Biosimilar Legislation Making Headway Towards Reconciliation Bill

With the intensity of horse trading that is underway on Capitol Hill, it is difficult to keep up with the latest developments on a number of areas that may affect the biosimilar industry. However, one measure was passed by the House Judiciary Committee on Wednesday with a large bipartisan margin; coupled with Senate clearance by its own Judiciary Committee in July, this might point to inclusion in the final reconciliation bill that is currently occupying both the executive and legislative branches.

This proposal would attempt to prevent reference drug manufacturers from filing patents that would result in very minor chemical alterations but drastically extend product exclusivity. It effectively limits the number of patents a reference manufacturer can assert, which would cut away much of the extraneous litigation associated with “patent thickets.”

US Representative Jerrold Nadler

Another proposal would help speed biosimilar agents to market. This proposal includes a curb on the use of citizen’s petitions to the Food and Drug Administration by reference manufacturers to try to derail a biosimilar developer’s track to FDA approval. This would apply both to generic and biosimilar drugs.

A third part of the proposal addresses pay-for-delay patent arrangements, which give reference manufacturers the ability to extend their monopoly on a pharmaceutical by paying generic or biosimilar competitors sums of money to delay their entry into the marketplace.

US Representative Jerrold Nadler (D-NY), Chairman of the House Judiciary Committee, said in a statement, “The streamlining of patent disputes is especially complicated by an emerging practice referred to as ‘patent thicketing.’ This is when a manufacturer seeks to prolong its exclusive rights to market a drug by seeking a voluminous number of patents with an eye towards fending off biosimilars attempting to enter the market.

“H.R. 2884 will help to address these tactics and ultimately, to lower drug prices.  The legislation limits the number patents that the brand-name manufacturer can assert in litigation, which forces the manufacturer to focus on its key patents with the goal of streamlining the resolution of disputes with companies that want to sell biosimilar versions of that biologic.”

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