Marilyn J. Chimes
Of Counsel
Dr. Chimes brings an unusual combination of experiences to the practice of law. A Doctor of Veterinary Medicine, as well as a Diplomate of the American College of Laboratory Animal Medicine, she has used her medical and pharmaceutical company experience in such areas as litigation, risk management and risk counseling, analysis of license and contract agreements, the development of medical, pharmaceutical and biotech products and other health-related engagements.
Dr. Chimes has had hands-on experience in pre-clinical drug safety evaluation, protocol design, report drafting and review, and a range of design, analysis and writing in the area of biomedical research. She is also registered to practice before the United States Patent and Trademark Office.
Dr. Chimes has experience in intellectual property law, including infringement and validity opinions, licensing, contracts, litigation, and some patent and trademark prosecution. She has advised clients on the development, protection, marketing, and defense of intellectual property. She also has extensive experience in health care law, including negotiation and drafting of corporate documents, agreements, policies, and procedures. Her clients have been primarily pharmaceutical, medical device, and health care companies, and groups of health care professionals. In addition, Dr. Chimes has represented closely held corporations and high net worth individuals in corporate and commercial matters, estate planning, and real estate transactions.
Dr. Chimes' representative legal engagements have included the following:
Health Law
- Advised pharmaceutical, medical device, pharmacy, veterinary, medical association, hospital, and charitable organization clients about a wide variety of issues at the intersection of law and medicine
- Counseled clients regarding regulations relevant to pharmaceutical compounds, medical devices, pharmacies, nursing facilities, animal shelters, veterinary practice, and personal health information in connection with various types of activities, events, and issues
- Assisted clients in compliance with FDA regulations and HIPAA regulations
- Drafted HIPAA policies, procedures, and authorizations, as well as business associate and data use agreements
- Counseled client on Japanese medical device laws and regulations before and after major revisions
- Negotiated business associate agreements for use with national outcomes database having hundreds of healthcare facility participants
- Pharmaceutical and medical litigation, including litigation related to drugs, vaccines, drug-eluting coronary stents, Medicare/Medicaid fraud, advertising, and organ transplants
- Counseled clients in various situations likely to lead to litigation
Intellectual Property Law
- Prepared infringement and validity opinions relating to, among other things, patents for various technologies, including methods of medical treatment and drug delivery, blood glucose monitors, drugs, chemical enantiomers, beverages, nutritional supplements, methanol to olefin conversion, mattresses, bumper beams, fuel modules, mechanical seals, pulse welding machines
- Drafted and reviewed agreements relating to intellectual property, including agreements for licenses, nondisclosure of confidential information, services, supplies, distribution, research and development, marketing, joint litigation defense, and settlement of litigation
- Counseled pharmaceutical and medical device company clients on creation and dissolution of joint ventures for product development and marketing
- Counseled clients on patent strategies
- Advised clients on licensing negotiation and litigation strategies
- Prepared trademark registrability and infringement opinions
- Prosecuted applications for trademarks and service marks, including preparation of applications, responding to office actions, and advising clients
- Worked with foreign associates to prosecute and assign trademarks and patents worldwide
- Advised certifying organizations on licensing, enforcement, and liability issues with certification marks
- Obtained copyright registrations
- Advised clients on listing of patents in FDA Orange Book
- Performed due diligence reviews and advised clients regarding intellectual property rights in connection with financing, acquisition, merger, and restructuring transactions
- Worked on prosecution of patent applications relating to medical reference systems, diabetic health monitoring methods, treatment systems for amblyopia, intraocular lenses, saddletrees, and fuel filters
- Advised clients regarding various legal and business issues relating to patents, trademarks, and copyrights
- Litigation involving disputes over intellectual property relating to biomarkers, canola oil, plastic packaging, light bulbs, a movie, and more.
Corporate Law
- Formed, maintained, merged, and dissolved for-profit and not-for-profit corporations and limited liability companies
- Drafted organizational documents for the international charitable work of a religious group
- Drafted contracts and service agreements for matters of research and development, employment, real estate purchases and sales, leases, publishing, and credit card payment processing
- Prepared assignments of shareholder and partnership interests
- Drafted and advised clients regarding letters to shareholders and donors
- Counseled corporate and association clients on various matters including healthcare related regulations, exports, officer compensation, product liability, employment, employee benefits, real estate, intellectual property, tax, accumulated earnings, contracts, insurance, security, voting, bylaws, public relations
- Served as vice president of the board of directors of a not-for-profit humane organization with annual operating expenses over $1 million and over 40 employees
Commercial Law
- Prepared documents for commercial and private loans exceeding $1 million
- Managed interconnected loans having combined value of over $160 million and continually changing real property collateral
- Prepared offering memoranda for private issues of notes
- Counseled corporate clients on export regulations
- Counseled clients on potential effects of pending and new legislation
- Worked on purchases and sales of corporate aircraft
Prior Experience in Veterinary Medicine:
1999 Relief Veterinarian
VetSmart (now Banfield, The Pet Hospital), Gurnee, Illinois
Examined and vaccinated dogs and cats in wellness program.
1992-1997 Veterinary Medical Officer (Consultant) - Attending Veterinarian
Research Service, Veterans Affairs Medical Center, North Chicago, Illinois
Directed animal care program; reviewed animal and human research protocols as member of IACUC and IRB; reviewed and monitored uses of animals in biomedical research; trained research and animal care personnel; assisted with selected research projects.
1991-1995 Necropsy Pathologist
Pathology Department, Division of Drug Safety Evaluation
Abbott Laboratories, Abbott Park, Illinois
Supervised and performed postmortem examinations of various species of animals used in preclinical studies of pharmaceutical compounds; trained technicians; described gross pathology of animals used in acute studies of chemical compounds; wrote and reviewed study protocols and reports for submission to FDA and other government agencies.
1987-1991 Clinical Veterinarian
Animal Health & Services Department, Division of Drug Safety Evaluation
Abbott Laboratories, Abbott Park, Illinois
Directed and performed preventive and therapeutic veterinary care and husbandry for animals used in chemical and pharmaceutical research and antibody production; monitored researchers’ use of animals; trained research and animal care personnel; developed and revised standard operating procedures in compliance with GLP regulations; actively participated in design of full-service biomedical research facility; assisted with research projects.
1987 Relief Veterinarian
Several animal hospitals in the Chicago metropolitan area
Performed examination, diagnosis, medical and surgical treatment, and anesthesia of small companion animals; counseled clients.
1984-1987 Clinical Veterinarian
Biological Resources Laboratory
University of Illinois at Chicago, Chicago, Illinois
Directed and performed preventive and therapeutic veterinary care and husbandry of animals used in biomedical and surgical research; assisted with selected research projects; developed and revised standard operating procedures.
Staff Veterinarian
1983-1984 Andover Animal Hospital, Andover, Massachusetts
1980-1983 Burrstone Animal Hospital, Yorkville, New York
1979-1980 Nanuet Animal Hospital, Nanuet, New York
Performed all aspects of small animal veterinary practice, including examination, diagnosis, medical treatment, surgery, anesthesia, client counseling, and emergency care.
Publications:
M.J. Chimes, Response to Protocol Review Scenario: Violators beware!, 36(8) LAB ANIMAL 13 (Sept. 2007)
M.J. Chimes, L.B. Ergin, & K.A. Donohue, Confidential and Proprietary Information, in J. Silverman et al. eds., The IACUC Handbook 407 (CRC Press, 2nd ed. 2007)
M.J. Chimes, Medical Corporations, in Business Entities and Corporate Law in Illinois (Matthew Bender, 2006)
M.J. Chimes, S.A. Scharf, & L.T. Spacapan, Introduction, in The Use of Toxicology in Tort Litigation: A Survey of Federal and State Jurisdictions (Am. Bar Ass’n 2005)
M.J. Chimes, Corporate Responsibility and Corporate Compliance: A Resource for Health Care Boards of Directors, Health Law Briefs (Jenner & Block, Chicago, Ill.), Fall 2003, at 3
M.J. Chimes, HHS Issues Interim Final Rule Requiring Electronic Submission of Medicare Claims, Health Law Briefs (Jenner & Block, Chicago, Ill.), Fall 2003, at 12
M.J. Chimes, Association Defeats Copyright Infringement Claim, Association Report (Jenner & Block, Chicago, Ill.), Spring 2002, at 6
M.J. Chimes, “Prosecution Laches” – a New Defense Against Patent Infringement, Intellectual Property News (Jenner & Block, Chicago, Ill.), Spring 2002, at 1
M.J. Chimes, Animal Law, 40 Contemporary Topics in Laboratory Animal Science 49 (2001) (book review)
B.H. Williams, M.J. Chimes, & C.H. Gardiner, Biliary Coccidiosis in a Ferret (Mustela putorius furo), 33 Veterinary Pathology 437-39 (1996)
M.J. Chimes, A Technique for Catheterization of Ferrets for Chronic Intratracheal Material Administration, 43 Laboratory Animal Science 346-49 (1993)
1992-1995: Co-author of more than 50 formal research reports of studies performed according to Good Laboratory Practice regulations submitted to U.S. Food & Drug Administration and various other government agencies to provide safety information on pharmaceutical compounds
Presentations:
Veterinary Medicine: The Role of Research in a Regulatory Agency, Food and Drug Law Institute Annual Conference, Washington, DC (April 8, 2005). Presented legal perspective on research by FDA Center for Veterinary Medicine.
Compounding Rx Symposium, Western Veterinary Conference, Las Vegas, NV
(February 20, 2005).
Discussed legal issues related to using compounded drugs to treat animals.
Professional Committee Memberships:
2005-2006 HIPAA Compliance Team, Jenner & Block LLP
2005- Public Relations Committee, American Veterinary Medical Law Association
2003-06 Vice President, Board of Directors, Tree House Animal Foundation, Inc., Chicago, Illinois
2001-2006 Board of Directors, Tree House Animal Foundation, Inc.
2000 Associates Committee, Jenner & Block
1999-2000 Publications Committee (adjunct), American College of Laboratory Animal Medicine
1995 National Board Examination Preparation Committee, American Veterinary Medical Association
1995 Assessment Subcommittee (representing veterinarians), National FFA Foundation,
Created Occupational Skills Standards for Agricultural Biotechnology Technicians
1994-1995 Certification Process Task Force, American College of Laboratory Animal Medicine
1993-1996 Research and Development Committee (Institutional Review Board),
North Chicago Veterans Affairs Medical Center
1992-1997 Subcommittee on Animal Studies (Institutional Animal Care and Use Committee),
North Chicago Veterans Affairs Medical Center
1989-1991 Drug Safety Research Building Design Committee, Abbott Laboratories
Professional Society Memberships:
American Bar Association
Illinois State Bar Association
Chicago Bar Association
American Intellectual Property Law Association
American Veterinary Medical Law Association (charter member)
American College of Laboratory Animal Medicine (Diplomate)
American Society of Laboratory Animal Practitioners
Association of Primate Veterinarians
American Association for Laboratory Animal Science
Laboratory Animal Science Association
American Veterinary Medical Association
Additional Accomplishments:
2006: Rode bicycle across the U.S.A. from Seattle, Washington, to Washington, D.C.
2006: Ran and finished Chicago Marathon
2005: Hiked Grand Canyon rim to rim in single day
