The Arnold-Venture funded advocacy group Initiative for Medicines, Access & Knowledge, Inc. (or I-MAK) is on a global media tour, espousing their point of view on the patent system. Some experts and congressional leaders don’t buy the rhetoric, and neither should you. Here are the top myths to look out for:
1. Myth: Biopharmaceuticals have extended patent protections.
In reality, the average time to first generic competition for a patented medicine is around 13 years — substantially less than the 20 years afforded other products by the patent system and in line with the patent terms drugs have historically received. Patents provide an incentive and protection for innovators. Medicine development requires demonstrating efficacy and safety through lengthy and costly clinical trials and often takes a decade.
2. Myth: Generics and biosimilars are blocked from entering the market by patents.
Today more than 90% of prescriptions for drugs are filled with generics – up from just 19% less than four decades ago. And the FDA has approved 39 biosimilars. Of those, 22 are already on the market in the United States, competing against nine brand biologics, with at least seven more biosimilar products scheduled to launch in 2023. The use of generics and biosimilars between 2011 and 2020 saved the U.S. health care system nearly $2.4 trillion.
3. Myth: There is no competition in the biopharmaceutical market because patents create monopolies.
No one has a monopoly on treating a condition. There are often multiple medicines to treat a particular disease, which brings costs down through added competition and offer additional options to patients for whom one treatment may work better than another. Further, medicines and biomanufacturing involve many innovations, such as active ingredients, dosage forms and forms of administration and methods of highly complex manufacturing, which often entail significant time and R&D investments long after a medicine’s active ingredient is patented and the medicine is initially approved by the FDA.
4. Myth: Patents and innovation that happen after FDA approval are not inventive.
Innovation does not stop the minute a medicine is first approved, which is good news for patients. Following a drug’s initial FDA approval, the level of research on additional uses increases by 300%, and there are three times as many clinical trials on additional indications often six years or more after approval as scientific knowledge and experience grow over time. These medical advances can be covered by additional patents, but a new patent does not extend an old patent and does not block competition for the original innovation. Post-approval R&D leading to new indications can take 3-6 years of additional R&D for Phase III clinical trials and result in meaningful advances for patients.
5. Myth: Public funding is responsible for biopharmaceutical innovation.
The biopharmaceutical industry spends three times as much on R&D each year than the total annual budget of the National Institutes of Health (NIH). Furthermore, only a small portion of the NIH’s total budget — 8% in 2018 — is dedicated to actual medicine development. The NIH is largely focused on basic research that accelerates scientific progress more broadly, while biopharmaceutical companies provide the specific expertise, infrastructure, capabilities, and financial resources needed to develop new medicines and bring them to patients. We each play our parts in the world-leading American innovation ecosystem.
6. Myth: The patent system is secretive and needs to be “opened up.”
Inventors are required to publicly share information about their invention after filing for a patent, and this is no different for inventions in medicines. This disclosure fosters the entry of brand-name competitors by encouraging them to invent around existing protections and also paves the way for cost-saving generic medicines to be developed, promoting competition.
The U.S. Constitution enshrines a right to protect inventions through a patent. But I-MAK and its patrons at Arnold Ventures want to strip innovators of those rights. Please consider the facts before accepting this misleading narrative.