Firm Secures Another Major Patent Litigation Win for Janssen Pharmaceuticals

May, 2023 - New York, New York

On May 15, 2023, Patterson Belknap obtained a significant trial victory on behalf of our clients, Johnson & Johnson (J&J) subsidiaries Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, and Janssen Research & Development, LLC, in a Hatch-Waxman patent infringement litigation regarding Mylan’s proposed generic versions of Janssen’s Invega Trinza® product. Invega Trinza, a once-every-three-month long-acting injectable antipsychotic medication for the treatment of patients with schizophrenia, generates approximately $600 million in annual sales in the United States. At stake in the case were nearly 13 years of patent protection provided by the sole patent covering Invega Trinza.

Following a two-week bench trial in late 2022, the U.S. District Court for the District of New Jersey ruled in Janssen’s favor on all issues, finding Mylan liable for inducing infringement of the patent-in-suit and rejecting Mylan’s challenges to the validity of the patent. According to the opinion, published on May 23, the Court was “unpersuaded” by Mylan’s arguments that it would not induce infringement, “disagree[d]” with Mylan’s assertion that the patent was invalid as obvious, and found Mylan’s expert’s opinions that the patent was invalid for lack of enablement and written description “unpersuasive.” The final judgment issued May 23 prevents the FDA from approving Mylan’s proposed generics until the expiration of the patent-in-suit, currently April 5, 2036, and will enable J&J to continue to reinvest revenue from sales of Invega Trinza to fund research for future pharmaceutical development.

We previously represented Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV in a successful Hatch-Waxman patent infringement case against the drugmaker Teva Pharmaceuticals regarding its proposed generic of Janssen’s blockbuster long-acting-injectable antipsychotic drug Invega Sustenna®. According to Bloomberg LP, combined U.S. 2022 sales of Invega Sustenna and Invega Trinza amounted to $2.7 billion, constituting 2.9% of Johnson & Johnson’s 2022 revenue.

The Patterson Belknap team, which included Barbara L. Mullin, Aron Fischer, Andrew D. Cohen, Lachlan Campbell-Verduyn, Jay Cho, Joyce Nadipuram, and A. Robert Quirk, was featured in the American Lawyer’s “Litigator of the Week” column for their work on the case.

To read the court’s Opinion, click here.

To read press from The American Lawyer, click here

To read press from Law360, click here

To read press from the New Jersey Law Journal, click here.

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