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Supreme Court To Review Whether Non-Public Sales Are Invalidating Under...

The Supreme Court recently agreed to review Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., a case with broad implications for the pharmaceutical industry. In the opinion below, the Federal...

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Surveying the CRISPR-Cas9 Patent Landscape in the United States

This post will discuss the patent landscape of the groundbreaking CRISPR-Cas9 systems in the United States, including pending legal disputes. A CRISPR-Cas9 system is a combination of protein and...

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Federal Circuit Affirms PTAB Finding That CRISPR-Cas9 Inventions Are...

The Federal Circuit in Regents of the University of California v. The Broad Institute weighed in on the disputed inventorship of the breakthrough CRISPR-Cas9 technology, holding that the University of...

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U.S.-Mexico-Canada Trade Agreement to Promote Innovation in Biotechnology

On September 30, 2018, the United States, Mexico, and Canada reached an agreement in principle to replace the North American Free Trade Agreement (NAFTA). The pending United States-Mexico-Canada...

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Supreme Court Holds That Non-Public Sales are Invalidating Under Post-AIA...

In a closely watched case directly addressing open questions after the enactment of the America Invents Act (AIA), a unanimous Supreme Court (Thomas, J.) held in Helsinn v. Teva that a sale to a third...

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The Biologic Transparency Act (S. 659)

The Biologic Patent Transparency Act (S. 659) was introduced by Senators Susan M. Collins ((R) Maine) and Tim Kaine ((D) Virginia) to address an unintended burden when new biological products are...

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Legislators Propose Framework To Reform Patent Eligibility Under Section 101

On April 17, 2019, Senators Chris Coons and Thom Tillis, and Representatives Doug Collins, Hank Johnson, and Steve Stivers unveiled a framework to reform 35 U.S.C. §101. Section 101 of the Patent Act...

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FDA Will Now Provide More Data on 180-Day Exclusivity in the Orange Book

In a recent alert, the FDA announced that effective June 18, 2019, the Agency will publish additional data in the Orange Book Paragraph IV Certifications list. To enhance the already published data,...

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Senator Sasse Proposes Legislation Extending the Patent Term for Inventions...

On March 30, 2020, Senator Ben Sasse, R-Neb., introduced a bill that would create the Facilitating Innovation to Fight Coronavirus Act. The first part of the legislation would shield healthcare...

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Northern District of California Relies on the Safe Harbor Defense of Section...

Two recent decisions from the Northern District of California show courts’ willingness to dispose of cases early in litigation through the safe harbor defense. The safe harbor of Section 271(e)(1)...

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