More BioPharma Voices Weigh In On Written Description
Bristol-Myers Squibb and several other companies filed an amicus brief in Amgen v. Sanofi on Wednesday, urging the Supreme Court to open the doors for pharmaceutical companies to obtain broader patent coverage. The case has a pending petition for a writ of certiorari at the high court, which, if granted, would review the Federal Circuit’s treatment of the written description requirement.
Currently, the Court of Appeals for the Federal Circuit interprets U.S. statutory requirements about adequately supporting the claimed subject matter to include (1) a written description requirement, in which the specification must show that the inventors were in possession of the invention, and (2) an enablement requirement, involving sufficient instruction as to how to make and use the invention. For the written description requirement, if the claims recite a genus or category, then the Federal Circuit has found that the specification needs a representative number of species within the scope of the genus, or structural features common to the members of the genus.
In October, we reported that the Federal Circuit applied the written description requirement in this case in a way that underscored this “representative number of species” standard. We also noted that the Federal Circuit stated that a newly-characterized antigen does not necessarily provide sufficient written description for a genus of conventionally-produced corresponding antibodies. Then, in February, the USPTO issued a memorandum with Examiner guidelines for following the Federal Circuit’s ruling.
In July, Amgen asked the Supreme Court to review the Federal Circuit’s written description test. BMS agreed in Wednesday's amicus brief that the court should take up this question.
The amicus brief, like the cert petition, questioned the Federal Circuit’s reading of the law on both legal and policy grounds. BMS and the other parties on the amicus brief argued that the written description requirement as interpreted by the Federal Circuit imposes requirements beyond those in the patent statute. On a pragmatic level, they also asserted that in biotechnology, these requirements often require patent applicants to make large numbers of embodiments before filing an application, which, they say, overburdens researchers and diverts resources from proceeding onward toward additional truly innovative work.
If the Supreme Court takes on this case and then ultimately discards part or all of the Federal Circuit’s approach to written description, it may make broader coverage more readily available, especially for biologics. Still, if history is our guide, then such a ruling could also somewhat reduce the level of certainty and guidance for lower courts and the USPTO in handling the statutory requirements for the specification’s support of the claims.