The U.S. Patent and Trademark Office (USPTO) is currently in the midst of a public comment period regarding proposed rule changes on terminal disclaimers, which are used to overcome non-statutory double patenting rejections. As of now, the USPTO has received a total of 114 comments on this issue.
Many industry stakeholders, including former high-ranking USPTO officials, have expressed concerns about the potential negative impact of the proposed rule changes on patent owners. On the other hand, supporters of the NPRM (Notice of Proposed Rulemaking) argue that these changes are necessary to address drug pricing issues, although some of the data they rely on is controversial.
The U.S. Chamber of Commerce has criticized the NPRM, stating that it could hinder innovation in the life sciences sector. They argue that the proposed rule changes are based on flawed methodologies and could discourage investments in medical innovations. The Chamber also highlights a recent USPTO study that contradicts claims of excessive patenting in the pharmaceutical industry.
Intellectual property strategist Robert Armitage has urged the USPTO to focus on statutory mandates when considering changes to terminal disclaimer rules. He argues that the NPRM may be outside the agency’s regulatory authority and conflicts with existing laws related to patent validity.
The Campaign for Sustainable Rx Pricing (CSRxP) believes that changes to terminal disclaimer rules are necessary to address the high cost of prescription drugs. They cite data showing significant price increases for many drugs and argue that delayed competition due to patent thickets can result in unnecessary costs for patients and taxpayers.
IPValue Management, a consultancy firm, points out that the NPRM ignores precedent set by the Federal Circuit and could increase prosecution costs for entities. They argue that the proposed rule changes could lead to more challenges to patent rejections, ultimately adding significant costs to the patent prosecution process.
Overall, the debate surrounding the USPTO’s proposed rule changes on terminal disclaimers highlights the complex relationship between life sciences innovation, drug pricing, and patent law. Stakeholders from various sectors are weighing in on the issue, each presenting their own perspectives and concerns. It remains to be seen how the USPTO will address these comments and whether any changes will be made to the proposed rules.
