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 on discretionary denials of petitions for inter partes review (“IPR”).  The Office uses discretionary denials

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 June 1, 2021, and the Draft Revised Implementing Regulations (“Draft Regulations”) of the Chinese Patent

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 Illinois on April 27, 2021, after Alvotech requested approval of its biosimilar, AVT02, a biosimilar

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 the terms of granted pharmaceutical and medical device patents that are valid only due to

The Federal Circuit has affirmed Bayer’s patent infringement victory related to Baxalta’s biologic product, Adynovate.  Bayer Healthcare LLC v. Baxalta Inc., No. 2019-2418, 2021 WL 771700 (Fed. Cir. Mar. 1, 2021).  At the district court, the jury found the claims of Bayer’s U.S. Patent No. 9,364,520 (“the ’520 patent”) enabled and infringed, and awarded