A role reversal in biotech patenting

Mar 08, 2019
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EU_backgroundThe difference in the patenting landscape between the United States and Europe used to be characterized as freewheeling versus cautionary; expansive versus patchwork. Think of Diamond v. Chakrabarty‘s “anything under the sun that is made by man” versus the long battle to finally allow the patenting of stem cells in Europe.

However, the conventional wisdom may be turning around in a big way. In the Tuesday IP track session Antibody Therapeutics: May I Have Them All, the four panelists ran through several theoretical scenarios involving the patentability of therapeutic antibody compounds and methods of use before both the US Patent & Trademark Office and the European Patent Office, as well as the courts who may eventually uphold or invalidate the patents.

The audience was invited to cast their vote on several questions using the MyBIO app, to no great success; we quickly reverted to the more low-tech but highly efficient ‘show-of-hands’ method. Two generally agreed-upon propositions were that: (1) the likelihood of getting a US application approved was dependent on the identity of the patent examiner (cue knowing laughter from the audience), and (2) Europe is starting to present a more streamlined application process, focusing more on the method of “using an antibody to antigen X for the treatment of disease Y” compared to the myriad structural and functional characteristics required by the USPTO.

Panelist Robin Silva, a partner at Morgan Lewis, summed up by advising the audience to continue to claim antibodies “six ways from Sunday and see what sticks.” That might be a harder slog, but in the long run may also be more profitable, both for drug developers and their patent attorneys.

Wednesday’s morning session, Inventions Patentable: Evaluating Proposed Amendments to Section 101 merely reinforced the theme, with panelists discussing how recent US court decisions such as Mayo, Myriad and Alice have in essence replaced the well-understood framework for a “patentable invention”- i.e., novelty, utility, inventiveness- with an “enoughness” test that the USPTO, courts and patent bar are struggling to understand and apply. This has left the US standing alone by excluding from patentability isolated natural products and basic diagnostic methods.

Whether the solution is a legislative fix, regulatory guidance or a change in judicial mindset, it cannot come soon enough to clear the atmosphere of confusion and unpredictability now present.

Michael Francisco

Michael Francisco

Senior Editor, Nature Biotechnology

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