“When the foundational data of a study cannot be disclosed and appropriately peer-reviewed, the integrity of the findings should be called into question and discounted within the realm of public debate.”
Innovation is the foundation of America’s ability to compete in a global economy, and the cornerstone of America’s foundation is our patent system. This is especially true when it comes to American leadership in life sciences. Yet, Washington is debating proposals, driven by political narratives, that will limit the availability of patents and that fail to consider the impact on innovation and American competitiveness.
Our founding fathers inherently understood that entrepreneurship ran deep within the fabric of our country and that a system was needed to unlock its genius. Developed by our founding fathers, the patent system has evolved with the times and continues to set the global standard on supporting inventors of all stripes. Decisions made by George Washington, Thomas Jefferson, and others continue to provide the legal certainty necessary for investors to support research and development.
In the context of this debate, we must examine the risks and potential consequences of weakening patent rights. The question is simple: If we do not maintain a robust and reliable patent system, what does the United States and its citizens stand to lose?
No Patents, No Investment
A politically attractive narrative promoted by activists that medicines can be produced at lower costs by disregarding patent rights has gained significant traction. What these activists conveniently ignore is that by weakening the patent system, private sector investment will dry up and drive up costs for long-term care, treatment, and prolonged suffering of people with life-threatening diseases. Many will be denied hope for any cure or life-prolonging treatment.
Strong patent rights provide innovators with the means to access capital and invest in medical research and development. Furthermore, patents offer a time-limited, exclusive-use right to inventors, allowing them a brief period to recoup their investment costs once their product reaches the market. Within the context of those property rights, and in return for the period of exclusivity they grant, the public gains the benefit of the inventors’ knowledge and may use their intellectual property as a building block for future advances that benefit society.
This legal certainty is crucial to the viability of the decades-long, multi-billion-dollar medical innovation process. Without this certainty, potential competitors would be free to wait and benefit from the research investments of others, ultimately creating a disincentive for any new research. In short, a reliable patent system is fundamental to the success of the industry.
The U.S. government is currently considering proposals that could weaken patent rights and stifle medical innovation, as well as innovation in other fields. From misguided efforts to restrict continuing innovation under the guise of “robust and reliable” patent rights, so-called collaboration efforts that will impose an undue burden of life-science innovators, and blatant calls to weaponize the Bayh-Dole act against universities and startup companies, bad proposals are gaining traction. The activists who have been pushing these proposals are using politically- driven narratives that ignore the facts and the potential harmful consequences for patients and consumers.
Let’s Stop Relying on Flawed Data
For example, activists have accused life sciences innovators of maintaining proprietary rights and keeping medicines expensive by claiming multiple trivial changes to a medicine in order to create what is commonly called a “patent thicket.” Advocates of weakened patent rights have repeatedly cited the I-MAK “Overpatented, Overpriced” report as evidence to support these accusations. However, this report falsely asserts that the average innovative medicine is covered by dozens of unworthy patents that unfairly extend the term of exclusivity. Despite its lack of transparency, inaccurate use of data, and flawed methodology, the report has been embraced by those seeking to weaken patent rights. Academics have consistently criticized the report, pointing out its lack of evidence to support the hyperbolic and politically motivated claims.
Senator Thom Tillis (R-NC), Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, expressed concerns over the unsubstantiated data provided by I-MAK, which had been relied on by policymakers. He requested that relevant executive branch agencies conduct their independent, objective assessments of the data and report on its factual accuracy. In addition, he asked advocacy organizations promoting the data to disclose their evidence, methodology, and data sets. However, the organizations refused to provide the requested information. Senator Tillis’s actions highlight the significance of the issue and the need for reliable, transparent data in policymaking.
When the foundational data of a study cannot be disclosed and appropriately peer-reviewed, the integrity of the findings should be called into question and discounted within the realm of public debate. This is especially true if a study’s claims contradict accepted empirical research and documented medical breakthroughs. Reliable, transparent data is essential to making informed policy decisions.
Real Life Examples of Patents at Work
Studies have shown that countries with strong patent rights have more robust and innovative life sciences sectors. They experience higher medical innovation outputs, better access to new medicines, and increased clinical trial activity. This evidence emphasizes the importance of strong patent rights in driving innovation in the life sciences and underscores the direct linkage between America’s strong patent system and our global leadership in life sciences.
Patent data demonstrates that the current system is pro-patient, pro-growth, and pro-access. Despite criticism from those who focus on “evergreening” and “patent-thicketing” practices, life sciences companies pursue multiple patents on medicines and technologies to ensure access to cumulative and incremental innovation. Different patents cover important aspects of the product, such as formulations, manufacturing processes, and indications. Furthermore, new patents represent improvements to the original product, such as better delivery efficacy, mitigation of side effects, and extended-release compounds. These incremental innovations provide continued benefits for patients and help advance the field of medicine.
The follow-on benefits for innovation have resulted in invaluable benefits for people worldwide. Consider Botox, which was initially approved to treat eye disorders. Now, there are over 11 approved treatments, including for cerebral palsy. Similarly, AZT was initially developed for cancer treatment, but after years of failed applications and significant investment in clinical trials and research, its potential as a lifesaving treatment for HIV/AIDS was discovered. These examples highlight the importance of continuing to invest in research and development, which is made possible by a strong patent system.
Embrace the Facts
The examples above are just a few among many that demonstrate the effectiveness of a strong patent protection system. It is essential that we maintain a healthy patent environment in order to continue driving toward our shared goal of life-saving innovation. Instead of promoting false political narratives, lawmakers should embrace the facts and recognize that a robust patent system is in everyone’s best interest. By doing so, patients will have access to new treatments and America will continue to lead the world. Is the alternative one that we should really contemplate?
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