Hon. Paul R. Michel

In 1980, the Supreme Court decided Diamond v. Chakrabarty, the seminal Section 101 case holding that non-natural, man-made organisms are patent eligible. The Court’s decision paved the way for substantial investment in the then-nascent biotech industry. Forty-five years later, one would think that there’s little room to debate the patent eligibility of genetically engineered host cells—particularly a host cell that can produce non-native viral plasmids and proteins useful in making life-saving, gene-based medicines. But that debate is front and center in Regenxbio v. Sarepta, a pending appeal at the Federal Circuit that follows more recent Supreme Court and Federal Circuit decisions that have turned Section 101 into a short-cut for bringing patent challenges under Sections 102, 103, and 112.

Patents require reliability so they can incentivize investments in new technologies, their primary though little-noticed function. Today, U.S. patents are so often invalidated that investors such as venture capital firms are losing trust in them. Corporate CEOs face the same problem: your right to exclude others from copying your invention can instantly and unpredictably evaporate at any point in the patent’s 20-year lifespan. As a result, our nation faces a crisis of underinvestment in the advanced technologies of the 21st Century, such as Quantum Computing, 6G telecommunications and genetic medicine.

Twenty years ago, Congress began hearing that the patent system needed a faster, cheaper way than district court suits to assess the validity of issued patents. In line with this goal, Congress emphasized that the new procedure was to be “an alternative to expensive district court litigation.”

At the core of Due Process and basic justice is the undeniable right to be heard by an impartial adjudicator on the charges brought against you. That includes the right to present witnesses and evidence in your defense and to cross-examine the witnesses against you. Neither has been afforded to Judge Pauline Newman. Instead, allegations by the U.S. Court of Appeals for the Federal Circuit (CAFC) chief judge, and certain staffers who report to the chief judge, are assumed to be both accurate and sufficient. Yet, Judge Newman has directly and publicly denied their accuracy and sufficiency.

On September 13, the Global Innovation Policy Center of the U.S. Chamber published its “IP Principles” paper declaring the Chamber’s “Beliefs about Intellectual Property.” It was promptly endorsed and signed by 32 external IP thought leaders, including the heads of nearly all major IP associations and organizations, and individual experts such as a former Director of the U.S. Patent and Trademark Office (USPTO), two retired judges (including myself), and leading IP academics…. In my view, the Chamber was exactly right to call for a “reset” in the policy debate over IP rights.