By Kevin E. Noonan —

The latest
challenge to Amgen's erythropoietin (EPO) franchise ended today, when
Hoffman-La Roche agreed to keep its pegylated derivative of human EPO, Mircera®,
off the market until July 1, 2014.  The U.S. Food and Drug Administration granted approval for Roche to market Mircera® in November,
2007 (it has already been approved in Europe and is sold in Austria, Sweden,
Germany, the United Kingdom, and Norway) but the company has been under an
injunction issued by Federal District Court Judge William G. Young pursuant to
a judgment of infringement against Roche at trial (see "Victory for Amgen in District Court Decision" – Part I, Part II, Part III).  While the terms
of the settlement are not public, according to Amgen there will be no payments
from either company.

The parties stipulated to final judgment and a permanent injunction against Roche in a paper
filed jointly with the District Court on Monday.  In the stipulation, Roche agreed
that the following claims of the patents-in-suit are "valid, enforceable
and infringed by Roche's Mircera® product":

(i)  
U.S.
Patent No. 5,756,349 (the '349 patent) claim 7,
(ii)  U.S.
Patent No. 5,547,933 (the '933 patent) claims 3, 7-8,
(iii)  U.S.
Patent No. 5,955,422 (the '422 patent) claim 1,
(iv)  U.S.
Patent No. 5,441,868
(the '868 patent) claims 1 and 2, and
(v)  U.S.
Patent No. 5,618,698 (the '698 patent) claims 6-9.

Roche also
agreed to dismissal with prejudice of its "claims, defenses and counterclaims."  The stipulation was entered by the
court as an order, to which it appended the following:

Except as
allowed under any license agreement reached between the parties, Roche, its
agents, servants, employees, counsel, and all persons and entities acting in
concert therewith, are hereby permanently enjoined for the life of U.S. Patent
No. 5,441,868, U.S. Patent No. 5,547,933, U.S. Patent No. 5,618,698, U.S.
Patent No. 5,955,422 and U.S. Patent No. 5,756,349 from infringing said patents
by the manufacture, importation, sale, offer for sale or non-exempt use of
pegylated Epoetin beta (otherwise referred to as "MIRCERA" or "CERA")
in the United States.

Settlement
eliminates risks for both parties.  Amgen sued Roche in a declaratory judgment
action in Massachusetts, asserting six patents:  U.S. Patent Nos. 5,547,933; 5,441,868; 5,618,698; 5,955,422 (claim 1); 5,756,349 (claim 7); and 5,621,080 (the '080 patent)  On October 23, 2007, a jury found that Mircera®
infringed the '933 patent, the '868 patent, and the '698 patent, and that these
patents, as well as the '422 patent and the '349 patent, were not invalid.  (The jury reached neither infringement nor validity of the '080 patent).  Specifically, the jury found that Roche's Mircera® infringed claims 3, 7, and 8
of the '933 patent (claim 12 was found not to be literally infringed but
infringed under the Doctrine of Equivalents); claims 1 and 2 of the '868
patent; and claims 6 through 9 of the '698 patent.  On October 1, 2008,
Massachusetts District Court Judge William Young ruled (in Amgen's favor for
each) on several post-trial motions, including:  1) affirming the jury's
infringement decision by denying Roche's motion for judgment as a matter of law
(JMOL); 2) reaffirming its pretrial decision to grant summary judgment
regarding infringement of claim 1 of the '422 patent; 3) "explaining"
its reasoning for ruling, also pretrial, that the claims of Amgen's
patents-in-suit are not invalid for obviousness-type double patenting (despite
the intervening Federal Circuit decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.);
4) denying Roche's motion for JMOL that claim 1 of the '422 patent and claims
3, 7, and 9 of the '933 patent are not invalid for indefiniteness for reciting
the term "human erythropoietin"; and 5) granting Amgen a permanent
injunction barring "Roche, its agents, servants, employees, counsel, and
all persons and entities acting in concert therewith" from infringing the claims
of the patents-in-suit for the remaining life of those patents.

The Federal
Circuit affirmed most of the determinations by the District Court and the jury,
including that the asserted claims of the '868 patent (claims 1 and 2) and the '698
patent (claims 6-9) are not invalid and were infringed, that claims 3, 7,
and 8 of the '933 patent and claim 1 of the '422 patent were infringed, and that
claims 9, 11, 12, and 14 of the '933 patent are not infringed by Mircera®.  However, the panel opinion vacated Judge Young's decision that the '933 (claims
3, 7, and 8), '349 (claim 7), and '422 (claim 1) patents are not invalid under
obviousness-type double patenting and remanded this issue to the trial court.  The Federal Circuit also vacated the
judgment that claim 7 of the '349 patent was not infringed and remanded for a
new trial on that issue.  This
decision put several of Amgen's patents at risk for invalidation under the
Federal Circuit's recent jurisprudence interpreting the scope of the "safe
harbor" of 35 U.S.C. § 121 (Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008) and Takeda Pharmaceutical Co. v. Doll (Fed. Cir. 2009)).  Invalidation of the '933, '349, and '422
patents would have reduced Amgen's patent protection on its various EPO
products (including Aranesp® and Epogen®) from May 2015 to August 2012 (more
than 3 years), which would have a significant (negative) effect on the
corporate bottom line.  Thus, by settling, Amgen has avoided invalidation
of these three patents, and Roche has avoided any damages or attorneys' fees
Amgen may have pursued.  Roche also
has obtained a date certain for entering the U.S. market with its pegylated EPO
product.

For additional information regarding this and other related topics, please see:

• "Obviousness-type Double Patenting after Amgen v. F. Hoffman-La Roche," September 27, 2009
• "Amgen Inc. v. Hoffman-La Roche Ltd. (Fd. Cir. 2009)," September 15, 2009
• "Amgen v. Hoffmann-LaRoche: Remaining Issues," October 13, 2008
• "Amgen v. Hoffmann-LaRoche: Back to the District Court," October 10, 2008
• "Victory for Amgen in District Court Decision – Part III," October 9, 2008
• "Victory for Amgen in District Court Decision – Part II," October 8, 2008
• "Victory for Amgen in District Court Decision – Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "How to Avoid a Permanent Injunction: The Lessons of Amgen v. Hoffmann-LaRoche," April 28, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008