The 1990s and early 2000s saw a proliferation of authorized commentary postulating that the DOE would play an important role in protecting innovations arising out of biotechnology, particularly biomolecules (i.e., proteins and DNA/polynucleotides), and stressing the necessity for biotechnology patentees to avoid amendments or arguments during patent prosecution that may set off PHE. Prosecution history estoppel (PHE), which might be triggered by a narrowing modification of a patent declared during patent prosecution or by arguments made during prosecution, imposes vital constraints on the flexibility of a patentee to assert the DOE. Nonetheless, before 2019, the Federal Circuit doesn’t seem to have issued an opinion finding infringement under the DOE in a case through which the relevant claim limitation recites a biomolecule.
It finally happened in Ajinomoto Co. v. Int’l Trade Comm’n, with a divided panel of the Federal Circuit holding that a declared limitation reciting a DNA sequence, defined when it comes to the amino acid sequence of a protein encoded by the sequence, was infringed under the DOE by a DNA sequence encoding a protein having a distinct (but similar) amino acid sequence and equivalent perform. It then summarizes and analyzes the results of a Westlaw search designed to identify any Federal Circuit choices using the DOE and PHE to declare limitation reciting a biomolecule, including the court’s most recent determination Ajinomoto. This article begins with a brief overview of the DOE and PHE and explains why DOE was at one time seen as notably vital for the enforcement of patent claims reciting biomolecules.
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