Patent Law Weblog
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- 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 Donald Zuhn — Earlier this month, the U.S. Food and Drug Administration announced that the agency has approved 35 new drugs over the past twelve months. With the exception of 2009, when 37 new drugs were approved, more drugs were approved in fiscal year (FY) 2011, which ended September 30, than in any other…
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By James DeGiulio — Earlier this year, we reported on the fading interest among larger pharmaceutical companies in developing new antibiotics, despite drug-resistant bacteria representing a serious public health issue (see "Increase in Drug-Resistant Bacteria Creating Need for New Antibiotics"). On October 19, Senators Richard Blumenthal (D-CT) (at right) and Bob Corker (R-TN) (below left)…
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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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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 — The Food and Drug Administration has been the subject of recent criticism from drugmaker advocates who allege that the FDA's tougher safety standards have slowed down the pace of drug approvals and have hurt the drug industry. However, despite these allegedly repressive safety standards, the head of the FDA's drug division,…
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By Kevin E. Noonan — Under the biologics pathway provisions of the Patient Protection and Affordable Care Act (P.L. 111-148), § 351(k) of the Public Health Service Act, codified at 42 U.S.C. § 262(k)), the FDA is given the authority to develop procedures for approving biosimilar applications. Recognizing the complexities of the issues involved, Congress…
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By James DeGiulio — Last year, following Genzyme's inability to supply patient needs for the enzyme replacement drug Fabrazyme, concerned Fabry patients petitioned the Department for Health and Human Services (HHS) to exercise the government's "march-in" rights under the Bayh-Dole Act and force Genzyme to license the patents covering the drug to other manufacturers who…
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By James DeGiulio — In December 2009, the Department of Health and Human Services denied a petition filed by U.S. Fabry patients to secure higher quantities of drug Fabrazyme, exercise Bayh-Dole march-in rights against Genzyme, and issue an open license to U.S. patents needed to manufacture the drug (see "HHS Denies Request to Exercise Bayh-Dole…
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By Kevin E. Noonan — Last week, Judge Claude M. Hilton, District Court Judge for the Eastern District of Virginia, denied APP Pharmaceuticals request to intervene in The Medicines Company's lawsuit against the U.S. Patent and Trademark Office over the timeliness vel non of its Patent Term Extension Request for its patent on the blockbuster…
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