A Look At The Economic Impact Of Drug Patent Differentiation – Law360

Report: Federal Trade Commission’s Efforts to Compel Delisting of Patents from FDA’s “Orange Book” Database

Introduction

By Jonathan Putnam, Ngoc Ngo and Ratib Ali (September 23, 2024, 5:28 PM EDT)

Sustainable Development Goals (SDGs)

The efforts of the Federal Trade Commission align with several Sustainable Development Goals (SDGs) set by the United Nations. These goals aim to promote sustainable development and address global challenges. The SDGs relevant to this report include:

1. SDG 3: Good Health and Well-being
2. SDG 9: Industry, Innovation, and Infrastructure
3. SDG 17: Partnerships for the Goals

Background

The U.S. Food and Drug Administration’s “Orange Book” database is a comprehensive resource that lists approved drug products with therapeutic equivalence evaluations. It includes information on patents that claim the approved drugs. However, the Federal Trade Commission has raised concerns about certain patents listed in the Orange Book that do not claim the underlying drug.

FTC’s Push for Delisting

The Federal Trade Commission argues that patents listed in the Orange Book should only include those that claim the approved drugs. They believe that delisting patents that do not claim the underlying drug would promote fair competition and prevent potential anticompetitive behavior by branded drug manufacturers.

Impact on Sustainable Development Goals

The Federal Trade Commission’s efforts to compel the delisting of patents from the Orange Book database have significant implications for the SDGs:

• SDG 3: Good Health and Well-being – By promoting fair competition, these efforts can potentially lead to increased access to affordable generic drugs, improving the affordability and availability of essential medications.
• SDG 9: Industry, Innovation, and Infrastructure – The push for delisting patents aims to foster innovation and create a level playing field for generic drug manufacturers, encouraging the development of new and more affordable drugs.
• SDG 17: Partnerships for the Goals – The Federal Trade Commission’s actions require collaboration between regulatory bodies, drug manufacturers, and other stakeholders to ensure the delisting process is fair and transparent.

Conclusion

The Federal Trade Commission’s efforts to compel the delisting of certain patents from the FDA’s “Orange Book” database are driven by the goal of promoting fair competition and improving access to affordable medications. These efforts align with several SDGs, including SDG 3, SDG 9, and SDG 17. By addressing the concerns raised by the FTC, it is hoped that the delisting process will contribute to achieving these sustainable development goals.

SDGs, Targets, and Indicators

1. Which SDGs are addressed or connected to the issues highlighted in the article?

• SDG 3: Good Health and Well-being
• SDG 9: Industry, Innovation, and Infrastructure
• SDG 17: Partnerships for the Goals

The article discusses the Federal Trade Commission’s push to delist certain patents from the U.S. Food and Drug Administration’s “Orange Book” database. This issue is connected to SDG 3 as it relates to access to affordable and essential medicines. It is also connected to SDG 9 as it involves innovation in the pharmaceutical industry. Additionally, SDG 17 is relevant as it emphasizes the importance of partnerships and cooperation to achieve the Sustainable Development Goals.

2. What specific targets under those SDGs can be identified based on the article’s content?

• SDG 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential healthcare services, and access to safe, effective, quality, and affordable essential medicines and vaccines.
• SDG 9.5: Enhance scientific research, upgrade the technological capabilities of industrial sectors in all countries, in particular developing countries, including, by 2030, encouraging innovation and substantially increasing the number of research and development workers per 1 million people and public and private research and development spending.
• SDG 17.16: Enhance the global partnership for sustainable development, complemented by multi-stakeholder partnerships that mobilize and share knowledge, expertise, technology, and financial resources, to support the achievement of the Sustainable Development Goals in all countries, in particular developing countries.

Based on the article’s content, the specific targets identified are achieving universal health coverage and access to quality essential healthcare services (SDG 3.8), enhancing scientific research and innovation in the pharmaceutical industry (SDG 9.5), and promoting global partnerships for sustainable development (SDG 17.16).

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

Yes, the article mentions indicators that can be used to measure progress towards the identified targets. Specifically, the article discusses the delisting of certain patents from the FDA’s “Orange Book” database, indicating a potential measure of progress towards achieving universal access to affordable essential medicines (SDG 3.8). The article also mentions the Federal Trade Commission’s push for delisting patents held by branded drug manufacturers, which implies efforts to enhance scientific research and innovation in the pharmaceutical industry (SDG 9.5). Additionally, the article highlights the role of partnerships between the Federal Trade Commission, the FDA, and other stakeholders, suggesting progress towards promoting global partnerships for sustainable development (SDG 17.16).

4. Table: SDGs, Targets, and Indicators

Source: law360.com