Juan M. Alvarez

Navigating Misinformation in Biopharmaceutical Patents

In November 2023, an article penned by Eric Aaronson, Chief Counsel of Corporate Affairs, Intellectual Property, and Intellectual Property Compliance, and Sharon Reiche, Deputy General Counsel, both of Pfizer Inc., was released. It highlights the critical importance of a robust patent system in driving innovation within the U.S. pharmaceutical industry.

Currently, over 90% of prescriptions in the United States are filled with generic or biosimilar medicines, most of which originated as patented drugs whose discovery was incentivized under the intellectual property (IP) framework decades ago.

The article examines how misinformation, particularly under the influence of the ‘illusory truth effect,’ lends weight to falsehood through repetition and can have a negative impact on IP policy in the industry. Entities such as the Initiative for Medicines, Access & Knowledge Inc. (I-MAK) are singled out for propagating unfounded claims against fair competition in the pharmaceutical sector. Despite being repeated and cited, these accusations often lack a basis in verifiable reality.

The case of Lyrica® is used to illustrate the effective operation of the biopharmaceutical ecosystem: an innovation is protected for a limited time, after which the door opens to generic versions, thus facilitating access to a broader population. The article clarifies that Lyrica®, approved in 2004, had generic versions available post-patent expiration in 2019, discrediting I-MAK’s claims of prolonged monopoly.

Terms such as ‘evergreening’ and the concept of ‘patent thickets’ are critically examined, highlighting that any new patent must undergo a rigorous examination process, and that the evolution of a drug from its chemical composition to approval is a process comprised of multiple inventions aligned to create safe and effective treatments.

The article concludes by emphasizing the need to preserve the infrastructure that has enabled such medical advances, underscoring that well-founded, evidence-based policies are essential for the future of accessible medicine.

The call to action is clear: informed and fact-based policies are the only way to ensure that pharmaceutical innovation continues to meet public health needs. Adherence to data, not deceptive narratives, must guide our commitment to progress and patient well-being.

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Juan is a Partner at Ibarra del Paso Gallego, where he specializes in Industrial Property,…

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