On January 4, 2022, the District Court for the District of Delaware granted Hikma Pharmaceuticals USA Inc.’s (“Hikma”) motion to dismiss Amarin Pharma Inc.’s (“Amarin”) infringement claims, finding that Hikma’s “skinny label” for its generic heart drug, icosapent ethyl, did not induce infringement of Amarin’s three patents. This decision comes on the heels of the

At the end of last month, three amicus curiae briefs were filed following the petition for a writ of certiorari in the Amgen, Inc. v. Sanofi, Inc. case. We previously discussed the petition for a writ of certiorari in detail here.

The first amicus brief was submitted by the Association of University of Technology

As we have previously discussed, on February 11, 2021, the Federal Circuit decided Amgen Inc. et al.  v. Sanofi, Aventisub LLC, et al. The Federal Circuit affirmed the district court’s grant of JMOL that Amgen’s Repatha® patents (U.S. Patent Nos. 8,829,165 and 8,859,741) were invalid for lack of enablement. The claims at issue

The U.S. Patent and Trademark Office (USPTO) recently instituted two of Mylan’s petitions seeking Inter Partes Review of Regeneron’s U.S. Patent No. 9,669,069 B2 (the “’069 Patent,” subject of IPR2021-00880) and U.S. 9,254,338 B2 (the “’338 Patent,” subject of IPR2021-00881), finding that Mylan (now part of Viatris) established a reasonable likelihood in prevailing in showing

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