Lonza Withdraws Majority of Claims in Patent Lawsuit Against Northwest Biotherapeutics

   Lonza filed suit against NWBT on July 27, 2007, in the U.S. District Court for the District of Delaware, alleging that all of NWBT's DCVax(R) products infringed certain gene expression patents held by Lonza. After the filing of a lawsuit, a period of up to 120 days is allowed for service of the complaint on the party sued. In this case, Lonza chose not to serve NWBT throughout the entire 120-day period. As a result, the filing of an answer and counterclaims by NWBT was delayed until this extended period had expired. During the 120-day period, NWBT provided further information to Lonza -- in addition to the already publicly available information sources -- showing that NWBT's DCVax(R) products do not use any gene expression system. When Lonza still chose not to withdraw its complaint, NWBT filed an answer and counterclaims as soon as the 120-day period expired, denying all infringement claims by Lonza, and seeking recovery for violation of the Delaware Deceptive Trade Practices Act, unfair competition, tortious interference with prospective contractual relations, and abuse of process, including, among other things, treble damages and punitive damages. Following NWBT's filing of this answer and counterclaim, Lonza agreed with NWBT to the dismissal of both Lonza's entire complaint and NWBT's answer and counterclaims in Delaware.

   However, simultaneously, Lonza filed a new, second lawsuit in the U.S. District Court for the District of Maryland, again alleging infringement by NWBT and potentially including again up to the full range of NWBT's DCVax(R) products. The new second lawsuit removed explicit references to DCVax(R) products other than DCVax(R)-Prostate, but still claimed that not only DCVax(R)-Prostate but also "other infringing products or technologies" of NWBT infringed Lonza's gene expression patents. In light of the information available to Lonza both from public sources and privately from NWBT, NWBT demanded that Lonza remove all allegations from the second complaint in Maryland relating to any product other than DCVax(R)-Prostate.

   Following NWBT's demand, Lonza has withdrawn from its Maryland complaint all allegations of infringement by NWBT products other than DCVax(R)-Prostate. This withdrawal was put into effect by Lonza's filing of an Amended Complaint in the U.S. District Court in Maryland on December 13, 2007 that accuses only DCVax(R)-Prostate of infringement (and asserts related state law claims).

   Thus, the only remaining allegation by Lonza of infringement now relates to NWBT's DCVax(R)-Prostate product. NWBT strongly disputes that its activities surrounding DCVax(R)-Prostate constitute any infringement by NWBT, and NWBT intends to fight the remaining Lonza claims vigorously.

   The only use of a gene expression system ever connected in any way, even indirectly, with any NWBT product has been the use by an unrelated third-party manufacturer of a gene expression system to produce two batches of recombinant PSMA protein for NWBT nine years ago and six years ago, respectively. The third party manufacturer chose the gene expression system it used, and was the only party who used that expression system in any connection with NWBT's product. NWBT did not use, nor has it ever used, Lonza's expression system. NWBT contracted to receive, and did receive, two batches of recombinant PSMA protein from the manufacturer. The PSMA protein that NWBT received was used in the manufacture of only one NWBT product: DCVax(R)-Prostate. The lots of DCVax(R)-Prostate product which involved these two batches of PSMA protein were used solely for early clinical trials in 1999 and 2000, and briefly in 2002, in the US. No other recombinant protein has ever been used to manufacture any other DCVax(R) product.

   Keywords: Bioengineering, Biopharmaceuticals, Biotechnology, Biotechnology Business, Biotechnology Company, Cancer Vaccines, Gene Therapy, Genetics, Genomics, Immunization, Northwest Biotherapeutics Inc., Oncology, Patent Actions, Patents Actions, Vaccination, Northwest Biotherapeutics Inc.

   This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.

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