The case involved Genzyme’s patents for treating a serious genetic muscle disease that can lead to death from heart failure. Biomarin Pharmaceutical Inc. filed inter partes review petitions challenging the claims as obvious based on several combinations of prior art references involving in vitro experiments, (i.e,. experiments that take place outside the human body). Genzyme argued that a person of ordinary skill in the art would not find those experiments predictive of results in a human patient, and that Biomarin should not now be permitted to use any prior art showing successful tests in humans because those studies were not discussed in the board’s institution decision. In its reply, Biomarin cited two in vivo studies (i.e., experiments that take place inside the human body) to further argue Genzyme’s patent claims are unpatentable as obvious. In its final written decisions, the Patent Trial and Appeal Board (PTAB) found the claims to be obvious based in part on the in vivo studies.
On appeal, the Genzyme argued that in finding the claims unpatentable, the PTAB had relied on facts and legal arguments not set forth in the institution decision. Specifically, Genzyme argued that although the PTAB held the claims unpatentable in view of the same combinations of references that were set forth in the institution decision, its citation to the two new in vivo studies denied notice of the issues to be considered by the PTAB and an opportunity to address those issues.
The Federal Circuit affirmed because it held that the PTAB is free to consider/rely on new evidence and that it did not “change theories midstream” (i.e., it was not a new ground of rejection) much less deny Genzyme notice of any such change. The Federal Circuit stated:
In particular, Genzyme objects to the [Patent Trial and Appeal] Board’s citation of two references dealing with in vivo testing, the Kikuchi and van der Ploeg ’91 references. However, the introduction of new evidence in the course of the trial is to be expected in inter partes review trial proceedings and, as long as the opposing party is given notice of the evidence and an opportunity to respond to it, the introduction of such evidence is perfectly permissible under the APA.
The Federal Circuit rejected Genzyme’s argument that the institution decision must refer to every bit of evidence that is relied on by PTAB in its final written decision because “[t]here is no requirement, either in PTAB’s regulations, in the Administrative Procedure Act, or as a matter of due process, for the institution decision to anticipate and set forth every legal or factual issue that might arise in the course of the trial. See Boston Carrier, Inc. v. ICC, 746 F.2d 1555, 1560 (D.C. Cir. 1984) (even when adjudicating charges of misconduct, an agency is not burdened with the obligation to give every applicant a complete bill of particulars as to every allegation that carrier will confront’).” The Federal Circuit also pointed out that Genzyme had opportunities to attack Biomarin’s references to the in vivo tests beyond arguing that they should have been kept out because they were not mentioned in the institution decision. It could have filed a motion to exclude the references or sought leave to file a surreply to provide a substantive response to them, but it did neither.
The opinion thus indicates that parties can use the inter partes review proceedings to build a record and introduce/present new evidence for the PTAB to rely on even if it was not included in the original institution decision, provided the grounds of rejection stay the same (i.e., parties might not necessarily be locked in to only the evidence in the petition/institution decision).
Genzyme Therapeutic Products LP v. BioMarin Pharmaceutical Inc., C.A. No. 15-1720 (Jun. 16, 2016).