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Making Sense Of Antibody Epitope Claims
By Benjamin Pelletier, Haynes and Boone
The antibody therapeutics industry has mushroomed into a sector whose value is estimated to reach $138.6 billion by 2024.
1 And this astounding economic growth has been accompanied by equally astonishing technological advancement. Obtaining certain types of patent rights to antibodies has become increasingly challenging in the United States.
2 To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.
Antibodies And Patent Claims
An antibody is, at its core, a professional binding molecule, whose sole purpose is to bind to its epitope – the three-dimensional arrangement of molecules to which it is attracted under the laws of physics. Each peptide subunit of an antibody contains a stretch of amino acid residues that are highly variable from one antibody to the next (aptly named the “variable region”), which conta
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Last month, in January 2021, the United States Patent and Trademark Office (“USPTO”) published a memorandum (the “January 2021 Memorandum”) clarifying how it will analyze claims for indefiniteness in AIA post-grant proceedings before the Patent Trial and Appeal Board (“PTAB”), namely patented claims in PGRs and CBMs and proposed substitute claims in IPRs. Prior to the January 2021 Memorandum, the PTAB applied two different approaches: the
Packard approach and the
Nautilus approach. According to the January 2021 Memorandum, the USPTO will now exclusively use the
Nautilus approach, as further explained below. This aligns the PTAB with the courts in civil actions.
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