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Intellectual Property & Technology Law Journal Edited by the Technology and Proprietary Rights Group of Weil, Gotshal & Manges LLP VOLUME 29 NUMBER 9 SEPTEMBER 2017 The Use of Genetic Evidence to Defend Against the approval of

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Edited by the Technology and Proprietary Rights Group of Weil, Gotshal & Manges LLP

Intellectual Property Technology Law Journal

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VOLUME 29 • NUMBER 9 • SEPTEMBER 2017 The Use of Genetic Evidence to Defend Against Toxic Tort Claims—Part I . . . . . . . . . . . . . . . . . . . . . 3

Toxic tort cases generally involve claims that an individual was harmed as a consequence of exposure to a chemical(s) (includ- ing a medication). These cases can be particularly diffi cult to litigate because of the challenges presented by demonstrating

r disproving causation. Because we do not fully understand

the extent to which a chemical exposure can affect a particular individual, experts typically offer opinions based on the general risk posed to the plaintiff by the exposure in question. Judge and juries fi nd this lack of plaintiff-specifi c evidence

unsatisfying. This multi-part article, by Susan E. Brice, a part-

ner at Bryan Cave LLP, and Whitney V. Christian, a senior toxicologist at Medtronic, explores how genetic and epigenetic biomarkers of cause and effect can be used to fi ll this gap for

defendants. In this fi

rst part of the article, the authors introduce the topic, discuss the human genome, and genes, the environ- ment, susceptibility, and disease. The fi nal parts of the article, which will appear in upcoming issues of Intellectual Property & Technology Law Journal, will explore genetic data and toxic tort law, genetic biomarkers, genomics and toxicogenom- ics, epigenetics, and tools for understanding causation at the genomic level.

FDA Amends Regulations for 505(b)(2) Applications and ANDAs—Part I . . . . . . . . . . . . . . . 11

This two-part article, by Shana K. Cyr, Li Feng, and Thomas L. Irving, patent attorneys at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, considers the U.S. Food and Drug Administration’s amendments to the regulations relating to the approval of new drugs. In this fi rst part of the article, the authors discuss the background of the regulations and certain

f the amendments that warrant consideration. The second

part of the article, which will appear in an upcoming issue of Intellectual Property & Technology Law Journal, will continue the discussion of the amendments and offer conclusions.

Trademark Rights Protection Mechanisms in the Domain Name System: Current Landscape and Efforts to Diminish Protection . . . . . . . . . . . . . 17

This article, by Brian J. Winterfeldt and Griffi n M. Barnett, attorneys at Mayer Brown LLP, presents an overview of these trademark Rights Protection Mechanisms (RPMs), key devel-

pments within the RPM review process and an analysis of
pportunities and risks this review presents for brand owners,

and predictions regarding the outcomes of the review process and what these outcomes may mean for brand owners moving forward.

When to Ask for Additional Discovery Can Be Just as Important as What to Ask for . . . . . . . . . 23

In Garmin Int’l, Inc. v. Cuozzo Speed Tech. LLC, the Patent Trial and Appeal Board (Board) set forth fi ve factors—commonly referred to as the Garmin factors—for determining whether “additional discovery” will be granted to a party during a proceeding before the Board, such as an inter partes review, covered business method review, or post-grant review. In their article, Nelson D. Runkle and Tyler Del Rosario, of Sughrue Mion, PLLC, discuss the fi ve factors and when to ask for additional discovery.

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Volume 29 • Number 9 • September 2017 Intellectual Property & Technology Law Journal 23

n Garmin Int’l, Inc. v. Cuozzo Speed Tech. LLC,1 the Patent Trial and Appeal Board (Board) set forth five factors—commonly referred to as the Garmin factors—for determining whether “additional discovery” will be granted to a party during a proceeding before the Board, such as an inter partes review (IPR), covered business method review (CBM), or post-grant review (PGR). Briefly, the five Garmin factors are:

1. More than a Possibility and Mere Allegation;
2. Litigation Positions and Underlying Basis;

3. Ability to Generate Equivalent Information by Other Means;

4. Easily Understandable Instructions; and
5. Requests Not Overly Burdensome to Answer.2

The Board infrequently grants additional discovery requests based on the above factors. Further, the burden on a party requesting additional discovery is heightened by additional considerations related to these five Garmin factors, which the Board may consider even if the parties do not raise the issue. These include the impact on schedule and the timing of the request. Impact on the Schedule In determining whether to grant additional discovery, the Board may consider whether the request places a significant burden on meeting the time schedule of inter partes review, even if not specifically addressed by the parties. Further, these considerations may be used in applying the fifth Garmin factor, whether a request is overly burden- some to answer. For example, in Wavemarket Inc. v. Locationet Systems Ltd.,3 the Patent Owner requested additional discovery from Petitioner.4 In particular, the Patent Owner sought to establish that various entities that were not named real parties in interest are in fact so, which could have resulted in dismissal

f the Petitioner’s challenge against the patent in

question.5 In an attempt to demonstrate this posi- tion, Patent Owner requested, inter alia, all indemnification agreements and communications about the indemnification by and between Petitioner and the entities. In denying the request for additional discovery and citing to the fifth Garmin factor, the Board stated, “the requested discovery may place a significant burden on meeting the time schedule

f inter partes review,” noting the proceedings in

the inter partes review were instituted nearly three months prior, and are no longer in the preliminary stage.6 The Board considered the time schedule burden even though the issue was “not addressed by the parties.”7 Similarly, in denying a request for additional discovery in Intri-Plex Technologies v. Saint Gobain Performance Plastics,8 the Board stated they are “mindful of the burden [additional discovery requests] may place on meeting the time schedule,” for inter partes review.9 Here, the Board noted the burden based on a broad request for Patent Owner’s sales documents of a certain category of product, spanning several years. The Board also noted the difficulties in meeting the inter partes review time schedule should the additional discovery request be granted. Although the Board may extend the due dates

f substantive filings, thereby alleviating the bur-

den of additional discovery on meeting the time schedule, the Board also may refuse an extension

Nelson D. Runkle is an associate in the Electrical/Mechanical Practice Group of Sughrue Mion, PLLC. A former Patent Examiner at the U.S. Patent and Trademark Office, he assists clients in the procurement of both U.S. and foreign patents, which includes the preparation and prosecution of patent

applications. T

yler Del Rosario is a law clerk at the firm analyzing patent cases, especially as they relate to PTAB rules, regulations, and decisions.

When to Ask for Additional Discovery Can Be Just as Important as What to Ask for

By Nelson D. Runkle and Tyler Del Rosario

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24 Intellectual Property & Technology Law Journal Volume 29 • Number 9 • September 2017 without good cause. For example, in SK Innovation v. Celgard,10 the Board denied the Patent Owner authorization to file a motion for additional discovery relating to secondary considerations of non-obviousness. In part, the Board did not believe there was sufficient time before the Patent Owner Response was due and the Board was unwilling to extend the due date a third time (when the due date already was extended by a month).11 In particular, the Board stated that “there is insufficient time remaining before the twice-extended Patent Owner Response due date to permit the parties to fully brief and the Board to fully consider the issues, and for SKI to produce any discovery that is ultimately ordered.”12 Timing of Request as Related to Progress of Instituted Trial Aside from the impact on the schedule, the Board also may consider how the timing of the request relates to the progress of the instituted proceeding. For example, in Apple v. Evolutionary Products,13 in denying Patent Owner’s request to file a motion for additional discovery, the Board found the issue was not ripe for discovery based on Patent Owner’s presented rationale. The Patent Owner’s request related to investigating whether Petitioner was coordinating with other parties the Patent Owner has sued for alleged infringement. The Patent Owner argued that “if such coordination is taking place, another defendant could be a real party-in [ ] interest or a privy [ ], thus creating estoppel.”14 The Petitioner countered that the discovery sought by Patent Owner was premature, because “estoppel with respect to a real party-in-interest or a privy in proceedings before the office under 35 U.S.C. § 315(e)(1) or in civil actions or other proceedings under 35 U.S.C. § 315(e)(2) arises only after a final written decision under 35 U.S.C. § 318(a).”15 In denying the request to file a motion for additional discovery, the Board stated because a final decision has not been rendered in the instant proceeding, proceedings in the district court are stayed, and there are no other proceedings before the Office, the “issue is not ripe for discovery.”16 Other timing issues, such as a party’s delay, also can be considered by the Board in determining whether to grant additional discovery. For example, in Schott Gemtron v. SSW Holding Co.,17 the Board found that a “delay in requesting additional discovery weighs against granting [a motion for additional discovery].”18 In this case the Patent Owner filed the motion for additional discovery to obtain evidence related to the Patent Owner’s assertion of commercial success as a secondary consideration of

nonobviousness. However, the Patent Owner did

not request a conference call seeking authorization for additional discovery until almost two months after institution of the trial.19 Similarly, in St Jude Medical v. University of Michigan,20 in denying Patent Owner’s request for additional discovery, the Board determined that the moving party failed to show “it acted timely in making the current request.”21 The Board also considers the constraints of regulations governing procedures before the Board in assessing whether requested additional discovery may yield information that can be used in the course of the trial, given the procedural posture of a case. The Board may deny a motion for additional discovery relating to substantive issues when a party files the motion after the end of routine discovery and after filing its last substantive brief in the pro-

ceedings. In particular, the first Garmin factor may

favor no additional discovery in these circumstances because the party has no opportunity to use the additional discovery as evidence in its arguments to the Board. The third Garmin factor also may be relevant in denying additional discovery when the requesting party is not diligent in its prior discovery to uncover the documents sought in additional discovery. For example, in Daicel v. Celanese International,22 the Board denied the Patent Owner’s motion for additional discovery when the Patent Owner filed the motion after its Patent Owner’s Response, because the Board believed the Patent Owner previously could have uncovered the contents

f the documents through cross-examination.23

The Patent Owner sought production of documents allegedly first uncovered by the Patent Owner during cross-examination and relied on by the Petitioner’s expert to support arguments of unpatentability, but not included in the expert’s Declaration.24 The Board denied the request after holding that the first, third, fourth, and fifth Garmin factors favored denying the motion.25 With respect to the first and third Garmin factors, the Board noted that the Patent Owner did not provide enough

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Volume 29 • Number 9 • September 2017 Intellectual Property & Technology Law Journal 25 evidence to show anything beyond speculation, despite having the opportunity to do so through its cross-examination of the Petitioner’s expert.26 The Board also stated that timing may be relevant to weighing the first factor: “[t]he timing of Patent Owner’s motion … further supports the conclusion that any information obtained is unlikely to be useful, because there is no further opportunity for Patent Owner to submit evidence into the record, absent leave of the Board.”27 In reaching its conclusion, the Board rejected the Patent Owner’s argument that information obtained through additional discovery could be included in a Motion for Observations on Cross-Examination because, “such observations are not a vehicle for raising new evidence to the Board; rather, they are to be used to call the Board’s attention to testimony

btained during cross-examination

… Furthermore, such observations would only be permitted in this case if Petitioner submits additional testimony from

Mr. Miura along with its Reply, which at this point

in the proceeding is conjecture.”28 Captioncall v. Ultratec29 provides another example where the Board held that a motion for additional discovery is untimely when filed after the requesting party’s last substantive brief. In Captioncall, the Board denied authorization for the Patent Owner to file a motion for additional discovery relating to draft claim charts of the Petitioner’s expert when authorization was requested nearly two months after a first deposition of the expert and the filing

f the Patent Owner Response.30

The Patent Owner argued that the motion would be timely because it expected that the Petitioner would file a second declaration by an expert in support of the Petitioner’s Reply and therefore the Patent Owner would use the documents in preparation of a second deposition of the expert.31 However, the Board disagreed with the argument that the motion would be procedurally timely because “Petitioner’s Reply is limited to responding to arguments raised in Patent Owner’s Response.”32 Furthermore, with respect to the first Garmin factor, the Board stated that the Patent Owner would unlikely find something useful because “Patent Owner lacks an opportunity to file a substantive paper addressing the documents” and because “[the expert] signed each of his dec- larations on January 28, 2015, the day before the Petitions were filed” thus implying that that draft claim charts would be similar to the one produced in the Petition.33 Although requests for additional discovery should be made in a timely manner, the Board has determined requests to be premature, particularly when the request involves an uninvolved third party. For example, in SAP America v. PiNet International,34 the Board determined a Petitioner’s request for additional discovery from a third party to be premature because the request was based on speculation that the Patent Owner will seek to amend the claims

r make certain unidentified arguments. In deny-

ing the motion, the Board stated “the Board is not inclined to authorize a motion to compel such discovery from an uninvolved third party without a more clear articulation of the reason such discovery is necessary, the scope of information sought and its intended use.”35 Similarly, in Hilti v. Milwaukee Electric Tool,36 the Board denied a Patent Owner’s first motion for additional discovery of documents that belonged to an uninvolved party, Snap-on, and related to secondary considerations of obviousness.37 However, unlike PiNet, the Board noted that the “proper mechanism” for seeking discovery from a non-party is “to request authorization under 37 C.F .R. § 42.52(a) to apply for subpoenas from a district court under 35 U.S.C. § 24.”38 Despite the denial, the Board in Hilti granted the Patent Owner’s second motion for additional discovery of the Snap-on documents after Snap-on was joined with the original Petitioner.39 Notably, like the motions in Daicel and Captioncall, this second motion for additional discovery was filed after the Patent Owner’s last substantive brief, the Patent Owner Response.40 Yet, this second motion was granted despite the Petitioners’ arguments that (1) the request was untimely for being filed after the Patent Owner Response and (2) the Patent Owner could have sought a subpoena from a district court earlier to obtain the documents.41 Alongside the request for additional discovery, the Board also granted the Patent Owner’s request to file, before the Petitioners’ Reply was due, a single page of supplemental briefing to address the documents to be newly discovered.42 Thus, the Board allowed the Patent Owner to enter the additional discovery documents into the record despite the Patent Owner having finished discovery and having sub- mitted its final substantive brief.

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26 Intellectual Property & Technology Law Journal Volume 29 • Number 9 • September 2017 The Board made its decision on both motions after considering the Patent Owner’s arguments that:

the request for additional discovery was timely

because Snap-on was only recently joined as a party;

a single page of supplementary briefing was suf-

ficient and no page limit exception was needed because the Patent Owner Responses did not use the full 60 pages allotted;

no further expert depositions were needed

because the Patent Owner stated that it would not rely on expert testimony in the supplemental briefing; and

under the current schedule, the Petitioners had

sufficient time to consider the supplemental briefing before their Reply was due.43 In particular, the Board stated that “the single page of supplemental briefing requested by Patent Owner is warranted in the interests of justice, where the supplemental information at issue relates to issues of secondary considerations raised for the first time in the Patent Owner’s Response, and Patent Owner diligently, if unsuccessfully, pursued production of that information via the motion for additional discovery.”44 Accordingly, “Patent Owner [was] authorized to file a single page of supplemental briefing, without relying on expert testimony, and may include supporting exhibits consisting of the eight Snap-On documents produced pursuant to this Order as supplemental information under 37 C.F .R. § 42.123(b).”45 Because the Board allowed the Patent Owner to submit supplemental briefing to discuss the documents produced through additional discovery, the Board also granted the Petitioners a 10 percent increase to the word count in their Reply Brief.46 Thus, in satisfying the already onerous Garmin factors, a party requesting additional discovery needs to consider timing on multiple fronts, to avoid prejudicing the tribunal’s ability to satisfy the schedule and to avoid making a request too early, as well as too late. As a corollary, the constraints imposed by the rules governing proceedings before the Board also may hamper a party’s ability to obtain additional discovery if not timed properly relative to milestones in the trial schedule. However, in rare circumstances, the Board may excuse a party’s later motions for additional discovery as timely when the party demonstrates diligence in seeking the discovery and is willing to limit the amount of materials that it will introduce into the record as a result of that discovery. Notes

1. IPR2012-00001.
2. See IPR2012-00001, Paper 26 at 6-7, (PTAB Mar. 5,

2013).

3. IPR2014-00199.
4. See IPR2014-00199, Paper 34 at 2 (PTAB Aug. 11,

2014).

5. Id.
6. Id. at 8.
7. Id.
8. IPR2014-00309.
9. See IPR2014-00309, Paper 40 at 9 (PTAB Sept. 4,

2014).

10. IPR2014-00679.
11. IPR2014-00679, Paper 31 (PTAB Feb. 5, 2015).
12. Id. at 2-3. Furthermore, the Board held that that the

Patent Owner did not establish good cause for a further extension when it substituted counsel for a second time without requesting an extension of time in connection with its Motion for Withdrawal of Counsel.

13. IPR2014-00086.
14. See IPR2014-00086, Paper 13 at 2 (June 3, 2014).
15. See Id. at 3.
16. See Id. at 4.
17. IPR2013-00358.
18. See IPR2013-00358, Paper 43 at 7 (PTAB Feb. 14,

2014).

19. See Id. at 7.
20. IPR2013-00041.
21. See IPR2013-00041, Paper 20 at 4.
22. IPR2015-00170.
23. IPR2015-00170, Paper 59 (PTAB Dec. 22, 2015).
24. Id. at 3.
25. Id. at 3-8.
26. Id. at 5-6.
27. Id. at 6-7.
28. Id. at 6-7.
29. IPR2015-00636.
30. IPR2015-00636, Paper 20 (PTAB Jan. 26, 2016).
31. Id. at 4.
32. Id.
33. Id.
34. IPR2013-00195.

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Volume 29 • Number 9 • September 2017 Intellectual Property & Technology Law Journal 27

35. See IPR2013-00195, Paper 17 at 6 (PTAB Oct. 16, 2013).
36. IPR2015-01164.
37. IPR2015-01164, Paper 19 (PTAB Mar. 29, 2016).
38. Id. at 3.
39. IPR2015-01164, Paper 32 (PTAB May 13, 2016).
40. Id. at 4.
41. Id.
42. Id. at 5-6.
43. Id. at 4-5.
44. Id. at 5-6.
45. Id. at 6.
46. Id. at 6.

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