First published in AIPLA Biotech Buzz

This morning, the Court of Appeals for the Federal Circuit (CAFC) (Circuit Judges Moore, Dyk, and Wallach) heard arguments on the patentability of mammalian clones, an issue of first impression. The case, In Re Roslin Institute(Edinburgh), came up to the Court after the USPTO's Patent Trial and Appeal Board (PTAB) upheld a rejection of U.S. Patent Application No. 09/225,233. Roslin's representative claim is drawn to "a live-born clone of a pre-existing, non-embryonic donor mammal . . ." Its best known embodiment is Dolly the sheep (for a more extensive legal and scientific introduction to this case, see "Individuality Lost: Is Roslin's Clone Innovation or Nothing But a Copy?"1).

As in its briefs, Roslin framed its arguments around two issues: "whether a clone meets the natural phenomenon exception" to patentable subject matter and "whether Dolly was a natural phenomenon." The USPTO adhered to the same general principle that it advocated earlier in the case, namely, that Roslin's claims are drawn to a genetically identical copy of something that exists in nature, making them not patent eligible. Indeed, although the claims stand rejected under 35 USC §§102 and 103, the hearing was heavily focused on patent eligibility under 35 USC § 101.

Roslin has argued, in its briefs, that the claimed clone is not identical to its parent/donor, in spite of its shared genetic information. For example, the claimed clones differ in name (clone), as well as in age (time delay), behavior, eye color and other phenotypic differences. Judges Wallach and Dyk placed their emphasis on understanding how Roslin's phenotypic differences can be used to characterize its clones, be it from an anticipation perspective or from a patent eligibility standpoint. According to Judge Wallach, Roslin's argument that clones and donors have phenotypic differences "cannot be reconciled" with a typical infringement position. In other words, if Roslin patented its claims and someone had made a phenotypically different clone, would they not infringe? This same issue was raised by the USPTO in its brief.

Roslin's reply was that such a phenotypically different clone would infringe, if the answer to the question "Does the clone fall within the scope of the claims" was "yes." That is because, according to Roslin, phenotypic differences [relative to the donor] are an "inherent part" of the claimed clones. This argument led Judge Dyk to ask the next question: "how can you distinguish your animals from prior art clones based on phenotypic differences [relative to the donor]?"

To address this distinction, Roslin introduced what it called the "4th dimension" factor: time delay. Specifically, Roslin argued that the claims require two animals: a clone and a donor. The next [clonal] generation has the same genetic information as the prior [donor] generation. This situation does not exist with the prior art clones. The closest would be twins, but even these animals do not have this time delay property: at most, the twins are genetically identical to each other but not to their parents. In other words, twins are a genetic mix of two parents as opposed to clones, which are a genetic copy of one parent.

Picking up on the copy/genetically identical feature of the claimed clones, Judge Dyk asked Roslin's counsel about their position in view of Sears, Roebuck & Co. v. Stiffel Co., 376 U.S. 225 (1964), standing for the general proposition that it can't be infringement to copy something that is itself not patentable. Noting that this is not an infringement case, Roslin fell back again on the phenotypic differences, stating that whether or not there was infringement would be dictated primarily by whether the copy is identical to that which exists in nature. In other words, Roslin contended that its clones are a copy of their donor in that they share the same genetic information but differ from their donor phenotypically and from other clones in their "time delay" property.

Judge Moore was the last member of the panel to intervene, but provided some insight into the Federal Circuit's perspective of the case. Judge Moore not only declared her difficulty in understanding Roslin's case, but further noted that she was "having a hard time" discerning why Roslin's case isn't "frivolous." According to Judge Moore, "genetically identical" is the line drawn by the Supreme Court in Myriad. Thus, it appears that because Roslin has admitted that their clone is genetically identical to the donor, and the donor exists in nature, Judge Moore conveyed that Myriad is apparently "quite clear" in its guidance as to what the CAFC is "going to do with this case."