Overview
Max Yusem is an of counsel in the Litigation practice of Paul Hastings and is based in the firm’s New York office. His practice focuses on complex litigation with an emphasis on intellectual property matters in the fields of pharmaceuticals and biotechnology.
Mr. Yusem has experience litigating cases arising under the Hatch-Waxman Act on behalf of innovator companies and the Biologics Price Competition and Innovation Act (BPCIA). He has represented leading life science companies in high-stakes disputes in district court litigations, patent office proceedings, and arbitrations involving pharmaceutical compounds, formulations, and methods of treatment, which involved a wide variety of therapeutics, covering areas such as cardiovascular, diabetes, oncology, central and peripheral nervous systems, hormone replacement, and hemoglobinopathy.
Mr. Yusem has also consulted and represented clients in numerous other areas including antibody technology, genetic testing, microfluidic devices, and ethanol processing. Mr. Yusem 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. Mr. Yusem is admitted to the New York State Bar.
Education
- The George Washington University Law School, J.D. 2013
- Johns Hopkins University, B.A. 2008
Representations
- 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®.
- 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.
- Prevailed on behalf of Abcellera in various IPR challenges to three of its patents covering its proprietary microfluidic cell culture systems, which Abcellera is also asserting in district court.
- 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.
- 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.
- 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).
- 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.
- Represented Illumina in connection with IPR challenges to patents covering methods of using cell free fetal DNA for non-invasive prenatal diagnosis.
- Currently representing Alkermes in a patent litigation involving its patent covering Vivitrol®, the first and only extended-release naltrexone injectable for the treatment of alcohol and opioid dependence.
- Currently representing COVID-19 vaccine developer BioNTech SE in defending against multiple patent infringement lawsuits involving mRNA technology.
- Currently representing bluebird bio and Third Rock Ventures in defending against a patent infringement dispute relating to bluebird’s innovative Zynteglo® gene-therapy product for treating beta-thalassemia.
- 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.
news
insights
- Paul Hastings Secures Win in First DNJ Zoom Hatch-Waxman Act Trial, Including Significant Ruling Rejecting Extension of Obviousness-Type Double Patenting Law - April 8th, 2021
- Takeaways from Paul Hastings’ Completion of the First Zoom Hatch-Waxman Act Trial in DNJ - October 7th, 2020
- Extension of Regulatory Approval Stay Helps Relieve Hatch-Waxman Time Pressure Caused by COVID-19 - April 27th, 2020
- Supreme Court Continues to Build Out Its Framework for Patent Eligibility in High-Tech and Life Sciences Sectors - July 21st, 2014
- Supreme Court Ruling in Alice v. CLS Bank Continues Framework for Patent Eligibility Set Forth in Mayo v. Prometheus - June 19th, 2014
- District of New Jersey Prevents Generic Challenger from Using Claim Construction as a Backdoor to Introduce Barred Invalidity Defense - June 16th, 2014
- Federal Circuit Clarifies That Foreseeability Does Not Preclude the Application of the Doctrine of Equivalents - February 20th, 2014
- Prometheus: A New Dawn for Biotech Patents - October 8th, 2012
Involvement
- Member, American Intellectual Property Law Association