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Nucleonics Plans Appeal of Courts Dismissal of Patent Infringement Litigation Brought by Benitec; Recent Decision on a Legal Technicality Does Not Address Patent Validity or Enforceability.


HORSHAM, Pa. -- Nucleonics nucleonics

the study of nucleons or of atomic nuclei and their reactions; nuclear physics.
, Inc., a biotechnology company focused on the development of novel expressed RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
 interference-based (eiRNA) therapeutics, announced today that it intends to appeal the decision made last Friday by the judge in the United States District Court for the District of Delaware The United States District Court for the District of Delaware is the Federal district court having jurisdiction over the entire state of Delaware. The Court sits in Wilmington. Currently, three judges and two magistrate judges preside over the court.  to dismiss the lawsuit filed against it by Benitec in March 2004. Nucleonics believes that the court erred on matters of law and fact and is preparing to appeal to the Court of Appeals for the Federal Circuit.

Robert Towarnicki, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Nucleonics stated, "Nucleonics has maintained since the litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 was filed by Benitec that the Benitec Patent issued in the United States as well as similar patent applications filed around the world by Benitec are invalid. To this end, Nucleonics' response to Benitec's lawsuit has been to invalidate the Benitec intellectual property worldwide and has eagerly sought its day in court. Now Benitec seeks to have the case dismissed on a technicality of jurisdiction, thereby avoiding adjudication on the merits on the merits adj. referring to a judgment, decision or ruling of a court based upon the facts presented in evidence and the law applied to that evidence. A judge decides a case "on the merits" when he/she bases the decision on the fundamental issues and considers . Nucleonics continues to believe that the patent is invalid and unenforceable and will pursue this case through the Appellate Court and continue to challenge the Benitec IP estate around the world."

Updating its efforts worldwide, Nucleonics is pleased to report that the US Patent Office, in response to the request for re-examination by Nucleonics, has issued a preliminary rejection of all claims of the Benitec Patent which is the issue of the litigation. Mr. Towarnicki added, "We are hopeful that the US Patent Office will make our court appeal moot by upholding the rejection of all the claims in the Benitec patent, however, we will remain proactive in our commitment to invalidate these patents and related applications."

Nucleonics has also enjoyed success in the European Patent Office, filing third party observations to Benitec's patent application that contributed to a final rejection of the Benitec application by the EPO EPO

see erythropoietin.

EPO Erythropoietin, see there
 after proceedings that included Benitec filing multiple amendments, two declarations by an expert and the inventor, and, finally an oral hearing before a panel of examiners. The claims were rejected for lack of inventive step, lack of sufficiency of disclosure Most patent law systems require that a patent application disclose a claimed invention in sufficient detail for the notional person skilled in the art to carry out that claimed invention. , and lack of novelty. Nucleonics believes the Benitec US Patent and related applications pending in the US and EPO suffer the same flaws.

With respect to Benitec's Australian patent, Nucleonics was surprised by the Australian Patent Office's reversal of its initial findings of invalidity in the re-exam requested by Nucleonics. According to Mr. Towarnicki, Nucleonics chose not to pursue further action in the Australian Patent Office since "Nucleonics now possesses an issued patent in Australia (No. 776150) that will prevent Benitec from practicing RNA interference in any vertebrate, including humans, without taking a license from Nucleonics."

About Expressed Interfering RNA (eiRNA)

Post-transcriptional gene silencing, also known as RNA interference or RNAi, is a phenomenon in which genes are silenced in a sequence-specific manner through targeted mRNA (messenger RNA) degradation. Researchers believe RNAi may offer potential as a novel way to silence genes involved in disease, including genes encoded by viruses such as Hepatitis B, Hepatitis C and HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , as well as genes involved in the establishment of inflammatory diseases and cancer.

Nucleonics is licensed under the RNAi technology of Andrew Fire, Craig Mello and their colleagues, widely recognized as the seminal work in this area. Nucleonics employs an expressed interfering RNA (eiRNA) approach whereby scientists insert plasmid DNA coding for relevant double-stranded RNA (dsRNA) into targeted cells, inducing the cells to produce and deliver specific dsRNA sequences. Cellular mechanisms then cleave cleat, cleave

claw of any cloven-footed animal.
 the dsRNA into specifically encoded siRNAs (short interfering RNA), which silence the targeted genes. Nucleonics' researchers have shown the ability of long or short dsRNA strands produced in this way to silence genes, including Hepatitis B, Hepatitis C, and HIV, in relevant cell lines for extended periods of time. Moreover, they have silenced multiple genes, as well as HBV HBV hepatitis B virus.

HBV
abbr.
hepatitis B virus
 replication, in adult mice without triggering an interferon response. Plasmid DNA approaches similar to that used by Nucleonics for expression of dsRNA have demonstrated human safety in over 500 patients to date, in the field of DNA-based vaccines. Nucleonics is initially directing its technology to the development of eiRNA therapeutics for Hepatitis B virus and Hepatitis C virus
This page is for the virus. For the disease, see Hepatitis C.
The Hepatitis C virus (HCV) is a small (50 nm in size), enveloped, single-stranded, positive sense RNA virus in the family Flaviviridae.
 infections.

About Nucleonics, Inc.

Nucleonics, founded in January 2001, is an emerging biotechnology company focused on the development of novel RNA interference-based therapeutics for viral and other diseases. Privately owned Nucleonics is headquartered in Horsham, Pennsylvania.
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Publication:Business Wire
Geographic Code:1USA
Date:Oct 5, 2005
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