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Intellectual Property

Patents

The value of patents to biotechnology innovation cannot be understated. They enable innovators time to recoup the massive development costs of a new biotech product. Strong intellectual property measures are necessary to advance biotechnology innovation, the creation of high-wage, high-value jobs, and the ability to bring life-saving treatments and cures to market.

BIO Toolkit Resources
innovation-drug
Patents Drive Innovation of both New and Improved Products

In the public debate over drug costs, there is a lot of discussion about so-called “evergreening.” 

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drugs
Hatch-Waxman: Carefully Balancing the Need for Innovation and Drug Competition
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patented
Strong Patents Drive Innovation
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Foreign Pricing
H.R. 3 Imports Risky Foreign Pricing Schemes
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BIO Comments on Patent Policy
Amicus Briefs
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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…
BIO Files Amicus Brief Supporting Supreme Court Review of Provisions that Protect Patent Owners in PTAB Review Proceedings
October 25, 2023
BIO filed an amicus brief supporting Supreme Court review of the time-bar and joinder provisions governing patent review proceedings in the Patent Trial and Appeal Board (PTAB). BIO’s brief argues that time-barred patent challengers, who themselves would be precluded from seeking administrative…
Letters, Comments & Testimony
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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.
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.
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