Current understanding of the PTAB process holds that a party’s petition challenging a patent must contain all evidence and arguments for institution that the party plans to present; otherwise, anything not included in the petition is forfeited. This understanding may be changing, however, as Judge Bryson’s June 14 Federal Circuit opinion in Genzyme Therapeutic Products Limited Partnership v. Biomarin Pharmaceuticals Inc. affirmed the use of new evidence at trial.
In Genzyme v. Biomarin, the Court upheld the use of new evidence at trial to describe the state of the art when the opposing party was given notice and opportunity to respond. The appeal was brought to the PTAB following decisions of two inter partes review proceedings, which held U.S. Patent Nos. 7,351,410 and 7,655,226–both owned by Genzyme–to be unpatentable as obvious. Biomarin filed the petition in June of 2013, requesting review of the two Genzyme patents, which both concerned the use of human acid a-glucosidase injections as treatment for Pompe’s disease. The Board instituted review of the patents on grounds of some of the references Biomarin presented and declined to institute review for others.
In response to Biomarin’s request, Genzyme argued that, because Biomarin’s instituted references for obviousness described in vitro experiments (studying molecules outside of their normal biological surroundings), a person of ordinary skill would not find it obvious that the studies would have the same effects on human subjects. Since the Board did not institute review based on any references that included in vivo data (studies within humans, animals, or plants), Genzyme claimed Biomarin should not be able to use any prior art involving successful in vivo tests to show obviousness.
In response to Genzyme’s assertion, Biomarin cited two in vivo studies, and the Board used these as support for its findings as to the state of the art regarding the topic. In its final written decision, the Board found by a preponderance of the evidence that the challenged claims of the two patents would have been obvious, as all that was left undetermined from the prior art was the specific dose of injection to be used within a previously suggested range and the proper dose schedule. The Board did not use the later references as support for its conclusions regarding the claims.
On appeal, Genzyme argued that the Board relied on arguments not discussed in the institution decision when finding the claims unpatentable, which it asserted was not permissible. The Court did not view this as problematic, however, as new evidence is expected in inter partes review trial proceedings, and there is no requirement for the institution decision to anticipate and set forth every issue that could potentially arise. As the Court explained, “The purpose of the trial in the inter partes review proceedings is to give the parties an opportunity to build a record by introducing evidence–not simply to weigh evidence of which the Board is already aware.”
Judge Bryson clarified that the important concern is whether Genzyme received adequate notice of the issues and was presented with an opportunity to respond. As long as these two requirements are met, the use of new evidence is permissible. The Court concluded that Genzyme could not plausibly argue it did not receive notice, as Genzyme raised the issue of the in vivo studies in its patent owner response, and Biomarin discussed the studies in its replies. Since both parties decided to address the relevance of in vivo references, Genzyme received notice that the Board might address the parties’ arguments about these references in its final written decision.
In addition, the Court held that Genzyme was presented with the opportunity to respond to the new evidence. At the oral hearing before the Board, Genzyme and Biomarin disputed the way the Board could use the in vivo references, but neither argued that the references could not be used at all. If Genzyme wanted the Board to disregard the references, it had procedural options available, such as filing a motion to exclude or asking for leave to file a surreply to submit a further response.
Genzyme, however, chose not to take advantage of these options and instead argued only that the references should be used for a limited purpose. The Court found this to be an unavailing reason to deny the use of evidence that Genzyme had notice of and opportunity to respond to if desired.
Ultimately, the grounds on which the Board invalidated the claims in its final written decision were the same grounds that were in its institution decision. The references were used to describe the state of the art but were not among the prior art references the Board used to establish any claim limitations. In affirming the case in favor of Biomarin, the Court expressed its distaste for the constraints that Genzyme suggested were placed upon the Board.
“Under the regime imagined by Genzyme, the Board would not only be prohibited from discussing any references not cited in its institution decision, but it would be confined strictly to the quoted or cited portions of even those references that were included in the institution decisions, requiring something approaching word-for-word parity between the institution and final written decisions.”
Such language by the Court suggests the allowance of new evidence during trial, if at least for describing the state of the art, which gives parties greater latitude when drafting the petition. This possibility has the potential to impact the strategic approach taken in PTAB litigation going forward.