On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira® (adalimumab). We previously discussed Boehringer Ingelheim’s Citizen Petition requesting a change in the FDA’s interpretation
Continue Reading Takeaways from FDA’s Approval of the First Interchangeable Biosimilar for Humira®
On September 16, 2021, eleven congressional leaders (“the Signors”) sent a letter to Andrew Hirshfeld, the acting director of the United States Patent and Trademark Office (“USPTO”), requesting the USPTO to reevaluate the Patent Trial and Appeal Board’s (“PTAB”) view
Continue Reading Key Members of Congress Urge USPTO to Curtail Discretionary Denials of IPR Petitions to Help Lower Drug Costs by Breaking Patent Thickets
On August 3, 2021, the China National Intellectual Property Administration (CNIPA) released the Draft Revised Patent Examination Guidelines (“Draft Guidelines”) for comments. The revisions in the Draft Guidelines reflect the recently amended Chinese Patent Law that came into effect on
Continue Reading Chinese Patent Linkage, Patent Term Adjustment, and Patent Term Extension Guidelines Unveiled For Comments
The recently enacted “Purple Book Continuity Act of 2019” went into effect as of June 25, 2021. The FDA must proactively update the Purple Book information every 30 days with an alphabetical list of licensed biologics, including the date of
Continue Reading Changes to the Purple Book: Progress in Transparency
On June 21, 2021, the Federal Circuit denied Amgen’s petition for en banc review of the court’s February 2021 decision in Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al., 987 F.3d 1080 (Fed. Cir. 2021), which found that
Continue Reading ‘The Sky is [Not] Falling,’ Federal Circuit Urges as it Continues to Dismantle Broad Pharmaceutical Patents
In the most recent of a series of litigations by AbbVie against manufacturers seeking to market biosimilar versions of Humira®, the world’s most profitable drug, AbbVie initiated an action against Alvotech in the district court for the Northern District of
Continue Reading Getting Lost in the Thicket: AbbVie Wields Its Expansive Humira® Patent Portfolio Against Alvotech’s Adalimumab Biosimilar
In an earlier post, we discussed the patent linkage system implemented in the Fourth Amendment to the Chinese Patent Law, which will come into effect on June 1, 2021. Another important change in the amendment is the introduction of
Continue Reading Patent Term Extension Introduced by the Fourth Amendment to the Chinese Patent Law
On May 6, 2021, the Brazilian Supreme Court determined that the minimum ten-year patent term set forth in Article 40 of the Brazilian Intellectual Property Statute (Law No. 9,279) was unconstitutional (ADI 5529), and, on May 12, 2021, retroactively reduced
Continue Reading Brazilian Supreme Court Ends Patent Term Extension and Retroactively Cuts Pharmaceutical and Medical Device Patent Terms
During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20 billion in 2020. While none have
Continue Reading Growing Competition for the World’s Most Profitable Drug as Multiple New Adalimumab Biosimilars Launch
Two bills were signed into law on April 23, 2021, with the aim of increasing access to and education regarding generic and biosimilar medicines.
The Ensuring Innovation Act was passed with the aim to “lower the price patients pay for
Continue Reading Congress Takes Aim at Reducing the Cost of Medicine
