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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

Notable Wins

Fish Wins Federal Circuit Affirmance of Reversal of $200 Million Damages Against Gilead

Fish won a unanimous Federal Circuit opinion today that affirmed its June 2016 post-trial wipe-out of a $200 million jury verdict against client Gilead Sciences, Inc. after proving Merck had forfeited its right to assert its hepatitis C drug patents against Gilead because of litigation and business misconduct constituting “unclean hands.”

Read more about this precedential opinion here and here.

Fish Wipes Out $2.5B Patent Verdict Against Gilead Sciences

Fish & Richardson won a motion for Judgment as a Matter of Law (JMOL) that reversed a $2.5 billion jury verdict against its client Gilead Sciences Inc. in federal court in Delaware.

Read about this historic win here and here.

 General Patent Litigation Firm of the Year: Fish & RichardsonPatent Impact Case of the Year: Fish & Richardson

Intellectual Property (IP) Firm of the YearIntellectual Property (IP) Practice Group of the Year

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July 30th, 2020 | 1:30 pm EDT
Webinar | Structuring Biotech & Pharma Startup Portfolios for Global Impact, Value, and Partnering
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July 23rd, 2020 | 1:30 pm EDT
Webinar | Biosimilars: A 2020 Mid-Year Review
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July 21st, 2020 | 1:30 pm EDT
Webinar | Navigating to the Safe Harbor: What to Know in Advance
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May 22, 2020
Fish Attorneys Author Law360 Article, "How Pandemic-Related Delays Affect Hatch-Waxman Litigants"
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April 30, 2020
USPTO Further Extends Certain Patent and Trademark Deadlines under CARES Act to June 1
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April 2, 2020
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Coronavirus Bill Authorizes USPTO and Copyright Office to Adjust or Waive Statutory Deadlines
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March 16, 2020
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February 11, 2020
Fish Named Law360 Life Sciences Practice Group of the Year
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