Schering-Plough Corp. v Federal Trade Comm'n, F.3d, 2005 WL 528439 (Eleventh Circuit, 8th March, 2005) (‘Schering-Plough II’).
2.
In re Schering-Plough Corp., No. 04–10688, 2003 WL 22989651 (FTC, 8th December, 2003) (‘Schering-Plough I’).
3.
See footnote 19 of Schering-Plough II op. cit.2005.
4.
Schering-Plough I. In re Ciprofloxacin Hydrochloride Antitrust Fitig., 2005 WL 736604 (EDNY) 31st March (‘Cipro III’).
5.
Anon (2005) ‘Appeals court rejects FTC bright-line rule on antitrust liability, reverse payments’, Pharmaceutical Faw & Industry® Report, Volume 3, Number 10, 11th March, 2005, p. 243.
6.
Schering-Plough II at footnote 10.
7.
Five drugs were involved, but Schering was apparently most interested in a particular cholesterol-lowering drug.
8.
The licence was for markets outside of the USA, which were valued as being the same or larger than the US market alone.
9.
At least in the minds of Judge Rueter and Schering, there was some doubt that ESI would satisfy the contingency for the $10m payment, because data submitted with the ANDA were old and perceived to be defective.
10.
In addition, Schering licensed enalapril and buspirone from ESI for $15m.
11.
15 USC § 45(c).
12.
Valley Drug Co. v Geneva Pharm., Inc., 344 F.3d 1294, 1312 (Eleventh Circuit, 2003) (‘Valley Drug). Valley Drug is also discussed in Cipro III..
13.
Pharmaceutical Law & Industry® Report (2005) op. cit. at p. 243.
14.
Walker Process Equipment, Inc. v Food Machinery & Chem. Corp., 382 U.S. 172, 177, 86 S.CT. 347, 15 L.ED. 247 (1965).
15.
Upsher was able to enter the market more than five years prior to the expiration of Schering's '743 patent.
16.
Clearly, an arbitrary cap of $2m will not pass muster in the Eleventh Circuit.
17.
See Asahi Glass Co., Ltd. v Pentech Pharmaceuticals, Inc., 289 F. Supp. 2d 986, 991 (N.D. Ill. 2003).
18.
See In re Cardizem CD Antitrust Litig., 332 F.3d 896, 902 (Sixth Circuit, 2003) and the discussion thereof in Cipro III (2005) op. cit. In view of changes to the law, a bottleneck situation should not generally occur for ANDAs for products in which the first Paragraph IV certification was filed after 8th December, 2003.
