Martha M. Rumore
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Dr. Martha Rumore is Of Counsel at Sorell, Lenna & Schmidt. She focuses on pharmaceutical and medical device intellectual property including all aspects of patent law:  prosecution, opinion work, litigation and transactional matters. Martha has authored freedom-to-operate, patentability, invalidity, infringement and non-infringement opinions, including opinions supporting Paragraph IV certification under  the Hatch-Waxman Act.

She has over seven years of law firm experience counseling  on early market opportunities for generic clients particularly in the area of Paragraph IV matters and has also prepared ANDAs and 510K applications.  She has experience in all facets of ANDA litigation-expert witness reports, depositions, scientific document review, complaint and answer, motion practice. Representative generic cases she has handled include Glaxo v. Andrex Pharmaceuticals, Medpointe v. Hi-Tech Pharmacal (2nd chair), and Schwartz Pharmaceuticals v. Sun Pharma.

She is a registered pharmacist and Professor at Touro College of Pharmacy where she teaches Pharmaceutical Law. She also taught Drug Regulatory Affairs and Food, Drug Cosmetic Law at Long Island University College of Pharmacy.

Bar and Court Admissions

Registered to practice before the United States Patent and Trademark Office

Courts of the State of New York, New Jersey and D.C.

Southern District of New York

U.S. Court of Appeals, Federal Circuit

U.S. District Court, District of New Jersey

Publications

Legal Aspects of Drug Information Practice. In Malone PM, Stanovich J., Kier K, Malone MJ (eds.) Drug Information: A Guide For Pharmacists. Norwalk, Connecticut, McGraw Hill, New York, 5th ed. 2014 pp. 503-568. 

Post Caronia: Is a new paradigm needed for off-label medication usage? J Medical Marketing: Device, Diagnostic and Pharmaceutical Marketing 2014 (Mar):13(4):online before print doi:10.1177/1745790414526613.

Legal Aspects of Drug Information Practice. In Malone PM, Mosdell K, Stanovich J., Kier K (eds.) Principles and Practice of Drug Information. Norwalk, Connecticut, Appleton & Lange, 4th ed. 2011 pp. 505-53, 5th ed. In press.

Patent, Trademark & Copyright Law. In Konnor D (ed.). Jurisprudence and Ethics for Pharmacists. New York, Hawthorne Press. 2008, pp. 125-149.

Rumore M. The Hatch-Waxman Act-25 Years Later. Keeping the Pharmaceutical Scale Balanced. August 2009. Pharmacy Times. Generic Drug Supplement. August 2009, pp. 4-7, 20.

Rumore M. Recent Trends in Lanham Act Litigation Involving Generic Substitution
(Abstract).  J. Amer. Pharm. Assoc., 48(2):288, 2008.

Rumore M, Safe Harbor or Pirate Cove? Merck v. Integra and Its Seeming Impact on International Research Activities. SciTech Lawyer 3(3):12-15, Winter 2007.

Restino L, Rumore MM. Safe Harbor or Uncharted Seas? Integra v. Merck Currents. N.J. Lawyer 14(20):1,6, 2005.

Vepachedu S, Rumore M. Patent Protection and the Pharmaceutical Industry in the Indian Union. Intellectual Property Today 11:44-46, Oct. 2004.

Rumore M. Determinants of Patenting in the U.S. Pharmaceutical Industry Based on Recent CAFC Case Law. J. Amer. Pharm. Assoc.  44:298, Mar/April 2004.

Rumore M. Ranbaxy Pharmaceuticals v. Apotex. Redefining Claim Drafting and Patent Prosecution Under Festo. ABA Intellectual Property Newsletter. 22:12-15, Summer 2004.

 

Recent articles

Rumore MM. Post Caronia: Is a New Paradigm Needed for Off-Label Medication Usage? J Medical Marketing. 2014;13(4):212-220.

Rumore MM. Law Update- 2014. NYC Council of Hospital Pharmacists Newsletter. Summer 2014.

Slattery E, Rumore MM, Douglas J., Seres DS. Three-in-one Versus Two-in-one Parenteral Nutrition In Adults: A Review. Nutrition Clin Pract.  doi: 10.1177/0884533614533611;  May 28, 2014.

Rumore MM, Houst B. Palytoxin Poisoning via Inhalation in Pediatric Siblings. Int. J Case Reports and Images. 2014; 5(7):501-504.

 

Presentations

Patel Y, Guber H, Giunta J, Figueroa G, Ho C, Rumore M, Sharkey C, Aprile J. Retrospective Analysis of Statin Titration versus Initiation at High-Moderate Intensity Dosing to Achieve Low Density Lipoprotein (LDL) Goals in the Veteran Population. American Society of Health System Pharmacists Annual Meeting. Poster Presentation. Dec 7-11, 2014.

Rumore MM, Afzal U, Sussman R. TPN Services in the NICU of a Metropolitan Hospital. American College of Clinical Pharmacy 2014 Virtual Poster Symposium, May 21, 2014.

Legal, Regulatory and Compliance Update for Controlled Substances: Implications for Pharmacy Practice. Greater New York Hospitals Association.  Webinar. April  22, 2014.

Piperacillin/Tazobactam (PT) Dosage Error Reduction in Pediatric Patients. Poster. New York State Council of Hospital Pharmacists Annual Meeting, Saratoga, NY, May 1, 2014.

Cost Avoidance Assessment of Pharmacist’s Interventions at a Metropolitan Pediatric Hospital, Poster. NSLIJ Afternoon of Innovation, New Hyde Park, NY, March 7, 2014.

Off- Label Medication Usage: Balancing the Standard of Care, Legal, and Safety Considerations. GNYHA Teleconference and Webinar. October 24, 2013.

Hatch-Waxman Amendments. New York Presbyterian Hospital. New York, NY., November 30, 2011.

Pharmacy Law and Regulatory Update. Grand Rounds Lecture. Cornell Medical Center, New York, August 11, 2011.

The Food Drug Cosmetic Act and Amendments. Touro College of Pharmacy, New York, NY, February 18, 2010.

The NDA/ANDA Process and Generic Biologics- Pros and Cons, Touro College of Pharmacy, New York, NY, Jan. 5, 2010.

Recent Trends in Lanham Act Litigation Involving Generic Substitution.
American Society of Pharmacy Law Annual Meeting. San Diego, California. March 17, 2008.

Patent Law Update. City University School of Law. Jamaica, NY. March 6, 2006.

Guidance on the FDA Guidance Answering Inter Alia The Question: What is a Listed Drug? In House CLE Lecture. Law firm of Brown Raysman Millstein Felder & Steiner. New York, NY, December 15, 2004.

Implications of Recent Amendments to the Hatch-Waxman Act. CILS Conference. Intellectual Property: A Means for Worldwide Protection. Sunshine Coast, Australia, October 21, 2004.

Use of Patent Claims Data for Competitive Intelligence, In-House lecture, GAF Corporation, Wayne, NJ, June 22, 2004.