Roche's Mircera® Remains Off the Market (For Now)

    By Kevin E. Noonan --

Last Friday, the U.S. District Court for the District of Massachusetts (Judge William G. Young, presiding) granted a preliminary injunction to Amgen against Hoffman La-Roche, preventing Roche from selling its Mircera® drug product, a form of recombinant EPO that has been covalently linked to polyethylene glycol.  Last November, the U.S. Food and Drug Administration granted approval for Roche to market Mircera® (it has already been approved in Europe and is sold in Austria, Sweden, Germany, the United Kingdom, and Norway).  Roche had moved for the Court to permit it to launch (offering Amgen a 20% royalty), and there has been industry speculation that Roche might decide to launch at risk (see "Roche Plans to Launch Anemia Biologic Miceria [sic] in U.S. Despite Court Setback").  Neither of those options are available to Roche in the face of Judge Williams' injunction.

The Court's injunction is pursuant to a jury judgment on October 23, 2007 that Mircera® infringed several Amgen patents.  That verdict found Roche's Mircera® infringed Claims 3, 7, and 8 of Amgen's U.S. Patent No. 5,547,933 (claim 12 was found not to be literally infringed but infringed under the Doctrine of Equivalents); claims 1 and 2 of U.S. Patent No. 5,441,868; and claims 6 through 9 of U.S. Patent No. 5,618,698.  (Amgen's infringed claims were directed to recombinant methods and recombinant EPO protein.)  In addition, the jury found that Roche had not sustained its burden of establishing that any of Amgen's asserted claims were invalid (see "Amgen Survives Another EPO Challenge").

In its injunction order, the Court analyzed whether Amgen was entitled to an injunction using the four-factor test set forth by the Supreme Court in eBay Inc. v. MercExchange, L.L.C.  The District Court relied upon the jury verdict that Amgen's asserted claims were infringed and not invalid; in addition, the Court found that Amgen's injury would not be adequately compensated merely with money damages, and that the balance of the hardships weighed in favor of granting the injunction.  The most difficult prong for the Court to establish was the public interest, particularly in view of Roche's representations of the advantages of its Mircera® product over Amgen's version of EPO (including inter alia less frequent dosing; see "Long-Acting Drug for Dialysis Anemia Equivalent to Weekly Agent").

The Court did not make the injunction permanent, however, and announced that it "may modify" the injunction in 30 days, unless the Federal Circuit exercises jurisdiction by accepting an appeal (presumably from Roche).  The District Court did indicate that it would impose the following conditions if it were persuaded (presumably by its considerations of the public interest) not to make the injunction permanent.  First, Roche would pay Amgen a royalty of 22.5%; on February 20th, Amgen rejected an offer for a 20% royalty from Roche (see "Amgen Rejects Roche's Micera [sic] License Payment Offer").  Second, Roche could be introduced to the Medicare patient population at a cost no less than the average sales price of Amgen's EPO products (sold under the names Epogen® and Aranesp®) (a requirement that would prevent Roche from passing its royalty obligations onto patients, but would not prevent Roche from selling Mircera® at a bargain price relative to Epogen®).  Third, Roche would have to provide clinical evidence to permit the Court to determine a "dosage conversion factor" between Mircera® and Epogen®.  Fourth, Roche must pay for an independent agency to monitor sales and determine royalty payments owed to Amgen.  Finally, Roche must agree to supply Mircera® to any patient needing it, at or below the authorized price (presumably, this is a provision that would prevent Roche from abandoning the Medicare market once it has entered it).

The Court also denied the various post-judgment motions (for judgment as a matter of law and a new trial) by the parties.

Comments

[Susan Friedman]

Frankly, I feel that Roche has taken responsibility for creating a new drug that can help the lives of millions of people suffering from renal disease. Amgen wants to block the market from any company wanting to help others in a timely and cost efficient manner. Amgen has made millions on its drug and has also killed many people doing it. Amgen charges much to much for it's drug (we cannot afford it) and does not have a program to help patients with the cost. Physicians receive monetary kickbacks for putting their patients on Amgen's product, not caring if it kills them. The FDA should remove Amgen's product and market Roche's instead. This is strictly a political move on Amgen's part - as they would stand to lose millions (as would the doctors prescribing the medication). The government should realize that children are dying from renal disease and anemia that is a cause from it. Development of newer and SAFER anemia drugs should be developed and soon.