Former Federal Trade Commission Chair Lina Khan recently appeared on The Weekly Show with Jon Stewart, where their discussion revived familiar tropes that life science companies misuse patents to block competition and keep drug prices high. These arguments have circulated for years and have become common myths known by names such as “evergreening” and “patent thicketing.” The arguments are false: data consistently refutes the allegation that manipulation of the patent system is able to prolong the market exclusivity of new medicines. Refuting these false narratives is particularly important at a time when Congress is considering legislation to combat alleged patent abuses to weaken patent rights.
Lawmakers have introduced legislation such as the Eliminating Thickets to Increase Competition (ETHIC) Act and the Affordable Prescriptions for Patients Act to prevent companies from compiling so-called patent thickets. As C4IP has written, these bills would not actually promote innovation, but would limit inventors’ ability to protect their inventions and deter future investment in innovation, including new medicines. It is crucial to debunk myths about patents in order to ensure that lawmakers do not inadvertently pass laws that undermine the IP rights that patients depend on.
Below, we refute three of the myths that surfaced in Khan’s and Stewart’s conversation:
| Claim: Drug innovators patent “minor changes” to their inventions to extend products’ patent life. |
| In reality: Patent law does not permit companies to extend the life of an existing patent through cosmetic tweaks. To receive a new patent, an invention must be useful, novel, and nonobvious, meaning it represents a real technical advance over what came before. Additionally, a new patent does not reset or extend the expiration date of an earlier patent covering the original drug, contrary to the myth of “evergreening.” When companies patent new versions of their medicines, the existing patents still expire on the same timeline and become available for competitors to copy. Lastly, it is also false that drug companies can extend the market exclusivity of their products simply by filing large numbers of patents, or “patent thickets,” on various aspects of their products. An investigation by the U.S. Patent and Trademark Office in response to an inquiry from Sen. Thom Tillis (R-NC) found that the number of patents on a given drug did not have any relationship to when generic competitors entered the market. It also found that the effective period of market exclusivity for all drugs studied was far below the statutory patent term of 20 years. |
| Claim: Excessive patenting blocks competition and keeps drug prices artificially high. |
| In reality: The structure of the U.S. pharmaceutical market shows the opposite. The market for generic medicines is thriving: Nine out of every 10 prescriptions filled in the United States are for generic drugs. American generic drugs are also typically cheaper than generics in other countries. Robust generic drug competition in the United States drives prices down and saves Americans billions of dollars each year. America’s generic drug ecosystem is a robust complement to our branded drug ecosystem, which does involve higher average prices but uses that additional revenue to fund the research and development that leads to new drugs and, eventually, new generics. Thanks to strong patent rights incentivizing innovation and allowing companies to earn a return on their R&D investments, the United States accounts for about 60% of new chemical entities in medicines, nearly double the contributions of the largest European countries combined. If policymakers weaken our patent system to reduce innovators’ return on new branded medicines, both new drug innovation and later generic drug development will falter. |
| Claim: Companies patent tangential improvements to the drug — such as new inhaler devices — to prevent competitors from copying the medicine itself. |
| In reality: As mentioned previously, patenting improvements or updates to products does not extend the life of the existing patents on the product. In this case, patenting a new and improved inhaler device would not delay competitors seeking to imitate the previous inhaler device and drug formulation, as the patents on those components would still expire on schedule. Patenting new devices and delivery mechanisms would be an ineffective way to prevent competitors from copying drug formulations, if that were companies’ intent. However, it is important to note that these innovations are not actually tangential, but in many cases offer substantial benefits for patients. For conditions like asthma, how a drug is delivered can directly affect whether patients receive the correct dose and adhere to treatment. Clinical studies show that inhaler design and ease of use play a significant role in promoting patient adherence to treatment and producing better health outcomes. Overall, patients often opt for medicines with improved delivery systems because those improvements offer meaningful benefits — and companies continue to invest in developing these types of innovations because they know it fills a genuine demand from patients. Limiting companies’ ability to patent additional inventions like these would hurt patients first and foremost. |