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  • Book Review: Patents for Business: The Manager’s Guide to Scope, Strategy, and Due Diligence

          By Christopher P. Singer —

    Patent Docs was given the opportunity to review a recently-published
    book by patent attorney M. Henry Heines, Ph.D., titled "Patents for
    Business: The Manager’s Guide to Scope, Strategy, and Due Diligence"
    (Praeger Publishers, Westport, CT (2007)).  In his text, Dr. Heines provides an easy-to-read overview of
    Heinespatents_reduce
    intellectual property issues that are most likely to come up in corporate
    situations.  Dr. Heines writes in a clear
    and concise style and touches on topics including due diligence, patentable
    subject matter (including the basic requirements of 35 U.S.C. §§ 102 and 103),
    claim scope and strategy, freedom to operate, and patent portfolio management
    and filing strategies.

    As the title suggests, this book is geared toward
    business professionals who have (or may have) dealings with patent-related
    issues.  As such, Dr. Heines avoids
    excessive patent attorney jargon (he provides a glossary for essential
    terminology) and distills important aspects of patent law for the non-patent
    practitioner.  This book would be a great
    help to any person who lacks an understanding of patents, the role they play in
    an overall business strategy, and what to expect when developing and managing a
    patent portfolio.  While a seasoned patent attorney may find the discussion too
    general, I would guess that every patent attorney has dealings with people that
    would enjoy, appreciate, and benefit from Dr. Heines’ book.

    "Patents for Business: The Manager’s Guide to Scope,
    Strategy, and Due Diligence    "
    is listed on amazon.com for $54.95.

  • Conference & CLE Calendar

    Calendar March 21-22, 2007 – Complex IP & Technology Transactions Conference (Law Seminars International) – Chicago, IL

    March 25-29, 2007 – American Chemical Society National Meeting – Chicago, IL

    April 16-18, 2007 – Biotechnology: Patent Prosecution, Licensing, Litigation &
    Hatch-Waxman     (Patent Resources Group) – Orlando, FL

    April 27, 2007 – Patent Claim Construction Workshop (Law Seminars International) – Atlanta, GA

    May 6-9, 2007 – BIO International Convention – Boston, MA

  • Patent Suits Up 4% in 2006

        By Donald Zuhn —

    Earlier this month, we reported that
    the PricewaterhouseCoopers 2007 Patent and Trademark Damages
    Study showed that patent actions had dropped more than 11% in 2005.

    180pxipo_org_logo
    The Intellectual Property Owners Association (IPO) reported today that data released this week from the
    Administrative Office of the U.S. Courts
    indicates that after falling by 11.5% in 2005, the number of filed patent suits
    rose 4% in 2006.  The data for the past
    10 years has been compiled by the IPO into a graph that can be obtained here.  As PricewaterhouseCoopers noted in its study,
    the only decline in filed patent suits over the past decade occurred in 2005.

  • Angiotech Receives Favorable Decision from EPO

        By Christopher P. Singer —

    Logo
    Angiotech® announced in a March 15, 2007 press release that the European Patent Office’s Technical Board of Appeal denied Conor
    Medsystems Inc.’s and Sahajanand Medical Technologies Pvt. Ltd.’s request to
    intervene and appeal a prior ruling by the Opposition Division of the EPO
    regarding Angiotech’s "Hunter" patent (EP 0706376 B1; see corresponding
    International Publication WO 95/003036.  The patent relates generally to stent
    technology and claims priority back to 1993.  Angiotech and Conor Medsystems, Inc. have been waging battles worldwide
    over the technology covered by this patent (and its related foreign
    counterparts), with each party having success in various countries.

    In its statement, Angiotech indicated that it will
    continue to vigorously defend its intellectual property on a worldwide basis.

    Conor_medsystem

  • Oxford BioMedica to Acquire Oxxon Therapeutics

        By Donald Zuhn —

    Oxford_biomedica
    Oxford BioMedica announced on March 12th that it has entered into an agreement to acquire Oxxon Therapeutics Ltd.  The transaction – valued at about US $31 million – will be completed, in part, by the issuance of more than 27 million Oxford BioMedica shares to Oxxon shareholders.

    Oxford BioMedica is a biopharmaceutical company focusing on the development of gene-based therapeutics in the areas of oncology and neurotherapy.  Oxford BioMedica’s oncology pipeline includes two drug candidates in Phase II trials and a Phase III trial with TroVax® to treat renal cancer.  The company’s neurotherapy pipeline includes a drug candidate for treating Parkinson’s disease.

    Oxxon Therapeutics is a private company specializing in antigen-specific immunotherapies for treating chronic infectious diseases and cancer.  In particular, Oxxon has completed Phase II trials for candidates Oxxon_therapeutics_2
    for treating melanoma and hepatitis B.  Oxxon has also developed the Hi-8® PrimeBoost® immunotherapy platform, a two-step treatment regimen designed to stimulate potent cellular immune responses.   

    Oxford BioMedica’s patent portfolio includes at least twenty-three U.S. patents and fifteen U.S. patent application publications,
    a number of which are directed to viral vectors and delivery systems.  Oxxon’s portfolio includes U.S. Patent No. 6,663,871,
    which is directed to methods and reagents for vaccination which
    generate a CD8 T cell immune response, and six U.S. patent application
    publications.

    Describing the reasons for Oxford BioMedica’s acquisition of Oxxon, Chief Executive Alan Kingsman noted that:

    The acquisition expands our immunotherapy pipeline and strengthens our intellectual property position in the field of immunology.  Oxxon’s Hi-8® MEL vaccine has generated encouraging Phase II results as a treatment of advanced melanoma.  The market opportunity for an effective melanoma vaccine is substantial and this is a cancer type where our immunotherapy, TroVax, cannot be developed because, unlike the vast majority of human tumours, melanomas do not have 5T4 on the surface of the tumour cells.  This acquisition is part of the implementation of a plan for the development of our pipeline following finalisation of a licensing deal for TroVax.

    Additional information concerning the acquisition can be found in a statement released by Oxxon.

  • Princeton Concedes Priority to Enzo in Signal Amplification Patents

        By Mark Chael —

    Enzo_logo
    On February 21, 2007, the Board of Patent Appeals and Interferences (BPAI) at the U.S. Patent and Trademark Office (USPTO) entered judgment in favor of Enzo Life Sciences, a subsidiary of Enzo Biochem, Inc., after Princeton University and Imclone Systems, Inc. requested adverse judgment in a prior filing in which they conceded priority to Enzo.  The interference at issue was declared on August 7, 2006 between Enzo’s pending U.S. Application No. 08/479,995 and Princeton’s U.S. Patent Nos. 4,882,269 and 5,424,188, which are licensed to Imclone.

    Princetonlogo
    Because the ‘995 application was filed before January 1, 1998 (see here) – and, therefore, before the publication rules took effect – the ‘995 application has not been made publicly available.  However, an analysis of the ‘269 and ‘188 patents indicates that the technology involved in the interference relates to the detection of target nucleic acids in a sample by amplifying the signal generated during the detection event, as opposed to amplifying the target nucleic acid itself.  In this type of signal-amplified nucleic acid detection, a primary probe that hybridizes to the target nucleic acid in the sample is added to the reaction mix, and then a family of signal-generating secondary probes that hybridize to different segments of the primary probe are added.  By hybridizing multiple signal-generating secondary probes to the primary probe, one is able to generate an enormous amplification of the signal generated by the primary hybridization event.  One advantage of using signal amplification in nucleic acid detection is the ability to use less toxic signal generating molecules (e.g., radionuclides).  As is readily apparent, this technology is widely applicable to a broad range of disciplines, including medical diagnostics, criminal forensics, and pharmaceutical research and development.

    Imclone
    One of the more interesting aspects of this interference is that both of the patents involved in the interference expired while the
    interference was pending.  Surprisingly, however, the expiration of the ‘188 patent
    was not promptly brought to the BPAI’s attention – an omission that will effectively
    give Enzo a three-month extension of term should a patent issue from
    the ‘995 application, since delays before the BPAI are not counted
    against a patent’s term.

    More information about this proceeding can be found in Enzo’s press release.

    A quick note about interferences for our overseas readers:  Since U.S. Patents are awarded to the "first to invent" rather than the "first to file," interferences may be initiated with respect to a particular U.S. patent application in order to determine the party that first invented a particular technology.  According to the Manual of Patent Examining Procedures (MPEP), fewer than one percent of all patent applications become involved in an interference proceeding.  However, with more than 900,000 patent applications currently pending in the U.S., there is the potential for approximately 9000 interferences, which may be one reason why there is a move afoot to change the U.S. patent system to a "first to file" system.

  • No New Abbott Medicines for Thailand

        By Jason Derry —

    Abbott Laboratories has announced that it will no longer launch new medicines in Thailand.  In addition, Abbott has decided to withdraw its current applications for medicines in Thailand.  The decision is based on Thailand’s recent decision to issue compulsory licenses for Abbott’s AIDS drug Kaletra, and the failure to reach an agreement with the Thailand government regarding reduced pricing for Kaletra.  International pharmaceutical companies have openly criticized Thailand’s issuance of recent compulsory licenses for two drugs (Abbott’s Kaletra and Plavix made by Bristol-Myers Squibb and Sanofi-Aventis) without first consulting the companies that owned the drugs.  On the other side of the issue, activists have been praising Thailand’s actions while criticizing Abbott’s decision as socially irresponsible.

    Additional information concerning the issue of compulsory licensing in Thailand can be found in the following Patent Docs reports:

    Abbott_laboratories

  • Patent Profile: Azaya Therapeutics’ PSL Nanoparticle Patent Issues

        By Donald Zuhn —

    Azayatherapeuticslogo
    The United States Patent and Trademark Office recently issued U.S. Patent No. 7,179,484 to Azaya Therapeutics, Inc.  The ‘484 patent, which relates to protein-stabilized liposomal formulations for the delivery of pharmaceutical agents, is the first U.S. patent to be awarded to the San Antonio-based pharmaceutical company.

    After receiving a Notice of Allowance in November 2006, Azaya announced that the ‘484 patent would allow the company to fully utilize its proprietary Protein Stabilized Liposome (PSL®) nanotechnology, which allows for the production of uniform liposomal particles of less than 200 nm in size in a single-step manufacturing process.  According to Azaya, the strength of its PSL® nanotechnology is that it can be used to encapsulate a large array of water insoluble drugs.

    Azaya has described the ‘484 patent as a "core technology patent" that will allow the company to further develop its lead product candidate, ATI-1123.  ATI-1123 is a PSL® formulation of Aventis’ Taxotere, which is a poorly water-soluble semi-sythetic taxane analog used in the treatment of non-small cell lung, prostrate, and breast cancer.  Prior to the development of Azaya’s PSL® nanotechnology, Taxotere’s poor water-solubility had been overcome by formulating the compound with a toxic carrier, Tween 80.

    In addition, Azaya has been using its PSL® nanotechnology to develop a secondary product candidate, ATI-1153.  ATI-1153 is PSL® formulation of SN-38, which is an active metabolite of Pfizer’s drug CAMPTOSAR® for use in treating colorectal cancer.  While SN-38 has proven to be more potent than alternative therapeutics, absent PSL® encapsulation, it cannot be administered directly to patients due to its water insolubility and high systemic toxicity.

    The ‘484 patent issued from U.S. Application No. 10/703,187 and claims the benefit of U.S. Provisional Application No. 60/424,230, which was filed on November 6, 2002.  Representative independent Claim 1 recites:

    1.  A method of preparing protein-stabilized liposome nanoparticles containing at least one lipophilic pharmaceutical agent, the method comprising:
        (a)  preparing an oil-in-water emulsion by a process comprising
            i)  preparing an organic solution comprising one or more phospholipids;
            ii)  mixing the at least one lipophilic pharmaceutical agent into said organic solution;
            iii)  infusing said organic mixture into an aqueous solution comprising an emulsion-forming protein, wherein said emulsion-forming protein comprises from about 0.1% to about 20% (w/v) of the aqueous solution, to form a the oil-in-water emulsion; and
        (b)  removing organic solvent from said emulsion to form the protein-stabilized liposome nanoparticles, wherein said liposome nanoparticles have sizes below 400 nm and said emulsion-forming protein adsorbed onto their surface.

    Dependent claim 30 recites:

    30.  A protein-stabilized lipid formulation comprising protein-stabilized liposome nanoparticles and a lipophilic pharmaceutical agent, the formulation prepared by a process selected from the group of processes consisting of those processes set forth in any one of claims 1, 2-9 and 10-29.

    Additional information concerning Azaya’s PSL® liposome nanoparticles and manufacturing process, including an animated simulation, can be found here.

  • USPTO News: Official Announcement Regarding Restriction Practice in Applications Containing Nucleotide Sequences

        By Christopher P. Singer —

    Uspto_seal_10
    The USPTO published a pre-OG notice regarding its new position on restriction practice in pending applications that relate to nucleic acid sequences.  Prior to this notice, the PTO had been officially operating under the direction of an Official Gazette notice dated November 19, 1996.  The old notice allowed for a partial waiver of requirements for restriction and unity of invention for applications relating to nucleotide sequences by permitting examination of a "reasonable" number — typically up to ten — independent and distinct molecules described by their nucleotide sequences in a single patent application.  This newly published notice effectively rescinds the 1996 notice, and requires that claims to polynucleotide sequences "be considered for independence, relatedness, distinction and burden as for claims to any other type of molecule."  Effectively, this means that applicants will be allowed to claim only a single polynucleotide sequence per patent application.

    The notice lists a number of factors that motivated the change, the most interesting of which (to me) is the 54-fold increase in the number of nucleic acid sequences in the GenBank® database (and a 91-fold increase in the number of nucleotides) between 1996 and February 2006.  Further, the Office believes that this change will provide applicants with a more focused and consistent course of examination, as a result of the decrease in the search and examination burdens. 

    This notice provides an official change in the PTO’s policy regarding the treatment of inventions relating to polynucleotide sequences.  However, this change likely will have little to no effect on the day-to-day practice of biotech restriction practice, as this notice seems to postdate what has already become common practice at the PTO.

  • Schering-Plough to Acquire Organon BioSciences from Akzo Nobel

        By Donald Zuhn —

    Scheringplough
    Schering-Plough Corporation announced on March 12th that its Board of Directors has approved the purchase of Organon BioSciences N.V. from Akzo Nobel N.V. for US $14.4 billion.  Schering-Plough chairman and CEO Fred Hassan noted that the acquisition would give Schering-Plough immediate access to central nervous system and women’s health care products, and fill a gap in the company’s late-stage pipeline by adding five compounds in Phase III development.  The five compounds in Phase III development are:

    • Asenapine – a novel psychopharmacologic agent for the treatment of patients with schizophrenia and acute mania bipolar disorder.
    • Sugammadex – for the reversal of neuromuscular blockade induced during surgical procedures.
    • NOMAC/E2 – an oral contraceptive product containing nomegestrol acetate, a novel progesterone, and estriadiol, a natural estrogen.
    • ORG36286 – a long-acting recombinant follicle-stimulating hormone for infertility.
    • Esmirtazapine (ORG50081) – for the treatment of insomnia and potentially for hot flashes in menopausal women.

    Organon_logo
    Organon BioSciences, a wholly owned subsidiary of Akzo Nobel, consists of two operating units: Organon, a human pharmaceuticals business, and Intervet,
    the world’s third largest animal health care company.  In 2006, Organon
    had US $3.4 billion in sales and Intervet had US $1.5 billion in
    sales.  Organon’s leading products include Follistim/Puregon, a
    follicle-stimulating hormone for infertility; Esmeron/Zemuron, a muscle
    relaxant; and NuvaRing and Implanon for contraception.  Kk_logo_intervet
    Among the
    products being offered by Intervet are Nobivac, a range of canine
    vaccines; Panacur, a de-wormer; Bovilis, a bovine biological for
    disease control and eradication; and Nobilis, a poultry vaccine to keep
    flocks free from infectious disease.

    Organon’s patent portfolio includes twenty U.S. patents and at least four U.S. patent application publications, including U.S. Patent Application Publication Nos. 2006/0084692 and 2006/0128688, which are directed to methods of treating bipolar disorders or schizophrenia using asenapine, and U.S. Patent Publication No. 2007/0027134, which is directed to a crystal form asenapine maleate.  Intervet’s portfolio includes six U.S. patents.

    Akzonobellogo
    Interestingly, Akzo Nobel’s sale of Organon BioSciences marked a
    departure from its announcement late last month that it planned to list
    the pharmaceutical company before the end of March (see Reuters report).
    Akzo Nobel’s plans for an Organon IPO had come on the heels of good
    news regarding Organon’s attempt to secure FDA approval for its
    schizoprenia drug asenapine.

    Schering-Plough said that it expects the deal to close by the end of this year.

    Additional information concerning the merger can be found in a statement released by Akzo Nobel.