In Genzyme Therapeutics v. Biomarin Pharma., the Federal Circuit considered what sort of notice and opportunity to be heard in an IPR will satisfy the Administrative Procedure Act (“APA,” 5 U.S.C. § 554(b) & (c)). Genzyme owns US 7,351,410 and US 7,655,226, which both concern methods of treating Pompe’s disease. When Biomarin petitioned for IPR of these two patents, Genzyme submitted a patent-owner statement arguing that the in vitro data in Biomarin’s petition were not sufficient to establish a reasonable expectation of success for the claimed methods, and therefore could not show that the challenged claims were more likely than not to be obvious.
The Board instituted IPR on both patents, despite Genzyme’s arguments about the insufficiency of in vitro data. In its petitioner response, Biomarin responded to Genzyme’s arguments about in vitro data by citing additional references that included in vivo data. Instead of arguing that these additional references do not establish a reasonable expectation of success, Genzyme pressed a procedural point, arguing that it was improper for the Board to consider references that were not included in the grounds of institution for each IPR trial. When the Board disagreed with Genzyme’s argument and relied on two of the in vivo references in its final written decision of unpatentability, Genzyme appealed this point to the Federal Circuit.
Judge Bryson wrote for a unanimous panel that also included Judges Moore and Reyna. The court disagreed with Genzyme’s argument in the strongest possible terms. The Federal Circuit noted that IPRs are trials, and that it is expected that additional evidence will come to light during the course of a trial. The Federal Circuit strongly disagreed with the idea that the Board is constrained to consider only those references that are cited in the institution decision. Indeed, the court noted that it had previously reversed the PTAB for refusing to consider a reference on the same grounds that Genzyme was urging here. Ariosa Diagnostics v. Verinata Health, 805 F.3d 1359, 1365 (Fed. Cir. 2015).
Rather, drawing on D.C. Circuit precedents, the court held that the APA is satisfied so long as the patentee has reasonable notice of the argument being advanced for unpatentability, and an adequate chance to respond. Here Genzyme was on notice of Biomarin’s reliance on the in vivo data from at least the point of Biomarin’s response brief. Also, during oral argument the PTAB questioned Genzyme extensively about several of the in vivo references. Genzyme could have moved under 37 C.F.R. § 42.64(c) to exclude the challenged references, but it did not. Therefore, the Federal Circuit held that Genzyme had been afforded adequate notice and opportunity to respond under the APA.
The Federal Circuit affirmed the PTAB’s holding of unpatentability for the challenged claims.
One panel of the PTAB has introduced a technique that may help solve the oft-raised complaint that a reply brief from Petitioner contains new evidence and/or argument not raised in the Petition. In early decisions, when this issue arose, the Board would simply dismiss the complaint by stating that it would, upon consideration of the entire record after the oral hearing, decide whether or not new evidence or argument had been relied upon. But, in Nintendo of Am. Inc. v. iLife Tech., IPR2015-00105, Paper 23, the Board offered Patent Owner a brief opportunity to point out the purported new evidence that will, frankly, probably make life easier on the Board.
More specifically, the Board addressed a complaint from Patent Owner that Petitioner’s reply brief included new arguments and referred to evidence not previously addressed in the Petition. Id. at 2. The Board introduced a new concept (a “Motion for Attention to New Material”???) that allowed the Patent Owner to file a 2-page brief that lists “the location and a concise description of any portion of the Petitioner’s Reply that Patent Owner wishes to draw to the Board’s attention, but it should not contain argument.” In turn, Petitioner was authorized to file a response to this paper, identifying an itemized list of what from the Patent Owner Response triggered Petitioner to include each item listed by the Patent Owner in its Reply. Again, no argument is allowed.
It is interesting to continue to watch the Board evolve to find new ways to solve the issues that come up so often in IPR proceedings.
Patent Owners have often made the argument that certain art of record in an inter partes review is not actually prior art. The proper way to remove that evidence from the record is via a Motion to Exclude, not merely by making arguments in a Patent Owner Response or at the oral hearing. This issue, and an improper attempt at exclusion, arose in ABB, Inc. v. Roy-G-Biv Corporation, IPR2013-00063, involving US Pat. No. 6,513,058.
Earlier in a previous inter partes review proceeding, Patent Owner had argued that the invention of the ‘058 patent was conceived and reduced to practice prior to the effective art date of the relied-upon prior art references. As such, Patent Owner asserted that the references relied upon in the challenge were not available as prior art. Decision at 5-6. The Board rejected this argument in the earlier IPR as lacking adequate evidentiary support for diligence in reducing the invention to practice. Id. at 6.
In this later proceeding, Patent Owner made additional arguments and cited additional cases, all in an unsuccessful attempt to convince the Board. As a backup argument, Patent Owner argued that Petitioner failed to meet its burden of proof in establishing the publication date of one of the references, and therefore the reference was not eligible as prior art. This challenge, however, was made at the final hearing – not as part of a motion to exclude the prior art reference. Id. at 8.
The Board found that Patent Owner’s argument was untimely, including that the final hearing “is not the place to advance a new theory of the case.” Order at 9. Further, pursuant to 37 C.F.R. § 42.64(b)(1), an objection to the admissibility of a reference must be served within ten business days of the institution of the trial. This must be followed by a motion to exclude the reference. Id. at 8. However, Patent Owner did not raise an objection to the reference nor did it file a motion to exclude. With these actions now time barred, the Board deemed Patent Owner’s attempt to challenge the art-date of the reference to be untimely. Id. at 9.
One of the most litigated aspects of inter partes review proceedings is the issue of whether an argument presented in a petitioner reply or at oral hearing is “new.” This issue arose in Level 3 Communications, LLC v. AIP Acquisition LLC, IPR2013-00296, Paper 42, at 9-10, wherein the Board discussed what will and will not be allowed in terms of new arguments at oral hearing.
Patent Challenger objected to four arguments asserted by Patent Owner during oral hearing:
- Reliance on a case not yet of record;
- A previously-unasserted argument of unpredictable results;
- A new argument regarding a reference of record; and
- Reference to a specific page of reference of record.
Order at 9.
The Board began by addressing Patent Owner’s reliance on a case at oral hearing that had not been previously discussed in the trial. Because Patent Challenger had no opportunity to address the new case, the Board sustained an objection to its use in this proceeding. Id. at 9.
Second, Petitioner objected to Patent Owner’s argument that the patent-at-issue disclosed unpredictable results and a characterization of the claimed invention. Patent Owner countered that its arguments were made in response to a new argument in Patent Challenger’s reply brief and should, therefore, be allowed. The Board sided with Petitioner, finding that there are no exceptions to the rule that new arguments may not be raised during oral hearing, even if in reply to another new argument. Accordingly, the Board sustained these objections, as well. Id. at 9-10.
Lastly, the Board addressed the fourth objection, listed above, where Patent Owner referenced a specific page of a reference of record during oral hearing. The Board noted that the specific page of the reference was previously admitted as evidence and Petitioner had access to it. Further, the reference citation was in support of a previously-asserted argument. Accordingly, the Board overruled this last objection. Id. at 10.
The Board reiterated its rule that no new arguments can be presented during oral hearing, disallowing arguments which depended on new references or which were not previously advanced. However, if argument or evidence relied upon were previously presented, the Board will allow discussion of it during oral hearing.