Johnson and Johnson 2006 Annual Report Download - page 73

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NOTES TO CONSOLIDATED FINANCIAL ST A TEMENTS71
Brand Name Patent/NDA Generic Trial Date30-Month
Product Holder Challenger Court DateFiled Stay Expires
DITROPAN XL®Ortho-McNeil Mylan D. W.V. 02/05 05/03 09/05
5, 10, 15 mg ALZAImpax N.D. Cal. 12/05 09/03 01/06
controlled release tablet
ORTHO TRI CYCLEN® LO Ortho-McNeil Barr D. N.J. * 10/03 02/06
0.18 mg/0.025 mg
0.215 mg/0.025 mg
and 0.25 mg/0.025 mg
PEPCID®Complete McNeil-PPC Perrigo S.D. N.Y. 02/07 02/05 06/07
RAZADYNE™Janssen Teva D. Del 05/07 07/05 01/08
Mylan D. Del 05/07 07/05 01/08
Dr. Reddy’s D. Del 05/07 07/05 01/08
Purepac D. Del 05/07 07/05 01/08
Barr D. Del 05/07 07/05 01/08
Par D. Del 05/07 07/05 01/08
AlphaPharm D. Del 05/07 07/05 01/08
RAZADYNE™ER Janssen Barr D. N.J. * 06/06 11/08
RISPERDAL® Tablets Janssen Mylan D. N.J.06/06 12/03 05/06
.25, 0.5, 1, 2, 3, 4 Dr. Reddy’s D. N.J.06/06 12/03 06/06
mg tablets Apotex D. N.J. * 06/06 11/08
RISPERDAL®M-Tab Janssen Dr. Reddy’s D. N.J.06/06 02/05 07/07
0.5, 1, 2, 3, 4 mg
RISPERDAL®Oral Janssen Apotex D. N.J. * 03/06 08/08
Solution, 1 mg/ml
TOPAMAX®Ortho-McNeil Mylan D. N.J. * 04/04 09/06
25, 50, 100, 200 mg tabletCobalt D. N.J. * 10/05 03/08
TOPAMAX®SPRINKLE Ortho-McNeil Cobalt D. N.J. * 12/05 05/08
15, 25 mg capsule Mylan D. N.J. * 10/06 03/09
* Trial date to be established.
In the action against Mylan and Dr. Reddy’s Laboratories
regarding RISPERDAL®(risperidone) tablets and M-Tabs, the
District Court in New Jersey ruled, on October 13, 2006, that the
RISPERDAL®patent was valid, enforceable, and infringed by the
generic products at issue, and entered an injunction prohibiting
Mylan and Dr. Reddy’s from marketing their generic risperidone
products until a date no earlier than patent expiration in Decem-
ber 2007. Mylan has appealed that ruling.
In the action against Mylan with respect to the patent on
TOPAMAX®, the District Court in New Jersey, on October 24,
2006, granted the Company’s subsidiary Ortho-McNeil Pharma-
ceutical, Inc.’s (Ortho-McNeil) motion for a preliminary
injunction barring launch by Mylan of its generic version
of TOPAMAX®. On February 2, 2007, the district court granted
Ortho-McNeil’s motion for summary judgment dismissing
Mylan’s claim the patent was obvious, the only remaining issue in
the case. The Company expects judgment in the case will shortly
be entered for Ortho-McNeil, and that Mylan will then appeal.
In the action against Mylan involving Ortho-McNeil’s
product, DITROPAN XL®(oxybutynin chloride), the court in
September 2005 found the DITROPAN XL®patent invalid and
not infringed by Mylan’s generic product. Those rulings were
affirmed by the Court of Appeals for the Federal Circuit on
September 6, 2006. Mylan and Impax received final FDA
approval and launched their products in November 2006.
In the weeks following the adverse ruling in the DITROPAN
XL®ANDA litigation against Mylan in September 2005, Johnson
& Johnson and ALZA received seven antitrust class action
complaints filed by purchasers of the product. They allege that
Johnson & Johnson and ALZA violated the antitrust laws of the
various states by knowingly pursuing baseless patent litigation,
and thereby delaying entry into the market by Mylan and Impax.