Shaheen & Bipartisan Group of Senators Launch Effort to Stop Patent Gaming and Increase Access to Lower-Cost DrugsMarch 07, 2019
**Legislation Would Help Generic Competitors to Biologics Cut through “Patent Thickets” in Order to Produce Lower-Cost Alternatives to These Life-saving Treatments**
**As Governor, Shaheen Fought to End Harmful Patent Strategies to Facilitate Expanding Access to More Affordable Prescription Medication – Watch here.**
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. Senator Jeanne Shaheen (D-NH) joined Senators Susan Collins (R-ME) and Tim Kaine (D-VA) yesterday to introduce the Biologic Patent Transparency Act. The legislation is cosponsored by Senators Rob Portman (R-OH), Mike Braun (R-IN) and Debbie Stabenow (D-MI).
“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.”
This has long been a top priority for Senator Shaheen. In 2002, then-Governor Shaheen testified before the Senate Commerce Committee on the benefit of generic pharmaceuticals that can take place when patents expire on time, which can expand the opportunity for more affordable prescription medication.
Watch Governor Shaheen’s testimony here.
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 the text of the bill.
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