F i s h

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F i s h

  1. 1. Regulatory and Government Affairs Group Fish & Richardson
  2. 2. REGULATORY AGENC IES Our Regulatory attorneys have experience practicing before a wide range of federal agencies, including the following: > Federal Communications Commission (FCC) > National Telecommunications and Information Administration (NTIA) > Food and Drug Administration (FDA) > Department of State/Directorate of Defense Trade Controls (DDTC) > Department of Commerce/Bureau of Industry and Security (BIS) > Department of the Treasury/Office of Foreign Assets Control (OFAC) > Department of Transportation/Federal Aviation Administration (FAA) > National Aeronautics and Space Administration (NASA) > National Oceanic and Atmospheric Administration (NOAA) > Department of Defense (DOD) > Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP) > Federal Trade Commission (FTC) > Consumer Product Safety Commission (CPSC) > Department of Labor/Occupational Safety and Health Administration (OSHA)
  3. 3. The professionals in Fish & Richardson's multidisciplinary Regulatory and Government Affairs group helps clients navigate federal, state, and international regulatory challenges. We work with clients to limit potential exposure to liability, manage crisis situations, and maximize business opportunities. Based in Fish’s Washington, D.C., office, our O U R G OA L I S T O A C HI EV E group combines highly sophisticated technical 1 0 0 PERC EN T SAT I SFA C T I O N expertise, a deep knowledge of our clients’ W I T H EA C H EN GA G EMEN T. industries, and the legal and political skills needed to help clients navigate the labyrinth of United States and foreign government regulations that affect their businesses. The cornerstones of our practice are quality, acces- sibility, responsiveness, and reliability. Fish attorneys work closely with in-house legal, technical, business, and marketing personnel on a variety of regulatory and government affairs matters. Our work typically involves tight deadlines and demanding schedules, and our goal is to achieve 100 percent client satisfaction with each engagement, which contributes to the long-term nature of our client relationships.
  4. 4. T ELEC OMMUNIC AT IONS AND TECHNOLOGY Our Communications and Spectrum Regulation Foreign radio regulations and Spectrum waivers practice encompasses a broad range of federal, international standards We have obtained dozens state, and international telecommunications laws At the international level, the firm is often called of rule waivers for manufac- and policies. Our extensive experience meets the upon to advise clients on foreign regulatory pro- turers of unique or emerging ever-changing business, regulatory, and technolog- grams and equipment licensing requirements in spectrum technologies, includ- ical needs of our clients. Our work regularly brings the European Union, Canada, Australia, South ing one of the first waivers us before the Federal Communications Commission America, and Asia. Altogether, we have advised ever issued by the FCC for (FCC), the National Telecommunications and clients on foreign national standards in more an ultra-wideband (UWB) Information Administration (NTIA), and state than 75 countries. We routinely assist clients communications device – and regulatory commissions. We are unique in that in complying with requirements for electronic have obtained two more since. we are able to draw upon the firm’s unsurpassed equipment and medical devices under various EU Additionally, we have secured technical expertise, which includes many attorneys Directives (e.g., EMC, LV, RTTE, Medical Implants, spectrum waivers and novel with PhD’s and other advanced degrees in science Medical Devices, RoHS, and WEEE), as well as with rule interpretations for man- or engineering, including communications and other international standards programs, including ufacturers of radio control electrical engineering. Further, in conjunction those of ETSI, CEN, CENELEC, the International and wireless security systems; with the firm’s Business Litigation practice, our Telecommunication Union, the International obtained a waiver of the cel- communications attorneys have extensive state Electrotechnical Commission, the International lular and PCS base station and federal appellate litigation experience. Organization for Standardization, and others. power limits for a manufac- turer of multichannel power Equipment authorization and compliance Spectrum leasing and broadband technologies amplifiers; and, as far as We have one of the strongest and most technically We represent numerous educational institutions we know, obtained the only oriented legal practices in the nation when it licensed by the Federal Communications two waivers ever issued for comes to obtaining equipment authorizations Commission to use Educational Broadband Service devices operating in federal under Parts 2, 15, 18, 20, 22, 24, 27, 68, and (EBS) frequencies in the 2.5 GHz band to government “restricted 90 of the FCC’s rules. We actively participate in provide video, data, and broadband services bands.” FCC rulemakings involving technical standards throughout the United States. Our attorneys are for RF devices, and are routinely involved in the experts in regulatory and transactional matters Our group planned and imple- development of test procedures and other stan- associated with this band, having participated mented a successful multifac- dards. We are also experienced in responding to in every major EBS rulemaking proceeding over eted legal, legislative, and FCC enforcement actions, having helped clients the last 28 years. We negotiate spectrum lease public relations campaign negotiate consent decrees and settlement agree- agreements on behalf of public and private that prevented the proposed ments with the agency. schools, universities, and ecclesiastical institu- reallocation of Educational tions. We have experience negotiating with virtual- Broadband Service spectrum License management ly all commercial operators. Our attorneys have from educational entities to For our corporate clients with a large number the technical knowledge and practical experience commercial cellular compa- of FCC licenses, we maintain in-house licensing to ensure that our clients receive every advantage nies. We subsequently man- databases. We also assist clients in responding in spectrum lease negotiations. We also assist aged a similar campaign to to enforcement and other proceedings when clients with FCC licensing matters, regulatory prevent the spectrum from necessary. compliance, license transfers and assignments, being sold to commercial band plan transitions, lease administration, interests. and related matters.
  5. 5. E-Rate procurement FCC compliance and enforcement E-Rate is the FCC’s program for subsidizing We routinely represent and assist equipment communications services for schools and libraries. manufacturers, distributors, and spectrum Fish has experience navigating the complex users who are charged with violating FCC Universal Service Administration Company (USAC) technical standards and marketing rules. application process. We assist schools in applying When necessary, we assist in the negotiation for funds and in adhering to the detailed regula- of formal consent decrees and corrective tions that govern each step of the process. We action plans and have devised strategies to also advise clients in responding to federal reduce monetary fines or other penalties inquiries regarding E-Rate funding, filing appeals, imposed by the FCC. In several instances, we and responding to requests for recoveries of kept noncompliant products on the market funds and other enforcement actions. while corrective measures were implemented, staving off significant monetary penalties in Spectrum allocation the process. In addition, our group provides A large part of our practice focuses on spectrum periodic updates about FCC enforcement allocation, technical standards, and test proce- actions on fr.com. dures. In addition to advising clients about spec- trum policies and compliance standards for both licensed and unlicensed services, we are adept in Interference resolution obtaining rule waivers for new or expanded uses Our group has worked with many federal of spectrum. Our experience in this area includes agencies to resolve spectrum interference successfully procuring novel rule interpretations issues involving medical implants, radio and waivers for clients attempting to bring new control systems, tank-level radar devices, and emerging technologies to market, including and ultra-wideband surveillance technologies. RFID and ultra-wideband systems, beam-forming We interface regularly with National antennas, microwave lighting, wireless medical Telecommunications and Information implants, and multichannel amplifiers and Administration (NTIA) officials and with repeaters. We also assist clients in developing spectrum managers in various federal successful spectrum strategies to enable them agencies where emerging commercial to pursue their marketing goals within the technologies create potential conflicts existing regulatory framework. with government spectrum users.
  6. 6. E X P O R T C O N T R O L S, F O R E I G N P O L I C Y, A N D NAT IONA L SEC URIT Y ISSUES Companies in the United States are subject to Exporter registration ITA R restrictions on the transfer – be it a one-time We assisted a prominent shipment or disclosure or the sale of an entire Technical Assistance Agreements information technology com- company – of hardware, software, technical data, pany, a communications satel- and services to foreign persons, including foreign Manufacturing License Agreements lite operator, a systems engi- employees, subsidiaries, vendors, suppliers, joint neering firm, and a number of venture partners, and investors, whether located Distribution Agreements other entities in proceedings in the United States or abroad. before the Department of Technology Transfer Control Plans State’s Directorate of Defense Fish represents clients in the space, satellite, Trade Controls. aviation, defense, electronics, and software Commodity Jurisdiction Requests industries to ensure compliance with the complex We helped numerous clients body of laws and regulations governing exports Commodity Classification Requests conduct internal export control of high-technology items, data, and services. We and trade compliance audits, routinely help clients assess their export control Export licenses including representation of a and trade compliance practices; identify licensing prominent U.S. company in the needs and apply for licenses; establish and imple- Deemed exports negotiation of a consent ment compliance programs and policies; train decree arising from alleged senior management, staff, and other employees; Encryption controls violations of the International perform audits; advise on discreet questions that Traffic in Arms Regulations. arise in the normal course of business; and repre- Nonproliferation controls sent clients before federal agencies and judicial EAR bodies with respect to actual or alleged events OFAC-specific licenses We obtained commodity of noncompliance. jurisdictions and commodity Entity screening classifications for clients Our attorneys advise on licensing and compliance from the Directorate of issues arising under the State Department’s Compliance programs Defense Trade Controls and International Traffic in Arms Regulations (ITAR), the Department of Commerce’s the Commerce Department’s Export Administration Training Bureau of Industry and Security. Regulations (EAR), and the various foreign assets and transactions control regulations administered Audits OFAC by the Treasury Department’s Office of Foreign Our group obtained licenses Assets Control (OFAC). We also help clients comply from the Department of the with U.S. antiboycott rules, Foreign Ownership Treasury’s Office of Foreign Control and Influence (FOCI) restrictions, the Assets Control to authorize Foreign Corrupt Practices Act (FCPA), and the transfer of equipment proceedings before the Committee on Foreign and support services to Iraq Investment in the United States (CFIUS). and Afghanistan and for humanitarian relief in Sudan. CFIUS We helped a U.S. data protec- tion and security company respond to inquiries from the Committee on Foreign Investment in the United States (CFIUS) that arose in connection with the pur- chase of that company by a European company.
  7. 7. S A T E L L I T E S A N D S PA C E S Y S T E M S Our clients appreciate that we combine our legal Space launch services FAA launch licensing training and skills with an in-depth knowledge We advise U.S. launch services providers on of the satellite and space industries. Many of obtaining licenses and authorizations from the Range safety our attorneys worked in the aerospace sector, at Federal Aviation Administration (FAA) needed to companies and at government agencies, before perform launches in the United States or abroad. FCC licensing entering private practice. Their background gives This involves ensuring that clients comply with the us the legal and technical know-how to get the FAA’s rules under the Commercial Space Launch ITU coordination job done – a rare combination of talent and expe- Act (CSLA), most notably the requirements to rience not found in many law firms. Moreover, demonstrate financial responsibility and to comply Commercial remote sensing because our knowledge of and experience in these with strict safety regulations at U.S. launch bases. satellite licensing areas are so extensive, we regularly advise clients We also represent clients before other federal not only on traditional regulatory matters, but agencies that have an interest in launch activities, Launch services agreements also on contracts, risk management and insurance, including the National Aeronautics and Space legislative and policy matters, and corporate and Administration (NASA) and the U.S. Air Force. Satellite purchase agreements finance issues unique to these complex industries. Because of the inherently international nature of Our clients tell us that this cross-functional launching satellites, we also advise clients on Transponder leases approach is efficient and highly effective. rights and obligations set forth in international space law treaties to which the United States is Space Act Agreements Satellites and ground stations a party. Consistent with our practice of offering Fish provides one-stop shopping for legal services space industry clients comprehensive services, we Space project risk management to satellite manufacturers, operators, and trans- also assist with the drafting and negotiation of ponder lessees. Our work involves all different launch services agreements, launch insurance Satellite launch and in-orbit types of satellite systems, including voice, data, contracts (first-party and third-party liability), insurance video, direct broadcast, global positioning, and and legislative and policy issues affecting this remote sensing. We routinely assist our satellite complex and highly technical industry. Outer Space Treaty clients with matters arising before the FCC, the NTIA, the National Oceanic and Atmospheric Space tourism Liability Convention Administration (NOAA), and international We are excited to be working with pioneers of regulatory bodies such as the International a new category of space transportation – space Registration Convention Telecommunication Union (ITU). This includes tourism. With our deep knowledge of the space obtaining licenses from the FCC for both the space industry and understanding of the complex laws and the ground segments of a system, advising on and regulations that affect space travel, we are the international frequency coordination process able to help clients in this emerging field meet at the ITU, coordinating with the NTIA on spec- the legal challenges, including export control, trum issues, and addressing legislative and policy launch and reentry licensing, and risk manage- issues that affect our clients’ businesses. We ment that they will face in their quest to make also help with satellite procurement contracts, space available to citizen astronauts. transponder sales and lease agreements, the drafting and negotiation of satellite in-orbit insurance contracts, and the processing of claims under those contracts.
  8. 8. A DV ERT ISING A ND MA RKET ING Our Regulatory and Government Affairs group Spam, e-mail marketing, and telemarketing Our group represented one of the advises clients on the broad array of state and Fish advises clients on federal, state, and interna- nation’s leading daily newspapers federal laws affecting how clients can advertise tional requirements applicable to inbound and out- in connection with a multimillion- and promote their products and services. This bound telephone, facsimile, and e-mail solicita- dollar prize promotion, including includes, for example, compliance with federal tions to homes and businesses (including Do-Not- lottery and sweepstakes advice and state laws concerning spam and e-mail mar- Call requirements). We help clients manage risks and contract negotiations with keting, telemarketing, sweepstakes and contests, in this heavily regulated area by preparing region- prize providers, fulfillment deceptive practices, product claim substantiation, al, national, and international telemarketing and companies, and cosponsors. “free” offers, and customer testimonials. We e-mail compliance plans. regularly prescreen advertising copy including We advised a major television print, television, and radio advertisements; Sweepstakes and contests network in connection with telephone scripts; and Web site materials for Our group helps clients structure sweepstakes a prime-time game show involv- compliance with such laws. and skill contests to comply with federal and state ing a $2 million prize, various lottery, gambling, and disclosure laws. We regular- reality-show concepts, and ly provide training assistance to legal and market- promotional tie-ins to network ing staff. We also draft and negotiate related television programming. sponsorship agreements, indemnification agree- ments, and other promotion-related contracts. Our group advised an online social network in connection Do-Not-Call compliance with a promotion involving We assist companies in complying with the user-generated content to be Do-Not-Call (DNC) requirements of the Federal incorporated into an upcoming Trade Commission, the Federal Communications movie’s soundtrack. Commission, and various states concerning con- sumer requests for privacy. This involves compli- We assisted an automobile manu- ance with three types of DNC lists: (1) company- facturer, a leading international specific lists that include the telephone numbers newspaper, and an online travel of individuals who have advised a company or its agency in connection with various representatives that they do not want to receive sweepstakes and contests offered further calls; (2) the FTC’s nationwide list that internationally. includes the telephone numbers of consumers who choose not to receive sales-related calls; and (3) state lists that include the telephone numbers of residents of certain states who choose not to receive sales-related calls. In addition to legal advice, we also offer training, monitoring, and recordkeeping assistance related to the foregoing. Coupons, gift cards, and rebates We assist clients with structuring coupon, gift card, and rebate offers to comply with federal and state legal requirements.
  9. 9. DRUG AND MEDIC A L DEV IC E REGULAT ION Clients find our regulatory knowledge and technical Hatch-Waxman, orphan drugs, Hatch-Waxman expertise invaluable when bringing to market new and pediatric exclusivity We routinely advise many major drugs, biologics, medical devices, dietary supple- Regulatory and patent attorneys work closely drug manufacturers on Hatch- ments, and cosmetics. Our Drug and Medical Device together on the various Hatch-Waxman issues that Waxman issues such as Orange practice delivers regulatory know-how with value surface with drug, biologic, and medical device Book listings, marketing added by the scientific expertise of our IP practice. approvals. We advise clients on the marketing exclusivities (including orphan Unlike most FDA practices, we have a unique techni- exclusivities that are available for new drugs and drug and pediatric), and safe cal capacity that comes from our world-class patent “first mover” generics and on Orange Book issues harbor protections from patent practice. One-stop shopping for both patents and involving patented drug products. Clients come to infringement. In addition, we regulatory work saves client resources because us for counseling and representation on “safe har- help clients obtain patent term clients need not explain their technology twice. bor” exemptions from patent infringement and for extensions for products undergo- assistance in securing their patent term extensions ing FDA review. We have vast experience with FDA regulation of for drugs, biologics, and Class III medical devices. various products, including small-molecule drugs, We also counsel clients on orphan drug approvals Medical devices biologics, homeopathics, and medical devices. We and pediatric exclusivity rights, as well as other In addition to regularly preparing counsel clients in areas such as gene and cell ther- FDA-related activities. Attorneys in the firm teach and filing 510(k) marketing appli- apies, antihypertensives, ophthalmics, anti-inflam- the Patent Resources Group’s Biotechnology cations with the FDA, we assisted matories, immunologics, antibiotics, anti-anxiety course, a high-level, three-day program that covers a university-affiliated hospital with medications, hormone therapies, and medical all aspects of Hatch-Waxman, including Federal the preparation of an investigation- gases. Our medical device practice covers products Circuit and Supreme Court cases that interpret al device exemption (IDE) applica- such as research and screening technologies, den- this complex and important statute. tion for use of a new device in treat- tal devices, implants, imaging agents, medical ing depression; obtained FDA desig- telemetry, PARS, catheters, cardiovascular devices, Medical device approvals and compliance nation of a novel product as a med- microwave therapies, pressure monitors, oximeters, Our medical device practice specializes in obtaining ical device and not a drug, thereby and various types of drug delivery technologies. We marketing authorization from the FDA, without avoiding the burdens and expense of also are experienced in a broad range of radiologi- which even the most innovative, lifesaving device filing a new drug application; and cal health technologies, including X-ray, MRI, PET, cannot be legally marketed. We have assisted both convinced the FDA to exempt from and medical lasers. domestic and foreign manufacturers through the 510(k) regulation a novel device FDA maze for a wide variety of devices, ranging that assists doctors in more accu- One of our unique specialties is advising on the from cutting-edge, 3-D X-ray equipment to cell rately performing biopsies and other interrelationship between patent and drug laws to phone-based medication reminder systems and procedures while using medical protect patent exclusivity for products worldwide. collagen-based bone filling augmentation material. imaging technology. In the United States, this means understanding We regularly interact with FDA staff to ensure the complex relationship between U.S. patent that clients meet all their regulatory requirements Homeopathic drugs and laws and the Hatch-Waxman Act. We advise and in the least burdensome manner possible. dietary supplements counsel clients on the scope and application of the We helped a manufacturer of organic 271(e)(1) safe harbor from patent infringement, We also provide advice regarding medical device homeopathic drugs come into com- Orange Book practice and patent litigation under labeling, quality system compliance, imports and pliance with federal and state 271(e)(2), marketing exclusivities for pioneers exports, establishment registration, device listing, requirements, and advised manufac- and generics, and patent term extensions. recall and other corrective actions, and a myriad turers of dietary supplements of of other FDA issues. In addition, we work directly their obligations under federal law. Drug and biologic regulation with Health Canada to obtain medical device Fish advises companies and research institutions licenses that provide clients with one-stop shop- Cosmetics at all stages of the product development process ping for both United States and Canadian We advised cosmetic manufacturers for new drugs and biologics. Our clients include marketing authorization. regarding federal labeling laws and companies on the cutting edge of technology, ingredient restrictions, as well as such as stem cell research, gene therapy, and on the FDA’s Voluntary Cosmetic tissue engineering. Registration Program.
  10. 10. INT ERNAT IONA L T EC HNOLOGY REGULAT ION Fish represents and advises clients on government International standards database Chair, Regulatory Group regulatory programs that impact technology We developed a 70-nation database on EMC, Terry G. Mahn products and services in more than 75 countries, electrical safety, telecommunications, radiation 202-626-6421 drawing on our years of experience in technology exposure, and ergonomic standards for a law, product standards, and government regula- large manufacturer of computer workstation tions. Fish attorneys are active members of national equipment. and international standards-making organizations, enabling us to keep current with up-to-the-minute RFID/spread spectrum changes that affect our clients. We also keep We represented and advised the manufacturer abreast of legal and regulatory developments by of a novel radio frequency (RF) identification utilizing our worldwide network of contacts consist- system that uses spread-spectrum technology ing of certification laboratories, notified bodies, on the regulatory policies and marketing and clinical experts to assist in product compliance authorizations required in more than 25 and market introduction. Manufacturers and ven- countries. dors rely on us to obtain timely equipment authori- zations and access to domestic and international Radio regulations markets. We advise on compliance issues associated Our group researched and developed a 40-coun- with domestic EMC, electrical safety, radiation safe- try product compliance and marketing strategy ty, environmental, and medical device standards. on the radio regulations that apply to a vari- For test houses and laboratories, we assist with ety of short-range radio technologies, including accreditation standards worldwide and offer one- keyless entry, security alarms, and low-power stop shopping for multinational clients seeking radar. We are regulatory advisors to a major equipment authorization. manufacturer seeking market approval in 50 countries for an “intelligent airbag” system that uses RF-based sensors in automobiles. Radioactive materials regulation We advised a manufacturer seeking market entry into a dozen European and Asian countries for an industrial product that uses a radioactive isotope. The scope of our work included counseling on hazardous/radioactive material regulations for all modes of trans- portation, use licensing, workplace safety, and product disposal. RF lighting We counseled a U.S. manufacturer of novel lighting technology that uses microwave energy to produce a low-cost, highly efficient source of lighting for large-scale commercial and industrial applications. We devised and execut- ed a regulatory strategy for amending the international (IEC/CISPR) standards applicable to this technology to ensure worldwide harmo- nization and market acceptability for the manufacturer’s product.
  11. 11. FR Atlanta Austin Boston Dallas Delaware Houston Munich New York San Diego Silicon Valley Twin Cities Washington, DC Fi s h & R i c h a rd s o n fr.com

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