Stephen Paul Mahinka

Email: smahinka@morganlewis.com

Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5205
Fax: 202.739.3001

education

Harvard Law School, 1974, J.D.

Johns Hopkins University, 1971, B.A., Phi Beta Kappa

Publications

Date	Title	Publication
01/19/12January 2012	The Consumer Financial Protection Bureau: What It Is and What to Expect View White Paper	White Paper
12/05/1112/05/11	Comparative Effectiveness Research: Impact on Pharmaceutical Pricing and Marketing, presented at the QI Productions Conference on Integrating Comparative Effectiveness Research, Philadelphia View Presentation	Speech
12/01/1112/01/11	FTC/DOJ Final Policy Statement on Accountable Care Organizations: Important Antitrust Issues Remain Unanswered, BNA's Health Law Reporter View Article	Article
10/31/1110/31/11	FTC/DOJ Final Policy on Accountable Care Organizations: Important Antitrust Issues Remain Uncertain for Healthcare Collaborations View LawFlash	Life Sciences and Healthcare LawFlash
10/18/1110/18/11	The CFIUS Review Process: Trends and Challenges, presented to the Delegation of the State-owned Assets Supervision and Administration Commission (SASAC), People’s Republic of China View Presentation	Speech
09/23/1109/23/11	The Biosimilars Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars, presented at American Conference Institute’s FDA Boot Camp, Boston View Presentation	Speech
06/06/1106/06/11	New Government Healthcare Policies - Impact on Growth and Investment in the Biopharma Industry, presented at the US – Japan Health Sciences Dialogue 11th Annual Meeting, Philadelphia View Presentation	Speech
05/23/1105/23/11	FDA Requests Comments on the Development of a User Fee Program for Biosimilar and Interchangeable Biological Products View LawFlash	Life Sciences and Healthcare LawFlash
03/03/1103/03/11	China's New National Security Review Process for Foreign Investments: U.S. CFIUS Review Moves East View LawFlash	International Alert
01/21/1101/21/11	Prevent Legal Risk, Be Successful in the U.S. Market, China Enterprise News (View Article)	Article
01/07/1101/07/11	FDA Food Safety Modernization Act Summary View Article	FDA and Healthcare LawFlash
12/23/1012/23/10	FDA Food Safety Modernization Act Greatly Expands FDA Enforcement Powers View LawFlash	FDA and Healthcare LawFlash
12/14/1012/14/10	The Antitrust Merger Review Process View Presentation	Speech
12/13/1012/13/10	The CFIUS Review Process View Presentation	Speech
10/28/1010/28/10	Preparing for a Biotechnology M&A – Corporate and Regulatory Insight to Keep Ahead of the Competition View Presentation	Speech
10/14/1010/14/10	Implications of DOJ / FTC Revised Merger Guidelines View Presentation	Webinar
10/07/1010/07/10	FTC Releases Proposed "Green Guides" Revisions View LawFlash	Cross-Practice Alert
07/20/1007/20/10	Potential Effects of Healthcare Reform Law on the Medical Device Industry and its Customers View Presentation	Speech
07/12/1007/12/10	Proposed Merger Reform's Effects On FERC Analysis, Law360 View Article	Article
05/11/1005/11/10	Life Sciences Mergers and Acquisitions: How Healthcare Reform Will Change Your Partnership Strategy, presented at a Elsevier Business Intelligence Webinar View Presentation	Speech
04/22/1004/22/10	How Regulatory Structures are Taking into Account Scientific Developments in Assessing Approved Food Contact Products, presented at the 2010 Food and Drug Law Institute Annual Conference, Washington, D.C. View Presentation	Speech
04/19/1004/19/10	Healthcare Reform Law: Comparative Effectiveness Provisions Concerning Healthcare Products and Services View LawFlash	Washington Government Relations and Public Policy LawFlash
12/01/09November/December 2009	21st Century Toxicology and its Implications for FDA Regulation of Food-Contact Substances, FDLI Update View Article	Article
10/01/0910/01/09	New Trends Affecting Pharmaceutical and Medical Device Life Cycle Risk Management, presented at the Fourth National FDA Regulatory Symposium, Washington, D.C. View Presentation	Speech
07/16/0907/16/09	Detecting Off-Label Promotion Issues That Can Derail a Life Sciences M&A, presented at ACI's 6th Annual Pharmaceutical Counsel's Guide to Off-Label Communications, Philadelphia View Presentation	Speech
03/27/0803/27/08	Solving the Challenges of Regulatory Compliance Through Technology, presented at the 51st Annual Food and Drug Law Institute/FDA Conference, Washington, D.C.	Speech
03/13/0803/13/08	Critical Regulatory Concerns that Must be Addressed in a Life Sciences M&A, presented at the American Conference Institute, New York View Presentation	Speech
01/01/082008	The Centrality of Regulatory Due Diligence in Life Sciences M&A (Chapter 2), Life Sciences Mergers and Acquisitions (Aspatore Books)	Chapter
11/08/0711/08/07	How Are New Safety Concerns Affecting FDA Approvals and CMS Reimbursement of Bio/Pharma Products, presented by The Center for Business Intelligence View Presentation	Speech
10/02/0710/02/07	Regulatory Trends Affecting Product Approvals and Reimbursement of New Drugs and Biologics, presented at the 8th Annual Philadelphia-Japan Health Sciences Dialogue, Philadelphia View Presentation	Speech
06/18/0706/18/07	New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25 View Article	Article
04/13/0704/13/07	Panel Discussion with the Director of the FDA Center for Drug Evaluation and Research, presented at the 50th Annual Food and Drug Law Institute/FDA Conference, North Bethesda, MD	Speech
03/15/0703/15/07	The Six Regulatory Issues That MUST Be Addressed in a Life Sciences M&A, presented to the American Conference Institute, New York View Presentation	Speech
03/02/0703/02/07	Potential Challenges to Pricing of Biotech Products: Medicare/Medicaid and Related Pricing Developments, presented at the 2007 BIO General Counsels' Committee Meeting View Presentation	Speech
12/04/062006/07	Overview of Healthcare Fraud Investigations in the U.S., PLC Cross-border Life Sciences Handbook 2006/07 View Chapter	Chapter
08/24/0608/24/06	Risk Management Strategy for the Pharma and Biotech Product Lifecycle: New Regulatory and Legal Focus and Approach, presented at the 2nd Annual FDA Regulatory and Compliance Symposium, Harvard University, Cambridge, MA View Presentation	Speech
06/18/0506/18/05	Starting or Expanding a Pharma/Biotech Business in the U.S.: New Legal and Regulatory Issues, presented at the 6th Annual Philadelphia-Japan Health Sciences Dialogue, Japan America Society, Philadelphia View Presentation	Speech
05/24/0505/24/05	Pharmaceutical Industry Mergers: Anticipating Antitrust Issues and Surviving the Investigation, presented at the American Conference Institute In-House Counsel Forum on Pharmaceutical Antitrust, Washington, D.C.	Speech
11/01/04November 2004	Licensing in the Pharmaceutical Industry: Strategies and Questions Regarding Antitrust Premerger Notification, FDLI Update View Article	Article
08/02/04July/August 2004	New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry, FDLI Update, Vol. 36 View Article	Article
05/17/042004	Applying Antitrust Law Effectively: The Importance of Simplifying Complexity, Winning Antitrust Strategies (Aspatore Books) View Chapter	Chapter
03/17/0403/17/04	How to Preserve Your Antitrust Immunity for Lobbying and Obtaining State Actions, presented at the Morgan Lewis Trade Association Teleseminar Series	Speech
02/03/0402/03/04	"Off-Label" Communications at Risk: Changes and Challenges to Reimbursement for Prescription Drugs, presented to the Washington Legal Foundation, Washington D.C. View Presentation	Speech
01/01/0401/01/04	The Role of Pharmaceutical Licensing in Product Lifecycle Management: Litigation and Settlement Under the Hatch-Waxman Act (Chapter 8), Licensing Deskbook (Loislaw)	Chapter
06/23/0306/23/03	FDA Approval of Generic Biologics: Adverse Effects on Industry Innovation and Valuation, presented at the Biotechnology Industry Organization Annual Conference, Washington, D.C. View Presentation	Speech
04/15/03April 2003	Pharmaceutical Licensing in Product Lifecycle Management: Litigation and Settlement Under the Hatch-Waxman Act: Parts One and Two (March and April 2003), Licensing Journal View Article	Article
02/28/0302/28/03	FDA Must Clarify Drug Makers' Ability to Publicly Defend Products, Litigation Legal Foundation Legal Update, Vol. 13, No. 7 View Article	Article
10/01/0210/01/02	FDA Approval of Drugs Under Section 505(b)(2): Potential Expansion and Legal Concerns, presented at the Regulatory Affairs Professionals Society Annual Conference, Washington, D.C. View Presentation	Speech
08/01/0208/01/02	FDA Challenges to Pharmaceutical Company Control of Product Lifecycle Management, FDLI Update View Article	Article
04/17/0204/17/02	Outstanding Issues for FDA's Center for Drug Evaluation and Research Affecting Pharmaceutical Product Lifecycle Management, presented at the Food and Drug Law Institute Annual Conference, Washington, D.C. View Presentation	Speech
03/18/0203/18/02	A Beautiful Space: A Real Estate Special Report, Legal Times, Vol. 25, No. 11 View Article	Article
03/01/02March 2002	Pharmaceutical Pricing: System Changes And Global Effects, Metropolitan Corporate Counsel	Article
10/01/01October 2001	Dealing With Antitrust Questions in Mergers and Acquisitions, presented at the Utility M&A Conference, San Antonio View Presentation	Speech
10/01/01October 2001	The Microsoft Ruling View White Paper	White Paper
08/01/01August 2001	U.S. Pharmaceutical Pricing: System Changes and Global Effects, Life Sciences Industry Report	Article
05/01/01May 2001	Preclosing Cooperation in Energy Mergers: Antitrust Issues and Practical Concerns, Project Finance Monthly	Article
01/01/01January 2001	It's Worse Than You Think: US Regulatory Changes Require Pharmaceutical Company Attention, International Financial Law Review: Competition & Antitrust (Special IFLR Supplement)	Article
11/01/00November 2000	Preclosing Cooperation in Energy Mergers: Antitrust Issues and Practical Concerns, The Electricity Journal View Article	Article
09/04/0009/04/00	Expect Big Change in Drug Pricing System, The National Law Journal View Article	Article
04/07/0004/07/00	Antitrust Issues in Electricity Mergers and Joint Activities, presented at the Edison Electric Institute Legal Conference, Colorado Springs, CO View Presentation	Speech

Date	Title	Description
Aug 12, 2011	Q&A With Morgan Lewis' Steve Mahinka	Stephen Paul Mahinka is interviewed.
Jul 15, 2011	Morgan Lewis Serves as Co-Counsel to BHP Billiton on $12.1 Billion Acquisition of Petrohawk	Morgan Lewis served as co-counsel to BHP Billiton on a definitive agreement for BHP Billiton to acquire Petrohawk for $38.75 per share, representing a total equity value of approximately $12.1 billion and a total enterprise value of approximately $15.1 billion.
Jul 13, 2011	Morgan Lewis Team Advises Kinetic Concepts on Company’s $6.3 Billion Acquisition by Apax	Morgan Lewis advised Kinetic Concepts, Inc. (KCI), on a definitive merger agreement under which a consortium comprised of private equity funds will acquire KCI in a $6.3 billion transaction.
Jun 01, 2010	Changing Spaces, ABA Journal	Stephen Paul Mahinka discusses Morgan Lewis's Washington, D.C. office move to 1111 Pennsylvania Ave. NW in ABA Journal's article on the change of traditional law firm space.
May 21, 2010	Planned Life Sciences Company Purchases Require Enhanced Due Diligence Under Health Care Reform Law, Life Sciences Law & Industry Report
Jan 18, 2010	The Life Sciences Industry: Trends and Predictions, PLC Life Sciences Cross-Border Handbook	Steve Mahinka is interviewed for a special feature on the future of the life sciences industry.
Jan 01, 2009	A new era for CFIUS, Financier Worldwide	Stephen Paul Mahinka is quoted regarding CFIUS filings under the new Administration and potential effects on foreign M&A.
Feb 01, 2008	The Impact of FINSA on Foreign Acquisitions in the U.S., Financier Worldwide	Stephen Paul Mahinka is quoted on the impact of the Foreign Investment and National Security Act (FINSA) on foreign acquisitions in the U.S.
Feb 22, 2007	Morgan Lewis's Antitrust Practice Recognized as Leading Competition Practice	Morgan Lewis is pleased to announce that the Antitrust Practice and several of its attorneys are recognized in both the ^PLCCross-border Competition Handbook 2006/2007 and Global Competition Review’s GCR 1.
Dec 20, 2006	Morgan Lewis's Life Sciences Practice Recognized in ^PLCCross-border Life Sciences Handbook	Morgan Lewis is pleased to announce that the Life Sciences Interdisciplinary Practice and several of its attorneys are recognized in the ^PLCCross-border Life Sciences Handbook 2006/07.
Dec 13, 2005	Morgan Lewis’ Life Sciences Practice Recommended in ^PLC Cross-border Life Sciences Handbook	Morgan Lewis is pleased to announce that Practical Law Company recommends the firm’s Life Sciences Practice and its attorneys in the ^PLCCross-border Life Sciences Handbook 2005/06.
Feb 14, 2003	Small Business Growth Strategies - In a Bind, Law Firm Finds Light at the End of the Tube	After 25 years in the same M Street location, the D.C. office of Morgan Lewis moved to a prestigious address on Pennsylvania Avenue early last year, occupying a building that it had spent more than five years planning and overhauling.

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Stephen Paul Mahinka

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