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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.

Webinar
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. 

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USPTO
Amicus Briefs
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BIO Files Amicus Brief in Petition for a Writ of Certiorari in American Axle & Manufacturing, Inc., v. Neapco Holdings LLC, et al., at the Supreme Court of the United States.
June 29, 2021
BIO and AUTM have filed an amicus brief in petition for a writ of certiorari the in American Axle & Manufacturing, Inc., v. Neapco Holdings LLC, et al., at the Supreme Court of the United States. BIO and AUTM are concerned that the Federal Circuit is misapplying the Supreme Court…
BIO Files Amicus Brief in Support of Rehearing Case Addressing Patent-Eligibility of Diagnostic Technology (U.S. Court of Appeals for the Federal Circuit)
April 22, 2019
BIO files amicus brief in support of a petition for rehearing related to patent-eligibility of diagnostic technology. 
BIO Files Amicus Brief in U.S. ex rel. Scutte v. SuperValu Inc. at the Supreme Court of the United States
March 28, 2023
BIO has filed an amicus brief in U.S. ex rel. Scutte v. SuperValu Inc., which addresses the issue of the intent requirement under the False Claims Act (FCA). Specifically, BIO urges the Court to uphold the view that a firm does not have the requisite intent to violate the FCA when…
Insights
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Covid Vaccine
COVID-19 Pandemic, Two Years Later
Covid Vaccine
We Can and Must SHARE Vaccines with the Globe
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Made in America Week: Celebrating America’s Vibrant Biopharma Industry
News
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Statement on USDA Report on Competition & Innovation in Seeds & Other Ag Inputs
March 6, 2023
BIO Statement on USTR Special 301 Report
April 29, 2022
BIO Statement on Reports of a Proposed Deal on COVID-19 Vaccine IP Rights Waiver
March 15, 2022
BIO Statement on Russia's Decision To Legalize Patent Theft
March 11, 2022
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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
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BIO Submits Comments to the USPTO on Discretion to Institute Trials Before the Patent Trial and Appeal Board
August 6, 2021
BIO submitted comments to the United States Patent and Trademark Office in response to the USPTO's consideration of “the codification of its current policies and practices, or the modification thereof,” relating to the exercise of its discretion under 35 U.S.C. §§ 314(a), 324(a), 315(d), and 325(d)…
BIO Comments on Proposed NIST Rule
April 9, 2021
The Biotechnology Innovation Organization (BIO) submitted the below comments to the National Institute of Standards and Technology on proposed revisions to regulations that would further the Return on Investment (ROI) Initiative for Unleashing American Innovation.
BIO's 2021 Special 301 Submission
January 28, 2021
Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access to U.S. persons who rely on IP protection. As…
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Sign-up to join BIOAction, BIO's grassroots advocacy program. You will be notified about relevant policy issues where we need you to contact your lawmaker.

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