Contingencies and commitments |
20. Contingencies and commitments
Contingencies
In the ordinary course of business, we are involved in various legal proceedings and other matters that are complex in nature and have outcomes that are difficult to predict. We record accruals for such contingencies to the extent that we conclude that it is probable that a liability will be incurred and the amount of the related loss can be reasonably estimated.
Certain of our legal proceedings and other matters are discussed below:
Roche Matters
Amgen Inc. v. F. Hoffmann-La Roche Ltd., et al.
On November8, 2005, Amgen filed a lawsuit in the Massachusetts District Court against F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH and Hoffmann-La Roche, Inc. (collectively, Roche Defendants) seeking a declaration by the court that the importation, use, sale or offer to sell pegylated erythropoietin (alternatively referred to as peg-EPO or MIRCERA) infringes Amgens EPO patents. Amgen alleged infringement of six of its U.S. Patents that claim erythropoietin products, pharmaceutical compositions and processes for making erythropoietin, specifically U.S. Patent No.5,547,933 (the 933 Patent), U.S. Patent No.5,621,080 (the 080 Patent), U.S. Patent No.5,955,422 (the 422 Patent), U.S. Patent No.5,756,349 (the 349 Patent), U.S. Patent No.5,618,698 (the 698 Patent) and U.S. Patent No.5,441,868 (the 868 Patent). Amgen sought a permanent injunction preventing the Roche Defendants from making, importing, using, offering for sale or selling recombinant human erythropoietin, including pegylated EPO, in the United States. The Roche Defendants amended answer asserted that all six of the patents-in-suit were not infringed, were invalid and were unenforceable due to inequitable conduct and counterclaimed asserting violations of federal and state antitrust laws. On June5, 2007, the Massachusetts District Court entered an order dismissing the 080 Patent from the case.
The Massachusetts District Court conducted a jury trial on infringement and validity, a bench trial on other issues of validity and enforceability, and heard pre- and post-trial motions. On October17, 2008, the Massachusetts District Court entered judgment that claim 1 of the 422 Patent, claims 3, 7, 8, 9, 11, 12 and 14 of the 933 Patent, claims 1 and 2 of the 868 Patent, claims 6 through 9 of the 698 Patent and claim 7 of the 349 Patent are valid and enforceable, and that claim 1 of the 422 Patent, claims 3, 7 and 8 of the 933 Patent, claims 1 and 2 of the 868 Patent, and claims 6 through 9 of the 698 Patent are infringed and permanently enjoined Roche from infringing the 422 Patent, the 933 Patent, the 868 Patent and the 698 Patent for the remaining life of these patents.
The Roche Defendants filed an appeal with the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) and Amgen filed a cross-appeal. On September15, 2009, the Federal Circuit Court affirmed the Massachusetts District Courts judgment with respect to infringement of the 933, 422, 698 and 868 Patents and vacated the holding of non-infringement of the 349 Patent. The Federal Circuit Court also affirmed the validity of Amgens patents except for a |