The Medication Affordability and Patent Integrity Act, introduced by Senators Maggie Hassan (D-NH) and Mike Braun (R-IN), would require life sciences innovators to share volumes of unnecessary and confidential information related to drug approval with the USPTO. Under the bill, firms would also have to provide lengthy certifications stating that all information submitted to the FDA and USPTO is consistent.
Proponents of the bill argue that such disclosures would help prevent drug companies from manipulating the patent system, keep weak patents from being issued, and lower drug costs for patients. A recent statement published by AARP exemplifies this mistaken line of thought.
Lawmakers are contemplating a major overhaul of a well-functioning system because of false narratives – not because of rigorous analysis of facts. The arguments used by proponents of the bill are unsupported by evidence and fail to recognize the larger problems that would arise from the legislation’s passage:
| Claim: “[D]rugmakers ‘game the system’ by submitting only partial information” to the USPTO and FDA. |
| In reality: Drug companies submit different information to the USPTO and FDA due to the agencies’ differing purposes and requirements. Obtaining a patent at the USPTO mainly hinges on determining whether the invention is new, useful, and non-obvious, so patent applications require inventors to describe and diagram the function of their invention. In contrast, the FDA’s drug approval process requires the disclosure of other information, such as clinical data – which is both confidential and not necessarily relevant to patentability. Where it may be relevant, there are already strict penalties at both the USPTO and FDA for applicants who falsify information, and there is no evidence to suggest that providing differing information to both agencies is routinely abused in a way that benefits drug innovators or harms patients. The effect of the proposed bill, therefore, would not solve any existing problem but create several other problems by needlessly forcing the publication of confidential trade secrets and adding to both agencies’ administrative workload. |
| Claim: By filing new patents on a drug, companies “can extend a drug’s exclusivity on the market.” |
| In reality: The pervasive belief that life science companies can extend the period of exclusivity on drugs by filing for additional, obvious patents is known as “evergreening,” and it is a myth. “Secondary” or “follow-on” patents related to existing inventions must pass the same, rigorous standards as other patents, meaning that only real and non-obvious innovations are able to be patented – such as a formulation that doesn’t cause painful injection-site reactions, in the case of medicine. However, regardless of the type of improvement being patented, new patents have no effect on the expiration of the original patent. Once the original patent term ends, competitors and generic manufacturers are free to copy the original form or formulation of the drug, so it is impossible for companies to “extend” the period of exclusivity on their invention. Attacks on follow-on patents amount to attacks on improvements that will improve patient health and outcomes, rather than actions that will improve patient access to drugs. |
| Claim: The proposed bill would “increas[e] access to safe, affordable prescription drugs and lower drug costs for consumers and taxpayers.” |
| In reality: The proposed bill is unlikely to reduce drug prices, as there is no evidence to show that widespread deception of the USPTO or FDA is taking place or contributing to high prices. However, aspects of the bill do threaten to hinder drug accessibility. Under the requirements of the bill, both the USPTO and FDA would receive much more information to sift through, potentially extending both agencies’ already-lengthy approval processes – currently, it takes about 10 months to get a drug approved at the FDA and nearly 26 months to receive a final patent decision at the USPTO. The bill’s new rules could also provide an opportunity for unscrupulous competitors or patent infringers to challenge innovative companies’ patents in court, which would then consume even more time and resources. If these changes are passed into law, it’s likely that patients would be forced to wait even longer for new treatments – or be deprived of them completely. |