Novartis Loses Patent Appeal Over $2.8 Billion Multiple Sclerosis Drug Against Chinese Pharma

Swiss drugmaker Novartis' logo is seen at the company's plant, in the town of Stein, Switzerland, on Oct. 23, 2017. (Arnd Wiegmann/Reuters)

A U.S. appeals court overruled its prior decision, deciding that the patent for Novartis AG’s blockbuster drug Gilenya was invalid.

The decision dealt a blow against the Swiss pharmaceutical company as it potentially paves the way for the introduction of cheaper generic versions of the drug. Though the drug made $2.8 billion in 2021 globally, this was already a drop in revenue compared with previous sales due to increased competition, the company reported.

The U.S. Court of Appeals for the Federal Circuit reversed its own 2020 ruling (pdf) in Novartis’s lawsuit against the Chinese drug maker, HEC Pharm Co. on June 21.

HEC was sued by Novartis (pdf), along with other drug makers in 2018, for filing for the right to market a generic of the Gilenya drug even though the drug was still patented.

Other drug makers have since entered confidential agreements with Novartis, allowing these manufacturers to launch generic Gilenya prior to the patent expiry of December 2027.

HEC lost the lawsuit in 2018, as well as subsequent appeal cases in 2020 and January 2022. However, the Chinese drug maker has now managed to reverse the outcomes in their favor.

The appealed case revolved around Gilenya’s ‘405 patent (pdf), which includes methods for treating relapsing multiple sclerosis with a specific dose of the medication. The patent called for daily administration of Gilenya’s 0.5 mg.

However, the patent’s specification fails to mention to not administer loading doses, which are higher or more frequent doses at the start of treatment.

“Instead, it describes administering fingolimod (Gilenya) at regular intervals,” the court documents show.

“Because the ‘405 patent fails to disclose the absence of a loading dose, the district court clearly erred” in its earlier decision, Chief Judge Kimberly Moore wrote in the appeals court’s latest verdict.

Nevertheless, not every judge agreed with the reversal, circuit judge Richard Linn dissented, arguing that the panel majority applied a higher standard to the case than it should have.

The renewed decision by the divided panel revives hope for Chinese drug maker HEC Pharm’s appeal to make a generic version of the multiple sclerosis drug, which is currently set to be patented until December 2027.

In a statement released on June 21, Novartis wrote that it “intends to vigorously defend the validity of the patent and is considering all available options.”

Since the formal mandate closing the appeal case has not been closed, Novartis said that they believe HEC and other filers “are not permitted to launch a generic version of Gilenya at this time.”

Novartis initially sued HEC in a Delaware federal court in 2018, after the Chinese company filed for approval of a Gilenya generic with the Food and Drug Administration (FDA), along with other drug makers. The application was approved in 2019.

Gilenya has been a commercial success for Novartis. It was the company’s third best-selling drug, making $2.8 billion in revenue in 2021 according to company reports (pdf).

HEC was also previously sued in 2014 by Eli Lilly for applying to market the generic of Efficient tablets, for which Eli Lilly had an exclusive license.

According to HEC Pharm GmbH’s website, “research and development is the engine of the company,” with “more than 1,500 scientists” working on the “development of generics, new pharmaceutical products and biologicals.”

The products currently for sale on the company’s website are only generic drugs.