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Life Sciences

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Hatch-Waxman

Fish attorneys have served as leading advisors to pioneers in the pharmaceutical, biotechnology, and life sciences fields for more than a century. For three consecutive years, we have been named the top US law firm for life sciences and biotechnology IP work by Managing Intellectual Property magazine. Clients choose Fish because of the technical and scientific expertise of our internationally recognized attorneys.

Large and small companies, along with academic and research institutions, turn to Fish’s team to protect their most valuable innovations. We offer biotechnology and pharmaceutical clients services that include:

  • Patent portfolio planning, strategic advice, opinions, and prosecution
  • Post-grant proceedings at the USPTO
  • Litigation services, including representation in Hatch-Waxman cases
  • FDA expertise
  • Counsel on licensing and other transactions

We have a rapidly expanding practice representing branded pharmaceutical companies in Hatch-Waxman litigation. Biotechnology and pharmaceutical companies trust Fish’s litigation team to handle these complicated, high-stakes cases because we are the world’s most experienced patent litigators.

Examples of our biotechnology and pharmaceutical work include:

  • Representing dozens of biotechnology and pharmaceutical clients in patent infringement litigation
  • Successfully litigating ANDA cases on behalf of branded pharmaceuticals
  • Obtaining patents for therapeutic agents and methods currently in clinical trials, including tumor-specific agents such as oncolytics viruses and humanized antibodies and methods for treating strokes
  • Patenting groundbreaking tissue engineering patents on breakthroughs that show promise in treating spinal cord injuries
  • Obtaining the first patent on a genetically engineered animal
  • Gaining FDA approvals for small molecule drugs and biologics, including gene and cell therapies, antibiotics, immunologics, and anti-anxiety medications
  • Conducting intellectual property due diligence on thousands of licensing agreements for the merger of two large pharmaceuticals companies in just a few months’ time

See below for our most recent client representation in the life sciences industry.

XELODA
Hoffmann-La Roche, Inc. v. Mylan Pharmaceuticals, Inc.
Hoffmann-La Roche Inc.  and Genentech, Inc. v. Roxane Laboratories, Inc.
Hoffmann-La Roche, Inc. and Genentech, Inc. v. Teva Pharmaceuticals, Inc.
Hoffmann-La Roche, Inc. v. Accord Pharmaceuticals Inc.
Fish represented Hoffmann-La Roche and Genentech in this Hatch-Waxman litigation for the blockbuster cancer therapy, XELODA.  XELODA is the first approved oral chemotherapy for the treatment of metastatic breast and colorectal cancer and Dukes’ C Stage III colon cancer, with 2012 sales of $660 million in the US and more than $1.578+ billion worldwide. While the terms are confidential, the settlement was exceedingly favorable. Fish was lead counsel in a series of four such Hatch-Waxman litigations, against Mylan Pharmaceuticals, Roxane Laboratories, Teva Pharmaceuticals, Inc. and Accord Pharmaceuticals Inc., all of which were pending as separate cases in the District of New Jersey. The Mylan, Teva and Roxane cases each settled just a couple weeks before their respective trials and a settlement in Accord followed shortly thereafter.

LANTUS, LANTUS SOLOSTAR
Sanofi-Aventis US LLC et al. v. Merck Sharp & Dohme Corp.
Fish represents the Sanofi parties in a Hatch-Waxman litigation asserting infringement of numerous formulation and device patents relating to Sanofi products sold under the trademarks Lantus® and Lantus Solostar® insulin.

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January 25th, 2018 | 1:00 pm EST
Webinar: Hatch-Waxman 201
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January 24th, 2018 | 11:30 am EST
2018 World Stem Cell Summit
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November 30, 2017
Minnesota Lawyer Named Teresa A. Lavoie and Dorothy P. Whelan "2017 Attorneys of the Year"
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October 17, 2017
Fish & Richardson Principal Anita Meiklejohn, Ph.D., Named 2017 “Top Woman of Law” Honoree by Massachusetts Lawyers Weekly
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October 13, 2017
11 Fish & Richardson Principals Named 2017 "Life Sciences Stars" by LMG Life Sciences
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September 27, 2017
Fish & Richardson Announces Mayo/Myriad Life Sciences Tracker
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September 19, 2017
Fish & Richardson Named 2017 General Patent Litigation Firm of the Year, Inter Partes Review Firm of the Year, and IP Boutique Firm of the Year by LMG Life Sciences
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August 11, 2017
Star Tribune: Mayo prevails in patent case, but legal fight isn't over
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July 10, 2017
Fish & Richardson Sweeps National Tier 1 IP Rankings from Managing Intellectual Property for Seventh Consecutive Year
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June 19, 2017
Teresa Lavoie Interviewed by Metropolitan Corporate Counsel, "How a Patent Prosecutor/Strategic Adviser Racks Up Wins"
Teresa Lavoie Interviewed by <i>Metropolitan Corporate Counsel</i>,
Author: Teresa A. Lavoie, Ph.D.
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