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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 new drugs. In this fi rst part of the article, the Toxic Tort Claims—Part I . . . . . . . . . . . . . . . . . . . . . 3 authors discuss the background of the regulations and certain of the amendments that warrant consideration. The second Toxic tort cases generally involve claims that an individual was part of the article, which will appear in an upcoming issue of harmed as a consequence of exposure to a chemical(s) (includ- Intellectual Property & Technology Law Journal , will continue ing a medication). These cases can be particularly diffi cult to the discussion of the amendments and offer conclusions. litigate because of the challenges presented by demonstrating or disproving causation. Because we do not fully understand Trademark Rights Protection Mechanisms the extent to which a chemical exposure can affect a particu- in the Domain Name System: Current Landscape lar individual, experts typically offer opinions based on the and Efforts to Diminish Protection . . . . . . . . . . . . . 17 general risk posed to the plaintiff by the exposure in question. Judge and juries fi nd this lack of plaintiff-specifi c evidence This article, by Brian J. Winterfeldt and Griffi n M. Barnett , unsatisfying. This multi-part article, by Susan E. Brice , a part- attorneys at Mayer Brown LLP, presents an overview of these ner at Bryan Cave LLP, and Whitney V. Christian , a senior trademark Rights Protection Mechanisms (RPMs), key devel- toxicologist at Medtronic, explores how genetic and epigenetic opments within the RPM review process and an analysis of biomarkers of cause and effect can be used to fi ll this gap for opportunities and risks this review presents for brand owners, defendants. In this fi rst part of the article, the authors introduce and predictions regarding the outcomes of the review process the topic, discuss the human genome, and genes, the environ- and what these outcomes may mean for brand owners moving ment, susceptibility, and disease. The fi nal parts of the article, forward. which will appear in upcoming issues of Intellectual Property & Technology Law Journal , will explore genetic data and toxic When to Ask for Additional Discovery Can tort law, genetic biomarkers, genomics and toxicogenom- Be Just as Important as What to Ask for . . . . . . . . . 23 ics, epigenetics, and tools for understanding causation at the In Garmin Int’l, Inc. v. Cuozzo Speed Tech. LLC , the Patent Trial genomic level. and Appeal Board (Board) set forth fi ve factors—commonly referred to as the Garmin factors—for determining whether FDA Amends Regulations for 505(b)(2) “additional discovery” will be granted to a party during a Applications and ANDAs—Part I . . . . . . . . . . . . . . . 11 proceeding before the Board, such as an inter partes review, This two-part article, by Shana K. Cyr, Li Feng , and Thomas L. covered business method review, or post-grant review. In their Irving , patent attorneys at Finnegan, Henderson, Farabow, article, Nelson D. Runkle and Tyler Del Rosario , of Sughrue Garrett & Dunner, LLP, considers the U.S. Food and Drug Mion, PLLC, discuss the fi ve factors and when to ask for addi- Administration’s amendments to the regulations relating to tional discovery.

When to Ask for Additional Discovery Can Be Just as Important as What to Ask for By Nelson D. Runkle and Tyler Del Rosario I n Garmin Int’l, Inc. v. Cuozzo Speed Tech. LLC , 1 request places a significant burden on meeting the Patent Trial and Appeal Board (Board) set the time schedule of inter partes review, even if not forth five factors—commonly referred to as the specifically addressed by the parties. Further, these Garmin factors—for determining whether “addi- considerations may be used in applying the fifth tional discovery” will be granted to a party during Garmin factor, whether a request is overly burden- a proceeding before the Board, such as an inter par- some to answer. tes review (IPR), covered business method review For example, in Wavemarket Inc. v. Locationet Systems Ltd ., 3 the Patent Owner requested addi- (CBM), or post-grant review (PGR). Briefly, the tional discovery from Petitioner. 4 In particular, the five Garmin factors are: Patent Owner sought to establish that various enti- 1. More than a Possibility and Mere Allegation; ties that were not named real parties in interest are in fact so, which could have resulted in dismissal 2. Litigation Positions and Underlying Basis; of the Petitioner’s challenge against the patent in question. 5 In an attempt to demonstrate this posi- 3. Ability to Generate Equivalent Information by tion, Patent Owner requested, inter alia , all indem- Other Means; nification agreements and communications about the indemnification by and between Petitioner and 4. Easily Understandable Instructions; and the entities. In denying the request for additional discovery and citing to the fifth Garmin factor, the 5. Requests Not Overly Burdensome to Answer. 2 Board stated, “the requested discovery may place a significant burden on meeting the time schedule The Board infrequently grants additional discov- of inter partes review,” noting the proceedings in ery requests based on the above factors. Further, the the inter partes review were instituted nearly three burden on a party requesting additional discovery months prior, and are no longer in the preliminary stage. 6 The Board considered the time schedule is heightened by additional considerations related to these five Garmin factors, which the Board may burden even though the issue was “not addressed by the parties.” 7 Similarly, in denying a request for consider even if the parties do not raise the issue. These include the impact on schedule and the tim- additional discovery in Intri-Plex Technologies v. Saint Gobain Performance Plastics , 8 the Board stated they ing of the request. are “mindful of the burden [additional discovery Impact on the Schedule requests] may place on meeting the time schedule,” for inter partes review. 9 Here, the Board noted the In determining whether to grant additional discovery, the Board may consider whether 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 Nelson D. Runkle is an associate in the Electrical/Mechanical schedule should the additional discovery request Practice Group of Sughrue Mion, PLLC. A former Patent Examiner at the U.S. Patent and Trademark Office, he assists be granted. clients in the procurement of both U.S. and foreign patents, Although the Board may extend the due dates which includes the preparation and prosecution of patent of substantive filings, thereby alleviating the bur- applications. T yler Del Rosario is a law clerk at the firm den of additional discovery on meeting the time analyzing patent cases, especially as they relate to PTAB rules, schedule, the Board also may refuse an extension regulations, and decisions. Volume 29 • Number 9 • September 2017 Intellectual Property & Technology Law Journal 23