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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In re Ciprofloxacin Antitrust Litigation By Kevin E. Noonan — The Second Circuit on Monday denied plaintiffs' petition for rehearing en banc of its decision that the "reverse payment" agreement between Bayer and Barr over ciprofloxacin hydrochloride (Cipro®) was not anticompetitive under the antitrust laws. One judge, Rosemary S. Pooler, dissented from the decision, as…
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By Kevin E. Noonan — The U.S. Patent and Trademark Office has acted promptly to comply with Judge Claude Hilton's Order earlier this week that the Office accept The Medicines Company (MDCO) Patent Term Extension Request for U.S. Patent No. 5,196,404, by granting the patent an interim patent term extension. In responding to the Order,…
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By Donald Zuhn — Last week, the Senate Appropriations Committee managed to accomplish something that the Senate as a whole could not: pass an appropriations bill containing a pay-for delay (or reverse payment) provision. Only one week earlier, the Senate had voted in favor of the House "2010 Supplemental Appropriations Act" (H.R. 4899), but not…
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By Kevin E. Noonan — Yesterday, Judge Claude M. Hilton, District Court Judge for the Eastern District of Virginia, handed The Medicines Company (MDCO) a victory in its long-standing dispute with the U.S. Patent and Trademark Office over the timeliness vel non of its Patent Term Extension Request for its patent on the blockbuster drug…
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By Donald Zuhn — Earlier this month, the House of Representatives passed the "2010 Supplemental Appropriations Act" (H.R. 4899) after tacking an additional $22.8 billion onto the Senate version of the bill, which called for $45.5 billion in discretionary funding for FY 2010. The bill would provide, inter alia, $37.12 billion for U.S. troops in…
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By Donald Zuhn — Ordinarily, the passage of a supplemental appropriations bill would likely go unnoticed by those in the pharmaceutical industry. Last week, however, the House of Representatives passed the "2010 Supplemental Appropriations Act" (H.R. 4899) after inserting a provision (among a host of other provisions) that would allow the Federal Trade Commission…
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By Kevin E. Noonan — Our opinions are always (perhaps inevitably) informed by our experience. And when our experience is limited, particularly when those limitations are coupled with passion, those limitations equally inform our opinions. These realities come to mind when reviewing a letter from two medical students in the journal Science in response…
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By Andrew Williams — Last month, in addition to Photocure ASA v. Kappos and Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., the Federal Circuit completed the hat trick of patent term extension cases with Wyeth Holdings Corp. v. Sebelius. In this case, the Court affirmed the statutory construction decision of the U.S. District Court…
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By Kevin E. Noonan — On April 29th, the U.S. Court of Appeals for the Second Circuit ruled that the "pay-for-delay" agreement between defendants Bayer AG and several generic drugmakers (including The Rugby Group, Watson Pharmaceuticals Inc., and Barr Laboratories Inc.) were not illegal under U.S. antitrust law and prevailing precedent. However, in a…
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By Kevin E. Noonan — On April 14th, the Federal Circuit rendered a decision construing statutory language in a rather straightforward and unremarkable (albeit not unanimous) opinion. But the statutory language at issue involved the 2003 Medicare Prescription Drug Improvement and Modernization Act, which amended the 1984 Drug Price Competition and Patent Term Restoration…
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