Why this biotech patent case is significant for the software industry

It’s with good reason that the patent case of Sequenom Inc v. Ariosa Diagnostics gained incredible attention in the biomedical community. When the biotech company Sequenom developed a new way to identify potential fetal health and developmental risks through a maternal blood test instead of through an invasive procedure, it was considered a breakthrough in neonatal medicine. According to the courts, however, this innovation cannot be protected by patent rights.

While the Sequenom case arises in the context of a patent for a bio­medical inno­vation, it also raises issues of tremendous signifi­cance for the software industry. The Federal Circuit’s decision to invalidate Sequenom’s patent reflects a growing trend that lower courts have been invalidating biotechnology and software patents at an unprecedented rate since the Supreme Court’s decisions in Alice v. CLS Bank and Mayo v. Prometheus. Some winnowing of unmeritorious patents following Mayo and Alice is both appropriate and expected. But the impact has been unpredictable, and there is a risk of misguided rulings that deny patent protection for true software innovation.

Now, the Supreme Court has an opportunity to weigh in and provide much needed clarification as to what is and is not patent eligible. As you can read in Microsoft’s amicus brief, we believe that the Supreme Court’s intervention is necessary because the decision in this case sets a precedent that could have far-reaching impact on future of innovation and patent eligibility, not just in biotech but across all industries.

Both the biomedical and technology industries are leading drivers of innovation and economic growth, but the current uncertainty is a disincentive for the research and development and the ingenuity that is the backbone of our nation’s competitive advantage. Innovation requires a “predictable, con­sis­tent and uniform”[1] sys­tem of patent pro­tection to sustain the investment that fuels that growth. Without the Supreme Court’s clarification, the unpredictability under existing law threatens serious damage to some of our country’s most important industries.

[1] Caltech, 59 f. supp. 3d at 986

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