In Genzyme v. BioMarin, Federal Circuit Permits "State of the Art" Analysis Using Non-Instituted References

Authored by Jeffrey M. Jacobstein, Sara A. Leiman, Ph.D., and Leslie A. McDonell

When challenging a patent through inter partes review (IPR), a petitioner typically includes all grounds of unpatentability and associated prior art in the initial paper. Similarly, an IPR institution decision by the Patent Trial and Appeal Board (Board) generally defines the only grounds and art available for dispute. However, a recent U.S. Court of Appeals for the Federal Circuit decision, Genzyme Therapeutic Products Ltd. Partnership v. BioMarin Pharmaceuticals Inc.,¹ identified certain exceptions to that general rule, indicating that petitioners may belatedly cite materials that establish the "state of the art" at the time of the invention, and that the Board may rely on such art in its final written decision.

Background

The Federal Circuit affirmed a Board decision invalidating two Genzyme patents directed to the treatment of Pompe disease as obvious. The Federal Circuit confirmed the Board's use of evidence offered by the petitioner after the institution decisions when those references merely established the "state of the art." This holding extends the reasoning in previous Federal Circuit cases discussing the circumstances in which evidence may he introduced after institution.²

The current case began as two IPR proceedings. Petitioner BioMarin submitted several grounds of rejection, alleging that different combinations of in vitro and/or in vivo studies rendered Genzyme's claimed methods obvious. Finding BioMarin's obviousness arguments redundant, the Board instituted IPR proceedings only on combinations of in vitro studies.

Despite the limited institution decision, BioMarin nevertheless cited several in vivo studies in its Petitioner's Reply. BioMarin argued that the Board's decision to institute IPR proceedings relied in part on the persuasiveness of expert declarations evaluating and applying the general understanding in the art (which included the in vivo studies). The Board ultimately agreed with BioMarin and declared Genzyme's patents obvious in light of the in vitro studies when considered in context of the "prior art as a whole," which included the in vivo studies.³

Genzyme appealed, alleging the Board relied on changed facts and legal arguments in the final written decisions that were not mentioned in the institution decisions, and failed to provide Genzyme with notice and an opportunity to respond to the new grounds of unpatentability. BioMarin countered that the Board correctly applied the in vivo studies as part of an overall evaluation of the state of the art. The Federal Circuit affirmed the Board's procedure and the final written decisions.

Conclusions and Strategies

Board May Use Any Reference in the Record When Formulating a Final Written Decision When determining the state of the art at the time of invention, the Board's consideration may extend beyond references cited in the institution decision. As explained by the Federal Circuit, "the introduction of new evidence in the course of the trial is to be expected in inter partes review trial proceedings" and is acceptable "as long as the opposing party is given notice of the evidence and an opportunity to respond to it."⁴ The Board may not, however, consider new arguments or grounds for unpatentability in the final written decision and may not support previously approved arguments or grounds using new references.⁵

Although the Federal Circuit has not provided a clear way to distinguish whether a petitioner's reference speaks directly to obviousness or merely informs the state of the art, the court's decisions to date suggest that it comes down to how the parties characterize the art.⁶ But unlike earlier Federal Circuit decisions, which focused on the petitioner's characterization of the art, the decision in Genzyme focused on the Board's wording. Here, the Federal Circuit concluded that the Board did not rely specifically on the in vivo studies to invalidate the patent claims. Instead, the Board listed the studies to describe how "the field related to the development of an enzyme replacement therapy for the treatment of Pompe disease had developed" by Genzyme's date of invention.⁷

Thus, one lesson to take from the decision is that petitioners may be able to use strategic characterization of references in order to have them entered into a proceeding after institution. The Board will be more likely to consider a reference after institution if the petitioner presents it as background information available to one skilled in the art at the time of invention. In contrast, the Board likely will disregard a new reference if the petitioner fails to articulate why it deserves consideration or if the petitioner's language suggests an attempt to present a new ground of unpatentability. Indeed, the Board's recent decision on remand in Ariosa clarified that it will not "play archaeologist with the record," for example, by sifting through expert declarations or by inferring a motivation to combine references from a claim chart, to construct an argument not clearly designated in a petitioner's brief.⁸

While the Patent Owner Must Have Notice and an Opportunity to Respond to the References Used to Invalidate a Patent, That Notice Does Not Need to Come from the Board

In the current case, the Federal Circuit held that Genzyme had notice of the in vivo studies and how the Board might use them because BioMarin relied on the studies in its Petitioner's Reply and the parties discussed them at oral arguments.

Thus, a second lesson to take from this case is that, when faced with new references presented after institution that potentially threaten a patent's validity, particularly where the references are characterized as informing "the state of the art," a patent owner may need to consider efforts to exclude those references from consideration by the Board. Alternatively, the patent owner should consider responding to the new material, even if it only appears to address background points regarding the state of the art. A patent owner's failure to do so may waive those arguments if raised at a later date.

In summary, the present Federal Circuit decision adds to the growing body of cases showing when and how a petitioner may attempt to bring in new facts and arguments after institution. It would therefore benefit patent owners to consider responding not only to the grounds of institution, but also to any non-instituted references perceived to factor into a "state of the art" analysis, in case the Board finds them admissible and persuasive. Likewise, careful descriptions of references cited after institution by petitioners, characterizing the new references as directed to the "state of the art," may increase the chance that they will be considered by the Board in the final written decision.

Endnotes

¹ Genzyme Therapeutic Prods. Ltd. P'ship v. BioMarin Pharm. Inc., No. 2015-1720 (Fed. Cir.June 14, 2016).

² See Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015); Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir. 2013).

³ Genzyme, slip op. at 11.

⁴ Id. at 9.

⁵ See generally Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir. 2015).

⁶ See Ariosa, 805 F.3d at 1365; Randall, 733 F.3d at 1360.

⁷ BioMarin Pharm. Inc. v. Genzyme Therapeutic Products Ltd. P'ship, IPR2013-00534, Paper 81 at 16 (PTAB Feb. 23, 2015).

⁸ See Ariosa Diagnostics v.Verinata Health, Inc., IPR2013-00276, Paper 64 at 17-19 (PTAB Aug. 15, 2016) (citing DeSilva v. DiLeonardi, 181 F.3d 865, 866-6 7 (Fed. Cir. 1999).