Overview
Max H. Yusem is a partner of the Intellectual Property practice at Paul Hastings and is based in the firm’s New York office. His practice focuses on complex patent litigation across the life sciences, pharmaceutical, biotechnology and technology industries, including cases arising under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA). Max has experience litigating high-stakes disputes in federal District Courts, the PTAB and the Federal Circuit, with experience spanning biologics, mRNA vaccines, gene therapy and antibody discovery platforms. These have involved a wide variety of therapeutics, covering areas such as diabetes, oncology, cardiovascular, central and peripheral nervous systems, hormone replacement and hemoglobinopathy.
Max was part of the team representing BioNTech in its high-profile vaccine patent litigations against CureVac, Moderna and Arbutus, in which the firm secured decisive victories and reshaped the legal landscape for mRNA therapeutics. He also led the Paul Hastings’ team in the successful defense of AbCellera’s antibody discovery platform, in which victories at the PTAB, Federal Circuit and Northern District of California preserved patent protection of core technology against AbCellera’s main competitor. In addition, Max played a central role in representing bluebird bio (now Genetix Biotherapeutics) in a complex patent, trade secret and antitrust dispute, achieving early summary judgment of noninfringement and eliminating exposure in excess of $1 billion.
Max received his law degree, with honors, from George Washington University School of Law in 2013, where he served on the George Washington International Law Review. He earned a Bachelor of Arts from the Department of Psychological and Brain Sciences at Johns Hopkins University in 2008. Max is a member of the New York State Bar and admitted to practice before the U.S. Court of Appeals for the Federal Circuit.
Education
- George Washington University Law School, J.D. (with honors) 2013
- Johns Hopkins University, B.A. 2008
Representations
- Successfully represented COVID-19 vaccine developer BioNTech in defending against multiple patent infringement lawsuits involving mRNA technology, including in E.D. Va. where competitor CureVac accused BioNTech of infringing hundreds of claims across 10 patents with allegations of damages of over $4 billion just in the U.S., with billions more worldwide. Max was responsible for the day-to-day management of the U.S. litigation, including developing case and trial strategy and coordinating with foreign litigation teams in the U.K., EU and other jurisdictions.
- Secured a precedent-setting victory for Mitsubishi Tanabe in the first virtual Hatch Waxman trial in the District of New Jersey, which involved challenges to an active ingredient patent, combination product patent, and method of treatment patent covering the first-in-class diabetes medications, Invokana® and Invokamet®.
- Successfully represented Boehringer Ingelheim in connection with patent challenges relating to its proposed biosimilar version of Humira® under the Biologics Price Competition and Innovation Act (BPCIA), resulting in a favorable settlement.
- Prevailed on behalf of AbCellera in various IPR challenges to its patents covering its proprietary microfluidic cell culture systems by its competitor Bruker. Max presented the winning oral arguments before both the PTAB and Federal Circuit, which upheld the validity of the patents. Max then was able to successfully represent AbCellera in asserting these patents in N.D. Cal. against Bruker, eventually obtaining a favorable settlement requiring Bruker to pay millions in upfront payments and an ongoing royalty.
- Prevailed on behalf of bluebird bio by presenting the winning oral argument in D. Del., where the court agreed to hear early summary judgment during fact discovery and found bluebird’s innovative Zynteglo® and Lyfgenia® gene-therapy products for treating beta-thalassemia and sickle cell disease did not infringe the asserted patents. This victory required the successful coordination between ongoing PTAB proceedings and allegations in D. Mass. of various federal and state laws, where the Paul Hastings’ team was able to obtain a complete early dismissal at the preliminary pleadings stage.
- Successfully represented Boehringer Ingelheim in a patent litigation involving various challengers to a compound patent covering its blockbuster Pradaxa® stroke medication, which resulted in walk-aways from six separate generics.
- Successfully represented Otsuka in a high-stakes international matter across various forums, including New York State Court and an international arbitration, which involved the cannabidiol product Epidiolex® indicated for the treatment of seizures.
- Prevailed in a challenge to a formulation patent in a district court litigation protecting Helsinn Healthcare’s Aloxi® antiemetic drug franchise brought by more than 20 generics in multiple courts.
- Successfully represented Alkermes in a patent litigation involving its method of treatment patent covering Vivitrol®, the first and only extended-release naltrexone injectable for the treatment of alcohol and opioid dependence.
- Represented Merck in connection with a generic challenge to Entereg® (alvimopan), an innovative treatment used for post-operative ileus, which resulted in the generic respecting the full term of the sole patent-in-suit.
- Currently representing Kyowa Kirin in connection with its patent portfolio for Nourianz® (istradefylline), which is an adjunctive treatment for Parkinson’s disease.
- Currently representing Boehringer Ingelheim in connection with its patent portfolio for Ofev® (nintedanib), which is a tyrosine kinase inhibitor approved for idiopathic pulmonary fibrosis, as well as various other lung diseases.
Involvement
- Member – American Intellectual Property Law Association