Re: Docket No. PTO-P-2022-0037 Director Vidal and Commissioner Califf:
The undersigned organizations are submitting additional comments to add to the record, after several of us participated in the USPTO-FDA Listening session on January 19, 2023. One common theme among the patient, consumer, and disability advocates was the need to improve opportunities for those most impacted, patients and consumers, to be included within the USPTO and FDA collaboration. As patient, consumer, and disability organizations, we urge the USPTO and FDA to better include the American public in any discussions for patent examination and approval reforms. Together, we must ensure that the patent system works for patients and the public and that evidence drives all decisions at the USPTO and FDA. We see a great opportunity for the USPTO and FDA to lead in early patient engagement best practices.
In the past, patients have been effectively excluded from key discussions on patent reform, often thought to be too technical. The recent comment made by PhRMA states that “patient groups and other stakeholders interested in participating in the patent prosecution process can use existing mechanisms to submit printed publications that are relevant to the examination.” We disagree, the current mechanisms are extremely difficult for the general public to engage in processes such as third-party art searches and more. Many patient groups do not know that public feedback mechanisms exist so there must be more public awareness and dissemination. Existing mechanisms and the status quo are not working for those who are not in the business of creating and patenting pharmaceuticals and medical devices and we want that to change. The USPTO currently makes extensive efforts to help small inventors engage with and understand the patent system, and similar outreach could be extended to patient communities.
And for the few of us who have found ways to participate in the formal regulatory processes, it is unclear on the follow-up of feedback from patient groups. Moreover, patent examiners are unlikely to give prior art submissions from third parties substantial consideration, but they may still cite those submissions on patents when they issue. That is a problem because district courts are less likely to invalidate and the Patent and Trial Appeal Board is less likely to review patents based on cited prior art. As a result, submitting strong prior art during examination is more likely to prevent than ensure its consideration. As patients, and consumers, we feel a deep urgency to introduce novel, meaningful patient engagement opportunities within this collaboration. Furthermore, opportunities for patient engagement should be accessible, including providing opportunities for virtual participation.
We also wish to note the importance of hearing from patient groups that are independent of industry funding or have displayed a clear firewall between industry funding. We have noted the silence of many patient groups when it comes to pharmaceutical policy, notably because of the significant financial support these groups receive from the pharmaceutical industry. To evaluate and provide unbiased decisions to the USPTO and FDA, patients or patient groups must be required to prove industry independence.
The USPTO should ensure that patient engagement opportunities allow for true input and patient involvement should be respected and considered. Equitable representation of patients should be of paramount importance. There are several core principles of ethical engagement, highlighted by T1International, including compensation, diversity of voice, and patient-led strategies. Some notable questions they include are:
Are you compensating patients as experts?
Have patients been involved in planning, leadership, and creating the overall strategy?
Have you informed patients of the purpose behind their participation?
Is there a clear plan for how patient contributions will inform any work moving forward?
An example that could be referenced as a strong model for engaging patients is the Institute for Clinical and Economic Review. Within this model, patient advocates are part of the voting councils and are allowed to vote as other healthcare professionals. Patient advocates on the voting council receive the same payment and are given the same opportunities to speak and ultimately evaluate the evidence from a patient-centric perspective for all appraisals.
In order to better incorporate patient voices in the patenting process, we suggest the creation of a pharmaceutical-specific art unit, as suggested by Professor S. Sean Tu. Applicants should be required to ex ante disclose applications that could be listed in the Orange Book or Purple Book for examination in a specialized art unit. This would allow patient advocates to voice their opinions on those patents that would affect their specific indications. Currently, it is difficult to determine which patent applications are relevant. We note that this should not be difficult to implement since the smallest molecule Orange Book patents originate from two art units in Workgroup 1610 and most biologics originates from two art units in Workgroup 1640.
The patient voice must be genuinely and meaningfully incorporated early relating to the implementation of this collaboration. We look forward to partnering and working closely with both agencies in ensuring that the American public is prioritized.
Sincerely,
Asian Americans with Disabilities Initiative
Chronic Illness Advocacy & Awareness Group
Consumer Action
Connecticut Health Policy Project
Connecting to Cure Crohn's and Colitis
Crohn's and Colitis Young Adults Network
Disability Rights California
Doctors for America
e-Patient Dave, LLC
Fight Like A Warrior
Generation Patient
Health Care Voices
IBDMoms
Initiative for Medicines, Access, and Knowledge
Islamic Civic Engagement Project
National Alliance of Multicultural Disability Advocates
Oregonizers
Patient Safety Action Network
People With Empathy
Propel a Cure
Sumaira Foundation
T1International
The Light Collective
Tigerlilly Foundation
Universities Allied for Essential Medicines
USA Patient Network
U.S. PIRG (Public Interest Research Group)