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June 8 — Expert testimony based on underlying facts or data can be critical in challenges to patent validity before the patent board, panelists said June 7.
“Please provide an expert if you can. You don't want to be relying on us to decide issues of science and fact on our own,” Michael Tierney, a Patent Trial and Appeal Board lead administrative patent judge, said at a session at the BIO 2016 International Convention. But he added that expert testimony without underlying facts or data is entitled to little or no weight.
The inter partes review (IPR) process providing for third-party challenges of patents, which took effect in September 2012, has become controversial because an estimated 75 percent of patents challenged across all industry sectors since the process began were invalidated.
The session used as its starting point a recent report by Bloomberg BNA that found that 40 percent of the biopharma patents whose validity was challenged in an IPR process before the PTAB have had some or all claims invalidated (10 LSLR 11, 5/27/16).
Meanwhile, the Supreme Court is reviewing a case involving IPR.
The high court is reviewing the U.S. Court of Appeals for the Federal Circuit's decision in Cuozzo Speed Techs., LLC v. Lee (10 LSLR 09, 4/29/16). In that case, the petitioner is arguing that Congress created the IPR process as a faster, less expensive alternative to patent challenges before a federal district court, and the PTAB uses the broadest reasonable interpretation standard (BRI) when considering patent validity while federal district courts use the “plain and ordinary meaning” of disputed terms.
At the session, as a tutorial for the audience, Kevin Noonan, partner at McDonnell, Boehnen, Hulbert & Berghoff LLP, and Teresa Stanek Rea, partner at Crowell & Moring LLP, used role play involving different motions concerning a hypothetical antibody patent before Tierney.
Tierney also offered lessons learned from IPR proceedings, beginning with claim construction, which is the meaning a court can give to disputed terms in a patent claim.
He said he had thought when the IPR became effective that decisions would turn on claim construction. “But that didn't turn out to be the case. Sometimes the claim construction has already been determined by a district court or it isn't even offered as an issue before the board. But it is still important,” Tierney said.
Tierney noted that an IPR petitioner’s proposed claim construction must be supported by citations to the record that justify the construction. The parties can rely on intrinsic and extrinsic evidence to support their constructions. The PTAB will construe terms as necessary to render a decision, whether or not parties provide proposed constructions, and isn't required to adopt claim constructions proposed by parties.
In their role playing before Tierney, Rea and Noonan often found that, when the judge was confronted with reports of experts who disagreed, he said he would be inclined to let the case go forward, although the board would evaluate the witnesses' testimony in reaching its decision.
On the issue of whether a patent claim is invalid as obvious in light of prior art—prior patents or publications—Tierney said, “The board evaluates the underlying factual determinations, identified in Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966), including any differences between the claimed subject matter and the prior art. Petitioners should pinpoint and address specific teachings in the applied art that disclose the claim elements, rather than rely on what others have said, such as the patent examiners.
Tierney listed five factors the PTAB uses in evaluating additional discovery requests:
“Requests for specific documents are more likely to be granted than requests for broad categories of documents,” Tierney said.
Tierney was asked during the question-and-answer session why the PTAB has been reluctant to grant motions to amend.
“When a patent owner enters a motion to amend during the initial review process before a patent examiner, motions to amend are entered into the record. But if the board were to accept a motion to amend, that would mean that it would be making a decision on an unexamined claim,” Tierney said.
“What we tend to do is that, if your claims are held unpatentable, then we look at a motion to amend. Sometimes we find that the patent owner is trying to amend the claim but the amendments are so small they are still covered by prior art.”
Tierney was asked what difference it will make to the PTAB if the Supreme Court rules in Cuozzo that both the district court and the PTAB must use the plain language standard and the board can no longer use the BRI.
“Most of the time, the BRI and plain language-based decisions will end up in the same place. In the vast majority of cases, it will not make a difference. In a few, it does,” Tierney said.
One audience member asked whether the board tended to grant motions to exclude testimony. “We would rather let it in and make a decision on the testimony after,” Tierney said.
To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna,com
To contact the editor responsible for this story: Randy Kubetin at email@example.com
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