Patent Law Weblog
recent posts
- 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
- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
- Why AI Will Not Take Over the World
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Category: Biosimilars
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By Kevin E. Noonan — The future is always the undiscovered country. But it tends to be one that people believe they can understand based on what has happened in the past. This is the reason people invest with successful money managers, and why every prospectus carries the disclaimer that "past experience does not ensure…
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By Donald Zuhn — Last week, 51 members of the House of Representatives sent a letter to President Obama, opposing the President's continued efforts to reduce the data exclusivity period under the Approval Pathway for Biosimilar Biological Products section of the Patient Protection and Affordable Care Act (PPACA). The President's latest attempt at reducing the data…
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By James DeGiulio — Choosing the appropriate regulatory pathway for biologics drug approval by the U.S. Food and Drug Administration has historically not been a strategic decision to be made by drugmakers. In most cases, only one pathway is applicable to the particular drug product. The traditional NDA 505(b)(1) path is for new drugs, the…
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By James DeGiulio — Earlier this year, the U.S. Food and Drug Administration declared that it would release regulatory guidelines for biosimilars by the end of 2011, and since the FDA's announcement, the biotechnology industry has eagerly awaited the agency's insight on gaining approval for biosimilars in a potentially multi-billion dollar U.S. market. Just last…
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By Donald Zuhn — On Monday, President Obama released his plan for economic growth and deficit reduction. The 80-page plan, entitled "Living Within Our Means and Investing in the Future," outlines how the President would pay for the proposals in the American Jobs Act, which he unveiled on September 8th. According to the President, the…
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By Donald Zuhn — With the eighth round of negotiations of the Trans-Pacific Partnership (TPP) agreement currently underway in Chicago, a number of Senators have written to the U.S. Trade Representative, Ambassador Ron Kirk, to push for the inclusion of intellectual property provisions that are consistent with U.S. biologics exclusivity standards (i.e., 12 years of…
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By Donald Zuhn — On August 4, Rep. Henry Waxman (D-CA) led a group of seven House Democrats in asking President Obama to exclude the 12-year data exclusivity period provided by the biosimilar approval pathway of the Patient Protection and Affordable Care Act (PPACA) from the intellectual property provisions of the Trans-Pacific Partnership (TPP) agreement…
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By Donald Zuhn — Last week, a group of seven House Democrats, led by Rep. Henry Waxman (D-CA), sought to have the 12-year data exclusivity period provided by the biosimilar approval pathway of the Patient Protection and Affordable Care Act (PPACA) excluded from the Trans-Pacific Partnership (TPP) agreement. According to a report in The Hill,…
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FDA Looks to Multiple Sources, Including EMA Guidelines, in Developing Biosimilar Approval Standards
By James DeGiulio — In an article published in the New England Journal of Medicine on August 4, U.S. Food and Drug Administration (FDA) executives presented a sneak preview of what to expect when the FDA issues its biosimilar standards under the Biologics Price Competition and Innovation Act (BPCIA) later this year. The article, entitled…
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By James DeGiulio — One of the highlights of the afternoon sessions at the BIO International Convention was a seminar appropriately entitled "A Brave New World: Patent Litigation Tactics and Strategies for Biosimilars," where an experienced panel of patent attorneys presented their interpretation of the new biosimilars pathway of the Biologics Price Competition and Innovation…
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