Roche Seeks Compulsory License for Anemia Drug, Citing Benefit of Price Competition

BIO Files Amicus in Anemia Drug Case, Says Roche Wants Court to Be 'Price Czar'

BNA Pharmaceutical Law and Industry Report
July 11, 2008

A biotechnology industry group July 7 urged the U.S. Court of Appeals for the Federal Circuit to reject drugmaker F. Hoffmann-LaRoche Ltd.'s public interest argument for selling an anemia drug in the U.S. market (Amgen Inc. v. F. Hoffmann-LaRoche Ltd., Fed. Cir., No. 2008-1300, amicus brief filed 7/7/08).

In the amicus brief filed in Roche's appeal of a lower court's order barring Roche from selling its anemia drug, Mircera, in the United States, the Biotechnology Industry Organization (BIO) argued that the appeals court should not override the exclusive patent right in order for an infringer to enter the market to possibly produce competitive pricing.

Amgen Inc. sells the anti-anemia drugs Epogen (Epoetin alfa) and Aranesp (darbepoetin alfa). Roche wants to sell Mircera (methoxy polyethylene glycol-epoetin beta) for treatment of anemia associated with chronic kidney disease in patients on dialysis and in patients not on dialysis. The Food and Drug Administration approved Mircera in November 2007, but a jury in October 2007 found that Amgen's patents were valid and were infringed by Roche's product.

In a Feb. 28 ruling, Judge William G. Young of the U.S. District Court for the District of Massachusetts rejected Roche's motion for a new trial and upheld "in all respects" the jury's verdict that Amgen's patents are valid and infringed by Roche's product.

At the same time, however, Young, in response to Roche's contention that the public interest would be served by the reduced drug price that it claimed would inevitably result from competition between Mircera and Amgen's Epogen and Aranesp products, said he might be willing to modify the injunction and let Roche go forward with Mircera sales if it met certain conditions. Young suggested that Roche might pay Amgen a 22.5 percent royalty and fund an independent agency to monitor Roche sales and royalty payments. On March 26, Young ordered the appointment of a special master to make recommendations on price parity and dose conversion ratios for Amgen's Epogen and Roche's Mircera.

On April 11, Roche filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit from the district court's decision. In its notice of appeal, Roche claimed that Young abused his discretion on multiple matters, including failing to consider and weigh evidence of Amgen's "unconscionable marketing conduct" in his preliminary injunction ruling as well as failing to adequately consider the negative effect on the public interest that would flow from the court's decision to grant of an injunction in Amgen's favor rather than enter in an ongoing-royalty remedy that would have placed Mircera in the marketplace.

Overrides Framers' Judgment

In its amicus brief, while taking no position on whether Mircera satisfies an "unmet medical need," as Roche argued, BIO urged the Federal Circuit to reject Roche's position that the court should weigh the possibility of price competition that would result if Roche put Mircera into the anemia drug market ...

... BIO next argued that in a number of laws, including the Bayh-Dole Act, the Hatch-Waxman Act, and the Medicare Act, Congress has struck a balance between incentives for innovation and access to lower-priced drugs that district courts are not free to second guess. The Hatch-Waxman Act, for example, actually increases patent term to an innovator as a recompense for regulatory delay. BIO cited many unsuccessful attempts to pass legislation authorizing compulsory patent licenses.

"Indeed," BIO stated, "if Congress had intended that § 283 be interpreted so broadly as to confer on district courts the discretionary power to order compulsory licensing whenever the 'public interest' might be served, there would have been no reason for Congress to grant express statutory authority for compulsory licensing in the limited circumstances set out in the patent statute." Rather, BIO stated, using the public interest prong to order "injunctions with terms" in an effort to promote drug price competition would undermine the system of incentives created by the patent statute and recognized by Congress.

Full story available from the BNA Pharmaceutical Law and Industry Report (password required).