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California Continues Responsible Support for Interchangeability of Biologic Drugs

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Yesterday, California’s State Assembly Committee on Appropriations took another decisive step when they unanimously voted in support of the revised SB 598 by recommending it back to the full Assembly after minor modifications. This is another important step taken by the California State Legislature to ensure patients and physicians who are managing chronic conditions are made fully aware of which biologic drug is ultimately administered by the pharmacist. When battling a serious disease, patients, physicians Read More >

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Fresenius v. Baxter: BIO files Amicus Brief in Federal Circuit

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The Biotechnology Industry Organization filed an amicus brief at the Federal Circuit in the case of Fresenius v. Baxter: BIO is concerned that the panel decision could have a number of unintended consequences, such as incentivizing defendants (or declaratory judgment plaintiffs) to employ dilatory tactics in the federal courts while re-arguing already-decided issues under claim construction more favorable to the patent challenger and lower burden-of-proof standards in the PTO.  Courts and parties may be forced Read More >

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TTIP: Global Regulatory Cooperation and Convergence

Moving Inside the Beltway: Brief Health Roundup

The Transatlantic Trade and Investment Partnership (TTIP) initiative holds tremendous promise for the long-term competitiveness of the Transatlantic economy by supporting research and development of innovative technologies. A concerted effort through the TTIP to unleash the potential of biotechnology in the Transatlantic economy can help bring innovative products to consumers, create jobs, and improve economic prospects on both sides of the Atlantic. The recent (TTIP) negotiations focus on several principles that BIO promotes to boost Read More >

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Bayh-Dole and Technology Transfer Continue to Deliver

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The Association of University Technology Managers released the 2012 AUTM U.S. Licensing Activity Survey Highlights which provides data on respondents from “161 universities, 32 hospitals and research institutes, and one third-party technology investment firm” (a response rate of 65%).  Here are some of the highlights: Start-Ups and Products: • 705 startup companies formed (+5.1% [over last year]), 554 of which had their primary place of business in the licensing institution’s home state (+13.8% [over last Read More >

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TPP and Innovation in the Bioeconomy: The Need for 12 Years of Data Protection

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A few weeks ago, BIO submitted a letter and white paper (PDF) to the U.S. Trade Representative outlining recommendations for policies to pursue with TPP negotiating partners to ensure intellectual property protection for innovative biologic products. Standards that enable biotechnology companies to protect and leverage their intellectual property are of critical importance to companies seeking breakthrough treatments and cures for patients in need worldwide. Implementing standards of protection that effectively protect innovation for biological products within the TPP region Read More >

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