SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 7, 1995
ROYCE LABORATORIES, INC.
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(Exact name of registrant as specified in its charter)
Florida 0-15178A 59-2202295
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(State or other (Commission File (IRS Employer
jurisdiction of Number) Identification No.)
incorporation)
5350 N.W. 165th Street, Miami, Florida 33014
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (305) 624-1500
16600 N.W. 54th Avenue, Miami, Florida 33483
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(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS
On August 4, 1995, the Company was sued by Bristol-Myers Squibb
Company, Inc. and E.R. Squibb & Sons, Inc. (collectively, "Bristol-Myers") for
patent infringement relating to Captopril. The suit was brought in the U.S.
District Court for the Southern District of Florida (Case No. 95-1682).
Bristol-Myers holds the patent for Capoten(Registered trademark). Captopril is
the generic version of Capoten(Registered trademark)
In March 1995, the Company received a tentative approval from the Food
and Drug Administration ("FDA") of the Company's abbreviated new drug
application ("ANDA") for Captopril. In order to market Captopril, the Company
must receive final approval of its ANDA, which will not be granted until the
expiration of patent protection for Capoten(Registered trademark) and is subject
to the Company remaining is substantial compliance with current good
manufacturing practices.
Under the recently adopted General Agreement on Tariffs and Trade
("GATT") treaty implementing legislation, patent protection for
Capoten(Registered trademark) was extended from August 8, 1995 until February
13, 1996. However, on June 26, 1995, the Company asserted in a certification
filed with the FDA that under GATT, the Company should have the right to market
Captopril after August 8, 1995, subject to the Company's possible obligation to
pay "equitable remuneration" to Bristol-Myers during the period between August
8, 1995 and February 13, 1996. This lawsuit was filed by Bristol-Myers in
response to the filing of the certification by the Company.
The suit seeks a declaration that Bristol-Myers' patent for
Capoten(Registered trademark) does not expire earlier than February 13, 1996,
that the Company is not entitled to market the product under GATT between August
8, 1995 and February 13, 1996 even with the payment of equitable remuneration
and that the Company's infringement of this patent is willful and deliberate. It
also seeks attorney's fees, costs and such other relief as the case may require
and the Court may deem just and proper. Although the Company has not yet
marketed Captopril, Bristol-Myers claims that the filing of the certification
with the FDA was itself an infringement of the patent. Bristol-Myers has stated
that its position is supported by an FDA ruling and a recent judicial opinion
of the U.S. Court of Appeals for the Federal Circuit.
The Company believes that its interpretation of the GATT treaty
implementing legislation is accurate. The Company is vigerously contesting this
suit. There can be no assurance as to the outcome of the suit.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the Company has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Dated: August 18, 1995 ROYCE LABORATORIES, INC.
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(Registrant)
By: /s/ PATRICK J. McENANY
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Patrick J. McEnany, President
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