AIPLA Files Amicus Brief in REGENXBIO Inc. v. Sarepta Therapeutics, Inc.

Written May 14, 2024

Arlington, VA. May 10, 2024 - The American Intellectual Property Law Association (AIPLA) filed an amicus brief in support of neither party with the Court of Appeals for the Federal Circuit in REGENXBIO Inc. v. Sarepta Therapeutics, Inc., a case on appeal from the U.S. District Court for the District of Delaware. The district court held that cultured host cells containing a recombinant nucleic acid molecule were not eligible for patent protection under Section 101 of the Patent Act because the individual nucleic acid sequences used in the recombinant molecule were not modified or changed from their naturally occurring state.


AIPLA’s brief urges the Federal Circuit to reverse the district court’s Section 101 holding. Under the Supreme Court’s decisions in Diamond v. Chakrabarty and Association for Molecular Pathology v. Myriad Genetics, Inc., a composition of matter combining natural components is eligible for patent protection so long as the resulting invention possesses “markedly different characteristics” from anything found in nature and “the potential for significant utility.” As the brief explains, the claimed host cells fit squarely within that paradigm: much like the inventions at issue in Chakrabarty and Myriad, they combine naturally occurring components to form an artificial, human-made product capable of performing a novel function. Contrary to the district court’s holding, the Supreme Court has never required that an invention’s individual natural components be modified from their natural state.


The brief goes on to explain the potential consequences of affirming the district court’s decision. Numerous biotech innovations rely on the types of natural combinations that the district court has declared patent ineligible. If the district court’s decision were elevated to Federal Circuit precedent, it would harm innovation in numerous biotech and biotech-adjacent fields. Moreover, as the brief explains, affirming the district court’s decision could undermine the competitiveness of U.S.-based biotech firms, and encourage those firms to relocate to foreign jurisdictions that offer patent protection for recombinant molecules and the host cells that contain them.