Regulatory and Government Affairs Group

Fish & Richardson

Our Regulatory attorneys have experience practicing before a wide range of federal agencies, including the following:

Federal Communications Commission (FCC)

National Telecommunications and InformationAdministration (NTIA)

Food and Drug Administration (FDA)

Department of State/Directorate of DefenseTrade Controls (DDTC)

Department of Commerce/Bureau of Industryand Security (BIS)

Department of the Treasury/Office of ForeignAssets Control (OFAC)

Department of Transportation/Federal AviationAdministration (FAA)

National Aeronautics and Space Administration(NASA)

National Oceanic and AtmosphericAdministration (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 andHealth Administration (OSHA)

>

>

>

>

>

>

>

>

>

>

>

>

>

>

R E G U L A T O R Y A G E N C I E S

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

group combines highly sophisticated technical

expertise, a deep knowledge of our clients’

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.

OUR GOA L IS TO AC HIEV E 100 PERC ENT SAT ISFAC T ION WIT H EAC H ENGAGEMENT.

Our Communications and Spectrum Regulationpractice encompasses a broad range of federal,state, and international telecommunications lawsand policies. Our extensive experience meets theever-changing business, regulatory, and technolog-ical needs of our clients. Our work regularly bringsus before the Federal Communications Commission(FCC), the National Telecommunications andInformation Administration (NTIA), and stateregulatory commissions. We are unique in thatwe are able to draw upon the firm’s unsurpassedtechnical expertise, which includes many attorneyswith PhD’s and other advanced degrees in scienceor engineering, including communications andelectrical engineering. Further, in conjunctionwith the firm’s Business Litigation practice, ourcommunications attorneys have extensive stateand federal appellate litigation experience.

Equipment authorization and complianceWe have one of the strongest and most technicallyoriented legal practices in the nation when itcomes to obtaining equipment authorizationsunder Parts 2, 15, 18, 20, 22, 24, 27, 68, and90 of the FCC’s rules. We actively participate inFCC rulemakings involving technical standardsfor RF devices, and are routinely involved in thedevelopment of test procedures and other stan-dards. We are also experienced in responding toFCC enforcement actions, having helped clientsnegotiate consent decrees and settlement agree-ments with the agency.

License managementFor our corporate clients with a large numberof FCC licenses, we maintain in-house licensing databases. We also assist clients in respondingto enforcement and other proceedings when necessary.

Foreign radio regulations and international standardsAt the international level, the firm is often calledupon to advise clients on foreign regulatory pro-grams and equipment licensing requirements inthe European Union, Canada, Australia, SouthAmerica, and Asia. Altogether, we have advisedclients on foreign national standards in morethan 75 countries. We routinely assist clientsin complying with requirements for electronicequipment and medical devices under various EUDirectives (e.g., EMC, LV, RTTE, Medical Implants,Medical Devices, RoHS, and WEEE), as well as withother international standards programs, includingthose of ETSI, CEN, CENELEC, the InternationalTelecommunication Union, the InternationalElectrotechnical Commission, the InternationalOrganization for Standardization, and others.

Spectrum leasing and broadband technologiesWe represent numerous educational institutionslicensed by the Federal CommunicationsCommission to use Educational Broadband Service(EBS) frequencies in the 2.5 GHz band to provide video, data, and broadband servicesthroughout the United States. Our attorneys areexperts in regulatory and transactional mattersassociated with this band, having participatedin every major EBS rulemaking proceeding overthe last 28 years. We negotiate spectrum lease agreements on behalf of public and privateschools, universities, and ecclesiastical institu-tions. We have experience negotiating with virtual-ly all commercial operators. Our attorneys havethe technical knowledge and practical experienceto ensure that our clients receive every advantagein spectrum lease negotiations. We also assistclients with FCC licensing matters, regulatorycompliance, license transfers and assignments,band plan transitions, lease administration,and related matters.

T E L E C O M M U N I C A T I O N S A N D T E C H N O L O G Y

Spectrum waivers We have obtained dozensof rule waivers for manufac-turers of unique or emerging spectrum technologies, includ-ing one of the first waiversever issued by the FCC foran ultra-wideband (UWB)communications device – andhave obtained two more since.Additionally, we have securedspectrum waivers and novelrule interpretations for man-ufacturers of radio controland wireless security systems;obtained a waiver of the cel-lular and PCS base stationpower limits for a manufac-turer of multichannel poweramplifiers; and, as far aswe know, obtained the onlytwo waivers ever issued fordevices operating in federalgovernment “restrictedbands.”

Our group planned and imple-mented a successful multifac-eted legal, legislative, andpublic relations campaignthat prevented the proposedreallocation of EducationalBroadband Service spectrumfrom educational entities tocommercial cellular compa-nies. We subsequently man-aged a similar campaign toprevent the spectrum frombeing sold to commercialinterests.

E-Rate procurementE-Rate is the FCC’s program for subsidizing communications services for schools and libraries.Fish has experience navigating the complexUniversal Service Administration Company (USAC)application process. We assist schools in applyingfor funds and in adhering to the detailed regula-tions that govern each step of the process. Wealso advise clients in responding to federalinquiries regarding E-Rate funding, filing appeals,and responding to requests for recoveries offunds and other enforcement actions.

Spectrum allocation A large part of our practice focuses on spectrumallocation, technical standards, and test proce-dures. In addition to advising clients about spec-trum policies and compliance standards for bothlicensed and unlicensed services, we are adept inobtaining rule waivers for new or expanded usesof spectrum. Our experience in this area includessuccessfully procuring novel rule interpretationsand waivers for clients attempting to bring newand emerging technologies to market, includingRFID and ultra-wideband systems, beam-formingantennas, microwave lighting, wireless medicalimplants, and multichannel amplifiers andrepeaters. We also assist clients in developing successful spectrum strategies to enable themto pursue their marketing goals within theexisting regulatory framework.

FCC compliance and enforcement We routinely represent and assist equipmentmanufacturers, distributors, and spectrumusers who are charged with violating FCCtechnical standards and marketing rules.When necessary, we assist in the negotiationof formal consent decrees and correctiveaction plans and have devised strategies toreduce monetary fines or other penaltiesimposed by the FCC. In several instances, wekept noncompliant products on the marketwhile corrective measures were implemented,staving off significant monetary penalties inthe process. In addition, our group providesperiodic updates about FCC enforcementactions on fr.com.

Interference resolution Our group has worked with many federalagencies to resolve spectrum interferenceissues involving medical implants, radiocontrol systems, tank-level radar devices,and ultra-wideband surveillance technologies.We interface regularly with NationalTelecommunications and InformationAdministration (NTIA) officials and with spectrum managers in various federal agencies where emerging commercial technologies create potential conflictswith government spectrum users.

Exporter registration

Technical Assistance Agreements

Manufacturing License Agreements

Distribution Agreements

Technology Transfer Control Plans

Commodity Jurisdiction Requests

Commodity Classification Requests

Export licenses

Deemed exports

Encryption controls

Nonproliferation controls

OFAC-specific licenses

Entity screening

Compliance programs

Training

Audits

Companies in the United States are subject torestrictions on the transfer – be it a one-timeshipment or disclosure or the sale of an entirecompany – of hardware, software, technical data,and services to foreign persons, including foreignemployees, subsidiaries, vendors, suppliers, jointventure partners, and investors, whether located in the United States or abroad.

Fish represents clients in the space, satellite, aviation, defense, electronics, and softwareindustries to ensure compliance with the complexbody of laws and regulations governing exportsof high-technology items, data, and services. Weroutinely help clients assess their export controland trade compliance practices; identify licensingneeds and apply for licenses; establish and imple-ment compliance programs and policies; trainsenior management, staff, and other employees;perform audits; advise on discreet questions thatarise in the normal course of business; and repre-sent clients before federal agencies and judicialbodies with respect to actual or alleged eventsof noncompliance.

Our attorneys advise on licensing and complianceissues arising under the State Department’sInternational Traffic in Arms Regulations (ITAR),the Commerce Department’s Export AdministrationRegulations (EAR), and the various foreign assetsand transactions control regulations administeredby the Treasury Department’s Office of ForeignAssets Control (OFAC). We also help clients complywith U.S. antiboycott rules, Foreign OwnershipControl and Influence (FOCI) restrictions, theForeign Corrupt Practices Act (FCPA), andproceedings before the Committee on ForeignInvestment in the United States (CFIUS).

I TA RWe assisted a prominentinformation technology com-pany, a communications satel-lite operator, a systems engi-neering firm, and a number ofother entities in proceedingsbefore the Department ofState’s Directorate of DefenseTrade Controls.

We helped numerous clientsconduct internal export controland trade compliance audits,including representation of aprominent U.S. company in thenegotiation of a consentdecree arising from allegedviolations of the InternationalTraffic in Arms Regulations.

E A RWe obtained commodityjurisdictions and commodity classifications for clientsfrom the Directorate ofDefense Trade Controls andthe Department of Commerce’sBureau of Industry and Security.

O FA COur group obtained licensesfrom the Department of theTreasury’s Office of ForeignAssets Control to authorizethe transfer of equipmentand support services to Iraqand Afghanistan and forhumanitarian relief in Sudan.

C F I U SWe helped a U.S. data protec-tion and security companyrespond to inquiries fromthe Committee on ForeignInvestment in the UnitedStates (CFIUS) that arosein connection with the pur-chase of that company bya European company.

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 N A T I O N A L S E C U R I T Y I S S U E S

Our clients appreciate that we combine our legaltraining and skills with an in-depth knowledgeof the satellite and space industries. Many ofour attorneys worked in the aerospace sector, at companies and at government agencies, beforeentering private practice. Their background givesus the legal and technical know-how to get thejob done – a rare combination of talent and expe-rience not found in many law firms. Moreover,because our knowledge of and experience in theseareas are so extensive, we regularly advise clientsnot only on traditional regulatory matters, butalso on contracts, risk management and insurance,legislative and policy matters, and corporate andfinance issues unique to these complex industries.Our clients tell us that this cross-functionalapproach is efficient and highly effective.

Satellites and ground stationsFish provides one-stop shopping for legal servicesto satellite manufacturers, operators, and trans-ponder lessees. Our work involves all differenttypes of satellite systems, including voice, data,video, direct broadcast, global positioning, andremote sensing. We routinely assist our satelliteclients with matters arising before the FCC, theNTIA, the National Oceanic and AtmosphericAdministration (NOAA), and internationalregulatory bodies such as the InternationalTelecommunication Union (ITU). This includesobtaining licenses from the FCC for both the spaceand the ground segments of a system, advising onthe international frequency coordination processat the ITU, coordinating with the NTIA on spec-trum issues, and addressing legislative and policyissues that affect our clients’ businesses. Wealso help with satellite procurement contracts,transponder sales and lease agreements, thedrafting and negotiation of satellite in-orbitinsurance contracts, and the processing ofclaims under those contracts.

Space launch servicesWe advise U.S. launch services providers onobtaining licenses and authorizations from theFederal Aviation Administration (FAA) needed toperform launches in the United States or abroad.This involves ensuring that clients comply with theFAA’s rules under the Commercial Space LaunchAct (CSLA), most notably the requirements todemonstrate financial responsibility and to complywith strict safety regulations at U.S. launch bases.We also represent clients before other federalagencies that have an interest in launch activities,including the National Aeronautics and SpaceAdministration (NASA) and the U.S. Air Force.Because of the inherently international nature oflaunching satellites, we also advise clients onrights and obligations set forth in internationalspace law treaties to which the United States isa party. Consistent with our practice of offeringspace industry clients comprehensive services, wealso assist with the drafting and negotiation oflaunch services agreements, launch insurancecontracts (first-party and third-party liability),and legislative and policy issues affecting thiscomplex and highly technical industry.

Space tourismWe are excited to be working with pioneers ofa new category of space transportation – spacetourism. With our deep knowledge of the spaceindustry and understanding of the complex lawsand regulations that affect space travel, we areable to help clients in this emerging field meetthe legal challenges, including export control,launch and reentry licensing, and risk manage-ment that they will face in their quest to makespace available to citizen astronauts.

S A T E L L I T E S A N D S PA C E S Y S T E M SFAA launch licensing

Range safety

FCC licensing

ITU coordination

Commercial remote sensingsatellite licensing

Launch services agreements

Satellite purchase agreements

Transponder leases

Space Act Agreements

Space project risk management

Satellite launch and in-orbitinsurance

Outer Space Treaty

Liability Convention

Registration Convention

Our Regulatory and Government Affairs groupadvises clients on the broad array of state andfederal laws affecting how clients can advertiseand promote their products and services. Thisincludes, for example, compliance with federaland state laws concerning spam and e-mail mar-keting, telemarketing, sweepstakes and contests,deceptive practices, product claim substantiation,“free” offers, and customer testimonials. Weregularly prescreen advertising copy includingprint, television, and radio advertisements;telephone scripts; and Web site materials forcompliance with such laws.

Spam, e-mail marketing, and telemarketingFish advises clients on federal, state, and interna-tional requirements applicable to inbound and out-bound telephone, facsimile, and e-mail solicita-tions to homes and businesses (including Do-Not-Call requirements). We help clients manage risksin this heavily regulated area by preparing region-al, national, and international telemarketing ande-mail compliance plans.

Sweepstakes and contestsOur group helps clients structure sweepstakesand skill contests to comply with federal and statelottery, gambling, and disclosure laws. We regular-ly provide training assistance to legal and market-ing staff. We also draft and negotiate relatedsponsorship agreements, indemnification agree-ments, and other promotion-related contracts.

Do-Not-Call complianceWe assist companies in complying with theDo-Not-Call (DNC) requirements of the FederalTrade Commission, the Federal CommunicationsCommission, and various states concerning con-sumer requests for privacy. This involves compli-ance with three types of DNC lists: (1) company-specific lists that include the telephone numbersof individuals who have advised a company or itsrepresentatives that they do not want to receivefurther calls; (2) the FTC’s nationwide list thatincludes the telephone numbers of consumers whochoose not to receive sales-related calls; and (3)state lists that include the telephone numbers ofresidents of certain states who choose not toreceive sales-related calls. In addition to legaladvice, we also offer training, monitoring, andrecordkeeping assistance related to the foregoing.

Coupons, gift cards, and rebatesWe assist clients with structuring coupon, giftcard, and rebate offers to comply with federaland state legal requirements.

A D V E R T I S I N G A N D M A R K E T I N GOur group represented one of thenation’s leading daily newspapersin connection with a multimillion-dollar prize promotion, includinglottery and sweepstakes adviceand contract negotiations withprize providers, fulfillmentcompanies, and cosponsors.

We advised a major televisionnetwork in connection witha prime-time game show involv-ing a $2 million prize, variousreality-show concepts, andpromotional tie-ins to networktelevision programming.

Our group advised an onlinesocial network in connectionwith a promotion involvinguser-generated content to beincorporated into an upcomingmovie’s soundtrack.

We assisted an automobile manu-facturer, a leading internationalnewspaper, and an online travelagency in connection with varioussweepstakes and contests offeredinternationally.

Hatch-Waxman, orphan drugs, and pediatric exclusivityRegulatory and patent attorneys work closelytogether on the various Hatch-Waxman issues thatsurface with drug, biologic, and medical deviceapprovals. We advise clients on the marketingexclusivities that are available for new drugs and

“first mover” generics and on Orange Book issuesinvolving patented drug products. Clients come tous for counseling and representation on “safe har-bor” exemptions from patent infringement and forassistance in securing their patent term extensionsfor drugs, biologics, and Class III medical devices.We also counsel clients on orphan drug approvalsand pediatric exclusivity rights, as well as otherFDA-related activities. Attorneys in the firm teachthe Patent Resources Group’s Biotechnologycourse, a high-level, three-day program that coversall aspects of Hatch-Waxman, including FederalCircuit and Supreme Court cases that interpretthis complex and important statute.

Medical device approvals and complianceOur medical device practice specializes in obtainingmarketing authorization from the FDA, withoutwhich even the most innovative, lifesaving devicecannot be legally marketed. We have assisted bothdomestic and foreign manufacturers through theFDA maze for a wide variety of devices, rangingfrom cutting-edge, 3-D X-ray equipment to cellphone-based medication reminder systems andcollagen-based bone filling augmentation material.We regularly interact with FDA staff to ensurethat clients meet all their regulatory requirementsin the least burdensome manner possible.

We also provide advice regarding medical devicelabeling, quality system compliance, imports andexports, establishment registration, device listing,recall and other corrective actions, and a myriadof other FDA issues. In addition, we work directlywith Health Canada to obtain medical devicelicenses that provide clients with one-stop shop-ping for both United States and Canadianmarketing authorization.

Clients find our regulatory knowledge and technicalexpertise invaluable when bringing to market newdrugs, biologics, medical devices, dietary supple-ments, and cosmetics. Our Drug and Medical Devicepractice delivers regulatory know-how with valueadded by the scientific expertise of our IP practice.Unlike most FDA practices, we have a unique techni-cal capacity that comes from our world-class patentpractice. One-stop shopping for both patents andregulatory work saves client resources becauseclients need not explain their technology twice.

We have vast experience with FDA regulation ofvarious products, including small-molecule drugs,biologics, homeopathics, and medical devices. Wecounsel clients in areas such as gene and cell ther-apies, antihypertensives, ophthalmics, anti-inflam-matories, immunologics, antibiotics, anti-anxietymedications, hormone therapies, and medicalgases. Our medical device practice covers productssuch as research and screening technologies, den-tal devices, implants, imaging agents, medicaltelemetry, PARS, catheters, cardiovascular devices,microwave therapies, pressure monitors, oximeters,and various types of drug delivery technologies. Wealso are experienced in a broad range of radiologi-cal health technologies, including X-ray, MRI, PET,and medical lasers.

One of our unique specialties is advising on theinterrelationship between patent and drug laws toprotect patent exclusivity for products worldwide.In the United States, this means understandingthe complex relationship between U.S. patentlaws and the Hatch-Waxman Act. We advise andcounsel clients on the scope and application of the271(e)(1) safe harbor from patent infringement,Orange Book practice and patent litigation under271(e)(2), marketing exclusivities for pioneersand generics, and patent term extensions.

Drug and biologic regulationFish advises companies and research institutionsat all stages of the product development processfor new drugs and biologics. Our clients includecompanies on the cutting edge of technology,such as stem cell research, gene therapy, andtissue engineering.

D R U G A N D M E D I C A L D E V I C E R E G U L A T I O N

Hatch-Waxman We routinely advise many majordrug manufacturers on Hatch-Waxman issues such as OrangeBook listings, marketing exclusivities (including orphandrug and pediatric), and safeharbor protections from patentinfringement. In addition, wehelp clients obtain patent termextensions for products undergo-ing FDA review.

Medical devicesIn addition to regularly preparingand filing 510(k) marketing appli-cations with the FDA, we assisteda university-affiliated hospital withthe preparation of an investigation-al device exemption (IDE) applica-tion for use of a new device in treat-ing depression; obtained FDA desig-nation of a novel product as a med-ical device and not a drug, therebyavoiding the burdens and expense offiling a new drug application; andconvinced the FDA to exempt from510(k) regulation a novel devicethat assists doctors in more accu-rately performing biopsies and otherprocedures while using medicalimaging technology.

Homeopathic drugs anddietary supplementsWe helped a manufacturer of organichomeopathic drugs come into com-pliance with federal and staterequirements, and advised manufac-turers of dietary supplements oftheir obligations under federal law.

CosmeticsWe advised cosmetic manufacturersregarding federal labeling laws andingredient restrictions, as well ason the FDA’s Voluntary CosmeticRegistration Program.

Fish represents and advises clients on governmentregulatory programs that impact technologyproducts and services in more than 75 countries,drawing on our years of experience in technologylaw, product standards, and government regula-tions. Fish attorneys are active members of nationaland international standards-making organizations,enabling us to keep current with up-to-the-minutechanges that affect our clients. We also keepabreast of legal and regulatory developments byutilizing our worldwide network of contacts consist-ing of certification laboratories, notified bodies,and clinical experts to assist in product complianceand market introduction. Manufacturers and ven-dors rely on us to obtain timely equipment authori-zations and access to domestic and internationalmarkets. We advise on compliance issues associatedwith domestic EMC, electrical safety, radiation safe-ty, environmental, and medical device standards.For test houses and laboratories, we assist withaccreditation standards worldwide and offer one-stop shopping for multinational clients seekingequipment authorization.

International standards database We developed a 70-nation database on EMC,electrical safety, telecommunications, radiationexposure, and ergonomic standards for alarge manufacturer of computer workstationequipment.

RFID/spread spectrum We represented and advised the manufacturerof a novel radio frequency (RF) identificationsystem that uses spread-spectrum technologyon the regulatory policies and marketingauthorizations required in more than 25countries.

Radio regulations Our group researched and developed a 40-coun-try product compliance and marketing strategyon the radio regulations that apply to a vari-ety of short-range radio technologies, includingkeyless entry, security alarms, and low-powerradar. We are regulatory advisors to a majormanufacturer seeking market approval in 50countries for an “intelligent airbag” systemthat uses RF-based sensors in automobiles.

Radioactive materials regulation We advised a manufacturer seeking marketentry into a dozen European and Asiancountries for an industrial product that usesa radioactive isotope. The scope of our workincluded counseling on hazardous/radioactivematerial regulations for all modes of trans-portation, use licensing, workplace safety,and product disposal.

RF lighting We counseled a U.S. manufacturer of novellighting technology that uses microwave energyto produce a low-cost, highly efficient sourceof lighting for large-scale commercial andindustrial applications. We devised and execut-ed a regulatory strategy for amending theinternational (IEC/CISPR) standards applicableto this technology to ensure worldwide harmo-nization and market acceptability for themanufacturer’s product.

I N T E R N A T I O N A L T E C H N O L O G YR E G U L A T I O N

Chair, Regulatory GroupTerry G. Mahn202-626-6421

Atlanta

Austin

Boston

Dallas

Delaware

Houston

Munich

New York

San Diego

Silicon Valley

Twin Cities

Washington, DC

FR

Fish & Richardson fr.com