US Patent Law Hinders Life-Saving Cancer Therapy Development

The converse of “if it ain’t broke, don’t fix it” applies to US patent eligibility laws—“if it ain’t fixed, it will be broke.” And patent eligibility laws are broken in the US. Many who work in this legal field, spanning senior judges, experienced practitioners, and scholars, share this sentiment. Congress or the US Supreme Court must take action.

Patent eligibility law in the US severely impedes development of new and improved anti-cancer drugs by curtailing venture capital funding needed by the scientific community.

As a 2022 empirical study showed, medical diagnostics firms received $9 billion less in VC funding as a result of the Supreme Court’s jurisprudence on patent eligibility.

The field of medical diagnostics has taken a huge leap backwards in the US. Groundbreaking and innovative artificial intelligence, personalized medicine, and even blockchain technologies are hindered by this broken law. The practical outcome is that certain technologies can gain patent protection in those fields in Europe, China, and other industrialized nations, but not in the US.

Two Supreme Court decisions from a decade ago focusing on medical diagnostic technology have had a profound effect on biotechnology and personalized medicine industries in the US. The Supreme Court created its own exceptions to the law governing patent-eligible subject matter, and has vastly broadened the scope of those exceptions.

The exceptions have caused havoc in the biopharmaceutical industry by making it nearly impossible to obtain a patent in some fields. They have also increased the number of medical diagnostic patents being invalidated—based on the pretext that the subject matter the patent encompasses, while highly innovative, is nevertheless patent-ineligible.

For example, take the discovery Dennis Lo and colleagues at Oxford University recently made. They discovered that DNA from a fetus circulates in the bloodstream of a pregnant woman. This new discovery and its related medical diagnostic test now allow more accurate and less invasive means to detect abnormalities in unborn children.

While this invention was lauded and found to be patent-eligible subject matter in the UK and Australia high courts, US laws found the same invention to be ineligible subject matter for a patent. Why?

Because the Supreme Court has created untenable exceptions to the law. Absent these court-created exceptions to the statutory language, this groundbreaking invention, like in other industrialized nations, would also qualify as patent-eligible subject matter.

Recent Supreme Court jurisprudence has set the bar very high for protecting a vast array of groundbreaking medical diagnostic technologies. In the context of oncology, for example, these technologies are vital to fighting cancer. They allow doctors to identify cancers at various stages, using biomarkers that are specific to the cancer in question.

These biomarker-based diagnostic tests also allow doctors to accurately predict the risk of healthy individuals getting cancer in the future, and the disease’s ultimate outcome. Such highly valuable facets of medical diagnostics technologies are under direct threat of being patent-ineligible subject matter based on Supreme Court jurisprudence.

Congress should act by abolishing Supreme Court-created exceptions to the written law. There is some hope, because Sens. Thom Tillis (R-N.C.) and Chris Coons (D-Del.) introduced in June the Patent Eligibility Restoration Act of 2023.

This proposed legislation attempts to clarify patent eligibility by proposing to eliminate the Supreme Court’s exceptions and replace them with a list of inventions deemed ineligible for patent protection.

If Congress fails to act, perhaps the Supreme Court will reverse course. Although the court declined certiorari in May in two cases that presented opportunities to clarify patent eligibility laws, new opportunities are available for the Supreme Court—most notably for stakeholders in the software and biotechnology industries.

Specifically, on Sept. 26, the Supreme Court considered whether an invention relating to early noninvasive detection of organ transplant failure is patent-eligible subject matter, as the patent covers a new medical diagnostic test based on the court’s natural phenomenon exception to patent-eligible subject matter.

Whether Congress or the Supreme Court takes action to clarify patent eligibility laws remains to be seen. Either way, corrective action is crucial for advancing technological innovation in the US, particularly in the biomedical field.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

Author Information

Shahrokh (Seve) Falati is professor of law at New York Law School, co-director of the school’s Innovation Center for Law and Technology, and director of the Patent Law Clinic.

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