Now for the opposite perspective...
Court Ruling Strengthens Affymetrix Patent Estate
Updated: Thursday, January 25, 2001 09:03 PM ET
Favorable Markman Decision in Cases Against Hyseq and Incyte
SANTA CLARA, Calif., Jan. 25 /PRNewswire/ -- Affymetrix, Inc. (Nasdaq: AFFX, news, msgs) announced today that the U.S. District Court for the Northern District of California issued a Markman ruling confirming the broad scope of four U.S. patents that Affymetrix has asserted in litigation against Incyte Genomics, Inc. (Nasdaq: INCY, news, msgs) and Hyseq, Inc. (Nasdaq: HYSQ, news, msgs). The Markman process is intended to provide early clarity to interpret the claims in a patent dispute.
Importantly, the patents have not been limited to photolithography, and have been construed to cover multiple methods of array fabrication, including synthesis and "spotting techniques." Specifically, the Court accepted Affymetrix' position that: -- Affymetrix array patents are not limited to arrays made by photolithography, but also cover arrays made by other manufacturing techniques; -- Affymetrix array patents are not limited to arrays containing nucleic acids that are synthesized in situ, but also cover arrays containing nucleic acids that are pre-formed and then deposited; -- Affymetrix assay patents broadly cover the detection of nucleic acids on arrays using multiple labels; -- Affymetrix software patents broadly cover computer programs that identify a base using hybridization.
"Today's Markman ruling strengthens these patents and solidifies our intellectual property portfolio. Our portfolio includes more than 100 issued, 36 allowed and over 300 pending patent cases in the U.S. alone," stated Vern Norviel, Senior Vice President and General Counsel of Affymetrix. "The ruling reinforces our cases against Incyte and Hyseq and we will move expeditiously to prove their infringement."
BACKGROUND
Today's Markman ruling interpreted patent Nos. 5,445,934 ('934), 5,744,305 ('305), 5,800,992 ('992), and 5,795,716 ('716) that have been asserted against Hyseq and Incyte.
Patents '934 and '305 are members of a patent family that covers arrays of more than 1000 oligonucleotides or at densities of more than 400 polynucleotides per square centimeter, respectively. The Court interpreted the '934 patent to include arrays containing oligonucleotides synthesized in situ as well as those pre-formed and then deposited on the arrays, stating that "the specification uses 'formation of a polymer' to mean both synthesis and immobilization of preformed polymers." The Court interpreted the '934 patent, one of the first to issue from this patent family, to cover oligonucleotides ranging in length from two to 100 nucleotides that are covalently joined to a solid surface.
The '305 patent was issued after the '934 and includes broader claims. Specifically, the Court found that '305 claims include polynucleotides of two nucleotides or more in length, whose sequence is either known or knowable and attached to a solid surface. The Court also agreed with the Affymetrix definition of "attached" to mean "secured or joined", covalently or not.
The Court found that a "discrete cell location" or "predefined region" implied activation using an energy source (as used by Incyte) for both the '934 and '305 patents, the United States Patent and Trademark Office has recently allowed additional claims in Affymetrix' patent applications without this limitation. The Court's interpretation combined with the recent notices of allowance establish that Affymetrix' family of array patents covers arrays made by a wide variety of techniques for in situ synthesis and deposition of pre-formed polynucleotides.
Patent '992 is part of a "2-color" patent family which covers assays frequently used with DNA arrays. The Court found that the claims of '992 apply to using two different labels to detect "the presence or absence of two or more nucleic acid molecules" using hybridization. In construing Claim 1 of '992, the Court accepted Affymetrix' definitions that the method applies broadly to various types of genetic analysis on arrays including expression, genotyping and sequence detection. Only Claim 4 of the patent was limited by the Court to nucleic acid coming from two cell types.
Patent '716 is a member of one of Affymetrix' emerging software patent families. The Court interpreted claims in '716 to cover "a computer program product that identifies an unknown base in a sample nucleic acid sequence."
The Court rejected all of Hyseq's arguments, including their attempts to limit the claims of the '716 patent to the method described in the specification, and therefore upheld the full breadth of this patent.
Importantly, '716 covers a computer program to determine a nucleotide base using hybridization, independent of whether the hybridization is done on an array, beads or any other technology platform.
This Markman ruling did not construe claims of patent 6,040,193 ('193) or 5,871,928 ('928) that have been asserted by Affymetrix against Incyte. Patent '193 is a member of an Affymetrix instrument patent family covering spotting systems. Patent '928 is a member of an array family of patents directed to assays on arrays with densities of more than 100 per square centimeter.
Affymetrix is a leader in developing and commercializing systems to acquire, analyze and manage complex genetic information in order to improve the quality of life. The Company's GeneChip(R) system consists of disposable DNA probe arrays containing gene sequences on a chip, reagents for use with the probe arrays, a scanner, and other instruments to process the probe arrays and software to analyze and manage genetic information. The Company's spotted array system enables individual researchers to create and analyze custom microarrays on an easy-to-use, cost efficient platform. Additional information on Affymetrix and GeneChip technology can be found at www.affymetrix.com.
All statements in this press release that are not historical are "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix' "expectations," "beliefs," "hopes," "intentions," "strategies" or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to, uncertainties relating to technological approaches, product development, manufacturing, market acceptance, personnel retention, equity dilution, uncertainties related to the ability to realize benefits from acquisitions, uncertainties related to cost and pricing of Affymetrix products, dependence on collaborative partners, uncertainties relating to sole source suppliers, uncertainties relating to FDA and other regulatory approvals, competition, risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix' Annual Report on Form 10-K for the year ended December 31, 1999, and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Affymetrix' expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
SOURCE Affymetrix, Inc
CONTACT: Edward M. Hurwitz, Vice President and Chief Financial Officer, 408-731-5000, or Anne Bowdidge, Director of Investor Relations, 408-731-5925, both of Affymetrix, Inc. |
