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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 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 on Case Addressing the America Invents Act’s Joinder Provision
December 28, 2018
BIO files an Amicus Brief on rehearing by the Precedential Opinion Panel of the Patent Trial and Appeal Board.
BIO Files Amicus Brief on Case Addressing Unfairness or Imbalance in Post-Grant Proceedings at PTO (U.S. Court of Appeals for the Federal Circuit)
April 9, 2018
BIO and PhRMA have submitted a brief in the U.S Court of Appeals for the Federal Circuit on behalf of appellant in Virnetx Inc. v. The Mangrove Partners. 
Letters, Comments & Testimony
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BIO's 2020 Special 301 Submission
February 6, 2020
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…
BIO's 2019 Special 301 Submission
March 27, 2019
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…
BIO Sends Letter to HHS Secretary Alex Azar Urging him to Release Pending Vaccine Clinical Trial Guidance
October 2, 2020
  On behalf of the scientists and researchers the Biotechnology Innovation Organization (BIO) represents, I am writing to request that you publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning emergency use authorization for vaccines to prevent the…
Patient-Take-Action
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