Stacy Lewis

A recent Federal Circuit decision demonstrates that for priority claims and patent term, the phrase “specific reference” is key. For example, amongst three related applications, to get the benefit of priority of an earlier U.S. patent application 1, application 3 in a priority claim has to have a “specific reference” to earlier application 1. A mere priority claim in application 3 to application 2, even though application 2 specifically “incorporates by reference” application 1, is not sufficient to allow application 3 to rely on the filing date of application 1. Rather, the priority chain is broken between applications 2 and 1, leaving application 3, at best, with a priority date of application 2 for purposes of patentability… From the Federal Circuit in Droplets, practitioners are reminded that both priority claims and incorporation by reference are very specific tools that should not be relied on during prosecution without careful consideration and deliberate use. Certainly, incorporation by reference does not trump “specific reference” and may lead to a break in the priority chain for purposes of patentability.

The Amgen v. Sanofi decision put most functional antibody claims into question, including epitope and competitive binding claims, as well as antibody claims based on a newly characterized antigen. After Amgen v. Sanofi, non-sequence based antibody claims may become more difficult to obtain before the USPTO from a written description standpoint.  Yet, to fully protect the essence of the invention and avoid design-arounds, such claims are extremely valuable to patent owners. To obtain antibody genus claims beyond those defined by sequences, the patent applicant will need to make and test a sufficient number of representative antibodies across the claimed genus, or establish a clear structure/function relationship among the members of the genus.  Patent applicants should carefully assess the amount of data they have acquired, in comparison to the scope of claims that they wish to obtain, before rushing to the Patent Office.