NJ Judge Invalidates Patent For Janssen Cancer Drug Zytiga

By Dani Kass

Law360 (October 29, 2018, 8:52 PM EDT) — A New Jersey federal judge has invalidated a patent covering Janssen Biotech Inc.’s blockbuster oncology medication Zytiga, but said a host of generic-drug makers would have infringed that patent with their oncoming drugs had it been valid.

Following a July bench trial, U.S. District Judge Kevin McNulty on Friday issued a 70-page opinion handing victory to several generic-drug companies. He found that combining the two drugs that make up U.S. Patent No. 8,822,438 was “less like serendipity and more like inevitability.”

The judge is considering a stay during appeal, and has required the status quo to stay through Tuesday and barred any generic launch before Wednesday, pending a Tuesday hearing.

The ‘438 patent — owned by BTG International Ltd. and exclusively licensed by Janssen — covers mixing chemotherapy medication abiraterone with prednisone, a steroid to reduce side effects. Had the patent been valid, Judge McNulty said the generic-drug makers would have infringed, as while their proposed labels stressed prednisone as a way to manage side effects rather than a combination treatment, in the end it worked the same as BTG’s patent.

The judge said he ruled on infringement even though he invalidated the patent “to facilitate appellate review.

Janssen and BTG first sued in 2015. They accused Actavis Laboratories, Amneal Pharmaceuticals LLC, Apotex Corp., Dr. Reddy’s Laboratories Inc., Mylan NV, West-Ward Pharmaceutical Corp., Hikma Pharmaceuticals LLC, Teva Pharmaceuticals Inc., Wockhardt Bio AG and others of infringement.

According to Janssen and BTG, the drug they’re trying to protect brought in $5.7 billion in sales between April 2011 and the end of 2017.

In the three years since the litigation began, multiple cases have been consolidated; Actavis and Apotex have settled; the Patent Trial and Appeal Board invalidated all 20 claims of the ‘438 patent, although Janssen has requested a rehearing; and BTG and Janssen agreed to remove a second patent — U.S. Patent No. 5,604.213 — from the litigation, as it expired in Dec. 2016.

Judge McNulty held a bench trial between July 23 and Aug. 2 to look at the ‘438 patent’s validity and possible infringement. He found that it would have been obvious to combine the two drugs and end up where BTG and Janssen did, even if someone wasn’t looking specifically for a treatment.

“The combination therapy, it is true, is patented as a ‘treatment.’ But even prednisone’s effects as a palliative and a side-effect minimizer would furnish a powerful motivation to combine it with abiraterone,” Judge McNulty wrote. “And the idea for such a combination, even if initially motivated only by those two effects, would have gotten the [person having ordinary skill in the art] to the same place. That road led straight to the practice of the patented method.”

While the generic-drug makers had also questioned the written description of the patent, Judge McNulty said it was adequate.

“Janssen strongly disagrees with the court’s ruling and will continue to defend the patent,” the Johnson & Johnson unit said in a statement. “We plan to appeal the decision.”

A Teva spokeswoman and counsel for Wockhardt declined to comment. Representatives for the remaining companies didn’t immediately respond to requests for comment Monday.

The patent-in-suit is U.S. Patent No. 8,822,438.

Janssen is represented by Anthony C. Tridico and Jennifer H. Roscetti of Finnegan Henderson Farabow Garrett & Dunner LLP and David T. Pritikin, Thomas D. Rein, S. Isaac Olson, Alyssa B. Monsen, Amanda Potter and Andrew Langford of Sidley Austin LLP.

BTG is represented by Keith J. Miller, Donald A. Robinson and Justin T. Quinn of Robinson Miller LLC.

Amneal, Dr. Reddy’s, Teva, West-Ward and Hikma are represented by James S. Richter, Charles B. Klein, Jovial Wong, Sharon Lin and Ryan B. Hauer of Winston & Strawn LLP.

Mylan is represented by Arnold B. Calmann, Jeffrey S. Soos and Katherine A. Escanlar of Saiber LLC and Shannon M. Bloodworth, Brandon M. White, Maria A. Stubbings and Bryan D. Beel of Perkins Coie LLP.

Amerigen is represented by Christopher Casieri and William D. Hare of McNeely Hare & War LLP.

Wockhardt is represented by Sheila R. Wiggins of Duane Morris LLP and Dennies Varughese and Cassandra Simmons of Sterne Kessler Goldstein & Fox.

The cases are BTG International Limited et al v. Amneal Pharmaceuticals LLC et al, case numbers 2:15-cv-05909, BTG International Limited et al., v. Amerigen Pharmaceuticals et al., case number 16-cv-02449, and BTG International Limited et al., Teva Pharmaceuticals USA Inc., case number 17-cv-06435, all in the U.S. District Court for the District of New Jersey.

–Editing by John Campbell.