The Affordable Prescriptions for Patients Act of 2019 (S. 1416) aims to lower prescription drug costs by limiting anticompetitive behavior from large brand name drug manufacturers. The bill includes proposals to prevent manufacturers from using two well-known gaming tactics: (1) product hopping, through both hard and soft switches; and (2) biologic product patent thickets. The expert opinions below focus only on Sec. 3 of S.1416, which aims to prevent patent thickets for biologic products.
Patent thickets occur when large manufacturers apply for additional patents for the sole reason of extending their period of exclusivity rather than to protect new innovation. Section 3 of the Affordable Prescriptions for Patients Act of 2019 aims to prevent patent thickets by imposing a 20-patent maximum to original reference biologic products. Manufacturers often apply for dozens of patents to extend their monopoly, but this proposed 20-patent limit would restricts patents filed on the actual product, the delivery method, and the manufacturing method, all of which cause biosimilars to be kept off market unnecessarily. Biologic manufacturers may fight the maximum limit in court on a case-by-case basis if they can prove that the additional patents cover a characteristic of the product that has been changed since the initial filing and was not filed solely to prevent the entry of biosimilar competition.
The expert panel agreed that this policy would reduce drug spending but were split on if it would be a minimal or moderate reduction. Nearly all experts believe this policy would not affect drug list prices, but they unanimously agreed that it would moderately decrease net prices. The experts agreed that this policy would moderately increase drug access for all patient groups, except Medicaid beneficiaries who would see no change.
The majority of the panel agreed that this policy would moderately advance drug spending policy. Experts unanimously agreed the likelihood of this policy being effectively implemented would be a weakness; however, the size of the affected population and the precedent-setting value would be strengths. It is still unknown if the magnitude of the impact the policy would have and the evidence in support of the policy are strengths or weaknesses.
Experts highlight many considerations for policymakers. Key considerations that the experts highlighted were that the policy does not address the strength and breadth of each individual patent that create the patent thickets and that 20 patents, the proposed maximum number of patents allowed, would still delay competition. Additional concerns that experts had were that this policy only addresses patents, but manufacturers would still be able to delay competition through other nefarious tactics and it is unclear if this policy is consistent with international intellectual property treaties. Policymakers should also consider how the large brand manufacturers will respond to this policy, particularly regarding secrecy. Finally, experts highlighted that this policy could actually undermine competition in the biosimilar market and negatively impact future innovation.