Senate Judiciary Committee: Support American IP, Not Misinformation!

Tomorrow, the Senate Judiciary Committee is scheduled to be marking up several intellectual property bills that threaten to undermine intellectual property (IP) protections for innovators. American innovation, particularly in the biopharmaceutical industry, is vital to improving patient access to life-saving treatments and medications.

As TAPP has stated in the past, American IP and innovation are crucial contributors to the U.S. international standing, especially when it comes to patient access to life-saving treatments and medicines. Members of the Senate Judiciary Committee must prioritize the protection of IP in order to improve patient access and not hinder the innovators who consistently push our medical industry further.

A total of six bills are set for markup — the competition concerns fueling them are misguided:

• Product Hopping

• Myth: “Product hopping” allows companies to market products as new after making slight changes to the original, therefore shifting utilization away from the preexisting product. That manner of thinking reflects a fundamental lack of understanding of the nature of post-approval innovation and the role of the U.S. intellectual property protection system. 

• Fact: The process of developing a new medicine is long, costly, and risky, and initial approval of a medicine by the Food and Drug Administration (FDA) is also rarely where that path ends. Additional research and development (R&D), typically takes place on previously approved products, and this investment can lead to new medical advances expanding treatment options for patients and providing new competition in the marketplace. 

• Patent Thickets

• Myth: Companies stack numerous patents on the same products to block competition. However, that is an inaccurate characterization of how the United States patent system actually works.

• Fact: A prescription drug can include various innovations, such as active ingredients, new delivery methods, additional uses, or improved manufacturing techniques. Each patent covers a single invention. Like other products in R&D-intensive industries, it is normal for a biopharmaceutical product to be protected by multiple patents, including patents related to inventions made later in the development process.

• Evergreening

• Myth: Critics of the intellectual property protection system argue that “evergreening” allows companies to extend market exclusivity by making minor adjustments to existing products in order to prevent generic competition. Once again, people who believe that innovation stops the moment a product is approved are woefully mistaken.

• Fact: Intellectual property protections play a significant role in motivating manufacturers to keep improving their FDA-approved medicines, whether by reducing side effects, enhancing product quality, addressing new diseases or conditions, or finding easier ways for patients to take their medications. 

All of this is why TAPP calls upon the Senate Judiciary Committee to reject the markups threatening U.S. innovation and instead prioritize the protection of our intellectual property system.