Patent Infringement Ruling Involving Cancer Drug Favors Pfizer

usnews.com

U.S. District Court Judge Gregory M. Sleet ruled against generic drug maker, Mylan Pharmaceuticals Inc., in a patent infringement action brought by plaintiffs Pfizer Inc., Pharmacia & Upjohn Company, Pharmacia & Upjohn Company LLC, Sugen, Inc., C.P. Pharmaceuticals International C.V., Pfizer Pharmaceuticals LLC, and PF Prism C.V. (“Pfizer”).

The litigation arose out of Mylan’s alleged encroachment on Pfizer’s three legally issued patents, U.S. Patent Nos. 6,573,293, 7,125,905 and 7,211,600, which cover the compound sunitinib malate – sold under the trade name “Sutent.” In 2006, the United States Food and Drug Administration approved Sutent for the treatment of advanced renal cell carcinoma, as well as certain gastrointestinal and pancreatic tumors. Four years later, Mylan submitted an Abbreviated New Drug Application to the FDA, which sought approval to manufacture and sell a generic version Sutent prior to the expiration of the ‘293, ‘905, and ‘600 patents. 

In June of 2010, Pfizer sued Mylan, claiming patent infringement and arguing that the generic drug manufacturer’s business plan involved developing drugs (such as Sutent), filing Abbreviated New Drug Applications, and challenging patents in order to obtain the potential for significant total sales.

On October 23, 2014, the Court held Pfizer’s patents were valid and granted final judgment in the brand-name drug maker’s favor. The ruling is a significant win for Pfizer, since according to Reuters, the drug has produced sales for Pfizer of approximately $578 million in the first half of 2014 alone, and in 2010, Pfizer represented that Sutent generated $1 billion in sales for the company annually.

The case is: Pfizer Inc. v. Mylan Pharmaceuticals, Inc., No. 1:10-cv-00528 (D. Del.)

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