Legislation would help generic competitors to biologics cut through “patent thickets” in order to produce lower-cost alternatives to these life-saving treatments
Washington, D.C.—In a bipartisan effort to encourage competition in the prescription drug marketplace and put an end to the harmful patent strategies that block new drugs from coming to market, U.S. Senators Susan Collins (R-ME) and Tim Kaine (D-VA) introduced the Biologic Patent Transparency Act. The legislation was cosponsored by Senators Rob Portman (R-OH), Jeanne Shaheen (D-NH), Mike Braun (R-IN), and Debbie Stabenow (D-MI).
“The past century could be termed the Age of Miracle Drugs. Today, however, we might define a ‘miracle drug’ as one that has not doubled in price since the last refill,” said Senator Collins. “We must provide drug makers with the ability to recoup their investments, but at the same time, we cannot be blind to the costs of these drugs, nor to cases where patent laws are manipulated to preserve monopolies. This legislation is an important step to stop the patent gaming that blocks consumers from accessing lower-cost biologics.”
“Biologic medicines can be life-changing for many patients, but we must do more to promote competition in the market to ensure patients can access and afford them. Our bill sheds light on the ways patents can be used to deter competition and encourages manufacturers to obtain key patents earlier, which will help bring new treatments to patients faster,” said Senator Kaine.
“One of the most effective ways to hold down drug costs is through competition, and I’m proud to cosponsor this bipartisan bill because it will increase transparency and reduce barriers that discourage efforts to bring generic alternatives to market,” said Senator Portman.
“Skyrocketing drug prices continues to be one of the biggest obstacles impacting our health care system today, and hurt Granite Staters who rely on medication for chronic conditions like diabetes. By increasing transparency in the patent process and reducing patent system abuses by brand name drug companies, this bill will break down barriers that have prevented generic companies from entering the market and provide consumers with more affordable prescription medication options,” said Senator Shaheen. “This is a common-sense, bipartisan approach to confront a serious problem and I urge members on both sides of the aisle to get behind this legislation so we can reduce prescription drug costs.”
“While drug prices for Americans are rising across the board, costs for critical biologic medications have been skyrocketing,” said Senator Mike Braun. “I’m proud to sign on to Senator Collins’ Biologic Patent Transparency Act to shed much-needed light on the legal tricks contributing to higher prices and turn off the music on the so-called ‘patent dance’.”
“We need transparency and information about how patents are being used – and abused – by Big Pharma,” said Senator Stabenow. “Our legislation takes an important step towards shining a light on drug companies’ deceptive practices.”
Biologic medicines represent a new and promising era in treatments and are used to treat serious and life-threatening conditions, from diabetes and rheumatoid arthritis to cancer and multiple sclerosis. Biologics are also among the most expensive drugs on the market, and their exorbitant cost can put these prescriptions out of reach for patients. Fewer than two percent of Americans use biologics, yet these drugs account for nearly 40 percent of total drug spending.
Biologic manufacturers often seek to protect their products by using “patent thickets” which range from dozens to even hundreds of patents. Too often, companies design these thickets with the intent of blocking competition, and although some of the patents may be invalid or unenforceable, expensive patent litigation can deter competitors from offering consumers lower-cost alternatives.
The Biologic Patent Transparency Act would require companies to publicly disclose the web of patents that protect their biologics, making it easier for competitors to evaluate and plan for the development of generic versions of these drugs. It would also discourage late-filed patents and require the FDA to regularly publish information in its “Purple Book” on approved biologics, such as patents, exclusivity, and biosimilarity.
Click HERE for a one-pager on the bill.
Click HERE for the text of the bill.