Patent policy changes proposed by USPTO and FDA would leave patients behind

Kathi Vidal, Director of the USPTO, and Robert M. Califf, FDA Commissioner, recently outlined several policy areas where they plan to collaborate on addressing drug pricing. PhRMA supports the goal of improving health care affordability for Americans, but we disagree that changes are needed to U.S. patent law and policy to increase generic and biosimilar competition.

In a recent joint blog post and series of letters, USPTO and FDA officials acknowledge that the United States intellectual property (IP) system has been a key factor in “thirteen of the top twenty most innovative and inventive pharmaceutical companies of 2021” being headquartered in the United States. This has “enormous benefits to Americans” due to unparalleled access to new medicines and treatment options. And we agree, our world-leading R&D ecosystem is good for patients and fuels innovation as well as the U.S. economy.

The blog refers to providing sufficient time and resources to review pharmaceutical patents, a goal that can also apply to other patents. But the agencies fail to address the negative impact some of their proposed policies could have on post-approval research and development, leaving patients who are waiting on new cures and treatments behind. It’s also important to note that our existing patent system has directly led to unprecedented generic and biosimilar competition. We all want to make sure medicines are more affordable for Americans at the pharmacy but upending our IP system is not the solution.

Here are the facts:

• Medical advances do not end once a medicine is approved by the FDA. In fact, after a medicine has been approved, biopharmaceutical companies continue post-approval research and development to assess a medicine for new uses or indications, to expand its use to a different population of patients or to change the dosage form or the way it is administered. Far from incremental, these additional inventions are critical for patient choice and benefit.
  
  
• The legal frameworks to allow biosimilar and generic competition in the United States have successfully balanced the goal of reducing costs with the need to maintain incentives for the development of new innovative medicines. In the last three years alone, 150 new treatments and cures have been approved by the FDA, and over 3,000 generic alternatives have been approved or are on the road to approval. In fact, today more than 90% of prescriptions for drugs are filled with generics, up from 19% 35 years ago. As of June 2022 there were 22 biosimilars launched against 7 innovator biologic medicines in the United States driving competition in oncology, supportive care, and immunology, with projected savings from biosimilars to total over $100 billion by 2024.
  
  
• Having a broad range of treatment options is fundamental to providing high value health care that best fits individual patient’s health, biology, and preferences. The Congressional Budget Office found that post-approval innovations that increase competition “have the effect of improving or maintaining an individual’s health… and adhering to a drug regimen for a chronic condition such as diabetes or high blood pressure may prevent complications… avert hospital admissions and thus reduce the use of medical services.”

Learn more about a better way to fix the health care system.