Item 8.01 Other Events.
Medicis Receives Notice of Allowance for SolodynŽ Patent
On October 13, 2009, Medicis Pharmaceutical Corporation (the "Company")
announced that the United States Patent and Trademark Office (USPTO) has issued
a Notice of Allowance for the Company's United States patent application
directed to the use of SOLODYNŽ (minocycline HCl, USP) Extended Release Tablets
in all five currently available dosage forms. The patent application is U.S.
Application No. 11/166,817, entitled "Method For The Treatment Of Acne." The
newly allowed claims include subject matter covering methods of using a
controlled-release oral dosage form of minocycline to treat acne. A press
release dated October 13, 2009 announcing the issuance of the Notice of
Allowance is attached as Exhibit 99.1 hereto and is incorporated herein by
reference.
Medicis Receives a Paragraph IV Patent Certification
On October 8, 2009, the Company received a Paragraph IV Patent Certification
from Lupin Ltd. ("Lupin") advising that Lupin has filed an Abbreviated New Drug
Application ("ANDA") with the U.S. Food and Drug Administration ("FDA") for
generic SOLODYNŽ in its forms of 45mg, 90mg and 135mg strengths. Lupin has not
advised the Company as to the timing or status of the FDA's review of its
filing, or whether it has complied with FDA requirements for proving
bioequivalence. Lupin's Paragraph IV Certification alleges that Lupin's
manufacture, use, sale or offer for sale of the product for which the ANDA was
submitted will not infringe any valid claim of the Company's U.S. Patent Nos.
5,908,838 (the "'838 Patent"), 7,541,347 (the "'347 Patent") or 7,544,373 (the
"'373 Patent"). The expiration date for the '838 Patent is in 2018. The
expiration dates for the '347 and '373 Patents are in 2027. The Company is
evaluating the details of Lupin's certification letter and considering its
options.
Item 9.01 Exhibits.
(d) Exhibits
99.1 Press Release dated October 13, 2009.