Backers of the Medication Affordability and Patent Integrity Act (S2780) aim to achieve this goal by changing the requirements for patenting new drugs. But if the bill becomes law, it will do no such thing. Instead, it will hurt American innovation and derail future research into life-saving therapies.

The bill is based on an erroneous premise: that pharmaceutical companies routinely hoodwink the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA), exploiting gaps in oversight to prolong patent protections and delay generic competition.

But our current patent system already includes robust safeguards to prevent deception. Legal precedent makes patents unenforceable if an applicant is found to have deliberately misrepresented or withheld information from the USPTO.

Given this deterrent, the proposed bill appears to be a solution in search of a problem, but it’s worse than redundant. It would actively threaten the development of new treatments.

S2780 would impose major new disclosure requirements on drugmakers, requiring them to provide all the information they share with the FDA to the USPTO. But these agencies serve different purposes and have different expertise. Submitting FDA-appropriate medical information to the USPTO is akin to asking a cardiologist to review an attorney’s work.

Patent examiners are skilled at assessing novelty, but unlike FDA scientists, are not equipped to parse clinical trial data. Flooding the USPTO with this information won’t lead to better patents. It will just overwhelm the agency and lead to bureaucratic paralysis.

This is particularly concerning given the USPTO’s current backlog. On average, it already takes more than two years from the time a patent application is submitted until a final decision on patentability is reached. Nearly 800,000 patent applications are currently waiting to be examined.

More alarmingly, the proposed bill risks exposing confidential proprietary information. The drug approval process necessarily involves sharing sensitive data with the FDA. But requiring broader dissemination raises the risk that competitors — both domestic and foreign — will be able to obtain valuable trade secrets. In an era of intense global competition in biotechnology, it would be short-sighted to give away America’s edge.

Supporters of the bill argue that requiring this level of disclosure will prevent drug patents on processes that should be considered obvious because they rely on already-existing knowledge. But this view misunderstands how drug development works. It can require years of research and significant investment to find a new use for an existing medicine, and such breakthroughs are far from obvious.

Moreover, new drug indications that incorporate previous knowledge can be extremely valuable to patients and the healthcare system. For instance, a drug initially developed for one condition might show surprising efficacy against an unrelated disease.

For example, raloxifene, initially developed to treat osteoporosis, was later found to reduce the risk of breast cancer. Tamoxifen, developed to treat metastatic breast cancer, was discovered to treat bipolar disorder. Discouraging patents for these new uses could leave promising avenues of research unexplored.

Moreover, by singling out pharmaceutical patents for special treatment, the proposed bill threatens innovation far beyond the drug industry. From green energy to artificial intelligence, huge swathes of our economy rely on consistent and predictable patents. Having a set of rules unique to one industry would create a patchwork system of protection. The effect would be chilling, causing companies in other sectors to lose confidence in the system.

The U.S. leads the world in pharmaceutical innovation precisely because we’ve struck a careful balance between rewarding invention and promoting competition. S2780 risks upsetting that balance, potentially driving research and development overseas to countries with more favorable intellectual property regimes.

Kristen Osenga is the Austin E. Owen Research Scholar and Professor of Law at the University of Richmond School of Law.

It’s encouraging to see both policymakers and the public pay attention to this important issue. Robust patent laws support the inventors, scientists and entrepreneurs who drive our economy — and there are plenty of ways we could improve the system. As legislators and federal officials explore reforms, they should stick to one guiding principle: Any new rule should make patent protections more predictable, not less.

Over the course of my career in academia, I’ve taught patent law and property law. Both are intended to protect owners’ legal rights to their possessions. Yet I’m struck by how differently these two ecosystems operate.

Both types of law try to provide owners with a sense of “quiet title,” which is achieved when competing legal claims to a property are removed. Quiet title to land, buildings and other real property is generally established quickly. Few homeowners worry about someone swooping in to claim that their house isn’t their own.

In the intellectual property system, however, an innovator can face endless challenges, even after being awarded a patent. These challenges are often brought before the Patent Trial and Appeal Board (PTAB) and take issue with a patent’s eligibility.

Congress established the PTAB in 2011 with a sound purpose. It was supposed to serve as a less expensive, more efficient venue than district court for questioning the validity of existing patents.

But over time, large companies have exploited the PTAB. They use it not instead of the court system, but in addition to it, challenging patents held by smaller competitors in multiple venues at once. Using this multi-pronged strategy, they mount comprehensive, costly offensives that put smaller inventors, who have fewer financial resources, at a disadvantage.

In 2020, then-Patent and Trademark Office Director Andrei Iancu sought to rein in these abuses. Through a decision known as the Fintiv rule, he empowered the PTAB to decline to review a patent challenge if that patent was already being litigated elsewhere.

Unfortunately, the Patent and Trademark Office recently weakened the Fintiv reform, broadening the circumstances under which the PTAB can allow a second challenge to go forward.

This has led to inconsistencies that make U.S. patent protections less reliable and less predictable. When patents are unfairly challenged and then invalidated by the PTAB, it signals to inventors that their rights — and their ability to establish quiet title — are not guaranteed. Faced with increasingly uncertain odds of recouping their investments in research and development, more inventors may choose not to undertake these efforts at all.

Sens. Chris Coons, D-Delaware, and Thom Tillis, R-North Carolina, introduced pending legislation, known as the PREVAIL Act. It aims to create a more level playing field within our patent system by reforming certain PTAB rules and procedures that currently allow large firms to prey on smaller innovators.

As the Patent and Trademark Office considers potential changes to the PTAB, it should do so with the similar objective of protecting inventors from abuse. In particular, it should clarify the circumstances under which the board can deny patent reviews. The PTAB needs a clear framework for rejecting challenges, especially one that avoids abusive duplicative proceedings.

By protecting innovative small companies from abuse by giant corporations, we

ensure that useful, exciting and even life saving inventions reach the public. With thoughtful reform, we can make the patent system more beneficial to all.

Kristen Osenga is the Austin E. Owen Research Scholar & Professor of Law at the University of Richmond School of Law.