Bill Overview
Title: Interagency Patent Coordination and Improvement Act of 2022
Description: This bill establishes the Interagency Task Force on Patents to support coordination and communication between the U.S. Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA) on activities relating to patents for human drugs and biological products. The task force's duties shall include establishing a process for the PTO to request from the FDA information relating to certain patent applications to help patent examiners carry out their duties.
Sponsors: Sen. Durbin, Richard J. [D-IL]
Target Audience
Population: People involved in or dependent on pharmaceutical and biotech industries
Estimated Size: 30000000
- The bill involves coordination between the U.S. Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA).
- It is specific to patents for human drugs and biological products.
- Major stakeholders include pharmaceutical companies and biotech firms who are involved in drug development.
- Consumers may ultimately be affected indirectly due to potential changes in the drug market or innovation landscape.
Reasoning
- This policy primarily affects professionals in the pharmaceutical and biotech industries, including researchers, legal teams, and regulatory affairs specialists, due to its focus on patent processes.
- The general population and consumer end are expected to see indirect impacts through possible changes in drug market dynamics.
- Given the significant presence of pharmaceutical and biotech sectors in the U.S., the policy is likely to see varied effects at different job levels and roles within these industries.
- The budget allows for the establishment and operation of the task force but is unlikely to extend beyond administrative and coordination areas initially.
- The well-being impacts are expected to be indirect and vary depending on job security, market competition, and innovation rates rather than direct consumer experience.
Simulated Interviews
Biotech Research Scientist (Cambridge, MA)
Age: 34 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 7/20
Statement of Opinion:
- This policy could streamline some of our internal processes, allowing for more seamless patent applications.
- I'm hopeful it could eventually reduce the time to bring new drugs to market, benefiting both companies and patients.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 9 |
Pharmaceutical Patent Lawyer (San Francisco, CA)
Age: 56 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- The increased coordination might result in more robustness and clarity in patent filing.
- Any improvement in patent recognition processes can be critical for my clients in terms of strategizing market entry.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 9 |
FDA Regulatory Analyst (Research Triangle, NC)
Age: 41 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Adding layers of coordination could either streamline or complicate regulatory workflows, depending on implementation.
- I'm cautious but optimistic that it could help reduce repetitive work.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
Biotech Startup Founder (Houston, TX)
Age: 29 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- If the policy means faster patent approvals and less bureaucratic red tape, it's a big win for early-stage companies like mine.
- Although optimistic, we will have to wait and see the actual implementation progress.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 9 |
| Year 10 | 10 | 9 |
| Year 20 | 10 | 9 |
Pharmaceutical Executive (New York, NY)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- The task force could help reduce the delays we often face due to unclear FDA-PTO communications.
- Reduction in these inefficiencies could significantly reduce costs associated with product development timelines.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 9 |
Academic Researcher in Drug Policy (Boston, MA)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 5/20
Statement of Opinion:
- I'm interested in how this policy will impact drug pricing and access over time.
- It seems like a positive move towards more efficient, industry-friendly patent processes.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 8 |
Entrepreneur involved in Generic Drug Manufacturing (Raleigh, NC)
Age: 39 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 0.0 years
Commonness: 7/20
Statement of Opinion:
- Greater transparency and interagency communication are always welcome.
- However, we need safeguards against any potential of creating an anti-competitive environment.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 5 | 5 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
PhD Student in Pharmacology (Philadelphia, PA)
Age: 28 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- I hope this policy might accelerate some of the patent review processes that often delay cutting-edge research translation to practice.
- For students and innovators, clearer paths can make career paths more promising.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 8 |
| Year 20 | 9 | 9 |
Retired Pharmaceutical R&D Executive (Austin, TX)
Age: 62 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 4/20
Statement of Opinion:
- It's refreshing to see efforts on streamlining patent processes, which often hold back innovation.
- The real impact, however, depends on how well the agencies can cooperate.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Advocate for Affordable Medicines (Los Angeles, CA)
Age: 44 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 0.0 years
Commonness: 6/20
Statement of Opinion:
- Coordination is key, but accessing affordable medicines is the critical issue.
- This policy might have indirect benefits, but it doesn't address basic access challenges.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Cost Estimates
Year 1: $5000000 (Low: $4000000, High: $7000000)
Year 2: $5000000 (Low: $4000000, High: $7000000)
Year 3: $5100000 (Low: $4100000, High: $7100000)
Year 5: $5200000 (Low: $4200000, High: $7200000)
Year 10: $5300000 (Low: $4300000, High: $7300000)
Year 100: $10000000 (Low: $8000000, High: $15000000)
Key Considerations
- The enhanced coordination aims to improve the efficiency of patent processing for human drugs and biological products.
- Initial costs are primarily administrative and related to operational setup.
- Potential indirect benefits on the pharmaceutical and biotech sectors due to streamlined processes.