Editor: Mr. Mahn, would you tell our readers about your professional experience?
Mahn: My educational background is in engineering, which is consistent with most of the attorneys at Fish & Richardson. I have spent my career specializing in two regulatory areas: Federal Communications Commission and the Food and Drug Administration. My practice is focused on the close interplay between the firm's IP-based technology platform and these two regulatory fields.
Editor: How did you come to Fish & Richardson? What were the things that attracted you to the firm?
Mahn: For many years clients would come to me with patent work that I would refer to patent law firms in Washington, including Fish & Richardson. Eventually, we determined that it might make sense to develop a technology-based regulatory practice within Fish & Richardson. Fifteen years ago I joined the firm as the first attorney who was not strictly an IP practitioner.
Editor: Please tell us how your practice has evolved over the course of your career?
Mahn: As I mentioned, I have focused my practice in a couple of specialty areas where I can add substantial value for firm clients. My practice has evolved along the regulatory trajectories that are dictated by changes in technology. For example, the recent FCC regulatory dynamic has involved a more sophisticated government regulation of the spectrum and with that, a lot of challenging equipment compliance issues. From this, I have developed a specialty in representing manufacturers of spectrum using equipment.
My practice before the FDA has focused on the interface between patents and drug regulation. Here, I have developed a niche specialty to serve the firm's large base of pharmaceuticals and biotech clients who are constantly seeking new ways to employ IP to protect their market share. This is what I refer to as my Hatch-Waxman Act practice.
Editor: What about your work with technology companies trying to develop industry standards using patents and technology?
Mahn: This is another facet of my practice that is focused on the firm's technology client base. I work with many companies as both technical and legal consultant on a variety of industry standards committees. These companies are concerned about IP being incorporated into industry standards which can help or hurt their competitive positions.
Editor: As head of the firm's Regulatory and Government Affairs Group, you are engaged in a highly specialized, cutting-edge practice. Would you give us an overview of the group and its work?
Mahn: We have about a dozen attorneys engaged in the regulatory practice, all of whom have their own base of business. The group also provides a high level support function for firm clients who come to us from the patent prosecution and patent litigation side of the business, which is substantial. These are clients who encounter government regulatory issues involving their products or technology and they expect Fish & Richardson, with its science and engineering expertise, to assist them in navigating these issues.
In addition to our specialized FCC and FDA practices, we also do export licensing work, another area of government technology regulation, which involves representation before the Departments of State, Commerce Department, and Treasury. Government contracting is yet another specialty field and here our attorneys concentrate on issues between government and the private sector when public funds are used to develop patented technology.
Editor: Is there a full-time cadre of attorneys?
Mahn: Yes, although our structure and culture are somewhat different from what you would expect to find in most general practice firms in Washington. At Fish, we tend to emphasize the technology-based subspecialties of our attorneys. Working off a large IP platform of technology clients, our group focuses on regulatory issues that are unique to this client base. This is in contrast to the traditional regulatory firms in Washington which provide a much broader, less technically focused practice.
Editor: I gather there is a political dimension to the work of the group.
Mahn: Yes, although we do not possess in-house lobbying or legislative expertise. We will engage political consultants when needed. Our appearances on the Hill and in the political arena tend to be as regulatory experts providing an analysis of the technology at issue and the government's regulation of the same.
Editor: Who are the clients? Is there a focus on particular industry sectors?
Mahn: We have a broad range of technology clients. For example, we do work for Lockheed Martin and PanAm Sat on space issues; Microsoft, Intel, LG, Honeywell and XM Satellite on FCC regulatory issues; and we represent Novartis, Astra-Zeneca and many biotech companies on drug regulatory matters, just to name a few. We also have a telemarketing and advertising practice built on technology platform and represent clients such as MGM, News America, and Fox. In general, our regulatory attorneys serve a broad range of clients primarily in electronics and health sciences fields which is the strength of the firms IP practice.
Editor: Would you tell us something about the services that the group provides the firm's high-tech clients?
Mahn: We represent and advise clients on product compliance issues, typically assisting them through the vast federal maze of technology regulation. We consult on regulatory policy; work to amend regulations on the books; seek regulatory waivers for leading edge technologies; and represent clients on various enforcement issues. In short, we work to ensure that our clients' products make it onto the market and then stay there in the face of what sometimes seems to be an onslaught of federal regulations.
Editor: How do your technology backgrounds help in relating to clients?
Mahn: In a firm like Fish, clients come to us expecting to be served by attorneys who speak their language and understand their technologies. These clients often require a multidisciplinary approach to their legal problems whether it be in the fields of engineering, life sciences or economics. The regulatory practice at Fish mirrors this approach by offering a blend of legal and technical expertise. I think this is the differentiating aspect of our regulatory practice.
Editor: Do you find yourselves engaged in the international arena?
Mahn: Regularly. Most of our clients operate globally and therefore, face the same regulatory and market access issues in foreign jurisdictions that they face in the U.S. Over the years we have done regulatory work for clients in some 70 foreign countries. You have to be skilled in the international arena to succeed in this kind of practice today.
Editor: Can you provide an example of the kinds of service the practice handles?
Mahn: Recently, a major satellite client ran into a problem with some products that were not FCC compliant. Because the issues were highly technical, the client's regular FCC counsel hired Fish to assist them. We worked with the client's engineers and the FCC technical and the regulatory staff to develop novel testing procedures to assure FCC compliance. This work involved several skills that we have refined: a clear understanding of FCC rules and equipment regulations; a technical understanding of the spectrum and interference issues involved; familiarity with various testing standards for equipment compliance; and, finally, access to and credibility with senior people at the FCC. In the end, we were able to shepherd the client through the regulatory thicket and get their products to market with a minimum of disruption to their business. There are numerous other examples that I could also cite in the areas of exporting licensing and FDA practice.
Editor: Are there particular trends in your practice?
Mahn: On the FCC side, the trend seems to be toward a new regulatory regime that will allow for much greater spectrum sharing and the authorization of new spectrum compatible technologies. On the FDA side, it is the constant battle between pioneer and generic drug manufacturers with patents being a pivotal factor for protecting market share. Recently, we have witnessed new approaches being taken by owners of drug patents that the FDA never dreamed of when the Hatch-Waxman regulations were first developed.
Editor: What about the future? Where would you like this practice to be in, say, five years?
Mahn: I would say to our clients that we strive to provide solutions to the regulatory challenges that impact their technology products and services. The more difficult the challenge, the more likely it fits into one of our regulatory specialties. We believe that we possess the requisite legal and technical skills to evolve with the regulatory challenges that confront the high tech clients on which this firm is built.
Published October 1, 2006.
