5 Key Takeaways | Best Practices in Patent Drafting: Addressing 112 and Enablement after Amgen
Nature of the Case and Issue(s) Presented: Astellas sued Lupin and Zydus based on the generics manufacturers’ ANDA filing and their efforts to make and sell generic mirabegron. In the leadup to the 2023 bench trial, the...more
The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents...more
In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...more
On May 18, 2023, the Supreme Court in Amgen Inc. v. Sanofi unanimously affirmed the Federal Circuit’s holding that U.S. Patent Nos. 8,829,165 and 8,859,741 did not enable certain functional genus claims describing a class of...more
The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement...more
Addressing the issue of written description in the context of antibody-related genus claims, the US Court of Appeals for the Federal Circuit reversed a $1.2 billion jury verdict and found genus claims using functional...more
An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more
A little less than four years ago, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement...more
In a case relating to compounds for the treatment of the Hepatitis C virus (HCV), the US Court of Appeals for the Federal Circuit upheld a district court’s grant of judgment as a matter of law (JMOL) for lack of enablement...more
The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more
One-E-Way, Inc. v. ITC, Fed. Cir. Case 2016-2105 (June 12, 2017) - A divided panel reverses a determination of indefiniteness by the ITC, ruling that under Nautilus, the claim language, in combination with the...more