Amgen’s “Anticompetitive Scheme” On EPO Should Be Invalidated By Court, Roche Says

Roche seeks monetary damages and a ruling that Amgen’s conduct regarding its “monopoly” on erythropoietin is unlawful in court filing.

Roche is seeking monetary relief and a ruling that Amgen's "monopoly" on the erythropoietin market is unlawful in documents filed Nov. 6 in Boston federal court.

The papers respond to a patent infringement suit filed by Amgen against Roche last year over the Swiss drug maker's continuous erythropoietin receptor activator candidate Mircera . Roche's BLA for Mircera is pending at FDA for the treatment of anemia for patients on dialysis with a February user fee date.

If approved and launched by Roche, Mircera would be the first product to compete against Amgen in the treatment of anemia associated with end stage renal disease and chronic kidney disease. It would also be the first continuous EPO product offering once monthly dosing advantages.

Amgen markets Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), and its technologies are protected by dozens of patents. The firm also has a licensing agreement with Johnson & Johnson for Procrit (epoetin alfa), although J&J is not prohibited from marketing the drug for the treatment of anemia associated with kidney disease.

Amgen's suit against Roche alleges that Mircera infringes six patents protecting "pioneering inventions" related to EPO and seeks declaratory and injunctive relief. The trial is slated to begin in September 2007 (¹ (Also see "Amgen Will Have Day In Court With Roche" - Pink Sheet, 24 Oct, 2006.)).

Roche, however, says Amgen's patents are "unenforceable" because of misrepresented information given to the Patent & Trademark Office. The six patents in the suit all share the same specification and all claim priority to expired patent, 4,703,008, according to Roche.

"Amgen's fraud on the PTO was motivated by Amgen's recognition that expiration of the '008 patent would endanger its long-standing dominance over the sale of erythropoietin stimulating agent [ESA] products," Roche says.

In addition, Roche claims that Mircera is a new chemical entity, different from recombinant human EPO in chemical and biological activity.

"Because of the differences between CERA on the one hand, and all the other ESAs currently the market, CERA promises to offer physicians and patients the first true alternative that, for at least a significant portion of patients, would prove appropriate either medically or as a matter of convenience and compliance," Roche maintains.

Further, in several counterclaims, Roche is seeking a declaratory judgment of patent invalidity, non-infringement and unenforceability against Amgen.

"Amgen's patent case against Roche is part of a broad, anticompetitive scheme by Amgen to unlawfully maintain or secure monopoly power in violation of the antitrust laws," the document says.

"Roche's CERA drug...presents the first credible challenge to Amgen's dominance over ESAs sold for ESRD and CKD," Roche states. "Recognizing that its patents are not likely to block Roche's eventual entry with CERA, Amgen has embarked on a course of anticompetitive conduct designed to hinder Roche's ability to enter or compete effectively in these markets."

Among the actions Amgen has initiated to block Mircera was the filing of a complaint against Roche with the U.S. International Trade Commission requesting an investigation into whether Roche was illegally importing pegylated EPO in the U.S. (² (Also see "Amgen Seeks Order Against Roche Peg-EPO Importation" - Pink Sheet, 12 Apr, 2006.)).

That complaint was later rejected by the commission. More recently, Amgen has gone on the offensive by signing an exclusive supply contract with a large ESA distributor, Fresenius, blocking the sale of other EPO products.

According to Roche, Amgen has also intimidated customers by threatening that the purchase of Mircera will result in price increases for Amgen's ESA products or that it will deny customers access to those products or withhold discounts that would otherwise be available.

In its court filing, Roche points out that approximately 65% of ESAs used to treat ESRD patients in the U.S. are purchased from Amgen by two large dialysis organizations.

"Amgen's anti-competitive scheme, if not invalidated by this court, will hinder or eliminate the competition that Roche's CERA is poised to create, limit the ability of patients and physicians to choose an alternative medicine that would provide benefits to patients not currently available and saddle consumers, patients and those who pay for their medicines with supracompetitive prices," Roche says.

- Jessica Merrill ([email protected])