Patent Law Weblog
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- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
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Category: Biosimilars
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By Donald Zuhn –- In a statement issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) earlier today, the advocacy group representing pharmaceutical and biotechnology research companies indicated that it "supports the development of a responsible, abbreviated approval pathway for biosimilars that includes a fair period of data protection that is critical for…
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By Kevin E. Noonan — The principal debate involving follow-on biologics legislation has revolved around the length of the data exclusivity term granted to innovators. The bill voted out of the Senate Health, Education, Labor and Pensions (HELP) Committee earlier this year has a 12-year data exclusivity term, which is shorter than the term…
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By Donald Zuhn — In an online paper published by the New England Journal of Medicine on Wednesday, a New York patent attorney and two Harvard professors contend that follow-on biologics (FOB) legislation being proposed in the House and Senate, which provides 12 years of data exclusivity, would "upset[] the delicate balance between the…
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By Donald Zuhn — On Tuesday, ten Governors sent a letter to Congressional leaders expressing their support for Congress' efforts to pass legislation that would create a follow-on biologics regulatory pathway. Noting that "[t]his critically important issue has a direct economic impact on our states, our nation's public health, our economic success, and our…
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Implications for Patent Protection for Avonex® Anti-Multiple Sclerosis Drug By Kevin E. Noonan — There is a tendency to blame the process when an undesired outcome occurs. That is happening in the wake of regulatory filings with the Securities and Exchange Commission regarding U.S. Patent 7,588,755 (the '755 patent), issued on September 15, 2009,…
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By Donald Zuhn — Earlier this month, James Love and James Glassman, writing in the Congressional newspaper Roll Call, expressed "alarm" regarding recent Congressional action concerning the establishment of a follow-in biologics (FOB) regulatory pathway ("Don't Kill Competition for High-Tech Drugs"). That action included the recent passage by the House Committee on Energy and…
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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 spring, Patent Docs discussed pending follow-on biologics legislation with California Healthcare Institute (CHI) president and CEO Dr. David Gollaher (see "CHI CEO on Patent Reform and Follow-on Biologics Legislation"). During the discussion, Dr. Gollaher mentioned that Deloitte Consulting LLP (a subsidiary of CHI member Deloitte LLP) had released its…
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By Kevin E. Noonan — Professor Henry Grabowski has been cited often in the data exclusivity debate, on the economic justification for a twelve-year data exclusivity period for biologic drugs. Dr. Grabowski (at right), a Professor at The Fuqua School of Business at Duke University, has some credibility (in addition to his academic credentials)…
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By Donald Zuhn — In a report originally published by the American Enterprise Institute for Public Policy Research (AEI) late last year, the nonpartisan public policy group advocated for a 12 to 14-year exclusivity period, concluding that "the social losses from providing for fairly long exclusivity periods (twelve to fourteen years) would be small…
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