Catalyst Continues Legal War Against Jacobus Pharmaceuticals


Catalyst Pharmaceuticals has filed new patent infringement lawsuits against Jacobus Pharmaceuticals and PantherRX Rare LLC over a treatment for the rare autoimmune disease Lambert-Eaton Myasthenic Syndrome (LEMS). The company claims a rival product infringes on a newly-granted patent.

The lawsuits were filed in both the U.S. District Court for New Jersey against Jacobus and the U.S. District Court for the Western District of Pennsylvania against PantherRx. Florida-based Catalyst said the companies have infringed on its patent for Firdapse (amifampridine), the first drug approved in the United States to treat LEMS. Specifically, Catalyst said patent No. 10,793,893, which was granted earlier this month by the U.S. Patent and Trademark Office, covers certain methods for treating disease using amifampridine drug products, including Catalyst’s Firdapse, in patients who are slow metabolizers of amifampridine. Catalyst claims Ruzurgi, a treatment for pediatric LEMS patients developed by Jacobus and its partner PantherRx, infringes on its patent when it is administered in accordance with its product labeling.

Catalyst has been fighting regulatory approval of Ruzurgi since the U.S. Food and Drug Administration first gave it the greenlight in 2019, a year after Firdapse was approved. Ruzurgi, which has a lower list price than Firdapse, was approved for pediatric use, but the data used for that approval was supported by evidence from well-controlled studies of the drug in adult LEMS patients. That suggests that doctors treating adults with LEMS could opt to prescribe Ruzurgi over Catalyst’s Firdapse. Catalyst filed a lawsuit against the FDA over those claims. The lawsuit alleged the approval of Ruzurgi for pediatric patients “violated multiple provisions of FDA regulations regarding labeling.”

In September, a federal judge dealt a body blow to Catalyst when he dismissed the lawsuit. A statement from Catalyst notes the judge said the strict interpretation of the Orphan Drug Act used by Catalyst is not necessarily wrong, but was “not the only reasonable way to interpret the plain language of the statute.” The judge said the language was ambiguous and, as a result, adopted the FDA’s interpretation. The judge also rejected Catalyst’s argument that the labeling for Ruzurgi was false and misleading.

Following that legal loss, Catalyst vowed to continue its fight and protect its intellectual property.

Patrick J. McEnany, chairman and chief executive officer of Catalyst, said the lawsuit seeks to protect its patent rights and intellectual property. Catalyst is seeking damages and an injunctive relief seeking to prevent further marketing of Ruzurgi.

“Catalyst has invested significant resources in neuromuscular drug discovery and in building an intellectual property portfolio that aids in the discovery and development of drugs for the treatment of rare neurodegenerative diseases that are without a safe and effective FDA approved therapy," McEnany said in a statement. “We intend to diligently and vigorously protect our patent rights for the benefit of our company and our stockholders and prevent infringing use by others. Catalyst remains confident in its patent portfolio, and has filed several additional patent applications claiming priority from the ‘893 patent to enhance the protection of the Firdapse patent estate.”

When Firdapse was first approved, Catalyst set a list price of $375,000 for the treatment. That prompted U.S. Sen. Bernie Sanders, an outspoken critic of high drug prices, to accuse Catalyst of price gouging, particularly since the family-owned Jacobus Pharmaceutical had been giving away treatments to 200 LEMS patients.

LEMS is an autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. LEMS affects approximately one in 100,000 people in the United States and about 3 million people globally. In LEMS, the body’s immune system attacks the connection between cells and muscles. The most common symptoms of the autoimmune disorder are proximal muscle weakness and fatigue. Symptoms can be life-threatening when the weakness involves respiratory muscles. Approximately 50 percent of LEMS patients have an underlying malignancy.

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