Patent Law Weblog
recent posts
- 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
- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
- Why AI Will Not Take Over the World
- BioNTech Sues Moderna over mRNA Vaccine Technology
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Category: Food and Drug Administration
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By Kevin E. Noonan — The Biotechnology Industry Organization (BIO) held a media briefing on Federal policy issues today, with most of BIO's executive staff assembling at BIO headquarters in Washington, D.C. In addition to the media present on site, BIO hosted several more members of the press by teleconference. Jim Greenwood (at left),…
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By Donald Zuhn — Last week, Rep. Bobby Rush (D-IL) (at right) introduced the Protecting Consumer Access to Generic Drugs Act of 2009 (H.R. 1706) in the House. The bill, which was co-sponsored by Rep. Diana DeGette (D-CO), John Dingell (D-MI), Michael Doyle (D-PA), Edward Markey (D-MA), Janice Schakowsky (D-IL), Bart Stupak (D-MI), and…
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By Donald Zuhn — Recently, a number of bills that would significantly impact the biotech and pharma industry have been introduced in Congress. These bills include the Preserve Access to Affordable Generics Act (S. 369), which would prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs…
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By Kevin E. Noonan — The Supreme Court handed down its decision in Wyeth v. Levine today, and in a 6-3 decision, declared that the labeling regulations and decisions by the Food and Drug Administration (FDA) did not preempt state tort liability based on "failure-to-warn" and strict liability theories. As Justice Alito noted (albeit…
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By Kevin E. Noonan — The Biotechnology Industry Organization (BIO) held one of its periodic meetings with the press today for a wide-ranging discussion of its policy goals and agendas for the new Congress and administration. A panel of BIO officials, headed by President and CEO James Greenwood, answered questions from more than a…
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By Donald Zuhn — Yesterday, Senator Herb Kohl (D-WI) (at right) introduced the Preserve Access to Affordable Generics Act (S. 369) in the Senate. The bill, which is co-sponsored by Senators Sherrod Brown (D-OH), Richard Durbin (D-IL), Russell Feingold (D-WI), and Chuck Grassley (R-IA), is designed to prohibit brand name drug companies from compensating…
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By Donald Zuhn — On Friday, Geron Corporation announced that the U.S. Food and Drug Administration has approved the biopharmaceutical company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. According to Geron's press release, the clinical trial, to be conducted on patients with complete…
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By Donald Zuhn — In an interview with TechJournal South, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood discussed the state of the biotech industry and the biotech issues the new Administration will be facing in the coming year (see "BIO President Sees Biotech Industry Challenges for New Administration"). Mr. Greenwood told the…
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By Donald Zuhn — As part of its ongoing "Conversations With" series, the Washington Legal Foundation (WLF) recently made available its latest question-and-answer offering, which examines the ongoing evolution of intellectual property rights in the United States and internationally. In the paper, entitled "The Changing Legal Landscape For Intellectual Property," former Attorney General and…
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By Kevin E. Noonan — The Federal Circuit today issued its decision in the Ciprofloxacin antitrust litigation, in an opinion that addressed the extent to which a patent-holding innovator drug company can enter into an agreement with a generic competitor that keeps the generic drug off the market. Bayer holds U.S. Patent No. 4,670,444 claiming…
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