The New Jersey-based company is seeking an injunction in the United States District Court for the District of Columbia to prevent the rule from taking effect in the coming months.

Merck spokesman Robert Josephson said in a statement: “Because this law unlawfully undermines our core purpose of conducting innovative research that saves and improves lives, Merck will I intend to take this matter to the U.S. Supreme Court.”

The White House, HHS and CMS did not immediately respond to requests for comment on the lawsuit.

At issue are the requirements surrounding the Inflation Act negotiation process, in which CMS will negotiate how much Medicare will pay for 10 widely used high-priced drugs that have no generic competition.

In its complaint, Merck said that the bargaining and the stipulated minimum discount that pharmaceutical companies are obliged to offer to avoid being levied on huge taxes is the government’s claim on property taken for public use. said it violated the Fifth Amendment’s Receives Clause, which requires it to provide “just compensation.” .

“The IRA uses the threat of heavy penalties to compel manufacturers to transfer patented drugs to Medicare beneficiaries for public use. [Inflation Reduction] The law disguises these seizures as “sales” by forcing manufacturers to accept government-mandated payments equal to a portion of the drug’s fair value. By definition and by design, it is not ‘just compensation,'” the company argued in its lawsuit.

Merck also claimed that free speech was being suppressed by participating in what it called “fake negotiations and agreements.”

“Corporate recruitment to legitimize government blackmail is a form of parroting practice prohibited by the First Amendment Forced Speech doctrine,” the complaint said.

The company also told the court that the government prevented Merck from making “a statement against it” in subsequent negotiations. Guidance CMS published in March The law prohibits companies from disclosing “any information orally exchanged during negotiations.”

“The IRA imposes severe penalties for requisitioning drugs while refusing to pay fair value, smiles at manufacturers, goes along with them, and asks if it’s all part of a ‘fair’ voluntary exchange.” “We are coercing you to do so,” the complaint alleges.

Timing is important. CMS plans to release a list of his first 10 drugs to be negotiated on Sept. 1. You have 3 months left. Merck’s widely prescribed blood sugar drug Januvia is also likely to be one of the drugs of choice. The company said it expects cancer drug Keytruda and diabetes drug Janumet to be selected in future rounds.