“Everyone knows that I believe in a strong patent system — that it’s essential to our economy, creating jobs and keeping America the world’s technology leader. Patents may be most important to the pharmaceutical and biologic industries. Without patents, companies cannot justify the tremendous investment needed to develop and bring to market the life-saving and life-improving innovations American companies offer patients in this country each year.”

“I’m hopeful [H.R. 3991] will be a positive step toward preventing future abuses of biologic patents. I also hope my colleagues will work with me going forward on additional steps to address the abuse of pharmaceutical, as well as biologic, patents, to ensure we do not miss any opportunities to limit abuse.”

WASHINGTON — Rep. Doug Collins (R-Ga.), Ranking Member of the House Judiciary Committee, offered the following opening statement at today’s markup of H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019.

Below are the remarks as prepared.

Ranking Member Collins: Thank you, Mr. Chairman. Everyone knows that I believe in a strong patent system — that it’s essential to our economy, creating jobs and keeping America the world’s technology leader. Patents may be most important to the pharmaceutical and biologic industries. Without patents, companies cannot justify the tremendous investment needed to develop and bring to market the life-saving and life-improving innovations American companies offer patients in this country each year.

Like every other area of law, benefits often come with challenges. I cannot say how often I hear that drug companies used their patents to keep generics out of the market for longer than appropriate or that drug patents contribute to higher drug prices for Americans.

For that reason, I applaud Congressmen Johnson and Roby for taking up the issue of biologic patent abuse. I’m hopeful this bill will be a positive step toward preventing future abuses of biologic patents. I also hope my colleagues will work with me going forward on additional steps to address the abuse of pharmaceutical, as well as biologic, patents, to ensure we do not miss any opportunities to limit abuse.

Some stakeholders complain about the number of patents the Patent Office grants drug and biologic companies covering aspects of the same drug, but most complaints center around the seemingly endless extensions a product receives because of additional patents filed by the manufacturer. They argue that some patents for minor improvements expire well after the patent on the original innovation expires. This provides market exclusivity and keeps drug prices high for ten or 15 years, or even longer. While most of those later patents do cover innovations, in several high-profile cases over the last twenty years, courts have invalidated several drug patents that were mere trivial improvements to earlier patented inventions. The key is that those later patents provide an unjust extension of patent exclusivity beyond the term of the patent on the true innovation.

That is why I, with Congressmen Jeffries, Cline and Mucarsel-Powell, introduced the Terminating the Extension of Rights Misappropriated Act of 2019, or the TERM Act. The TERM Act represents a substantive challenge to patent abuse by taking on a form of patent gamesmanship known as “evergreening.” It targets patents that companies cannot show are more than mere trivial improvements and should, therefore, not be allowed their full patent term. The TERM Act applies to both pharmaceutical drug patents and biologic patents. Through a targeted approach to tackling evergreening, the TERM Act deals with and discourages specific abuses, without having any impact on the development of true life-saving innovations. The TERM Act, I believe, completes the work H.R. 3991 begins.

I had hoped we could have considered these bills simultaneously. Nevertheless, I look forward to the day when Mr. Nadler agrees to mark up the TERM Act and tackles the substantive problem of evergreening.