Active Ingredients: Ciprofloxacin
Their family traveled a lot before settling in Beverly Hills. Bayer, however, has labeled this theory as "plaintiffs' theory of infringing entry, which it likens to a market in stolen, infringing goods. Bayer Mot.The cohort database was continually updated until the inclusion of five patients serious adverse effects; renal toxicity is.
Bayer maintains that the 444 Patent, not the challenged agreements, blocked generic entry.
This analogy is unpersuasive.
Bayer in effect is substituting its self-fulfilling prophecy for plaintiffs' allegations, since unlicensed market entry is "infringing" only if the patent holder ultimately prevails.
Therefore, Bayer's argument assumes that the district court would have found the 444 Patent valid and that Barr's generic product would infringe the patent. But the district court made no such finding.
Therefore, defendants' claim that generic entry upon FDA approval is precluded is rejected. For instance, in Elan, the generic manufacturer, Elan, chose to delay marketing its product until the resolution of its lawsuit with Bayer, even though the parties agreed that, since the statutory stay had expired, Elan could come to market.
See 212 F. In this case, the complaints do not allege that Barr had the desire or intent to enter the market before resolution of the patent litigation.
In fact, the complaints seem to undermine plaintiffs' assertion. Consequently, without allegations that Barr intended to enter the market upon FDA approval, before a court decision on the validity of the 444 Patent, plaintiffs' claim of injury-in-fact based on this theory cannot withstand a motion to dismiss.
HMR and Rugby argue that plaintiffs have failed to allege an actionable antitrust injury flowing from HMR and Rugby's conduct because neither HMR nor Rugby exercised control over Barr's entry into the Cipro market prior to a resolution in the patent litigation and neither HMR nor Rugby had the legal capacity to produce Cipro.
Although neither HMR nor Rugby were parties to the patent litigation, the complaints clearly establish their participation in the challenged agreements. See I. Moreover, Barr and Rugby were to share equally in the profits derived from those sales.
However, the amendment provided that Rugby still retained the exclusive right to distribute any Cipro that HMR obtained the right to market or jointly market with Barr. The parties also agreed that all monies received from Bayer in connection with the settlement of the patent litigation would be split equally between Barr and HMR.
However, a fair reading of plaintiffs' complaints fails to establish any facts from which a jury could infer that either HMR or Rugby could have influenced or controlled Barr's decision to enter the domestic Cipro market prior to a resolution of the patent litigation.
In addition, to the extent plaintiffs allege that HMR and Rugby could have entered the market with their own generic Cipro product following Barr's statutory exclusivity period, this claim also fails.
The complaints do not allege otherwise. Moreover, any inference that HMR or Rugby would seek FDA approval in this situation is mere conjecture and unsupported by any facts in the complaints.
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