New report ignores benefits of patent system to innovation and patients

A recent report from the Initiative for Medicines, Access & Knowledge – known as I-MAK – highlights fundamental misunderstandings about America’s patent system and how it benefits patients and medical innovation. I-MAK accuses biopharmaceutical companies of blocking competition and gaming the system by patenting new innovations, when in reality, new patents do not extend old patents, and they do not prevent competitors from launching new products.

Furthermore, America’s intellectual property (IP) system paves the way for generic and biosimilar competition. Here are a few key facts:

• Today, more than 90% of prescriptions for drugs are filled with generics, up from just 19% 35 years ago.
• A recent analysis showed that while patents protect new innovations for 20 years, the average time to market for generic competitors is only 13 years from when the brand medicine was launched.
• As of June 2022 there were 22 biosimilars launched against 7 innovator biologic medicines in the U.S. driving competition in oncology, supportive care and immunology, with projected savings from biosimilars to total over $100 billion by 2024.

I-MAK’s report ignores the fact that for a new patent to be granted, the request must be for something new and non-obvious. In the biopharmaceutical space, that can include finding a new dosage form, a new way to administer a medicine to patients or even an entirely new disease or population a medicine can treat.

This research and development that happens after FDA approval, often including costly and labor-intensive clinical trials, paves the way for important advances in patient care. The majority of cancer R&D is done after FDA approval. Nearly 60% of oncology medicines approved a decade ago received additional indications for other types of cancer. Doctors would not have known those medicines worked for more patients without the critical R&D that happened after the products were approved.

Intellectual property (IP) protections, including patents, incentivize manufacturers to continue working to improve their FDA-approved medicines. Progress is a good thing, and should be encouraged, not attacked.

We know there is work to be done to build a better health care system for patients, and it can be achieved without gutting critical incentives for innovation. The biopharmaceutical sector supports common sense solutions that would lower out-of-pocket costs that don’t undermine future treatments and cures. We are eager to work with the Biden Administration to pursue policies that protect access, choice and innovation.