Intellectual Property

Intellectual property is the lifeblood of the biotechnology industry. Strong patents, and an efficient, predictable, and objective patent system, are critical to ensuring a steady stream of capital to biotechnology companies developing innovative medicines, alternative energy sources, insect- and drought-resistant crops, and a wide range of other innovative biotechnologies that are helping to feed, fuel, and heal our planet. This quintessentially-American industry leads the world in innovation, providing the United States with a global competitive advantage and spurring economic growth and the creation of high-paying jobs here at home.

Navigating Parallel BPCIA and PTAB Proceedings – Recent Developments and Strategic Consideration

Wednesday, January 26, 1:00 pm EDT

This panel will discuss recent developments in BPCIA litigation, PTAB practice, and potential legislative and policy reforms that may be on the horizon.

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Explore What's New in Biotech IP

Biotech Intellectual Property Law in Focus is a new webinar series offering timely, relevant insights into the latest issues in the biotech intellectual property sector. This focused webinar series will cover what's new and important in the biotech IP landscape today, featuring expert perspective and information you can put into practice the very next day.

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IP Attaché Program

BIO works with the United States Patent and Trademark Office’s (USPTO) IP attaché program, which strives to improve Intellectual property (IP) systems internationally for the benefit of U.S. stakeholders. IP attachés are posted at U.S. missions around the world to address IP issues arising in their assigned regions.

Find an attaché in your region

Amicus Briefs

BIO Files Amicus Brief in California Supreme Court in Continuing Gilead Tenofovir Cases

November 4, 2024

BIO filed an amicus brief in the Supreme Court of the State of California, encouraging its review of the lower court decision in the Gilead Tenofovir Cases.The Court of Appeal decision operates from a misunderstanding of the drug development and FDA approval processes, particularly failing to see…

BIO Files Amicus Brief in Continuing Effort to Preserve FDA’s Expert, Scientific Authority on Drug Approvals

October 12, 2023

BIO filed an amicus brief in a continuing effort to challenge courts' decisions that undermine FDA authority and hinder patient access to medications.The brief was filed in the Supreme Court of the United States (SCOTUS), following the August 2023 ruling of the U.S. Court of Appeals for the Fifth…

BIO Files Amicus Brief Supporting Reversal of Court Decision Regarding SEC Regulations on Proxy Advisory Firms

June 27, 2023

BIO filed an amicus brief in the U.S. Court of Appeals for the Sixth Circuit, seeking the reversal of a lower court's ruling that would set aside the 2022 rescission of the Securities and Exchange Commission (SEC) 2020 Rule regulating proxy advisory firms.Proxy advisory firms are firms that provide…

Press Releases

WTO 13th Ministerial Conference outcome "positive" for IP, future of biotech industry

March 1, 2024

Following the conclusion of the WTO 13th Ministerial Conference in Abu Dhabi, John Murphy -- BIO's Chief Policy Officer -- made the following statement: “We are encouraged that WTO Members did not agree to extend an intellectual property waiver to Covid-19 therapeutics at the WTO 13th…

Using March-In as a Price Control Mechanism Is a “Dangerous Precedent To Set”

December 7, 2023

The White House just announced plans to use Bayh-Dole “march-in rights” to step in and license patent rights of drugs “developed with federal funding” to other manufacturers when the price of the drug is deemed too high. BIO's Chief Advocacy Officer, Nick Shipley, made the following statement: …

New USITC report shows "no credible evidence" supporting a TRIPs waiver expansion

October 17, 2023

The United States International Trade Commission (USITC) today released its “COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities” report. The report aims to analyze various issues and information gaps concerning COVID-19 diagnostics and therapeutics. …

The BIO IP Counsels Committee Conference offers timely, relevant educational sessions on the latest issues in the biotech IP sector. Attend informal networking events designed to promote discussion and foster relationships among industry colleagues, and learn practical tips you can put into use the next day.

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Letters, Comments & Testimony

BIO Comments to the USPTO’s MAY 10, 2024 Proposed Rulemaking on Terminal Disclaimer Practice, 89 Fed. Reg. 40439, Docket No. PTO-P-2024-0003

May 10, 2024

BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.

Comments of the Biotechnology Innovation Organization (BIO) to The USPTO February 13, 2024 Inventorship Guidance for AI-Assisted Inventions, 89 FR 10043

May 15, 2024

On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for Comments. See 89 FR 10043 (the “Guidance”). BIO is the…

Joint statement from pharmaceutical trade bodies on the WTO TRIPS Waiver and upcoming WTO 13th Ministerial Conference

February 23, 2024

The meeting of global trade ministers at the World Trade Organization’s 13th Ministerial Conference in Abu Dhabi offers an important opportunity to build on and strengthen the open and rules-based international trading system to support better health outcomes for people across the world and help…

Become an Advocate for Biotechnology

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