dcsimg Brian J. Malkin

Brian J. Malkin

Senior Counsel

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Practices
Industries
Education
  • University of Maryland, BS, Biochemistry, 2004
  • The George Washington University Law School, JD, Editor-in-Chief, The Advocate, 1991
  • The George Washington University, BA, Economics, 1988
Admissions
  • District of Columbia
  • Maryland
  • New York
Affiliations

Advisory Board Member, Rare Disease Report

Chair, Food, Drug and Cosmetic Law Section, New York Bar Association

Deputy Chair, Primer Committee, Food and Drug Law Institute

Editorial Board Member, Generic Line, FDAnews

Brian leads the firm’s FDA regulatory teams. He has more than 21 years of food and drug law practice and over 10 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian’s regulatory experience includes all types of FDA-regulated products: drugs (including animal drugs), biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. Brian’s intellectual property experience includes FDA and patent litigation for both innovator and generic companies.

Immediately prior to law school, Brian worked as a legislative correspondent in the U.S. Senate Committee on Labor and Human Resources. He began his legal career as a regulatory counsel at the U.S. Food and Drug Administration, where he worked for more than nine years in both the Office of the Commissioner and the Center for Drug Evaluation and Research. At FDA, he focused on new product evaluations, compliance issues related to clinical investigations and intellectual property (e.g., patent term restoration). Brian’s work resulted in new product approvals as well as new industry guidance documents and policies, such as the animal efficacy rule for counter-terrorism products.

Following several years of practice in an FDA law firm, Brian recognized an unmet need to understand both food-and-drug and intellectual-property law for lifecycle management and diligence, particularly concerning products affected by the Hatch-Waxman Act, such as generic and 505(b)(2) new drug applications. As a result, Brian returned to university to obtain a Bachelor of Science degree in biochemistry. Prior to joining McGuireWoods, he practiced for more than nine years at an intellectual property law firm, where he worked on a variety of new product evaluations, FDA and patent litigations, due diligence projects, patent prosecutions, and licensing and commercial transactions.

Given his particular experiences, Brian frequently is asked to speak and write on numerous FDA- and intellectual-property-law issues, including clinical trials and new product development for complex and challenging products, such as biotechnology products, orphan drugs, generic drugs, 505(b)(2) new drug applications, patent-term restoration under the Hatch-Waxman Act, biosimilar products, tobacco products, patent-term adjustment, risk management and due diligence.

Community

Brian has been actively involved in promoting the biotechnology community locally, nationally and internationally. Locally, Brian is working with BioBuzz to help stimulate a more active bioscience workforce and a more dynamic bioscience industry throughout Maryland, Virginia, the District of Columbia and beyond. In February 2014, Brian worked with the Montgomery County Department of Economic Development to present a program on “Innovative Strategies for New Product Development.” In June 2014, Brian worked with McGuireWoods to sponsor the 2014 Biomanufacturing Technology Summit (biosimilars) sponsored by the Institute for Bioscience and Biotechnology Research at the University of Maryland. In addition, Brian served on a board of judges for a local entrepreneur contest for a chemical and life sciences class at the University of Maryland’s Mtech Biotechnology Research and Education Program and had been featured as a guest lecturer: "Entrepreneurship for Life Sciences Lessons in Start-Ups for Life Sciences Innovation". He also currently mentors several health law students through a program coordinated by the Maryland State Bar Association’s health law group. Nationally and internationally, Brian has networked with biotechnology groups in Maryland, Massachusetts and Washington state, as well as with the Biotechnology Industry Organization. He also has presented at conferences featuring topics such as orphan drugs, biosimilars, and updates from FDA’s Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research. Brian was proud to join McGuireWoods in sponsoring and participating in Life Science Nation’s Redefining Early State Investments Conferences, which were held in Boston in March 2014 and September 2014 and in San Francisco in January 2015, which featured early-stage life sciences companies, investors and service providers. In November 2013, Brian co-presented a variety of programs for a Korea-Maryland USA Bio Expo in Rockville, Maryland, on the following topics: (1) current good manufacturing practice (cGMP) and its role in regulatory drug quality, (2) current drug shortages and orphan drug disease pharmaceutical development, and (3) innovative strategies for new drug development/biobetters; in October 2014, Brian presented at the same conference on: Dietary Supplements and Functional Food Regulations.

Blogging

Brian is a co-editor of McGuireWoods LLP's FDA Life blog which covers news and trends impacting the FDA and life science industry.

vCard
T: +1 202 857 1704F: +1 202 828 2964bmalkin@mcguirewoods.com2001 K Street N.W.
Suite 400
Washington, DC 20006-1040
T: +1 202 857 1704F: +1 202 828 29647 Saint Paul Street
Suite 1000
Baltimore, MD 21202-1671
Representative Regulatory Work
  • Drugs/Biologics: Premarket
    • Worked with innovator drug companies to develop strategies for approval of new drug applications (NDAs), including those filed as 505(b)(2) NDAs and biologics license applications (BLAs). The approval strategies included developing clinical strategies, pre-investigational new drug applications (INDs) and pre-NDA/pre-BLA FDA meetings. During the process, analyzed, recommended and prosecuted patents to build patent portfolios, including patents for possible listing in FDA’s listing of approved NDAs (Approved Drug Products with Therapeutic Equivalence Evaluations, also known as “the Orange Book”).
    • Worked with innovator drug companies to review existing patent portfolios and recommend and assist in the listing of Orange Book patents.
    • Worked with innovator companies to develop risk management programs, including risk evaluation and mitigation strategies (REMS), some with elements to assure safe use (ETASU), to help mitigate risks. Worked with innovator drug companies to bring over-the-counter (OTC) drugs to market, such as OTC drugs based on FDA monographs or prescription-to-OTC NDA, which includes developing clinical plans for demonstrating the ability of the general public to effectively diagnose and treat their conditions with OTC drug products.
    • Worked with generic drug companies to conduct a prelitigation analysis of the Orange Book-listed patents and expected approval requirements to develop a regulatory strategy for approval, including noninfringement strategies and patent invalidity or unenforceability arguments.
    • Represented generic drug companies in pre-IND or pre-ANDA FDA meetings and drafted controlled correspondence or meeting request packages requesting clarification of the anticipated approval requirements, which included developing bioequivalence recommendations.
    • Worked with generic drug companies to obtain samples for products under ETASU REMS and develop shared or separate REMS programs with the same essential elements.
    • Developed ANDA litigation strategies for innovator and generic drug companies, including identifying patents to assert in infringement or declaratory judgments.
    • Drafted patent notice letters for ANDA applicants with patent challenges to Orange Book-listed patents.
    • Drafted suitability petitions for ANDA applicants to file ANDAs with statutory deviations from the referenced innovator’s drug product.
    • Worked with biosimilar (also known as follow-on biologics) applicants to develop clinical trial strategies for approval, which included considering biosimilar approvals in other countries, such as possible 505(b)(2) NDA approval strategies for certain products.
  • Medical Devices: Premarket
    • Assisted a Canadian-based company to register is establishment with FDA and evaluate FDA’s mobile medical application guidances for classification of its activity monitor device adapted for rehabilitative use, which incorporated smartphone application connectivity and monitoring.
    • Determined proposed medical device classification and developed regulatory strategy for clearing/approving an artificial pancreas incorporating marketed glucose monitors and insulin pumps and smartphone applications and algorithms, in view of FDA’s mobile medical application and information technology guidances.
    • Reviewed FDA’s database of cleared and approved medical devices involving mobile medical applications for possible reference for new mobile medical applications to reduce the likelihood for a premarket approval application requirement by FDA.
    • Worked with medical device companies to determine the appropriate classification for their proposed devices, including assisting with their 510(k) clearances and premarket approval applications (PMAs).
    • Worked with medical device companies to develop clinical trial programs for 510(k) clearances and premarket approval applications, including investigational device exemptions (IDEs).
    • Worked with companies to develop strategies for approval of combination drug/device and combination drug products, including clinical programs.
    • Worked with companies to develop appropriate medical device labeling, including repackaging products.
  • Drugs/Biologics/Medical Devices: Regulatory Review
    • Worked with innovator companies to address clinical holds placed on their INDs or IDEs and overcome otherwise stalled product development plans.
    • Worked with innovator companies to develop proprietary names, including addressing concerns by FDA’s Division of Medication Error Prevention and Analysis (DMEPA).
    • Worked with innovator companies to help them understand and participate in the advisory committee process and other public meetings for new product development and other issues, including using information from advisory committee meetings to assist in regulatory approval or lifecycle management strategies.
    • Worked with innovator companies to develop drug labeling that included claims in patents, risk management strategies or other critical safety or effectiveness elements for marketing and approval.
    • Reviewed drug labels for possible carve-out strategies by generic drug companies to develop noninfringement strategies or obtain approval prior to the expiration of certain exclusivities.
    • Reviewed drug labels for possible noninfringement, invalidity or unenforceability defenses in patent litigations by generic drug companies.
    • Worked with innovator and generic companies to address and evaluate FDA’s complete response letters.
  • Foods, Dietary Supplements
    • Reviewed food additives and dietary ingredients for preapproval or generally-recognized-as-safe (GRAS) status.
    • Reviewed food and dietary supplement labeling for compliance with FDA regulations and requirements, including Dietary Supplement Health and Education Act (DSHEA) requirements.
    • Reviewed food and dietary ingredient structure/function-type claims, including recommending or developing clinical trials for adding new claims.
  • Cosmetics
    • Reviewed formulations (ingredients) for FDA compliance and proposed labeling for new cosmetic products, including making recommended labeling changes to avoid regulatory actions such as potential-drug-versus-cosmetic claims.
  • Tobacco Products
    • Reviewed tobacco product portfolios for tobacco product companies and made recommendations for compliance with the Family Smoking Prevention and Tobacco Control Act, including addressing import/export issues.
    • Filed domestic establishment, domestic and international product listings, and health document submissions for tobacco product companies.
    • Reviewed proposed new tobacco products to determine whether they qualified as substantially equivalent or as new or modified-risk products.
  • Drugs/Biologics/Medical Devices/Foods/Dietary Supplements/Cosmetics : Marketing, Enforcement, and Lifecycle Management
    • Reviewed advertising and promotion material for marketed products, including reviews by the Division of Prescription Drug Promotion (OPDP) to address agency concerns or raise arguments for innovator or generic companies in ANDA litigations with regard to the listing or assertion of method-of-use patents.
    • Worked with companies to address development and conduct of postmarket studies, including product recalls, discontinuations or withdrawals.
    • Worked with companies to promote alignment with good clinical practices (GCPs) and manufacturing practices (GMPs) and address potential clinical hold or recall situations.
    • Worked with companies to address observations and recommendations made in FDA inspections, including developing corrective action plans and audits
    • Worked with companies to address FDA untitled or warning letters including drafting responses and discussing resolution agreements with FDA officials.
    • Worked with companies to develop strategies for FDA administrative proceedings, including filing or responding to citizen petitions and challenging FDA review division decisions prior to filing legal actions against the FDA.
    • Represented companies in lawsuits against FDA for arbitrary and capricious actions, including evaluating whether to bring such actions.
    • Worked with innovator companies to file patent-term restoration applications with the U.S. Patent and Trademark Office and consider other possible patent-term adjustments or extensions.
    • Worked with companies to license their patent technologies and new product applications and develop product development partnerships.
    • Conducted due diligence investigations for patents, regulatory approvals and licensing agreements for companies seeking to acquire new products or companies, including research and development agreements that were part of settlement agreements. Most of these investigations resulted in formal due diligence reports and recommendations.
    • Developed regulatory and patent portfolio strategies and presentations for sales of products or companies to potential buyers and their counsel following audit of regulatory and intellectual property due diligence documents.
    • Provided regulatory litigation support for patent infringement litigations, including reviewing status of product approvals and regulatory requirements (including guidance documents), developing expert reports and litigation documents for stays and other actions, and otherwise integrating the patent litigation and regulatory strategies.
Representative Litigations
  • Represented Exela Pharmsci Pvt. Ltd. in a lower-court ANDA litigation concerning alleged infringement for filing an ANDA for a generic form of Alphagan® P (brimonidine tartrate) (Allergan Inc. v. Exela Phamsci Inc., In Re Brimonidine, MDL No. 1866, (D.Del 07-516)). Exela prevailed on appeal to the Federal Circuit.
  • Represented Ranbaxy Laboratories and Ranbaxy Inc. in Medicis Pharmaceutical Corp. v. Ranbaxy Inc. et al. (D.Del. No. 09-435). Medicis settled with Ranbaxy and provided various licensing agreements.
  • Represented Paddock Laboratories, Inc., for filing an ANDA for a generic form of Loprox® gel (ciclopirox) in Medicis Pharm. Corp. and Sanofi-Aventis Deutschland GmbH v. Paddock Laboratories, Inc. (D.MN. 06-2588). Medicis and Sanofi settled with Paddock prior to discovery based on the pleadings.
  • Represented Lupin Ltd. and Lupin Pharm., Inc., for filing an ANDA for a generic form of Lotrel® (amlodipine besylate/benazepril hydrochloride) in Novartis Corp. v. Lupin Ltd. and Lupin Pharm., Inc. (D.N.J. 06-5954).
  • Represented Lupin in Teva v. Lupin (D.N.J. 07-02896). Teva sued Lupin for its manufacture of carvedilol active ingredient used in its filed ANDA for a generic version of Coreg® (carvedilol).
  • Represented a global pharmaceutical company in a patent litigation in the District Court of Delaware regarding an injectable drug product. Client obtained a favorable settlement.
Representative Patents
  • Advised Exela Pharmsci Inc. regarding methods to distribute substitute medical therapies for medical therapies with restricted distribution (U.S. Patent No. 7,885,827: Method and System for Delivering Substitute Medical Therapies with Restricted Access).
  • Advised Par Pharmaceutical Inc. regarding a method to sort data for complex compositions, including biologics without the need for a reference standard (U.S. Patent No. 7,246,020: System and Method for Sorting Data).

At the FDA, Brian received a variety of awards for outstanding service. In addition to frequent speaking and writing opportunities in the FDA and intellectual property space, he has been elected to a variety of premier editorial board and bar association leadership roles. Some of these included:

  • June 2014 - Brian began his two-year term as Chair of the Food, Drug and Cosmetic Law Section of the New York Bar Association, after serving on its Executive Committee for several years. Under Brian’s tenure, the Section co-sponsored its first set of comments to FDA on its proposed laboratory developed tests frameworkand is actively participating in other regulatory and legislative outreach.
  • April 2013 – Brian was selected as the Vice Chair of the Primer Committee for the Food and Drug Law Institute, after serving on the committee for several years.
  • April 2015 – Brian was selected as a member of the Drugs/Biologics Committee for the Food and Drug Law Institute
  • December 2012 - Brian was selected for the advisory board of the Rare Disease Report.
  • 2013 – Brian was selected for the editorial board FDA News, Generic Line.
  • Named to "Washington, D.C. Top Attorneys," Food and Drugs, Washington Post, 2014.
  • Named to "Washington, D.C. Super Lawyers," Food and Drugs, Super Lawyers, Thomson Reuters, 2014.
Author, "The FDA’s Ever-Broadening Regulatory Oversight Creates Need for Increased (and More) User Fees: How Will This Affect Enforcement, the Increasing Need for Sponsor Self-Regulation, and the FDA’s Regulatory Priorities?," Recent Developments in Food and Drug Law (2015 Edition), Aspatore/Thompson Reuters, December 2014
Co-author, The Drug/Biologics Approval Process: An FDLI Primer, Food and Drug Law Institute Update Magazine, January 2013
Author, "Challenges to the Development of a Biosimilars Industry in the United States," Aspatore/Thompson Reuters Recent Developments in Food and Drug Law (2013 Edition), December 3, 2012
Co-author, "Should FDA Understake More Than a "Ministerial" Role with Respect to Patent Information?," Food and Drug Law Institute Policy Forum, February 23, 2011
Co-author, "Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009," Food and Drug Law Institute Update Magazine, February 1, 2011
Co-author, "Biosimilars Are a Reality: Key Feautres of the Biologics Price Competition and Innovation Act," Food and Drug Law Institute Update Magazine, June 1, 2010
Author, "The Letter of the Law: How FDA Regulation Will Impact Your Business," Tobacco Reporter, August 1, 2009
Panelist, "Foreign Corrupt Practices Act and Corporate Accountability," Pennsylvania Bar Institute 21st Annual Meeting, November 4, 2015
Speaker, "Developments in Global Intellectual Property," 18th Annual IGPA Conference, International Generic Pharmaceutical Alliance, September 17, 2015
Panelist, "Drug Compounding in the Animal Drug Industry: Assessing Fair and Foul Practices," Legal, Regulatory and Compliance Forum on Animal Health, Veterinary Medicines and Therapeutics, American Conference Institute, September 10, 2015
Speaker, "Develop Strategies to Continue Building Successful Benefit-Risk Assessments," Benefit-Risk Assessment & Decision Making Summit, CBI, August 8, 2015
Speaker, "Protecting Both Innovation and Competition: Finding Compromise Within Federal and State Biosimilars Substitution Laws," ACI's 6th Annual Summit on Biosimilars, American Conference Institutue, June 2, 2015
Panelist, "Breakout Session: Center for Drug Evaluation and Research (CDER)," 2015 FDLI Annual Conference, Food and Drug Law Institute, April 20, 2015
Panelist, "Biosimilars Patent Litigation," 11th EGA Legal Affairs Forum, European Generic Medicines Association, March 27, 2015
Panelist, "FDA, LDT and IVD: The ABC’s of Clinical Lab Test Development," Food, Drug and Cosmetic Law Section Annual Meeting, New York State Bar Association, January 29, 2015
Panelist, "Analyze the FDA's Newly Released REMS Standardization Report" and "Highlight Key Consideration to Collaborate Successfully in a Single Shared REMS," 7th Risk Evaluation and Mitigation Strategies Summit, ExL Pharma, January 22, 2015
Speaker, "Insights into developing the Best Regulatory Pathway for your Venture and Methods of Designing an Efficient and Productive Clinical Trial," Climbing the Regulatory Summit, December 10, 2014
Speaker, "FDA Update: Recent Developments and New Initiatives," 6th Annual Medical Device and Life Sciences Conference, November 18, 2014
Moderator, "Issues Concerning Development of Rare Disease and Special Population Medical Devices," AdvaMed 2014: The MedTech Conference, October 7, 2014
Panelist, "The Case for Small Markets with Large Returns: Orphans/Rare Disease Panel," Redefining Early Stage Investments, Life Science Nation, September 17, 2014
Panelist, "Pre-Conference Primer: Biosimilars 101: Comprehensive Deep Dive Into the Relevant Legal, Regulatory and Scientific Factors Companies Must Know," 5th Annual Conference on Biosimilars, American Conference Institute, June 4, 2014
Speaker, "Breakfast Break-out: Career Opportunities in Food & Drug Law," 2014 Food and Drug Law Institute Annual Conference, April 24, 2014
Moderator, "Lifesciences/Med Device Policy: FDA Approval Processes, Medical Device Tax and Beyond," 11th Annual Healthcare and Life Sciences Private Equity and Finance Conference, McGuireWoods LLP and McGladrey LLP, February 26, 2014
Guest Speaker, "Safety v. Competition (Federal Trade Commission Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition February 4, 2014 Overview)," BioCentury This Week, Television Program, February 16, 2014
Speaker, "Biotechnology Roundtable: Innovative Strategies for New Product Development," Montgomery County Department of Economic Development, February 5, 2014
Speaker, "FDA Regulation: The Intersection of Policy and Politics, The Opportunities and Challenges for Innovation – Perspectives from Two Former FDA Officials," New York State Bar Association's Annual Meeting of the Food, Drug and Cosmetic Law Section, January 30, 2014
Speaker, "Understand the FDA Report [Risk Evaluation and Mitigation Strategies ("REMS") Standardization] and the Impact on the Industry," ExL Pharma's 6th Risk Evaluation and Mitigation Strategies Summit, January 28, 2014
Speaker, "Current Good Manufacturing Practice (cGMP) and its Role in Regulatory Drug Quality", "Current Drug Shortages and Orphan Drug Disease Pharmaceutical Development", and "Innovative Strategies for New Drug Development/Biobetters," Korea-Maryland USA Bio Expo, November 8, 2013
Speaker, "Update on FDA’s Draft Guidance for Electronic Source Data in Clinical Investigations," Clinical Data Management Innovation Conference, Q1 Productions, October 29, 2013
Speaker, "Standardizing Shared REMS," Public Meeting, Standardizing and Evaluating Risk Evaluation and Mitigation Strategies, Food and Drug Administration, July 25, 2013
Speaker, "Developing a Single, Shared REMS in a Collaborative Setting," Global Clinical Risk Management & Regulatory Policy Conference, Q1 Productions, July 11, 2013
Speaker, "Center for Biologics Evaluation and Research Breakout Session," Food and Drug Law Institute Annual Conference, April 24, 2013
Speaker, "Pivotal Cases for FDA Practitioner: 2012-2013 Updates” and “In-House/Outside Counsel Panel: Effective Communication Regarding FDA/Regulatory Advice," New York State Bar Association, Food, Drug and Cosmetic Law Section, January 24, 2013
Speaker, "Mastering the Intricacies of the Orphan Drug Designation Process: A Step-by-Step Guide to Navigating the Pathway," Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process, American Conference Institute, November 29, 2012
Speaker, "Preparing for the Evolution of the Generic Drug and Biosimilars Industry" and "Biobetters and Extending into the Marketplace Beyond Patent Expiration," Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars, Q1 Productions, July 12, 2012
Speaker, "Exclusivities and Forfeitures: New Developments, Controversies and Concerns," Maximizing Pharmaceutical Patent Life Cycles, American Conference Institute, October 5, 2011
Speaker, "Ascertaining the Type and Volume of Clinical Data Necessary to Establish Biosimilarity," Biosimilars, American Conference Institute, June 8, 2011
Speaker, "Exploring Patent Term Adjustment and Patent Term Extensions and Understanding their Applicability to Drugs and Biologics," Paragraph IV Disputes, American Conference Institute, May 2, 2011
Speaker, "Development and Regulation of Tobacco Products, Nicotine, and Alternative Tobacco Products under the Family Smoking Prevention and Tobacco Control Act and Beyond," Food and Drug Law Institute, Annual Conference, April 5, 2011
Speaker, "Patent Term Extension: Laying the Groundwork for Patent Term Restoration," Life Science Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions, American Conference Institute, January 27, 2011
Conference Chair and Speaker, "Non-patent Exclusivity," FDA Boot Camp, American Conference Institute, August 25, 2010
Speaker, "Defining Biosimilars: Proving (or Disproving) Interchangeability and Biosimilarity," Follow-on Biologics, American Conference Institute, June 21, 2010
Speaker, "Patent and Intellectual Property Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More," Paragraph IV Disputes, American Conference Institute, April 26, 2010
Speaker, "Post-Conference Workshop Manufactures' Working Session - Preparing for and Implementing a REMS," Risk Evaluation and Mitigation Strategies, American Conference Institute, April 21, 2010