Welcome to the Big Molecule Watch!


Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.

If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).

We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.

IPR Tracker: Rituxan IPRs

As we’ve covered in previous posts and in the IPR section of this blog, several IPR petitions have been filed against patents relating to the biologic products Humira (adalimumab) and Rituxan (rituximab). The PTAB has now issued decisions on whether it will institute IPR on the three Rituxan (rituximab) IPR…

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Impending TPP Agreement's Potential Impact on Biologics

On June 23, 2015, the U.S. Senate authorized President Obama to negotiate on a “fast-track” basis the Trans-Pacific Partnership agreement (TPP).  TPP is a proposed trade agreement between several pacific countries concerning a variety of matters, including intellectual property and pharmaceutical products.  Negotiations over TPP, which have been taking place…

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Amgen files IPR petitions on two Humira patents

On Friday, June 26, 2015 Amgen Inc. filed IPR petitions (IPR2015-01514 and IPR2015-01517) against two Humira (adalimumab) patents owned by AbbVie Inc., in an effort to clear the way for its Humira biosimilar, ABP 501.  The patents, 8,916,157 and 8,916,158, are directed to improved formulations of Humira, which Amgen argues are…

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UK Patents Court Invalidates Genentech Herceptin Patent

On June 24, 2015, the UK’s High Court of Justice Patents Court invalidated a Genentech patent (EP 1037926 (“the ’926 patent”)) for the combined use of Herceptin (trastuzumab) in combination with the chemotherapeutic taxane for treatment of HER2-positive breast cancer.  Hospira brought this action as part of a series of patent…

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