BETHESDA, Md., Dec. 20 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. , Northwest Biotherapeutics (“NWBT”) announced today that Lonza Group AG has withdrawn all claims of patent infringement involving NWBT’s DCVax(R)-Brain product and other NWBT DCVax(R) products other than DCVax(R)-Prostate. Lonza had alleged that NWBT’s DCVax(R) cancer vaccine products infringed certain gene expression technology patents held by Lonza. However, as could be seen from publicly available information sources -- available before the Lonza lawsuit was filed as well as since then -- NWBT does not use any gene modification or gene expression system in its DCVax(R) products.
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.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines, and therapeutic antibodies. The Company is currently conducting a large clinical trial in Glioblastoma multiforme, which is designed and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company also has a second technology platform, involving monoclonal antibodies to CXCR4, which is at the late pre-clinical development stage.
For further information, please visit the company web site at http://www.nwbio.com.
Disclaimer
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expects,” “believes,” “intends,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding the progress and NWBT’s expectations concerning the pending litigation with Lonza Group AG. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as uncertainties concerning the progress and ultimate outcome of the litigation involving Lonza Group AG. Additional information on these and other factors, which could affect the company’s results, is included in its Securities and Exchange Commission (“SEC”) filings. Finally, there may be other factors not mentioned above or included in the company’s SEC filings that may cause actual results to differ materially those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACT: Anthony Deasey of Northwest Biotherapeutics, Inc.,
+1-240-497-9036
Web site: http://www.nwbio.com/
