This lawsuit involves a dispute between Amgen and Genentech regarding the labeling and patent infringement of a drug called MVASI. Amgen admits certain allegations related to the labeling of the drug, but denies others. They also admit certain language in the patent claims, but deny other allegations related to the patent. Amgen asserts several affirmative defenses, including failure to state a claim, lack of subject matter jurisdiction, invalidity of the patents, non-infringement, exemption under the safe harbor provision, no willful infringement, no recovery of costs, no exceptional case, no equitable relief, lack of standing, compliance with the BPCIA procedures, waiver and estoppel, failure to mitigate harm, unclean hands, and inequitable conduct. In summary, the lawsuit involves disputes over the labeling and patent infringement of the drug MVASI, with Amgen denying many of the allegations made by Genentech and asserting various affirmative defenses.