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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
Browse all Amicus Briefs
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 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…
BIO JOINS AMICUS BRIEF CHALLENGING COURT’S EFFORTS TO UNDERMINE FDA’S AUTHORITY TO BRING TREATMENTS AND CURES TO PATIENTS
April 11, 2023
The Biotechnology Innovation Organization (BIO) today signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to a single drug known as mifepristone) that would create regulatory barriers and potentially upend FDA’s authority to approve life-saving and life…
Letters, Comments & Testimony
Browse all Letters, Comments & Testimony
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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