The first patent application or applications filed by a company can be the only opportunity to claim the most broad embodiments of a platform technology. To define the scope of what is invented, functional language often is employed in the claims, particularly where the invention is of pioneering nature, such that there is no prior art barring patentability. Such claiming strategy had been successfully employed for many years, but functional language no longer is accepted by patent offices in many jurisdictions. In the United States, such claims recently have been rejected or invalidated as not adequately described and/or not enabled. In other jurisdictions, claims are rejected as claiming by a result to be achieved.
The Court of Appeals for the Federal Circuit recently invalidated claims in which functional language was employed. In Abbvie Deutschland v. Janssen Biotech and Centocor Biologics, App. No. 2013-1338, -1346 (Fed. Cir., July 1, 2014), the court found that a claim to a neutralizing isolated humanized antibody:
“that binds to human IL-12 and disassociates from human IL-12 with a Koff rate constant of 1×10‑2s-1 or less, as determined by surface plasmon resonance”
was invalid because the patent failed to satisfy the requirement for an adequate written description. The functional language provided no structure.
The court stated:
“ [I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.”
The court continued:
“ . . . patents must at least describe some species representative of antibodies that are structurally similar to Stelara [the alleged infringing antibody]….There is also no evidence to show whether one of skill in the art could make predictable changes to the described antibodies to arrive at other types of antibodies such as Stelara. . .”
Whether one agrees with the holding in this case and the reasoning, it represents the current view of courts and patents offices in the United States and elsewhere.
A fundamental principle of patent law is that a patent provides an inventor a limited right of exclusivity in exchange for disclosure of the subject matter as claimed. Patent applications as filed often include broad claims that recite functional language, which are rejected. To limit claims to disclosed embodiments can be of limited value. Competitors can rely on the disclosure of the patent to prepare other embodiments, and avoid infringement.
In light of the trend of courts and patent offices to limit the scope of patent protection, patent drafting strategy is critical to obtaining a commercially viable scope of protection. To do so requires a knowledge of the prior art to circumscribe the scope, detailed and extensive disclosure in the patent application to define a genus or genera and subgenera and as many representative species as possible. Common structure and function of the member of the genera and subgenera should be described to evidence possession and invention of the genus and subgenera. The claims should include functional and structural limitations that define the genera and subgenera. For jurisdictions that do not permit any functional claiming, the disclosure should include detailed structural descriptions of many species so that claims can recite structure to thereby provide a reasonable scope of protection.
-Submitted by Stephanie Seidman, McKenna Long & Aldridge LLP