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.

Amicus Briefs
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…
August 24, 2023
The Biotechnology Innovation Organization (BIO) today signed onto an amicus brief to challenge the Federal Trade Commission (FTC) lawsuit to block the acquisition of Horizon by Amgen. The amicus brief was filed in the U.S. District Court, Northern District of Illinois, Eastern Division.  In…
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…
Letters, Comments & Testimony
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)…
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.
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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