In a set-back to brand-name drug companies, the U.S. Supreme Court cleared the way for a generic drug-manufacturer to sell its products after gaining approval from the Food and Drug Administration.
The court lifted an injunction against Sandoz, Inc., which markets a biologic drug to stimulate production of white blood cells. The company had been marketing Zarxio in the United States, until Amgen, Inc. obtained an injunction for alleged patent infringement in Sandoz v. Amgen.
However, the justices reversed and said injunctive relief was not available under the applicable federal law.
Biologics are a type of drug derived from natural, biological sources such as animals or micro-organisms. They are used to treat many conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, plaque psoriasis, breast cancer, and diabetes.
In the United States, a manufacturer of a biologic product may market the drug only if the FDA has licensed it. But to obtain approval, a manufacturer of a biosimilar product must give notice to a previously licensed manufacturer, who becomes “the sponsor.”
Before the manufacturer markets its product, the sponsor may seek a preliminary injunction prohibiting any sales until a court decides the issue of patent validity, enforcement, and infringement.
Sandoz won approval for Zarxio — the first biosimilar drug to win U.S. regulatory approval — but Amgen sued alleging patent infringement and procedural violations of under the Affordable Care Act. Among other concerns, Amgen said Sandoz should have given notice and waited 180 days before selling its product.
In 2015, the U.S. Circuit Court of Appeals for the Federal Circuit agreed and enjoined the company for violating the 180-day rule. The U.S. Supreme Court reversed.
“Congress did not intend sponsors to have access to injunctive relief, at least as a matter of
federal law, to enforce the disclosure requirement,” Justice Clarence Thomas wrote for the unanimous court.
However, the court remanded the case for a determination about whether the plaintiff may obtain injunctive relief under state law.
According to reports, the decision has major implications for the pharmaceutical industry because it will dictate how long brand-name makers can keep biosimilars off the market. Six months can mean hundreds of millions of dollars in sales.