It is a prevailing truism amongst the US patent legal community that the current patent eligibility laws are significantly flawed and in desperate need of intervention, either from Congress or the Supreme Court. The flaws in these laws are causing widespread impediments to the development of new and improved anti-cancer drugs by choking off venture capital funding critical for scientific research in the field.
An empirical study conducted in 2022 shows that due to the existing jurisprudence on patent eligibility laid down by the Supreme Court, medical diagnostic firms have received $9 billion less in venture capital funding. Read the study here.
Despite the enormous strides in medical diagnostics, ground-breaking technologies like artificial intelligence, personalized medicine, and even blockchain are being held back by current US patent law. As a result, certain technologies that are patentable within European, Chinese, and other industrialized nations do not enjoy the same protection in the US.
Two decisions by the Supreme Court a decade ago, focusing on medical diagnostic technology, have profoundly shaken the biotechnology and personalized medicine industries in the US. View the first decision here and the second decision here. These rulings have created exceptions to patent eligibility laws and have largely broadened their scope.
As a prime example, consider the discovery by Dennis Lo and his team at Oxford University. The scientists discovered that DNA from a fetus circulates in the bloodstream of a pregnant woman, leading to a new diagnostic test that can detect abnormalities in unborn children in a less invasive and more accurate manner than before. This invention was deemed patentable in the UK and Australia, but oddly enough, not in the US due to the infirmities within the country’s patent law. Find out more.
Efforts are being made to rectify the situation. Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) introduced the Patent Eligibility Restoration Act of 2023 in June, aiming to clear up patent eligibility and eliminate the Supreme Court’s exceptions. Read about it here.
Should Congress fail to act, perhaps the ball will be in the Supreme Court’s court once more. Although the Supreme Court declined certiorari in two cases that may have clarified patent eligibility laws, new opportunities still exist. On Sept. 26, the Supreme Court considered whether a patent on a diagnostic test for early noninvasive detection of organ transplant failure is patent-eligible subject matter. Review the full case here.
The road to correcting patent eligibility laws could be long and fraught, but such steps are vital for advancing technological innovation in the US, particularly in the biomedical field.