Pfizer Wins Court Battle Over Manufacturing Process for Norvasc

February 8, 2007
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

New York, NY (Jan. 31)-Pfizer, Inc. scored a victory over Synthon IP in a patent infringement lawsuit over the manufacturing process for ?Norvasc? (amlodipine).

New York, NY (Jan. 31)-Pfizer, Inc. (www.pfizer.com) scored a victory over Synthon IP (Gainesville, VA, www.synthonip.com) in a patent infringement lawsuit over the manufacturing process for “Norvasc” (amlodipine). Norvasc is one of Pfizer’s top-selling drugs with 2006 sales of $1.3 billion.

According to Pfizer, the federal district court in the Eastern District of Virginia (Alexandria) ruled that Synthon obtained, by inequitable conduct, two US patents that covered a process and an intermediate compound used to make the active ingredient in Pfizer's Norvasc.

Pfizer said the court found that Synthon had knowingly failed to disclose to the US Patent and Trademark Office (Washington, DC, www.uspto.gov) Pfizer publications and other information it had in its possession that described the process Synthon sought to patent.

“It's very difficult to meet the standards for establishing inequitable conduct,” said Allen Waxman, Pfizer's general counsel, in a company statement. “But in this case it is clear that Synthon improperly used Pfizer's own published material to obtain a patent that it then tried to enforce against us.”

Pfizer said it intends to seek attorneys’ fees from Synthon. The case may be appealed.

In its statement, Pfizer explained that Synthon had asserted that Pfizer's process for manufacturing Norvasc infringed Synthon patents issued in 2003 and 2005. In August 2006, a federal court ruled that one of those patents was not infringed by Pfizer and was invalid on multiple grounds, principally because it was based on Pfizer's prior published work. Synthon had dropped its claim of infringement on the second patent prior to trial.