Morgan Lewis

Life Sciences Publications of Interest

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Practice Highlights

Honors

PLCCross-border Quarterly 2012 Life Sciences Legal Market Review

  • Life Sciences Regulatory Super League - Ranked 8th among law firms worldwide

PLCCross-border Life Sciences Handbook 2011/12

  • U.S.:
    • Commercial and Partnering - Highly Recommended
    • Competition/Antitrust - Highly Recommended
    • Corporate - Recommended
    • Government Enforcement and Investigations - Highly Recommended
    • Regulatory - Recommended
    • Regulatory (Medical Devices) - Recommended
  • England: Regulatory - Recommended
  • Japan: Corporate and Commercial - Recommended

Chambers Global 2011: Global Life Sciences - Recommended - Band 3

Chambers USA 2011: National for Life Sciences - Band 3; Washington, D.C. for healthcare/ pharmaceutical/ medical products regulatory - Band 3

UK Legal 500 2010: London: Pharmaceuticals and Biotechnology

Best Lawyers in America 2011: Biotechnology and Healthcare Law Named

BioPharm Insight 2011

  • Ranked 3rd - Global League Table of Legal Advisers on Licensing Agreements - Based upon Volume
  • Ranked 6th - Global League Table of Legal Advisers on Licensing Agreements - Based upon Value
  • Ranked 4th - League Table of Legal Advisers on North American Licensing Agreements - Based upon Volume
  • Ranked 9th - League Table of Legal Advisers on North American Licensing Agreements - Based upon Value
  • Ranked 3rd - League Table of Legal Advisers on European Licensing Agreements - Based upon Volume
  • Ranked 4th - League Table of Legal Advisers on European Licensing Agreements - Based upon Value
  • Ranked 2nd - League Table of Legal Advisers on Asia-Pacific Licensing Agreements - Based upon Volume
  • Ranked 5th - League Table of Legal Advisers on Asia-Pacific Licensing Agreements - Based upon Value
U.S. News & World Report/Best Lawyers 2010: Ranked Tier 1 National Practice - Biotechnology

Clients

16 of the top 20 pharmaceutical companies

7 of the top 20 biotechnology companies

9 of the top 20 medical device companies

Related Events

06/06/12-06/08/12 ABA’s Civil False Claims Act and Qui Tam Enforcement 2012
Katie McDermott, presenter, "Investigation of a False Claims Act Case"
06/06/12-06/07/12 2012 Health Law Institute in Minneapolis
Arianne Callender, speaker, "Fraud and Abuse Update"
06/09/12-06/12/12 The Business of Medicine 2012 San Diego Summit
Kathleen McDermott, presenter, "Shining a Light on the Sunshine Act: What You Need To Know"
View all events

Related News

05/04/12 Regulatory Policy: CBER Importance Boosted With Attention To Biologic Drugs, Biosimilars, Speakers Say
Life Sciences and Healthcare partner Stephen Paul Mahinka is quoted.
04/25/12 Q&A With Morgan Lewis' Randall Sunberg, Law360
Business and Finance partner Randall Sunberg is interviewed as part of Law360 's Q&A series.
04/05/12 Biosimilars Naming and Labeling: An FDLI Dialogue, Update Magazine
Life Sciences and Healthcare partner Stephen Paul Mahinka is quoted.
View all news

Related Publications

05/22/12 Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges, presented at the AHLA/FDLI's Intersecting Worlds of Drug, Device, Biologics and Health Law
05/09/12 Eleventh Circuit Rejects FTC Challenge to Reverse Payment Settlement
Decision by court of appeals affirms that settlements that do not expand the exclusionary scope of a patent are not subject to antitrust challenge.
05/03/12 HHS Plugs Payment Suspensions as Key Tool in Latest Takedown
The Medicare Fraud Strike Force's use of a pivotal ACA regulation to suspend payments during criminal investigations signals a turning point in its prosecution strategy.
View all publications
193 Publications Found
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Spring 2007 The Legal Implications of Phase I Clinical Trials, European BioPharmaceutical Review Spring 07

Outside Publication | Article
Anthony Warnock-Smith

04/26/07 Sailing to FDA Product Approval: Innovations in the Clinical Trial Paradigm, presented at Bay Bio 2007, San Francisco

Presentation | Speech
Phoebe Mounts

04/17/07 Managing Customer Communications in a Post-Neurontin World, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.

Presentation | Speech
M. Elizabeth Bierman

04/17/07 The AdvaMed Code of Ethics, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

03/16/07 U.S. Patent and Trademark Office Issues Notice on Patent Applications Containing Nucleotide Sequences

LawFlash/Client Alert | Intellectual Property LawFlash
Intellectual Property

On March 12, 2007, the U.S. Patent and Trademark Office posted a notice on restriction requirements in patent applications containing nucleotide sequences. The 2007 Notice rescinds a 1996 Notice on the subject and is effective ... more

03/15/07 The Six Regulatory Issues That MUST Be Addressed in a Life Sciences M&A, presented to the American Conference Institute, New York

Presentation | Speech
Stephen Mahinka

03/14/07 Unique Challenges in Private Versus Public Life Sciences M&A, presented to the American Conference Institute, New York

Presentation | Speech
Randall Sunberg

03/02/07 Potential Challenges to Pricing of Biotech Products: Medicare/Medicaid and Related Pricing Developments, presented at the 2007 BIO General Counsels' Committee Meeting

Presentation | Speech
Stephen Mahinka, Andrew Ruskin

01/22/07 FTC Critical of Recent “Pay-For-Delay” Settlement Tactics in Hatch-Waxman Patent Litigations; Proposed Senate Bill Would Limit Them

LawFlash/Client Alert | Intellectual Property LawFlash
Intellectual Property

The Federal Trade Commission (FTC), in a statement made by Commissioner Jon Leibowitz before the Senate Judiciary Committee on January 17, expressed its concern over recent court decisions allowing cash or other incentive paymen... more

2007 Business Process Outsourcing: Process, Strategies, and Contracts (John Wiley)

Outside Publication | Book
Barbara Melby

November/December 2006 Morgan Lewis on Life Sciences
November/December 2006

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: The Next Wave of Wage and Hour Litigation: Pharmaceutical Product Representatives Seek Overtime: In recent years, class and collective actions filed under the Fair Labor Standards Act (FLSA) and... more

2006/07 Overview of Healthcare Fraud Investigations in the U.S., PLC Cross-border Life Sciences Handbook 2006/07

Outside Publication | Chapter
Stephen Mahinka, Kathleen Sanzo

2 November 2006 Defective Defence, Legal Week

Outside Publication | Article
Anthony Warnock-Smith

10/16/06 Mid-Stage Company Exit Strategies: Path to Glory?, presented at Biotech 2006, Philadelphia

Presentation | Speech
Randall Sunberg

10/06/06 Biotechnology Mergers and Acquisitions, presented at Law Seminars International

Presentation | Speech
Emilio Ragosa

09/13/06 Finance Sector Mini-Plenary Session, presented at the LES Annual Meeting, New York

Presentation | Speech
Randall Sunberg

09/11/06 From Term Sheet to Contract: A Roadmap for Biotech and Pharma Collaborations, presented at the LES Annual Meeting, New York

Presentation | Speech
Randall Sunberg

July/August 2006 Morgan Lewis on Life Sciences
July/August 2006

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: New Developments and Product Liability Implications of FDA Prescription Drug Labeling Rule: The January 2006 Food and Drug Administration (FDA) final rule on prescription drug labeling, with its sign... more

06/30/06 China Revises Its Guidelines for Patent Examination

LawFlash/Client Alert | Intellectual Property LawFlash
Intellectual Property

On May 24, 2005, China’s State Intellectual Property Office (SIPO) promulgated a new version of its Guidelines for Patent Examination. The new Guidelines will be effective as of July 1, 2006. This document highlights some major... more

February/March 2006 Morgan Lewis on Life Sciences
February/March 2006

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: The Increasing Role of Congressional and Advocacy Strategies for Life Sciences Products: In view of recent widely publicized issues regarding lobbyists' activities and ethics, many life sciences comp... more

October/November 2005 Morgan Lewis on Life Sciences
October/November 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In This Issue: Manufacturing Outsourcing in the Medical Device Industry: An Overview of the Process and Key Legal Issues: In today’s increasingly competitive global economy, medical device companies are continually ... more

October/November 2005 Manufacturing Outsourcing in the Medical Device Industry: An Overview of the Process and Key Legal Issues, Morgan Lewis on Life Sciences
October/November 2005

Newsletter | Article
Barbara Melby

In today’s increasingly competitive global economy, medical device companies are continually seeking ways to drive down production costs while at the same time improve quality and accelerate time-to market. Outsourcing the manu... more

August/September 2005 Morgan Lewis on Life Sciences
August/September 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Medicare Amendments Preserve Strategic Obstacles for Generics: In the 2003 Medicare Prescription Drug, Improvement and Modernization Act (the “Medicare Amendments”), Congress addressed a “critical” is... more

07/30/05 Current Trends and Provisions in Pharma-Biotech Strategic Alliances, presented at the International Forum on Biotech Commercialization in Greater China/Asia Pacific, Rutgers Business School, NJ

Presentation | Speech
Randall Sunberg

06/18/05 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

Presentation | Speech
Stephen Mahinka

06/08/05 Partnering with Large Pharma, presented at the New Jersey Technology Council Commercialization Center for Innovative Technologies, NJ

Presentation | Speech
Randall Sunberg

05/24/05 Defining the "Market" and Its Effect on Antitrust Analysis of Pharmaceutical Company Conduct and Transactions presented at the American Conference Institute; In-House Consul Forum on Pharmaceutical Antitrust, in Washington, D.C.

Presentation | Speech
Scott Stempel

05/24/05 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.

Presentation | Speech
Stephen Mahinka

May/June 2005 Morgan Lewis on Life Sciences
May/June 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Life Sciences Mergers and Acquisitions: Potential Intellectual Property Pitfalls: When negotiating a life sciences merger or acquisition agreement, the merged or acquired entity must fully understand ... more

03/30/05 Pharma-Biotech Negotiation Workshop, presented at BIOMEDEX 2005, Montreal

Presentation | Speech
Randall Sunberg

March/April 2005 Morgan Lewis on Life Sciences
March/April 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Changing Strategies in Joint Research and Collaboration Agreements: The Impact of the Cooperative Research and Technology Enhancement Act: Under U.S. patent law, publications that describe (either alo... more

2005 Information Technology Outsourcing: Process, Strategies, and Contracts (John Wiley)

Outside Publication | Book
Barbara Melby

January/February 2005 Morgan Lewis on Life Sciences
January/February 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Outsourcing in the Pharmaceutical Industry: Most if not all major pharmaceutical companies have outsourced, or are evaluating the benefits of outsourcing, one or more of their non-core business functi... more

January/February 2005 Morgan Lewis on Life Sciences
January/February 2005

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

November 2004 Licensing in the Pharmaceutical Industry: Strategies and Questions Regarding Antitrust Premerger Notification, FDLI Update

Outside Publication | Article
Stephen Mahinka, Harry Robins

10/29/04 Making 50-50 Collaborations Work Effectively, presented to JP Morgan Chase, Newport Conference Center

Presentation | Speech
Randall Sunberg

10/28/04 Protecting the Product Life Cycle - Patent Law for Chemists, presented at the American Chemical Society Western Regional Meeting, Sacramento, CA

Presentation | Speech
Jeffry Mann

10/17/04 Biotech and Pharma M&A and Collaborations: Protecting the Deal and Preserving Your Upside, LES Annual Meeting, Boston

Presentation | Speech
Randall Sunberg

10/13/04 Outline of Issues for a Biotech Company to Consider in Preparing for an IPO

Presentation | Speech
Steven Cohen

September/October 2004 Morgan Lewis on Life Sciences
September/October 2004

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: OIG Crosshairs Shift to Medical Device Manufacturers: Aggressive federal and state scrutiny of and enforcement against pharmaceutical companies and providers for anti-kickback violations and healthcar... more

10/05/04 Biotech and Pharma M&A and Collaborations: Protecting the Deal and Preserving Your Upside, presented at Biotech 2004, Philadelphia

Presentation | Speech
Randall Sunberg

July/August 2004 New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry, FDLI Update, Vol. 36

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

July/August 2004 Morgan Lewis on Life Sciences
July/August 2004

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: FDA Issues Draft Guidances on Advertising and Promotion: The Food and Drug Administration released three new draft guidance documents regarding direct–to–consumer (DTC) advertisements of drugs, biolo... more

07/24/04 Strategic Alliances and Business Development, presented at the BioForum 2004, Shanghai

Presentation | Speech
Randall Sunberg

April/May 2004 Morgan Lewis on Life Sciences
April/May 2004

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Protective Provisions in Pharmaceutical/Biotech Strategic Alliances: Strategic alliances continue to be an important component of the product development and commercialization process in the life scie... more

March/April 2004 Strategic Implications of FDA’s Proposed Safety Reporting Requirements, On Drugs: Legislation, Litigation, and Policy Proposals

Outside Publication | Article
Michele Buenafe

02/13/04 Protecting Your Downside While Maximizing Your Upside: Protective Provisions in Biotech Deals, presented at the LES Winter Meeting, San Francisco

Presentation | Speech
Randall Sunberg

February 2004 Morgan Lewis on Life Sciences
February 2004

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Congress gave final approval on November 25, 2003 to a bill that represents the broadest changes in the Medicare Program since i... more

September/October 2003 Morgan Lewis on Life Sciences
September/October 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Ensuring That Communications on Product Development Are Not Misleading for Investors: When publicly disclosing progress on product development, publicly traded life sciences companies, including biote... more

09/09/03 Pharma and Biotech Collaborations, PA Biotech, 3 Rivers Venture Fair

Presentation | Speech
Randall Sunberg

July/August 2003 Morgan Lewis on Life Sciences
July/August 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Policy Shifts for Accelerated Approval of Oncologics: Because of ongoing scrutiny by patient groups and Congress of the benefits and progress of FDA’s program for accelerated approval of drugs and bio... more

06/24/03 Getting from Biotech to BIG Biotech, BIO 2003, Washington, DC

Presentation | Speech
Randall Sunberg

May/June 2003 Morgan Lewis on Life Sciences
May/June 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: How Life Sciences Companies Can Respond to Sarbanes-Oxley: The Sarbanes-Oxley Act of 2002 represented a sweeping revision of the federal securities laws, affecting virtually every public company (and ... more

04/30/03 Closing Plenary Session: Facilitating Global Reach in the Life Sciences Industry, BIOTechnica America, Monterey, CA

Presentation | Speech
Randall Sunberg

March/April 2003 Morgan Lewis on Life Sciences
March/April 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Biotech Companies Raise Capital Without Diluting Equity Structure by Monetizing IP Licenses: Independent auditors have occasionally used the term “pipe dream” to describe the operation of companies in... more

02/28/03 FDA Must Clarify Drug Makers' Ability to Publicly Defend Products, Litigation Legal Foundation Legal Update, Vol. 13, No. 7

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

01/31/03 Issues to Consider in a New Venture Spin-Out

Presentation | Speech
Steven Cohen

January/February 2003 Morgan Lewis on Life Sciences
January/February 2003

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: A Shift in the Hatch-Waxman Balance: FDA's Proposed Rule: The Hatch-Waxman Act, which created today’s generic drug system, was premised on balancing two divergent interests — facilitating the approval... more

01/31/03 Realizing Value from New Venture Spin-Outs as an Alternative to an M&A Transaction

Presentation | Speech
Steven Cohen

November/December 2002 Morgan Lewis on Life Sciences
November/December 2002

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Pharmaceutical cGMP Regulation - Increasing, Consistent, Decisive: Since the beginning of 2002, FDA has sought to ensure more consistent enforcement of current good manufacturing practice (cGMP) requi... more

10/22/02 Promotion and Development Collaborations Between Established Players, presented at the American Conference Institute, New York

Presentation | Speech
Randall Sunberg

September 2002 Morgan Lewis on Life Sciences
September 2002

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: How Biotech Companies Can Avoid Accounting Meltdowns: Volatile financial markets and investor skepticism following recent accounting meltdowns have raised new challenges for public companies. Ine... more

July 2002 Morgan Lewis on Life Sciences
July 2002

Newsletter | Morgan Lewis on Life Sciences
Life Sciences

In this Issue: Welcome and Introduction BuSpar® and Tiazac® Antitrust Cases Leave Unanswered Questions: Over the last few years, an increasing number of antitrust cases have challenged various action... more

04/30/02 Issues to Consider in a New Venture Spinout

Presentation | Speech
Steven Cohen

March 2002 Pharmaceutical Pricing: System Changes And Global Effects, Metropolitan Corporate Counsel

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

2003 Consumer Products Regulation (Chapter 13), Developments in Administrative Law and Regulatory Practice 2002-2003 (ABA Section on Administrative Law)

Outside Publication | Chapter
Kathleen Sanzo

August 2001 U.S. Pharmaceutical Pricing: System Changes and Global Effects, Life Sciences Industry Report

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

09/04/00 Expect Big Change in Drug Pricing System, The National Law Journal

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

03/29/00 Breakthrough: Management Issues Facing a Growing Biotechnology Company, presented at BIO 2000, Boston

Presentation | Speech
Randall Sunberg

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