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.

USPTO Releases New Guidance on Patentability of Antibody Claims

Last month, Robert Bahr, Deputy Commissioner for Patent Examination Policy at the USPTO issued a memorandum to the Patent Examining Corps addressing written description of antibody claims.  Many patents covering biological products contain antibody claims. A major focus of the USPTO memorandum is the Federal Circuit’s decision in Amgen v….

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BPCIA Litigation Roundup (Q1 2018)

Below is our first quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017).

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Congress Mulls Passage of CREATES Act

The CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act), currently pending in Congress states as its aim to promote drug price competition by removing an impediment to the development and approval of lower cost generics or biosimilars. Currently some branded companies are using safety requirements, including restricted…

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Immunex Moves To Stay Dupixent® Patent Litigation Pending IPR

Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex moved to stay the litigation pending resolution of two IPR proceedings the PTAB instituted on February 15, 2018 (IPR2017-01879 and IPR2017-01884) regarding the sole asserted patent: U.S. Patent No. 8,679,487….

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PTAB Invalidates Bevacizumab Method of Use Patent

Last week, the Patent Trial and Appeal Board issued a final written decision in IPR2016-01771, filed by Hospira to challenge U.S. Pat. No. 7,622,115. The Board invalidated all 5 claims of the ’115 patent, which is directed to methods for treating cancer in a patient comprising administering an effective amount…

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Merck Launches Ontruzant®, First Trastuzumab Biosimilar in Europe

Last week it was reported (here and here) that Merck launched Samsung Bioepis’ Ontruzant® in the United Kingdom, the first biosimilar trastuzumab launched in Europe.  Ontruzant® is a biosimilar of Roche’s Herceptin® and is approved to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer.  This launch follows…

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Biologics IPR Updates

Last week, the Patent Trial and Appeal Board (“Board”) denied institution of four IPR petitions on biologics-related patents.  First, the Board denied institution of IPR2017-01987 and IPR2017-01988, both filed by Sandoz Inc.  These IPRs sought to challenge U.S. Patent Nos. 8,911,737 and 8,974,790, respectively, both owned by AbbVie Biotechnology Ltd., and…

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Biologics Provisions Suspended in Signed CPTPP

We previously reported on the announced agreement to enter into the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). As previously announced, the final version of the CPTPP suspended all of the biologics provisions (Article 18.51) that appeared in the TPP.  According to past reports, the biologics provisions were heavily…

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