What is the “nondelegation” doctrine, and why should inventors (and creators) care?

BREAKING NEWS: See the epilogue…

The nondelegation doctrine is the general principle that elected legislators cannot delegate the power to legislative to another person or entity. In the United States, this delegation typically takes the form of delegating to an agency the authority to interpret, clarify, and create regulations implementing laws passed by Congress, effectively shaping the practical enforcement of legislation. The Supreme Court is expected to determine whether, and how strongly, to adopt that doctrine.

Let’s take an example we’re all familiar with: Food and drugs. Congress wanted to make sure that food and drugs are safe for human use. Accordingly, they created the Food and Drug Administration and set guidelines for it to follow. However, they did not create a comprehensive, non-changeable list of drugs and foods that are regulated. Instead, they gave the FDA authority to:

  1. Develop regulations for ensuring the safety, effectiveness, and proper labeling of food, pharmaceuticals, medical devices, and cosmetics.
  2. Approve or disapprove new drugs or medical devices for the market.
  3. Establish guidelines and procedures for conducting clinical trials, inspections, and enforcement actions against violators.

Imagine if every new drug, every new delivery device, even the minutiae of how clinical trials of that drug were conducted, had to be set forth in legislation. There would be an upside: Congress and the President would have to be able to govern. They would have to be able to quickly approve or disapprove new drugs and clinical trial techniques.

An inability to compromise would be widely seen as an utter collapse in the functionality of government, and after a few episodes like that (imagine an inability to approve a new cancer treatment because legislators insist on attaching unpopular “riders” to the bill, for example), voters would migrate to the political middle. Why? Because issues that are delegated to agencies typically impact the day-to-day lives of people. Culture war issues and even big picture regulatory issues (i.e. is crypto a security?) impact a subset of people. But issues like a new foodborne pathogen that can’t be tracked due to a lack of legislation would be front of mind for everybody in the United States.

That, in my opinion, is a real upside to the nondelegation doctrine. The downside is readily apparent, however: Congress doesn’t have the expertise to determine exactly how radioactive materials are to be transported, which drugs are safe and effective, what tax deduction for each mile driven should be in each tax year, etc. Even if they did have that level of expertise, they would not have the time to deal with it.

How much time would be required? The Code of Federal Regulations consistent of 50 titles organized by subject matter across approximately 200 physical volumes occupying around 200,000 pages and 100 million words. Now imagine that every time something that is currently regulated by a federal agency needs to be adjusted, it requires an act of Congress, signed by the President. Congress simply does not have the bandwidth to legislate every detail of the law.

If a federal agency has the power to “determine whether medical devices are safe and effective”, professionals simply spend all day every day at the FDA making those determinations. If Congress decides to review safety and efficacy itself, it would drown in micro-management legislation. So what happens if the Supreme Court implements the maximum version of the nondelegation doctrine? Those questions would move to the courts. After all, when legislation is ambiguous, the courts determine the intent of Congress. The courts have already taken on determining regulatory questions, meaning that the courts are positioned to second-guess what agency experts decide (I’m not saying this is good or bad; it is simply the rule now that Chevron Deference has been overturned). Without agencies to at least issue regulatory guidance, even the most minor statutory ambiguity will give rise to federal legislation.

I know. This is a blog about innovation, creators, IP and IP law. Why am I talking about nondelegation? Because the United States Patent and Trademark Office (USPTO) is an agency. The Copyright Office is an agency. The USPTO has created a huge number of regulations as well as a book explaining how those regulations work (the MPEP). It also has the power to determine fees and to invalidate issued patents and trademarks. The Copyright Office is generating regulations about how to deal with AI and copyright, and regularly issues exemptions to the anti-circumvention rules that prohibit people from breaking digital rights management.

In the most extreme version, the Supreme Court rules that Congress may not delegate anything to agencies. Yes, this would overturn quite a few cases. But let’s imagine it happens. In this most extreme version, the USPTO could not determine patentability of an invention — it would require an act of Congress. Nobody thinks that extreme version will occur. The more likely outcome is that the Court will move the “line” in the major questions doctrine, and prohibit Congress from delegating decisions of a certain level of importance.

Under a robust version of this implementation, issuance of patents would remain with the USPTO, but the ability to set rules for invalidation of patents via IPR, the time frames for patent prosecution, and similar global rules would revert to Congress. It seems unlikely that the Court would want to burden Congress this way, particularly because the President is obligated to “take Care that the Laws be faithfully executed“, which implies that there is some level of discretion in determining what is a faithful execution of law.

The more likely outcome is that questions that set the framework for less major decisions would become subject to nondelegation. Rather than being able to say that drugs must be “safe and effective”, Congress might be required to define what “safe and effective” is, in highly detailed language. The FDA could then make determinations about individual drugs so long as they stay within the exhaustive legislative guidelines.

The Supreme Court will hear arguments on the case tomorrow, Wednesday March 26, 2025. Stay tuned for updates.

Epilogue: Added Apr. 6, 2025

President Trump’s unilateral imposition of sweeping tariffs against every country on earth appears to run counter to the Constitution’s delegation of the right to regulate foreign trade to Congress under Article 1. If there was ever a case that would probe the limits of the right of Congress to delegate major questions, this is it. Tariffs will impact the price and availability of everything — from chachkies you might buy at the Dollar Store to a new car. Imposition of global tariffs is clearly a major question — the major legal question is whether the Supreme Court will enable the Executive Branch become even more autocratically powerful, or whether they will turn to the text of the Constitution to require checks and balances between Article 1 (the legislature) and Article 2 (the executive).

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