHF. Teva replied that it has not done such a thing and has successfully developed a patented method of use. The jury disagreed, arguing that Teva either knew or should have known that their labels and advertisements would cause doctors to infringe.
After GlaxoSmithKline won the jury trial, Teva Pharmaceuticals sent the case back to the district court for review. The district judge dismissed the jury’s findings, saying that they were based on insufficient evidence to prove that the doctor relied on the label to use the drug in an impermissible way, and that any infringement was caused by non-Teva factors (for example, the cardiologist knew in advance that it was used Carvedilol). In an appeal to the Federal Circuit Court of Appeals, GlaxoSmithKline argued that the District Court had exceeded its authority. The Federal Circuit found this convincing and restored the jury’s verdict in its October 2020 decision. Immediately, a group of relevant stakeholders voiced their voices, and they worried that this ruling made Hatch-Waxman’s thin label clause meaningless.
In February, the court accepted Teva’s request for retrial, leaving criticism of its October 2020 decision Full of hope It will narrow the scope of its investigation to protect the generic drug industry’s ability to use “thin labels” to launch non-branded alternatives at risk, which is the approach set out in the Hatch-Waxman Act of 1984.
The latest decision of the Federal Circuit
The court did not narrow the scope of its investigation, but responded to the criticism one by one, showing how every possible reason considered by the jury to induce infringement was found to be persuasive by the jury, and how the results of the investigation induced by Teva were supported by the jury. Overall evidence.
In doing so, it clarifies one point that makes generic drug companies insomniac: whether the claim of chemical equivalence itself is an inducement by marketing a drug’s AB rating. To their collective relief, the court found that this was not the case.
The AB rating is the approval of the company’s scientific evidence by the regulatory agency, proving that its drug is bioequivalent to its reference material, so it is equally safe and effective. This rating makes it legally possible for generic drugs to be interchanged with their brands, thereby reducing drug prices for suppliers and patients.
The court found that, based on this set of specific facts, if the label does not adequately divide the patent use, the AB rating is evidence of infringement.
“Under these limited circumstances, Teva’s AB rating statement, when substantive evidence supports the jury’s presumed decision on the content of the label, is further affirmative evidence in support of the jury’s inducing decision,” the court said.
In a footnote, it distanced these situations from the “real section viii peeling” (ie, sufficiently thin labels that did not mention any patent infringement uses), stating that Teva had switched to AB ratings to support its “partial labeling” The court stated that the jury “is free to use it as evidence to induce patent infringement.”
The court specifically mentioned the expert testimony of doctors, namely how or whether they read the label of a generic drug before prescribing it to the patient.
Most people found that the evidence that Teva mentioned that its drug is related to cardiovascular disease patients is convincing evidence that it induced CHF patients to use the drug, and this indication is still patented. As the dissident pointed out, even though the same doctor admitted that they did not read the label before prescribing the medication.
“The idea is that the label itself does not explain the problem,” George Washington University professor Dmitry Karshtedt said in a telephone interview. “The question becomes, how useful can expert testimony be? Here it does, which makes this a very specific result of the investigation — or at least the court is trying to express it that way.”
Photo: Gearstd, Getty Images
