Patent Law Weblog
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- Meanwhile, Back at the PTAB with CRISPR
- Judge Newman Seeks Recourse from Supreme Court
- Quo Vadis mRNA Vaccine Technology? The State of the IP Lawsuits
- Moderna Settles Patent Litigation with Arbutus et al.
- USPTO and DOJ Statement of Interest in Collision Communications: Another Thumb on the Scale in Favor of NPE Patent Plaintiffs
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Category: Biosimilars
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By Kevin E. Noonan — Earlier today, Patent Docs participated in a conference call with Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO) and Joshua Boger, Ph.D., Chairman of BIO’s Board and President and CEO of Vertex Pharmaceuticals Inc. Mr. Greenwood, who represented Pennsylvania’s Eighth District in the U.S.…
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By Donald Zuhn — Regular Patent Docs readers have likely noticed that we have been paying close attention to the lobbying efforts of various players in the biotech/pharma industry. Our interest in the lobbying expenditures of these companies and organizations stems from the push by Congress over the past year to pass patent…
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By Kevin E. Noonan — The Subcommittee on Health of the House of Representatives’ Committee on Energy and Commerce recently solicited comments and information on so-called "follow-on biologics" (FOBs) from stakeholders and other interested parties. The Subcommittee on Health’s letter, signed by Subcommittee chairman Frank Pallone, Jr. (D-NJ, 6th Dist.) and ranking member…
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By Donald Zuhn — Earlier this year, we reported on the campaign undertaken by Insmed Inc., a biopharmaceutical company based in Richmond, VA, to raise national awareness about the importance of establishing a regulatory pathway in the U.S. for follow-on biologics. As part of that campaign, Insmed commissioned an economic study of the…
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By Donald Zuhn — Last week, Senator Amy Klobuchar (D-MN) (at right) convened a hearing of the Joint Economic Committee (JEC), a bicameral Congressional Committee composed of ten members from both the Senate and the House of Representatives, to examine rising pharmaceutical prices and the impact of such price increases on the pharmaceutical…
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By Donald Zuhn — Insmed Inc., a biopharmaceutical company based in Richmond, Virginia, announced today that it has retained the former Chairman of the House Ways and Means Committee, Bill Thomas (at right), as a strategic advisor in its continuing effort "to bring follow-on biologics to U.S. customers and consumers." The former Representative…
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By Kevin E. Noonan — Insmed Inc. announced today that a just-completed clinical trial showed that its INS-19 product, a recombinant human granulocyte colony stimulating factor (G-CSF) was "bioequivalent" to Amgen’s FDA-approved Neupogen®, a product used for treating neutropenia, a blood deficiency disorder associated with, inter alia, chemotherapeutic drug treatment. One of the…
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By Donald Zuhn — Last week, the mainstream media turned its attention to the lobbying efforts of biotechnology and pharmaceutical companies. The impetus for this increased coverage was a report on lobbying issued by the Center for Public Integrity (CPI). The CPI, which describes itself as a nonprofit, non-partisan, and non-advocacy organization dedicated…
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By Donald Zuhn — Last week, the Congressional Budget Office (CBO) released a report on the Biologics Price Competition and Innovation Act (S. 1695), which would establish a pathway for the FDA to approve follow-on biologics. The report was commissioned last summer by the Senate Committee on Health, Education, Labor & Pensions, which…
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By Donald Zuhn — Last month, we reported on the lobbying expenditures for a number of biotech and pharmaceutical companies in the first quarter of 2008. Included on our list were Cephalon, Inc., which spent $512,000, Abbott Laboratories, which spent $880,000, and Amgen Inc., which spent $2.5 million. That list continues to grow…
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