The bill Senator Collins introduced would help generic competitors to biologics cut through “patent thickets” in order to produce lower-cost alternatives to these life-saving treatments
Click HERE to read Senator Collins’ floor statement
Washington, D.C.—In a continuation of her efforts to increase the affordability and accessibility of prescription drugs, U.S. Senator Susan Collins (R-ME), the Chairman of the Aging Committee, spoke on the Senate floor this afternoon to urge her colleagues to support the Biologic Patent Transparency Act. Senator Collins introduced the bill last week with Senators Tim Kaine (D-VA), Rob Portman (R-OH), Jeanne Shaheen (D-NH), Mike Braun (R-IN), and Debbie Stabenow (D-MI) to help block the harmful patent strategies that prevent lower-cost generics from coming to market.
“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. “America’s system of protecting innovation has provided our citizens with tremendous benefits, especially in the area of pharmaceuticals. We must provide pharmaceutical manufacturers 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. Passing the Biologic Patent Transparency Act is a major step we can take to put a stop to the patent gaming that blocks consumers from accessing lower-cost drugs. I encourage my colleagues to support this crucial legislation.”
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.
Senator Collins has made it a priority to lower the soaring costs of prescription drugs. In 2015, Senator Collins and then-Senator Claire McCaskill (D-MO) launched the Senate’s first bipartisan investigation into the causes, impacts, and potential solutions to egregious price spikes for certain off-patent drugs. They released a report on their investigation in 2016. Following their investigation, Senators Collins and McCaskill authored a bill to improve generic competition and lower the cost of prescription drugs that was signed into law as part of the FDA Reauthorization Act.
Following reports on the skyrocketing price of insulin, Senator Collins chaired a hearing in May 2018 on the reasons for the price spikes and the impacts that these increases have on patient access. In addition, in November 2018, Senators Collins and Jeanne Shaheen (D-NH), the co-chairs of the Senate Diabetes Caucus, wrote to the three largest insurance companies—United Healthcare, Anthem, and Aetna—requesting information on insulin prices and rebates.
In October 2018, Senator Collins’ legislation to prohibit the use of pharmacy “gag clauses” was signed into law after passing both the House of Representatives and the Senate with overwhelming bipartisan support. The Patient Right to Know Drug Prices Act and the Know the Lowest Price Act prohibit an egregious practice that concealed lower prescription drug prices from patients at the pharmacy and caused consumers to needlessly overpay.
Click HERE for a one-pager on the Biologic Patent Transparency Act.
Click HERE for the text of the Biologic Patent Transparency Act.