Falkner v. Inglis
CAFC (May 26, 2006) (“great expenditures of time and effort . . . ordinary in the field of vaccine preparation” so “mere fact that experimentation may have been difficult and time consuming does not mandate a conclusion . . . [of] ‘undue’ [experimentation]”).
Falkner v. Inglis was an appeal to the Court of Appeals for the Federal Circuit (CAFC) from a decision of the Board of Patent Appeals and Interferences (BPAI) awarding priority of invention to Inglis. Inglis showed an earlier date of invention, but Falkner claimed that date did not include the specific poxvirus of the contested claim and, thus, Inglis was not in possession of the poxvirus invention nor had he enabled the poxvirus invention .
When producing vaccines, the traditional method is to inactivate genes in a viral vector known as “inessential” genes. Thus, while the vector becomes substantially less pathogenic, there is still some risk the vector virus, even though attenuated, could still cause a harmful infection. Safer vaccines, however, may be made by deleting or inactivating an essential gene. This procedure is applicable to many different vector viruses, including poxviruses.
The earlier Inglis applications described vaccine vectors in general and focused on the subgenus of herpesviruses, but also contained several passages related to poxvirus-based vaccines. Falkner, however, argued that the passages did not adequately describe and enable the poxvirus invention. Falkner argued that Inglis did not identify the essential genes in the poxvirus or describe their inactivation, that none were produced, and that the bulk of the Inglis applications was directed to herpesviruses, not poxviruses. Falkner’s applications described poxvirus vaccine vectors in detail and to the exclusion of others (e.g., herpesvirus vaccine vectors).
The Court affirmed the BPAI decision awarding priority to Inglis, stating that Inglis’ applications provided extensive disclosure of the selection of an essential gene, deletion or inactivation, and production of mutated viruses with the deleted or inactivated gene. In addition, the Court noted that the differences between herpesviruses and poxviruses were well known. While the Court noted that it would require difficult and time-consuming experimentation to get from the Inglis disclosures to the poxvirus, it would not rise to the required level of “undue experimentation”. Finally, the Court concluded, examples with poxviruses were not required, actual reduction to practice of poxviruses was not required, and recitation of the “essential regions” of the poxviruses are not required since they are well known.
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