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  • Conference & CLE Calendar

    Calendar_19
    August 23-24, 2007 – Current Issues in Complex IP Licensing: Business and Legal Factors for Licensing Transactions (Law Seminars International) – Seattle, WA

    August 24, 2007 – Managing Patent Prosecution and Litigation: New Regulations, Rules and Challenges, along with Practical Tips for Success (Law Seminars International) – San Francisco, CA

    September 6-7, 2007 – Emerging Issues in Biotechnology Law (American Law Institute & American Bar Association) – Washington, D.C.

    September 18-19, 2007 – Pharma/Biotech Patent Boot Camp (American Conference Institute) – San Francisco, IL***

    September 24-25, 2007 – Biosimilars 2007 (Scherago International, Inc.) – George Washington University, Washington, D.C.

    September 26-27, 2007 – Advanced Forum on Biotech Patents (American Conference Institute) – Boston, MA***

    September 27-28, 2007 – Biotechnology: Business and Legal Developments (Law Seminars International) – Seattle, WA

    October 12, 2007 – Intellectual Property Law Summit 2007 (West LEGALWorks and Intellectual Property Law Association of Chicago) – Chicago, IL

    October 25-26, 2007 – Biotech and Pharma Public-Private Partnerships Forum (American Conference Institute) – Washington, D.C.***

    ***Patent Docs is a media sponsor of this conference or CLE.

  • ALI-ABA Biotechnology Law Conference

    Washington Monument #2 The American Law Institute (ALI) and American Bar Association (ABA) will be holding a conference entitled: "Emerging Issues in Biotechnology Law" on September 6-7, 2007 in Washington, D.C.  The conference will address current issues in biotechnology and related legal developments, including collaborations with academia, business alliances, working with the federal government and Department of Defense, clinical trials, intellectual property, agricultural biotechnology, third-wave-industrial biotechnology, FDA response to emerging technologies, and international issues.

    Aliaba_180_70_new
    The program for the Biotechnology Law conference as well as detailed descriptions of the conference's presentations can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

    The registration fee for the conference is $1,195.  Those interested in registering can do so here, by calling 1-800-CLE-NEWS, or by faxing 215-243-1664.

  • Patent Profile: Oncolytics Announces Issuance of Patent for Viral Treatment of Cellular Proliferative Disorders

        By Donald Zuhn —

    Oncolytics_biotech
    On Tuesday Oncolytics Biotech Inc. announced that it had been granted U.S. Patent No. 7,252,817.  The ‘817 patent, which relates to methods for treating cell proliferative disorders such as neoplasms by administering modified modified herpes simplex viruses (HSV) to proliferating cells having an activated Ras-pathway, was the twenty-second U.S. patent to be awarded to the Calgary-based biotech company.

    According to the statement released by Oncolytics, the ‘817 patent expands the company’s intellectual property portfolio to viruses other than reovirus.  Oncolytics focuses on the development of oncolytic viruses as potential cancer therapeutics.  As we reported previously, Oncolytics has had an ongoing clinical program related to the use of REOLYSIN®, Oncolytics’ proprietary formulation of the human reovirus (Respiratory Enteric Orphan virus), alone or in combination with radiation or chemotherapy, for the treatment of a number of human tumors, including colorectal, prostate, pancreatic and non-small cell lung, melanoma, and ovarian cancers.

    The ‘817 patent issued from U.S. Application No. 10/418,290, filed April 13, 2003, and claims the benefit of U.S. Provisional Application No. 60/164,878, filed November 12, 1999.  Representative independent claim 1 of the ‘817 patent recites:

    1.  A method for treating a neoplasm in a mammal, comprising the steps of:

    (a)  selecting a mammal with a neoplasm wherein cells of the neoplasm are unable to activate a PKR-mediated response to viral infection; and

    (b)  administering to the cells of the neoplasm an effective amount of at least one modified HSV under conditions that result in substantial lysis of the cells of the neoplasm, wherein in the modified HSV, the gamma1-34.5 gene is lacking, inhibited or mutated such that PKR activation is not blocked.

    For additional information concerning this and other related topics, please see:

  • Archemix Announces Agreements with Isis and SomaLogic

        By Jason Derry —

    Archemix
    Archemix Corp. has announced alliances with Isis Pharmaceuticals and SomaLogic.  Archemix, a biotechnology company located in Cambridge, MA, filed an initial public offering July 25, 2007.  Archemix focuses on developing apatmers as directed therapeutics to prevent and treat chronic and acute diseases.  One of Archemix’s lead drug candidates is currently set Isis_pharmaceuticals
    to move into Phase IIa clinical trials for treating acute coronary syndrome and into Phase Ib clinical trials for treating thrombotic thrombocytopenic purpura.  The alliance with Isis gives Archemix access to several oligonucleotide composition and method patents.  The alliance with SomaLogic clarifies a cross-licensing agreement by which Archemix will hold exclusive rights to therapeutic areas, while SomaLogic holds exclusive rights in diagnostics and ex vivo Somalogic
    detection applications.  In addition, Archemix has the option to give targets for aptamer development to SomaLogic.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  • Patent Profile: Rosetta Genomics Announces Issuance of Human miRNA Patent

        By Donald Zuhn —

    Rosetta_genomics
    Rosetta Genomics, Ltd. announced on July 31, 2007 that it had been granted U.S. Patent No. 7,250,496.  While the ‘496 patent discloses two large groups of genes: 20,600 genomic address messenger (GAM) genes, which selectively inhibit the translation of disease-associated target genes, and 6,635 genomic record (GR) genes – miRNA-like genes that modulate the expression of known target genes, the claims of the ‘496 patent are directed to only one of the 27,235 disclosed sequences: human microRNA miR-492.

    The ‘496 patent is the second U.S. patent to be awarded to Rosetta Genomics.  Patent Docs previously reported on the issuance of the Rehovot, Israel-based biotech company’s first U.S. patent (U.S. Patent No. 7,217,807), which Rosetta asserts is the first microRNA gene patent to be issued worldwide.

    Rosetta Genomics focuses on diagnostic and therapeutic product development based on microRNA – small, single-stranded forms of RNA generated from endogenous hairpin-shaped transcripts that regulate protein production.  A complete description of microRNAs (as well as a nice animation) can be found at the company’s website.

    The ‘496 patent issued from U.S. Application No. 10/310,914, which was filed December 6, 2002, and which claims the benefit of U.S. Application No. 10/293,338, which was filed November 14, 2002.  The lone independent claims of the ‘496 patent recites:

    1.  An isolated nucleic acid wherein the sequence of the nucleic acid consists of the sequence of SEQ ID NO: 12003.

  • Reversal in Microsoft Case Weakens Patent Reform Argument

        By Donald Zuhn —

    Url_2
    As we reported yesterday, the San Francisco Chronicle waded into the patent reform debate over the weekend, appearing to have aligned itself with the "laptop" (or tech) group over the "pill bottle" (or biotech/pharma) group.  In making a case for the tech firms’ position that patent reform is "badly needed," the newspaper’s editorial observed that "[i]n a much-mentioned case, Microsoft was hit with a $1.5 billion penalty when it violated a relatively small patent used in its MP3 software."  However, on Monday, a District Court judge in the Southern District of California put a dent in the Chronicle’s argument by vacating the jury’s record-setting patent infringement award (see Reuters report).

  • Nucleonics Files Petition for Rehearing En Banc

        By Kevin E. Noonan —

    Nucleonics
    Horsham, Pennsylvania biotech company Nucleonics, Inc. announced today that it has filed a petition with the Court of Appeals for the Federal Circuit for rehearing en banc of the Court’s July 20, 2007 decision upholding dismissal of its declaratory judgment counterclaims against Benetic Australia Ltd. over patents on RNA interference (RNAi) technology.

    The case involved a patent infringement suit brought against Nucleonics by Benitec over U.S. Patent No. 6,573,099 claiming "gene silencing" technology.  Although Benitec’s infringement action was mooted by the Supreme Court’s decision in Merck KGaA v. Integra Life Sciences decision (and Benetec moved for its compliant to be dismissed without prejudice), Nucleonics wanted the District Court to hear its declaratory counterclaims of invalidity and unenforceability.  The District Court dismissed Nucleonics’ counterclaims on the grounds that the Court did not have jurisdiction under the Declaratory Judgments Act, because the basis for Benitec’s infringement case had evaporated in view of the Merck decision.

    Federal_circuit_seal
    The Federal Circuit affirmed, based on its interpretation of the Supreme Court’s MedImmune, Inc. v. Genentec, Inc. decision, "disapproving" of the CAFC’s prior "reasonable apprehension of imminent suit" test (see Patent Docs report).  The Federal Circuit held that the requirements of Article III jurisdiction contained in the Declaratory Judgments Act, even when interpreted under the Supreme Court’s MedImmune decision, included that there be an underlying dispute between the parties to trigger jurisdiction, and that MedImmune had not absolved declaratory judgment plaintiffs from the burden of establishing that there was an underlying controversy between the parties that created a cause of action for the declaratory judgment defendant.  Holding that Nucleonics had "not made a showing of ‘sufficient immediacy and reality’ to support declaratory judgment jurisdiction," the Federal Circuit affirmed dismissal of Nucleonics’ declaratory judgment counterclaims.

    Nucleonics has now asked the full Court to reconsider the decision.  Under Federal Circuit Rule 35(b), a party may petition for rehearing en banc if either:

    (A)  the panel decision conflicts with a decision of the United States Supreme Court or of the court to which the petition is addressed and consideration by the full court is therefore necessary to secure and maintain uniformity of the court’s decisions; or
    (B)  the proceeding involves one or more questions of exceptional importance, for example, where the panel decision conflicts with the authoritative decisions of other United States Courts of Appeals that have addressed the issue.

    If Nucleonics’ petition is denied, or if the CAFC sitting en banc should affirm the panel decision, Nucleonics may give the Supreme Court another opportunity to review a Federal Circuit decision on declaratory judgment jurisdiction.  Since the crux of Justice Scalia’s decision in MedImmune was contained in a footnote, the Supreme Court may welcome the additional opportunity to address the issue more thoroughly (or at least more directly) by granting certiorari.

  • San Francisco Chronicle Opines on Patent Reform

        By Donald Zuhn —

    Url
    In an editorial appearing in Sunday’s edition of the San Francisco Chronicle, the Bay area newspaper appears to have, perhaps not surprisingly, taken sides with tech companies on the issue of patent reform.  In an editorial entitled "The laptop vs. the pill bottle," the Chronicle acknowledges the ongoing battle between biotech/pharma companies and tech firms over an "obscure, but crucial" area of the law that the newspaper contends hasn’t undergone major revision since the 1950’s (dismissing or simply forgetting about significant revisions to U.S. patent law that took effect in 1995 and 2000).  However, despite labeling the battle between these two groups "a neighborhood quarrel," the Chronicle seems to find favor with the tech firms’ argument that current U.S. patent law has created "a legal battleground where scattershot court decisions and murky rules are hindering innovation and clogging courts," and therefore, ultimately calls for "badly needed" changes.  With respect to the Patent Office’s role in improving the system, the editorial concludes, without offering much support, that "[a]ll sides in the debate acknowledge that applications should be harder to win, thus cutting down on later conflicts."

    For additional information on this topic, please see:

  • Patent Profile: Digilab Peptidomics Receives U.S. Patent No. 7,202,044 for Alzheimer’s Disease Biomarkers

        By Kwame Mensah —

    Dbvn_170_73
    Digilab Peptidomics announced last month that the U.S. Patent and Trademark Office had granted U.S. Patent No. 7,202,044, which is directed to a panel of biomarkers for the diagnosis of chronic dementia or a predisposition to such diseases.  According to the company’s press release, by using proprietary Peptidomics® technologies, Digilab scientists identified a group of Osteonpontin marker peptides that correlates to Alzheimer’s disease, vascular dementia, and Parkinson’s disease.  Diglab believes that these new Peptidomics® biomarkers can be used in an alternative or supplementary method to the mini-mental score, as well as prove to be useful in early and reliable detection methods for the above diseases.  The ‘044 patent is one of three U.S. patents to be issued to the Hannover, Germany-based biotech company,  formerly known as BioVisioN AG.

    The ‘044 patent issued from U.S. Application No. 10/476,976, which is a national stage application of International Application No. PCT/DE02/01665, filed May 8, 2002, which claims the benefit of German Application No. DE 101 22 543, filed May 9, 2001.  The lone independent claim of the ‘044 patent recites:

    1.  A method for detecting Alzheimer’s disease in a patient, comprising the step of identifying, in a biological sample from said patient, an elevated concentration of at least one dementia-related osteopontin marker peptide selected from the group consisting of DROPN-5(SEQ ID NO:5), DROPN-10(SEQ ID NO:10), DROPN-20(SEQ ID NO:20), and phosphorylated DROPN-10(SEQ ID NO:10), when compared to a control, said elevated concentration of said at least one dementia-related osteopontin marker peptide being indicative of the existence of Alzheimer’s disease in said patient.

    And dependent claims 2 and 3 recite:

    2.  The method as claimed in claim 1, wherein the step of identifying includes the step of determining the relative concentration of said at least one marker peptide, compared with the concentration of the same peptide in a control sample, where

    a)  the concentration change, which is specific for the particular marker peptide, in the biological sample is found relative to a control sample, and

    b)  a significant marker peptide concentration change with an error probability of less than at least in 90% a) is regarded as positive detection result for the chronic dementia disease.

    3.  The method as claimed in claim 1, wherein the identifying step is carried out in combination with a mini-mental state examination or a mini-mental score to increase the sensitivity and/or specificity thereof.

  • Court Report

        By Sherri Oslick —

    Gavel_21
    About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Lonza Group AG v. Northwest Biotherapeutics Inc.
    1:07-cv-00467; filed July 27, 2007 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 5,122,464 ("Method for Dominant Selection in Eucaryotic Cells," issued June 16, 2992), 5,591,639 ("Recombinant DNA Expression Vectors," issued January 7, 1997), 5,658,759 (same title, issued August 19, 1997), 5,770,359 ("Recombinant DNA Sequences, Vectors Containing Them and Method for the Use Thereof," issued June 23, 1998), 5,827,739 (same title, issued October 27, 1998), 5,879,936 ("Recombinant DNA Methods, Vectors and Host Cells," issued March 9, 1999), 5,891,693 (same title, issued April 6, 1999), and 5,981,216 ("Transformed Myeloma Cell-Line and a Process for the Expression of a Gene Coding for a Eukaryotic Polypeptide Employing Same," issued November 9, 1999) based on Northwest’s manufacture and anticipated sale of its DCVax® products, including DCVax®-Brain, used to treat brain cancer.  View the complaint here.


    Astrazeneca AB et al. v. Dr. Reddy’s Laboratories, Ltd. et al.
    1:07-cv-06790; filed July 27, 2007 in the Southern District of New York

    Infringement of U.S. Patent Nos. 5,690,960 ("Pharmaceutical Formulation of Omeprazole," issued November 25, 1997) and 5,900,424 ("Omeprazole Magnesium Salt Form," issued May 4, 1999) following a paragraph IV certification as part of Dr. Reddy’s filing of an ANDA to manufacture a generic version of Astrazeneca’s Prilosec OTC (omeprazole magnesium, used to treat heartburn).  View the complaint here.  [NB: While the complaint recites Astrazeneca’s Nexium® as the subject of the ANDA filing, Patent Docs has reason to believe that this was an inadvertent error in the complaint, and that plaintiffs intended to refer to Prilosec OTC.]