Alza Corporation and Janssen Pharmaceutica, Inc. v. Mylan Laboratories Inc., et al.
Economic Advice in Litigation
The Situation
Plaintiffs Alza Corporation and Janssen Pharmaceutica, Inc. brought suit for patent infringement against Mylan Laboratories, Inc. and two subsidiaries. Mylan counterclaimed, asserting that its product did not infringe, and that the patent was invalid. Mylan developed a generic transdermal fentanyl patch that is bioequivalent to Janssen's Duragesic(R), an opioid transdermal patch. It filed an Abbreviated New Drug Application with the United States Food and Drug Administration, seeking approval to market its patch before the patent expires.
NERA's Role
Retained by the plaintiffs, NERA analyzed the effect of the patent on the market; research indicated that the invention described in the patent had been a commercial success. NERA Special Consultant Dr. Marion Stewart testified on the plaintiffs' behalf at a deposition prior to the trial. Mylan subsequently dropped its contention that the patented invention had not been a commercial success.
The Result
The United States District Court for the District of Vermont ruled that the patent covering Duragesic(R) was not invalid, and that Mylan would infringe that patent if it launched a generic version of the product before the patent expired.
