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- 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)
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Category: Biosimilars
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By Kevin E. Noonan — In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human breast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science 244: 707-12 (1989). Following up on this discovery, Dr. Slamon and his collaborators found that a…
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By Andrew Williams — Last year, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") as "a riddle wrapped in a mystery inside of an enigma" in the Amgen v. Sandoz case. Nevertheless, one of the provisions of the BPCIA was still shrouded in mystery after that opinion — the Notice of…
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By Kevin E. Noonan — Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal to reduce the exclusivity term for biologic drugs from 12 years to 7 years (see…
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By Kevin E. Noonan — Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES Act of 2016". According to Senator Grassley: [C]oncerns have been raised that some brand-name companies are…
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By Andrew Williams — In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United States. As we previously reported, Sandoz petitioned the Court on February…
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BIO and Biosimilars By Andrew Williams — The 2016 BIO International Convention begins next week in San Francisco. This convention has become an important destination for all organizations working in the biotechnology space, but the large amount of information and opportunities available can appear daunting at first glance. To assist our readers, we recently provided…
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By Andrew Williams — As we reported last week, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody. On Tuesday, April 12, counsel for Janssen submitted a letter to Judge Mark L. Wolf of the U.S. District Court for the District of…
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By Kevin E. Noonan — The Biologic Price Control and Innovation Act (BPCIA), enacted as part of President Obama's Affordable Care Act (better known as "Obamacare," Public Law 111-148), provided for the first time in the U.S. a path for FDA approval of biosimilar drugs, i.e., "generic" versions of biologic drugs that, unlike generic versions…
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By Andrew Williams — Earlier today, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody. This marks only the second biosimilar approved by the FDA pursuant to the BPCIA, and only the first to approve a therapeutic monoclonal antibody. Biologics License Application…
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By Kevin E. Noonan — Last Friday, Amgen filed a declaratory judgment action in the District Court for New Jersey against Sandoz, in the latest iteration of biosimilar litigation between the parties (see complaint). Amgen's and Sandoz's actions and legal position both provide the District Court with another opportunity to parse Congressional intent and the practical…
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