United States: PTAB Grants Discovery To Underlying Test Data

Discovery in inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) is typically quite limited, and the PTAB normally is reluctant to grant motions for additional discovery. It is instructive, therefore, when the PTAB does so. In a recent order in Mylan Pharmaceuticals Inc. v. Allegan, Inc., IPR2016-01127, Paper 28 (PTAB May 31, 2017) (Order), the PTAB granted a motion in part for additional discovery for pharmacokinetic (PK) data underlying figures in certain exhibits that had been submitted in Rule 132 declarations during the prosecution of one of the patents-at-issue, U.S. Patent No. 8,685,930. In particular, declarations of Drs. Schiffman and Attar were said to include figures used to allege the criticality of, and unexpected results from, a claimed formulation to treat dry eye, also known as keratoconjunctivitis sicca (Paper 27 at 2). After going through the Garmin factors, the PTAB ultimately allowed the additional discovery in part (Order at 3-5).¹

The PTAB found the first Garmin factor to be the most relevant, i.e., whether or not there is more than a possibility and mere allegation that something useful will be discovered (Order at 3). The PTAB focused on the fact that figures relied on in the declarations "failed to provide the necessary parameters for scientific interpretation, including raw data values and error rates" (id.). The PTAB agreed with Petitioner that such "underlying data is necessary to evaluate figures fully, will aid Petitioner's rebuttal to Patent Owner's arguments and evidence, and will afford Petitioner a fair cross-examination of Patent Owner's witnesses" (id.). Based on the same motion, the PTAB denied discovery into data underlying figures from a separate, peer-reviewed publication that summarized the efficacy data of Patent Owner's phase 2 and phase 3 clinical trial studies (id. at 4). These figures were distinguished in that, unlike in the Schiffman and Attar declarations, the figures included mean value and error rates (id.).

In support of its motion, Petitioner pointed to an IPR (Corning)² in which the PTAB ordered production of underlying data necessary to evaluate an expert's conclusions (Paper 23 at 5). Interestingly, the Patent Owner tried to distinguish Corning by arguing that the underlying data was generated specifically for the IPR; in contrast, the data underlying the declarations in this case was not generated for the IPR (Paper 27 at 6-7). Although the PTAB "note[d] that . . . [37 C.F.R.] § 42.65 favors the disclosure of the underlying facts or data on which an expert's testimony is based" (Order at 3), which may be a tangential reference to the Corning argument, the PTAB did not otherwise address the Patent Owner's attempt to distinguish data created for an IPR from data that is not.

Notably, while 37 C.F.R. § 42.65(b)³ requires data to be submitted in a declaration that meets specific requirements, there is no indication in the Order or the accompanying party briefs that Patent Owner submitted a declaration meeting these requirements, or that the Petitioner objected to the lack of such a declaration. Although not an issue in this case, another provision relevant to data submissions in IPR proceedings is 37 C.F.R. § 42.61, which is directed to admissibility of a "specification or drawing" of a United States patent application or patent. In particular, § 42.61(c) states that "[i]f there is data in the specification or a drawing upon which a party intends to rely to prove the truth of the data, an affidavit by an individual having first-hand knowledge of how the data was generated must be filed." Thus, if a party intends to rely on the data in the challenged patent itself, an affidavit may be required for admissibility purposes.

Accordingly, parties should carefully consider any data being presented, regardless of when or where generated, to determine if grounds for objection or additional discovery are warranted. Likewise, parties seeking to rely on such data should be prepared to submit the affidavits required under §§ 42.61 and 42.65.⁴

Footnotes

¹ The PTAB has identified the following five factors in determining whether additional discovery is in the interests of justice: (1) more than a possibility and mere allegation that something useful will be discovered; (2) requests that do not seek the other party's litigation positions and the underlying basis for those positions; (3) ability to generate equivalent information by other means; (4) easily understandable instructions; and (5) requests that are not overly burdensome to answer. Garmin Int'l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001, slip op. at 6-7 (PTAB Mar. 5, 2013) (Paper 26) (informative).

² Corning Inc. v. DSM IP Assets B.V., IPR2013-00043, Paper 27 (PTAB June 21, 2013).

³ The text of 37 C.F.R. § 42.65 is as follows: Expert testimony; tests and data. (a) Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight. Testimony on United States patent law or patent examination practice will not be admitted. (b) If a party relies on a technical test or data from such a test, the party must provide an affidavit explaining: (1) Why the test or data is being used; (2) How the test was performed and the data was generated; (3) How the data is used to determine a value; (4) How the test is regarded in the relevant art; and (5) Any other information necessary for the Board to evaluate the test and data.

⁴ On June 12, 2017, the PTAB issued an order effectively mooting a large portion of the order discussed in this post that allowed additional discovery into the data underlying the Schiffman and Attar declarations (Paper 33). Specifically, in a dispute regarding the scope of the additional discovery order, the parties agreed that the data underlying several of the exhibits in these declarations pertained to clinical data, not PK data (id. at 2). In addition, Patent Owner represented that those exhibits are not necessary to support its case (id.). Given these facts, the PTAB acknowledged that its original order pertained only to PK data, not clinical data, and since the parties agreed the data underlying certain exhibits in the declarations related only to clinical data, such data was outside the scope of the additional discovery order. Accordingly, the additional discovery order now pertains only to Exhibit C in the Schiffman declaration and Exhibit B in the Attar declaration. The PTAB additionally warned that if the excluded exhibits are used in the proceeding, they will be given no weight per § 42.65, since the underlying data is not being produced.

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