Aegis or Achilles Heel: The Dilemma of Homology in Biopatents in the Wake of Novozymes
Zusammenfassung
Biopatente offenbaren oft Polypeptid- und Nukleinsäuresequencen in der Erfindungsbeschreibung. Die Ansprüche decken oft einen Homologiebereich um die offenbarte Sequenz ab, um einen umfassenderen Schutz zu bieten. Bei mangelnder Stützuhng durch die Erfindungsbeschreibung steht Homologieansprüchen jedoch eine Schwierigkeit gegenüber. Der Oberste Gerichtshof Chinas hat entschieden, dass bei Homologieansprüchen eine mangelnde Stützung vorliegt; durch eine weitere Eingrenzung nach der Ursprungsart kann diese Anforderung jedoch erfüllt werden. Die vorliegende Studie erklärt, dass die Homologie selbst der Kern solcher Konflikte sein sollte. Die Homologie beeinflusst das Vertrauen einer Fachperson in die Funktionalität unbekannter Sequenzen, und ist Teil vieler Patentierungserfordernisse. Daher ist die Einschätzung der Stützung kein isoliertes Problem. Eine Disparität verschiedener Anforderungen erzeugt eine Anforderungslücke und stellt für die Biotechnologie eine Benachteiligung dar. Ein angemessener Test für die Stützungsanforderungen wird daher geliefert, um dem technischen Beitrag einen angemessenen Schutzbereich zuzuerkennen.
Abstract
Biopatents frequently disclose sequences of polypeptides and nucleic acids in the written description. The claims often cover a homology range surrounding the disclosed sequence to get a broader protection. However, homology claims face a hurdle that they may lack support by the written description. The Supreme Court of China ruled that homology claims lack support, but a further limitation by species of origin satisfies this requirement. This study explains that homology per se should have formed the essence of such disputes. Homology dictates the skilled person’s confidence on the functionality of unknown sequences, and is involved in multiple patentability requirements. Thus, the assessment of support is not an isolated matter. Disparity of different requirements creates an unclaimable gap, and constitutes a discrimination to biotechnology. An appropriate test for the support requirement is thus furnished to confer a scope of protection commensurating to the technical contribution.
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