Drug industry patents go under Senate Judiciary Committee’s microscope

Reviewed by James Ives, M.Psych. (Editor)May 8 2019

Congress isn't making much headway in finding a solution to the problem of soaring prescription drug prices, but lawmakers from both parties are tinkering on the edges with legislation that aims to increase competition among drugmakers.

A comprehensive piece of drug-pricing legislation is a high priority for Senate Finance Committee Chairman Chuck Grassley, (R-Iowa) and Sen. Ron Wyden (D-Ore.). And it could be introduced by mid-June, according to congressional staff.

But while that is hashed out, a slate of options to reform drug patents is working its way through the Senate Judiciary Committee, which had a hearing Tuesday featuring academics, patient advocates and a representative from the pharmaceutical industry. Their mission: to increase competition without decreasing innovation in the industry.

"I think we're dangerously close to building a bipartisanship consensus around change," Sen. Dick Durbin (D-Ill.), said during the hearing.

The four proposed bills share a common goal: avoiding some of the thorny issues around drug pricing, like whether the government will set drug prices or negotiate with manufacturers on what federal programs will pay. Instead, the patent reform proposals get at the ways branded drug manufacturers use patents, and the legal monopolies that are granted with patents, to keep lower-priced generic competitors from reaching patients.

"A package of patent reforms are important because they fix systemic problems that allow prices to go up and keep them high," testified David Mitchell, the president of Patients for Affordable Drugs, a Washington, D.C.-based advocacy group focused on lowering prescription drug prices.

Sen. John Cornyn (R-Texas) offered specific examples of drugs that have benefited from  system issues, including Humira, an expensive drug for arthritis and psoriasis that is protected by 136 patents.

That's called a "patent thicket," because it prevents a generic alternative from entering the market for more years — in this case, until 2023 for a drug first approved for use in the United States in 2002. "Is there anyone on the panel who'd like to defend the status quo?" he asked.

"There is no way a biosimilar can deal with a hundred patents," testified Michael Carrier, a professor at Rutgers Law School. "This is an abuse of the system."

Among the proposed bills, the Stop STALLING ("Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics") Act, is the bipartisan brainchild of Sen. Amy Klobuchar (D-Minn.) and Grassley. The bill is supposed to put a stop to "sham" citizen petitions to the FDA. Critics say these petitions are often introduced by drugmakers under the guise of patient advocacy to slow FDA approval of new generic medicines. "Nearly every one of these citizen petitions is brought by a brand company. None are filed by individuals. I love the legislation. I would go even stronger," Carrier said.

Grassley is also the lead sponsor on the bipartisan Prescription Pricing for the People Act of 2019. It directs the Federal Trade Commission to investigate mergers of pharmacy benefit managers, the middlemen that negotiate between drugmakers and health plans.

Klobuchar and Grassley teamed up again on another measure, the Preserve Access to Affordable Generics and Biosimilars Act, which they  say would end "anti-competitive behavior" — specifically, deals struck between branded companies and generic companies to keep a generic, or a biosimilar, off the market. Klobuchar,  a Democratic presidential candidate, has frequently discussed her opposition to this practice on the campaign trail.

James Stansel — the executive vice president and general counsel of the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, and the lone voice of the pharmaceutical industry on the panel — cautioned against moving too aggressively on this point. "We want to make sure we don't do something that's anti-competitive in the hopes it would be pro-competitive," he said.

There's also the CREATES ("Creating and Restoring Equal Access to Equivalent Samples") Act, introduced by Sen. Patrick Leahy (D-Vt.) with 31 bipartisan co-sponsors and endorsed by nearly every witness on Tuesday's panel. It's supposed to crack down on branded companies that refuse to sell samples of their drugs to generic companies, a necessary step to increasing the number of generics on the market.

Versions of all four of those bills have also been introduced in the House and advanced out of the House Judiciary Committee.

"The American people are being played for chumps," said Sen. John Kennedy (R-La.). "Just chumps. And it's got to stop."