Intellectual Property Adjunct Professor

Brian J. Malkin

Bethesda, MD ***** • ************@*****.*** • 301-***-****

Experienced FDA and Intellectual Property attorney seeking in-house position in legal or regulatory department focusing on regulatory, intellectual property, or public policy responsibilities eager to be part of a corporate development team. PROFESSIONAL EXPERIENCE

McDermott Will & Emery LLP, Washington, DC July 2020 - Present Partner

Counsel pharmaceutical and biologic clients including drug manufacturers, pharmacies (compounding and retail), biotechnology clients, medical device companies and cannabis companies on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law as they develop new products and protect their innovations though life cycle management, bring their products to market, and pursue transactional opportunities. Develop medtech regulatory strategies, risk evaluation and mitigation strategies (REMS), and patent portfolios with a focus on innovator products

(including orphan and DEA-scheduled products), biosimilar and complex generic or 505(b)(2) NDA products, and combination drug products, including new and emerging areas such as regenerative medicine and cannabis-based products.

• Conduct lifecycle company audits resulting in follow-on products, new patents, and regulatory strategies.

• Draft FDA meeting requests and associated documents and participate in FDA meetings for new product development and to resolve stalled product development or compliance issues. Review and advise on compliance risks for FDA- regulated product labelings and promotional materials.

• Work with biotechnology companies to form partnerships and participate in resultant joint development committees for coordinating new product development and advise on ongoing regulatory and patent strategies.

• Participate in company- and venture-fund FDA and IP diligence and compliance with securities filings, corporate presentations, and public statements to critically evaluate new FDA-regulated companies or products.

• Manage patent portfolio dockets including international associates resulting in new patents and litigation settlements.

• Draft comments to FDA guidances on bioequivalence and therapeutic equivalence related to generic and 505(b)(2) NDAs for multinational generic drug company and proposed rulemakings on orphan products and develop regulatory/legislative strategies with lobbyists regarding orphan products for 505(b)(2) NDA company. ArentFox Schiff LLP (formerly Arent Fox LLP), Washington, DC January 2017– July 2020 Counsel

• Conducted FDA and intellectual property stock offering/investment bank due diligence for start-up drug, biotechnology, and medical device companies, reviewing and editing prospectus documents, press releases, and road show presentations.

• Drafted citizen petitions related to orphan drugs, biosimilar products, and complex generic drugs including persuasive scientific and bioequivalence arguments and expert declarations. Drafted orphan drug designations and related documents, resulting in new orphan drug opportunities.

• Drafted client comments to FDA guidances regarding FDA’s listing practices in the Orange Book and various bioequivalence-related proposals and proposed rulemakings regarding Orange Book and Purple Book listings as well as other bills to enhance drug competition and developed regulatory and legislative strategies for large, multinational generic drug company.

• Worked with regulatory authorities to permit marketing of gray-area consumer products, including cannabis-derived and psychedelic products with federal and state regulatory implications.

• Negotiated/drafted supply agreements for pharmaceutical/biotechnology clients, including CREATES Act samples. McGuireWoods LLP, Washington, DC March 2014 - January 2017 Senior Counsel

Led the firm’s FDA regulatory industry teams handling matters impacted by diverse FDA-regulated products: drugs

(including animal drugs and compounded products), biologics, medical devices, foods and dietary supplements, tobacco products, cannabis-derived products, and cosmetics.

• Conducted FDA and intellectual property due diligence for lenders related to debt financing and mergers and acquisitions for primarily mid-cap level product manufacturers in the drug, biologic, and medical device areas.

• Developed product development and life cycle management strategies for new products including patents.

• Drafted client comments to FDA guidance regarding bioequivalence and clinical trials and proposed rulemakings and developed legislative strategies for large, multinational generic drug company.

• Drafted patent term extension/restoration applications and handled inter-related regulatory issues regarding determining which patent to seek extension and how to maximize regulatory exclusivities.

• Drafted clinical trial audit agreements and managed clinical trial audits and responses to FDA deficiency letters. Brian J. Malkin Page 2

Haug Partners (formerly Frommer, Lawrence & Haug LLP), NYC & Washington, DC August 2004 - March 2014 Partner

• Litigated Hatch-Waxman cases for both branded/innovator and generic pharmaceutical and biotechnology clients as well as litigations related to biotechnology and pharmaceutical products including prelitigation strategies, settlements

(including antitrust considerations), and various contractual rights, including pharmaceutical ingredient/product supply agreements.

• Reviewed trademarks, copyrights, and trade secret information for potential for infringement and developed strategies to protect new products in development. Performed due diligence for new products or companies involving review and analyses of patent portfolios, regulatory strength and potential for generic or follow-on competition, partnership and licensing agreements, and ongoing litigations.

• Developed, drafted, and implemented regulatory strategies for biotechnology and pharmaceutical products including new product development, life cycle management, and generic, biosimilar, or 505(b)(2) NDAs. Hyman, Phelps & McNamara, P.C., Washington, DC January 2001 – May 2002 Associate

U.S. Food and Drug Administration (FDA), Rockville, MD September 1991 – January 2001 Regulatory Counsel

• Implemented and directed the Patent Term Restoration Program under the Hatch-Waxman Act, answered queries regarding the application process and precedent, and developed and executed new policies.

• Developed and executed new regulatory policies for human subject protection, resulting in new legislation, FDA regulations, or public health recommendations, including animal efficacy trials. EDUCATION

University of Maryland, College Park Bachelor of Science, Biochemistry May 2004 The George Washington University Law School Juris Doctor June 1991 The George Washington University Bachelor of Arts, Economics with Special Honors February 1988 PROFESSIONAL ACTIVITIES COMMUNITY INVOLVEMENT

Georgetown University Law School, Washington, DC September 2018 – Present Guest Professor

Serve as guest lecturer for health law LLM courses covering topics including clinical trials, pharmacovigilance, FDA regulatory reviews, and cannabis law.

Yeshiva Katz Biotech IP and FDA, New York, NY September 2018 – Present Adjunct Professor

Developed and teach course covering intellectual property and regulatory considerations and topics for biotechnology entrepreneurs involving case studies and projects. DC Bar Intellectual Property Community, Washington, DC September 2019 – Present Steering Committee Member (former Co-Chair)

Develop new Intellectual Property Community engagement with over 30 new active members as committee chairs or members, fostering partnership with the International Trade Commission Trial Lawyers Association and new programs such as IP for FDA Lawyers, International IP Litigation, and Cannabis IP, and programs for young and diverse IP attorneys. NY State Bar Association (NYSBA) Food, Drug and Cosmetic Law Section, New York, NY June 2015 – Present Executive Committee Member (former Chair) (6 years) Develop new Section initiatives including legislative comments and innovative cross-sectional programming including intellectual property, antitrust law, and entertainment, arts, and sports law, and new programming to bring young and diverse attorneys into food and drug law.

NYSBA Cannabis Law Section (formerly Committee on Cannabis Law), New York, NY June 2015 – Present Member (former initial Co-Chair and founder)

Develop thought leadership for the developing area of cannabis law involving related disciplines including FDA and health law, intellectual property, corporate and business law, banking law, labor law, and environmental law in continuing legal education programs and opinions, including drafting legislative comments and reports and recommendations for the NYSBA House of Delegates to review and approve as NYSBA’s official positions.

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