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Ipr biotech june 2010 (final)

JUNE 2010
From the Desk of Chairman
IPR Biotechnology : Part 8 - 63
Gene duplication or chromosomal duplication or gene amplification is believed to play a major role in evolution. This view has been current and accepted for over hundred years now. The duplication of a generesults in an additional copy that is free from selective pressure and allows the new copy of the gene tomutate without adversely affecting the organism. This freedom from the deleterious consequence enablethe mutation of novel genes that could virtually enhance the fitness of the organism or code for a new organism.
The 'Special Feature' in the present issue of WISTA:IPR Biotechnology deal with gene duplication, its origin,
selection, fate of duplication events, and their importance, selection, fate of duplication events, and theirimportance. It also describes in brief eleven out of over one thousand patents granted on the subject till date.
Application of biotechnology innovations in the areas of health and agriculture has created new perspectives and hope for green solution . However, patenting of biotechnology and life science inventions has faced severalhurdles in view of such inventions needing additional criteria apart from the basic criteria of patentability applicableto industrial inventions. Products of biotechnology are either living or non-living. The living products are comprisedof lower life form as bacteria and higher life forms as plants, animals and humans; while the non-living productsinclude proteins and antibodies. Though most of the countries now consider lower life forms and non-livingbiotechnological innovations as patentable, the patenting of higher life forms still remains controversial.
The 'Perspect' in this issue covers patenting life, its various implications and the challenges confronted by it.
Fine Tuning' features protein cohensins, their function, the mechanism of their function, and the central role these play in meiosis. Other features covered include: Scan Around the Globe; Watch-Out IPR; In Focus, StrategicAlliances, On to Excellence; Clinical Trials; Awards; and Legal Scene.
We welcome comments and suggestions.
Dr K V Swaminathan
CONTENTS
RESEARCH & ANALYSIS TEAM
• From the Desk of Chairman [P 2 ]
Dr Shelley Lahiri
Consultant
• Scan Around the Globe: Swine Flue-Breakthrough (Australia); Court Ruling on viagra
Patent (Brazil); China Phormaceuticals and Healthcare Report(China); DNA Testing Mr B K Wadhawan
Director
Patent (Israel); Italy's Pharmaceutical Industry (Italy); Alexion to Launch Soliris®(Japan); Grape Anthacnose (Thailand); Alcohol-Related Brain Defects (USA) Mr S S Kalra
Director
Kibra Protein (USA). [P 3 - 4]
• Watch-Out IPR: Amplification Consumables Patent; Anti-Inflammatory Antibody;
Diagonostic Capability in Diabetes; HSV Antigen Licensing; iPSC Patent;Patent for HealthSport; Patent for Intermezzo Formulation. [P 5 - 6]
• Perspective: Patenting Life. [P 7]
• In Focus: Alzheimer's Vaccine; Anti-Malarial Drug; Cholesterol Effect on Bone Marrow;
Computational Model for Gene Activity; Controlling Transcription Elongation in Bacteria; Nano-Scale Cell Probe Temperature-Sensing Proteins. [P 8 - 9]
• Strategic Alliances: Agreement Over Treximet Patent; Alliance for InDevR's Virus
technology by WITT.
Counter Patent; Alliance to Improve Drug Discovery; Avecia-Pfizer Agreement; Cancer
Vaccine Collaboration;Collaboration on Cancer Screening Tech; Marketing Pact on
MRSA Assay; Strategic Alliance for Commercial Strength. [P 10 - 11]
Editor : Dr K V Swaminathan
Printed and Published by
On To Excellence: PoyMedix,Inc. [ P 12 ]
Special Feature: Gene Duplication. [P 13 - 15]
Clinical Trials: Laevo-Bambuterol Trial; Ventricular Assist System. [P 16]
Awards: Beike Biotechnology Awarded ISO 9001 Certification; ONRL Small Busi-
ness Award. [P 16]
Fine Tuning: Protein Cohesine. [P 17]
Legal Scene: Gemzar Patent; Ifrigement Case Against Boston; IP Advocate Settles
Legal Battle;Johnson & Johnson &Johnson Resolves Patent Litigation; Lower Court's Ruling on Patent Claims; Novamont Patents Valid; Nycomed's Patent- Invalid;Sadanta-Infocrossing Lawsuit Takeda Settles Infrigement Lawsuit. [P 18 - 19]
VOL 11 ISSUE 12
IPR BIOTECHNOLOGY
JUNE 2010
dysfunction drug in June. Pfizer Inc., which holds the SCAN AROUND THE GLOBE
patent, contends its patent runs until June 2011.
(Brazil – Business Week, Apr 26, 2010) China Pharmaceuticals and Healthcare Report
Swine Flu-Breakthrough
China Pharmaceuticals and Healthcare Report In a breakthrough that offers new hope for the provides industry professionals and strategists, containment of influenza outbreaks, the Australian corporate analysts, pharmaceutical associations, biotechnology company Marinova Pty Ltd has isolated government departments and regulatory bodies a natural extract from seaweed which has been with independent forecasts and competitive shown to inhibit the H1N1 virus. The extract, known as intelligence on China’s pharmaceuticals and Maritech® 926 is a fucoidan compound derived from the Undaria pinnatifida species of seaweed.
In vitro tests performed under contract by the In February 2010, the authors of the Report National Institute of Allergy and Infectious Diseases upgraded Chinas patented drug market forecast (NIAID), part of the National Institutes of Health following clarification of the country’s intellectual (NIH) in the US, have shown that Maritech® 926 property (IP) law. Clear legal definitions of can inhibit the H1N1 influenza virus at extremely fundamental terms, such as patented pharmaceuticals will provide assurances to foreign multinationalslooking to launch their products in the most Maritech® 926 is a natural polysaccharide promising emerging pharmaceutical market in which has immediate market potential in nutritional the world. Sales of patented drugs in China are supplements, hand washes and nasal delivery expected to increase from US$4.51bn in 2009 to products which target the spread and prevention US$28.63bn in 2019, representing a compound Marinova Pty Ltd has extensive research and (China – Research and Markets, Apr 26, 2010) manufacturing facilities in Hobart, Tasmania. The DNA Testing Patent
company is dedicated to creating innovative andchemically consistent extracts from marine plants for use in medical, nutritional and skin care healthcare technology leader, has received patent applications. Using its proprietary solvent-free protection in the State of Israel for its proprietary Maritech® process, Marinova has the unique ability Variation Identification Platform (VIP) DNA to supply high-purity fucoidan ingredients testing technology. The Israeli patent extends which not only meet HACCP, ISO 9001, GMP and Arrayit’s current patent portfolio.
organic quality requirements, but also comply Israeli patent empowers Arrayit to develop and with FDA and European pharmaceutical standards.
commercialise economical diagnostic tests for (Australia - PR News, May 04, 2010) important medical conditions including humandiseases. The VIP approach uses microarrays, which Court Ruling on Viagra Patent
are diagnostic devices that contain thousands of patient Pfizer registered its first patent on Viagra in samples printed as microscopic spots on a glass June 1990, so the 20-year term ends this year. Pfizer substrate. One VIP microarray can test up contends the patent was not finalized by the to 80,000 patient samples simultaneously, using miniaturization, automation and massively parallelVIP devices to acquire the medical information.
Brazil’s top appeals court has ruled that the Improved testing speed, accuracy and healthcare patent on Viagra expires next month in the South cost reductions are among the benefits of testing American nation, a year earlier than argued by the manufacturer. That means other companies canbegin making generic versions of the erectile (Israel – Arrayit Corporation, Feb 04, 2010) IPR BIOTECHNOLOGY
JUNE 2010
Italy’s Pharmaceutical Industry
shows the causes of anthracnose. Isolates ofSphaceloma ampelinum, the anamorph stage of The pharmaceuticals in Italy,' an industry profile, Elsinoe ampelina, were collected from various is an essential resource for top-level data and analysis regions of Thailand. Nineteen single-conidial isolates covering the pharmaceuticals industry. It includes were evaluated for differences in conidial data on market size and segmentation, plus textual morphology, DNA patterns and pathogenicity.
and graphical analysis of the key trends and Pathogenicity analysis using nine grape genotypes competitive landscape, leading companies and and five S. ampelinum isolates showed that ‘Wilcox321’ and Illinois547-1 were highly resistant Italy’s pharmaceuticals market consists of ethical drugs only and does not include consumer (Thailand – Wiley Anthracnose, May 05, 2010) healthcare or animal healthcare. Market values Alcohol-Related Brain, Defects
have been calculated at ex-factory prices.
(Italy – Datamonitor, Apr 26, 2010) reported that alcohol consumption in early Alexion to Launch Soliris®
pregnancy increases levels of a little-known lipidcalled ceramide, significantly increasing suicide Alexion Pharmaceuticals, Inc. and Alexion among cells critical to skull and brain formation.
Pharma International Sàrl announced that the launch of Soliris (eculizumab) as a treatment for as a brain-boosting agent and under study for stroke patients with PNH in Japan will begin in the third and traumatic brain injury, may block skull and brain damage that can result from alcohol Alexion’s accelerated plans for the launch of Soliris in Japan are based on recent approval of the The researchers suspected ceramide, known price for Soliris(R) (eculizumab) in Japan by an to induce cell death and be activated by alcohol, as advisory committee of Japan’s Ministry of Health, a culprit in the damage. They found high levels of ceramide both in mouse cells and pregnant mice positions the MHLW to list Soliris for reimbursement exposed to alcohol along with a five-fold increase in through Japan’s National Health Insurance (NHI) apoptotic, or dying cells. There is a clear correlation.
system. Following this listing, Alexion will begin Follow up studies include determining whether discussions with individual hospital treatment CDP-choline can rescue cells after the fact or centers to place Soliris on their formularies, a whether it or a similar supplement would need to process expected to take an additional one to (USA – ScienceDaily, Jun 01, 2010) PNH is an ultra-rare, debilitating and life- Kibra Protein
threatening blood disorder defined by chronic redblood cell destruction, or hemolysis. Soliris, a first- A group of scientists at Johns Hopkins and in-class terminal complement inhibitor, is the first Florida State University, worked on a protein, namedKibra, which is linked to a relay of chemicals therapy approved in Japan for the treatment of responsible for shaping and sizing tissue growth by patients with PNH. Soliris received orphan drug coordinating control of cell proliferation and death.
designation from the MHLW in 2009 and wasapproved for marketing under the Ministry’s The scientists manipulated Kibra’s role in a priority review process in April 2010.
signaling network called the Hippo pathway, whichconsists of several proteins working together as a (Japan – Business wire, Jun 02, 2010) braking system. Counterparts of the components Grape Anthacnose
in the Hippo pathway in flies are found in most The grape cultivators in Thailand are mostly animals, suggesting that this pathway may act as a“global regulator” of organ size control.
victim of anthracnose disease. Anthracnose is oneof the major diseases. Genetic diversity and (USA– Johns Hopkins Medical Institutions, Mar pathogenicity analysis of Sphaceloma ampelinum IPR BIOTECHNOLOGY
JUNE 2010
The patent also includes claims that relate to WATCH-OUT IPR
methods of treatment of Type 2 diabetes with highaffinity IL-1 beta antibodies in conjunction withadditional agents.
Amplification Consumables Patent
A second patent covers methods of treating Enigma Diagnostics Limited, the decentralised IL-1 related inflammatory diseases, including and point-of-care molecular diagnostics company, rheumatoid arthritis and osteoarthritis, with XOMA has been granted with US Patent No. 7,659,096.
052 and other antibodies and antibody fragments The claims cover the use of amplification with similar binding properties for human consumables in several current real-time and end point PCR instruments. The consumables incorporatea thermally conducting layer and reaction wells in The patents expire in 2027 (US 7,695,718) and combination with a reaction mixture and a blocking 2026 (US 7,695,717), respectively. With these agent. Enigma Diagnostics Ltd is the exclusive patents, the intellectual property portfolio for licensee of this patent from the UK Defence XOMA 052 includes four issued patents in the US This is the most recent patent to issue in Enigma’s expanding portfolio of over 300 patents Diagnostic Capability in Diabetes
and patent applications. This portfolio includespatents relating to intelligent sample preparation The stimulation and modeling company Entelos, consumables and novel amplification technologies Inc. has been granted US patent (No. 7,654,955) for current and ‘next generation’ molecular entitled “Apparatus and Methods for Assessing diagnostic systems and sample preparation devices.
Metabolic Substrate Utilization” to the company.
Enigma continues to expand its worldwide licensing These methods further strengthen the Entelos®; Metabolism PhysioLab®; platform and leverage applicable and important IP portfolio which now insights about human physiology that can lead to improved diagnosis, clinical testing, and personalizedtreatment across a highly variable patient population.
(Enigma Diagnostics Limited, Apr 19, 2010) This method may also be used to improve the Anti-Inflammatory Antibody
selection of patients for clinical trials of metabolictherapies and diagnostics.
development of therapeutic antibodies, announced The newly patented method extends the ability of that the US Patent and Trademark Office has the Entelos Metabolism PhysioLab platform to issued two new patents that significantly expand explore, simulate, and predict differences in fuel the company’s intellectual property portfolio relating utilization (e.g., fat, carbohydrate, and protein to its anti-inflammatory antibody, XOMA 052, metabolism) between patients, a key predictor in that targets interleukin-1 beta (IL-1 beta). One of the patents covers methods of treating Type 2 The Entelos Metabolism PhysioLab platform is diabetes with high affinity antibodies and antibody an innovative, predictive computer model that fragments that bind to IL-1 beta, including XOMA represents the underlying physiology of metabolic 052. The high affinity antibodies, such as XOMA disorders such as obesity and diabetes and uses 052, offer potential advantages in Type 2 diabetes.
simulated “virtual patients” to help predict responses.
Additional claims in this patent relate to methods These virtual patients enable new therapies and of reducing or preventing complications or conditions interventions to be efficiently “flight tested” in a associated with Type 2 diabetes, including retinopathy, computer before expensive clinical testing in humans, renal failure, wound healing and cardiovascular reducing the risk and time to market for novel drugs.
disease, with these high affinity IL-1 beta antibodies.
IPR BIOTECHNOLOGY
JUNE 2010
HSV Antigen Licensing
nutritional supplement and over-the-counterdrug products.
discovery and development company, announced The Mexican Institute of Industrial Property that it has licensed an extensive patent estate from has approved HealthSport’s patent application the University of Washington and the Fred relating to its bi-layer edible film strip technology.
The patent issuance opens the door for sales pending and issued patents related to herpes and distribution into Mexico, and is expected to simplex virus (HSV) type 2 antigens. The addition of accelerate HealthSport’s move into the international these patents complements the novel antigens marketplace. The Mexican market for OTC drugs discovered by Genocea’s unique and proprietary is larger than that of China and is a natural next antigen discovery technology. The combination of step into international sales and distribution of Genocea’s novel intellectual property with the patent estate from the University of Washington providesthe company with a broad compendium of HSV strengthens HealthSports’s commitment to developproducts based on its next-generation drug (Genocea Biosciences, Feb 24, 2010) iPSC Patent
Fate Therapeutics, Inc. received a Notice of Patent for Itermezzo Formuation
Allowance from the United States Patent andTrademark Office for US Patent Application Transcept Pharmaceuticals, Inc. is a specialty Number 10/997,146 entitled “Methods for pharmaceutical company focused on the development Reprogramming Somatic Cells.” Upon issuance, the and commercialization of proprietary products patent will cover foundational induced pluripotent that address important therapeutic needs in neuro stem cell (iPSC) technology for identifying agents science. The most advanced Transcept product that enable the reprogramming of human somatic candidate is Intermezzo(R) (zolpidem tartrate cells, including pluripotency genes, small molecules sublingual tablet), for which a New Drug Application (NDA) was submitted to the US Food and DrugAdministration (FDA) in September 2008 seeking approval as a prescription sleep aid for use in the Whitehead Institute for Biomedical Research and middle of the night at the time a patient awakens and scientific founder of Fate Therapeutics, has a priority date of November 26, 2003 and is believed Transcept Pharmaceuticals, Inc. announced to be the earliest art that describes broad methods that the first patent covering the composition and and key agents to reprogramme human somatic cells method of use of Intermezzo(R) (zolpidem tartrate to a pluripotent state. Fate Therapeutics holds an sublingual tablet), has been issued by the United exclusive license to the application in commercial fields, including for drug discovery and therapeuticpurposes.
Transcept announced the issuance of a Notice of Allowance for claims under the application for claims under this patent, US Patent Application Serial earliest allowed claims in the US for iPSC technology.
No.11/060,641, on December 14, 2009. The newly (Fate Therapeutics, Inc, Feb 04, 2010) issued patent, US Patent No. 7,658,945, titled Patent for HealthSport
“Compositions for Delivering Hypnotic AgentsAcross the Oral Mucosa and Methods of Use HealthSport, Inc. is a fully integrated developer, Thereof,” will expire no earlier than February 2025.
manufacturer and marketer of unique andproprietary branded and private label edible film strip (Transcept Pharmaceuticals, Inc, Feb 09, 2010) IPR BIOTECHNOLOGY
JUNE 2010
Besides the above, Stan Allen and the triploid PERSPECTIVE
Pacific Oyster, Craig Venter and ExpressedSequence Tags (EST), Myriad’s patent claims on PATENTING LIFE
the BRCA genes, and lots of interesting minutiaeare also some of major events.
Introduction
Patenting of Human Genetic Material
Thanyani reported about a patent application by a renowned geneticist, Dr Craig Venter (first person Representatives during 2007 to prohibit the to decode the human genome). In December 2007, patenting of human genetic material.
the scientist filed a patent application (US20070264688) in respect of synthetic bacterium, Application of the Biotech Directive
including a synthetic genome which is copy, with According to the Biotech Directive, the human only few changes, of the genetic sequence of a body, at the various stages of development, and natural bacterium Mycoplasma genitalium. Cases the simple discovery of one of its elements, including like this illustrate the fact that patenting ofbiotechnology and life science inventions do not the partial sequence of a gene without an asserted always fit easily into legislation originally developed utility, cannot constitute patentable inventions.
to protect industrial inventions while technology However, a nature identical synthetic element (or gene) isolated from the human body could bepatentable, as long as the utility is disclosed.
Prof Daniel Kevles reviewed the history of patenting “life and its pasts” in a recent talk at Duke Human Embryoic Stem (hES) Cells
Law School that talk provided an overview of themajor events, that have shaped our current The European Group on Ethics in Science and intellectual property regime. Application of New Technology give the patentable importance only biotechnology innovations in areas such as health to the stem cell lines not on the modifed stem cells.
and agriculture have opened new perspectives, Directive differently. Austria and Ireland prohibit Earlier Perception of Organism
stem cell research entirely. Germany and Italyprohibit derivation of hES cells, but scientists may Prior to 1980, living organisms were deemed import them for research. The UK and EPO patent a part of nature and therefore, not patentable.
Ananda Chakrabarty challenged the orthodox view, offices grant patents relating to human embryonic by finding that genetically modified bacteria (i.e.
pluripotent (limited development potential) stem oil-slick eating bacteria) were patentable. He had cells because they do not have the potential to modified bacteria to create oil dissolving develop into an entire human body, unlike totipotent bioengineered microbes. The court stated that as cells (capable of developing into differentiated cells), long as sufficient input by mankind was involved the patenting of which is not allowed.
in the invention, the subject matter was patentable.
Conclusion
(Ironically, because of safety and environmentalconcerns the invention was never commercialised).
According to At Van Rooy and Simon Thanyani, Most countries now also consider lower life inventions in relatively new fields of life sciences, such as metabolomics (the systematic study of thechemical fingerprints that various cellular metabolic After patenting of lower forms was accepted, processes leave behind), are constantly pushing scientists steped on towards the higher life forms.
the boundaries of technology and patent law. The PhilipLeder of Harvard University filed a patentapplication for the Onco-mouse which had a effective commercialisation of these inventions susceptibility to contracting cancer, useful in cancer depends in part on exclusive patent rights research. The application was initially rejected in remunerating the patentee for its investment.
Europe but later granted (1992) on the basis that the Patent laws internationally should adapt to European Patent Office (EPO) sought to balance advancements in technology and specifically in the public’s interest in alleviating cancer.
IPR BIOTECHNOLOGY
JUNE 2010
cells move from the bone marrow to peripheral, circulating blood. Sometime cholesterol may beresponsible for acute leukaemia as cholesterolempties cells from the bone marrow microenvionment Alzheimer’s Vaccine
by which it may create more space for malignant AFFiRiS AG’s Alzheimer’s vaccine AD02 has leukaemia cells to come into the bone marrow.
been progressed to multicentre Phase II clinicaltesting in Austria and five other European countries.
During the past year the safety and tolerability of implications for transplants and bone marrow the vaccine was confirmed; now the focus is on its efficacy. Indeed the start of this efficacy study (Instituto Gulbenkian de Ciencia, May 11, 2010) comes only five months after the completion ofthe corresponding Phase I study. The company is Computational Model for Gene Activity
active in several disease areas and is currentlydeveloping a total of twelve prospective products The human genome contains instructions for in all stages of the development pipeline up to making all the cells in our body. An individual cell’s make-up (e.g. muscle or blood) depends on howthese instructions are read. This is controlled by gene Anti-Malarial Drugs
mechanisms holds a key to greatly improvingour understanding of biological systems.
The scientists of the University at Reading’s Department of Chemistry, aim to make anti-malarial One important regulatory mechanism is based drugs more affordable in third world countries on genes that actively promote or repress the activity where more than 1.5 million people die of the disease of other genes. The new research addresses the every year. University’s new Chemical Analysis problem of identifying the targets these regulator Facility (CAF) facilitates this research. Using the CAF’s facilities, the scientists produce artemisininfrom Chinese wormwood plant. It is an antimalarial The new method, presented in Proceedings of drug effective against quinine-resistant malaria. This the National Academy of Sciences (PNAS), is based fundamental research will help pharmaceutical on careful modelling of time series measurements of companies to mass-produce artemisinin in a more gene activity. It combines a simple biochemical model of the cell with probabilistic modelling to deal with incomplete and uncertain measurements.
Cholesterol Effect Bone Marrow
Researchers from the University of Manchester (UK), Aalto University (Finland) and the European Progenitors of blood cells develop in the bone (Germany), say the new method identifies targets microenvironments, called niches, before exiting into peripheral blood in a highly controlled fashion. Itis well established that external stimuli affect these (University of Manchester, Apr 26, 2010) niches and in turn the production of mature blood Controlling Transcription Elongation in
cells. For example, patients with high cholesterol Bacteria
levels (hypercholesterolemia) have more peripheralblood cells and increased platelet levels (thrombocytosis). Researchers in Portugal show Center have discovered and characterized a general that high levels of cholesterol can affect the mechanism that controls transcription elongation microenvironment of the bone marrow, so that more in bacteria. The mechanism, relies on physical IPR BIOTECHNOLOGY
JUNE 2010
cooperation between a moving ribosome and RNA that are controlled by pectoral muscles, or deep polymerase (RNAP) that allows for a precise brain implants used for treating depression.
adjustment of the transcriptional yield in response totranslational needs. The study could lead to the (Stanford University, Apr 02, 2010) development of new ways to interfere with bacterial Temperature-Sensing Proteins
gene expression and serve as a new target forantimicrobial therapy.
specialized sensory neurons to detect temperature, pressure, and other physical stimuli on the skin. These transcription rate depends on codon usage, or the neurons are located in the spinal column and are frequency of rare codons which modulates the speed connected to the skin and organs through long of a ribosome. Finally, the authors illustrate that it is the speed of the ribosome that determines the speedof RNAP, whereby the acceleration or deceleration On the surface of these axons are ion channel of a ribosome by chemical or genetic manipulation (pore-forming) proteins, which span the axon’s leads to corresponding changes in RNAP speed.
membrane, connecting the inside with the outside.
Some of these ion channels act like temperature The implications of the study are important receptors or “molecular thermometers” by opening because it could lead to the development of novel and closing according to the temperature. At a ways to disrupt gene expression and the creation of particular temperature, the receptors open. This new antimicrobial therapies. Not only does this allows an influx of ions into the neuronal processes, cooperation mechanism save energy by limiting any and this electrical signal is relayed through the excessive transcripts that cannot be translated in a timely manner, but it also prevents prematuretranscription termination by Rho factor, ensuring Scientists at the Scripps Research Institute and continuous coupling between transcription and the Genomics Institute of the Novartis Research translation. Thus, bacteria rely on macromolecule Foundation (GNF) have shed new light on the trafficking and cooperation, a fundamentally novel molecular mechanism that enables us to sense mechanism, to finely control expression of each temperature, such as the heat from a sizzling stove.
individual gene in response to nutrient availability In addition to contributing to our knowledge of basic biology, the findings could one day lead to newtherapies for conditions such as acute or chronic (NYU Langone Medical Center, Apr 23, 2010) Nano-Scale Cell Probe
To better understand temperature sensation, The inner electrical activity of individual cells the team focused on a protein called TRPV1, which is eavesdropped by means of nanotechnology.
is a member of a small family of proteins known to For the first time, researchers have created a way enable temperature sensation, and is involved in to implant an inorganic device into a cell wall inflammation and the communication of pain to the without damaging it. A nanometer-scale probe brain. After producing thousands of mutants of this designed to slip into a cell wall and fuse with it could protein, the scientists were able to identify a region offer researchers of extended eavesdropping on of the protein that enabled temperature sensitivity the inner electrical activity of individual cells. The and to detail some of the molecular mechanisms at key design feature of the probe is that it mimics natural gateways in the cell membrane. With The findings could lead to the development of modification, the probe may serve as a conduit for novel therapies for conditions such as acute inserting medication into a cells heavily defended interior. It also provides an improved method ofattaching neural prosthetics, such as artificial arms (Scripps Research Institute, Apr 24, 2010) IPR BIOTECHNOLOGY
JUNE 2010
Alliance to Improve Drug Discovery
STRATEGIC ALLIANCES
AB SCIEX, a global leader in life science analytical technologies, announced that it Agreement over Treximet Patent
has collaborated with the University of Geneva’s Mass Spectrometry Centre to create new workflows agreement with Teva Pharmaceuticals USA, Inc.
and analytical strategies intended to significantly (Teva) to resolve a US patent infringement suit improve drug discovery and development. This related to Teva’s filing of an Abbreviated New collaboration is focused on developing specific applications for use with a groundbreaking platform and Drug Administration (FDA) to market a generic that will be the life science industry’s first mass version of Treximet® (sumatriptan/naproxen spectrometry system to combine both qualitative and sodium) marketed by POZEN’s exclusive US quantitative analysis at high resolution and high licensee, GlaxoSmithKline. Under the terms of the settlement agreement, Teva will be dismissed Accurate mass measurement allows the elemental without prejudice from the consolidated litigation composition of a molecule to be determined, which currently pending in the United States District is used within the life science industry to discover Court for the Eastern District of Texas against and identify compounds. AB SCIEX is uniquely Teva, Par Pharmaceutical, Inc, Alphapharm Pty combining qualitative and quantitative analysis with Ltd., and Dr Reddy’s Laboratories, Inc, but will high resolution, speed and high sensitivity to greatly agree to be bound by the outcome of such litigation improve the quality and timeliness of the data or any resulting settlements with third parties.
pharmaceutical companies use to make decisionsabout drug discovery and development.
The University of Geneva’s Mass Spectrometry Alliance for InDevR’s Virus Counter
Centre, whose scientists are among the world’s InDevR, developer of advanced life science leading experts in mass spectrometry-based products, teamed up with Sales Partnerships Inc.
pharmaceutical applications, is applying this for its new Virus Counter product line.
innovative technology for metabolite identification.
Metabolite identification is a critical application for The Virus Counter is a unique bio-analytical tool studying the efficacy and safety of new chemical that enables scientists to measure virus particle entities in the drug discovery and development concentration within minutes, which is 200 times pipeline, ranging from early drug discovery to faster than the most commonly used biological method and 1000 times less expensive than the standard physical method. The unprecedentedefficiency and accuracy of virus quantification with Avecia-Pfizer Agreement
the Virus Counter is anticipated to dramatically Avecia Biotechnology, Inc., a leading provider accelerate vaccine and antiviral therapeutic research of drug development and manufacturing services for oligonucleotide therapeutics, has reached Sales Partnerships (Inc) is a leading provider agreement with Pfizer Inc. regarding the commercial of outsourced sales services in North America. SPI, the winner of the 2009-2010 American Business (pegaptanib sodium injection), marketed in the EU Awards as the top sales firm in America, continues by Pfizer for the treatment of wet age-related The agreement includes technology transfer, The alliance expands sales capabilities of the process validation and commercial supply of a key (Avecia Biotechnology, Inc, Apr 26, 2010) IPR BIOTECHNOLOGY
JUNE 2010
Cancer Vaccine Collaboration
applied for funding of the collaboration by the Israel China Bi-national fund and received initial approval.
immunomodulators to treat cancer and viral According to CEO of Zetiq Technologies, the diseases, announced that it has established a collaboration agreement further demonstrates Zetiq’s strategic collaboration with Japan’s National ability to commercialize its CellDetect technology.
Cancer Research Center (NCRC) to evaluate next-generation peptide-based cancer vaccines.
Clinical research will be conducted at NCRC, and Marketing Pact on MRSA Assay
IRX Therapeutics will provide its proprietary Molecular Detection Inc. (MDI), a company IRX-2 immunomodulatory regimen, clinical trial developing Detect-Ready(TM) assays designed to design and technical support. This is the first increase the speed and accuracy of infectious disease collaboration of its kind between the NCRC and a diagnosis, and Inverness Medical Deutschland GmbH announced that they have entered into an exclusive NCRC, one of Japan’s pre-eminent cancer distribution agreement for MDI’s Detect-Ready treatment and research centers, performed a MRSA assay in the key European markets of rigorous, global search and evaluation of Germany, Austria and Switzerland. The companies immunomodulators with high potential to enhance also announced that the Detect-Ready MRSA assay immune responses to a Wilms’ tumor gene (WT1) is available to customers in these countries. The peptide-based cancer vaccine. WT1 is expressed Detect-Ready MRSA assay offers healthcare at high levels in hematologic malignancies and also providers a high-performance MRSA screening in various types of solid tumors. IRX Therapeutics’ test with an unmatched combination of accuracy, IRX-2, a cell-derived biologic that has been speed, flexibility and cost-effectiveness. Inverness shown experimentally to be a broad spectrum Medical Deutschland, which is a leading distributor and potent activator of immune cells, was selected of quality medical diagnostic products in these markets, is a subsidiary of Inverness MedicalInnovations, Inc., a global market leader in point- According to CEO of IRX Therapeutics, this collaboration is one of the most significantmilestones achieved in the development of IRX-2.
received CE mark certification for sales in the Collaboration on Cancer Sereening Tech
(Molecular Detection Inc, Mar 26, 2010) Bio-Light's subsidiary zetic Technology and Strategic Alliance for Commercial Strength
biomics Biotechnologies of China, have signed a Percorso Life Sciences, LLC (PLS) announced collaboratrion agreement, which will take place in a strategic alliance with Capital Biotechnology two stages. During the first stage Biomics Ventures, LLC (CVB) to strengthen its commercial Biotechnologies will be responsible for preparing reach in the mid-Atlantic region. PLS specializes for clinical trials and for the registration and in providing solutions for the life science organizations regulatory approval process with the SFDA, the seeking to enter or further strengthen their commercial medical regulatory authority in China. According to focus in the North American market. Percorso the agreement, Zetiq will supply Biomics with an actively partners with its clients to develop and exclusive knowledge and patent license of the execute innovative business and channel strategies product in China, so as to enable Biomics to hold clinical trials and obtain registration and regulatory approval.
According to the President and CEO of CBV this Upon successful completion of the regulatory strategic alliance enables CBV to strengthen Percorso approval, the second stage will ensue, whereby Biomics Life Sciences’ commercial scope in the mid- will be granted exclusive rights to market and distribute the product in China. The two sides have IPR BIOTECHNOLOGY
JUNE 2010
This methodology enables the design of small ON TO EXCELLENCE
amphiphilic polymers or oligomers, taking into accountbackbone structures, side-chain architectures andsolvent effects, and improves the likelihood of PolyMedix, Inc.
synthesizing compounds with desired properties.
Inception
the design of PolyMedix’s defensin mimetic antibiotic compounds, which represent a new class biotechnology company, was founded in 2002. It of antibiotic drugs and antimicrobial biomaterials is a developer of biomimetics (protein-mimicking that are believed to work in such a way that polymers and compounds comprised of small makes bacterial resistance unlikely to develop.
molecules), as well as other first-in-class therapies The company’s two leading defensin-mimetic for lethal, acute disorders via a proprietary drug candidates have both completed Phase 1B clinical design technology. The company focuses on trials and Phase 2 is slated for this year: developing treatments for some of the debilitatingand life threatening infectious diseases, and acute cardiovascular disorders with significanttherapeutic, as well as commercial potential.
PMX-30063 antibiotic that mimics a defenseprotein from the host immune system Products
PolyCides™ are a family of antimicrobial technologies: DeNovo Compound Design, Coarse Grain Modeling, Transmembrane ProteinReceptor Solubilization. It has a comprehensive The overarching goal of the R&D effort of the computational platform which possesses a wide company will focus on creating antimicrobial sutures range of capabilities from generating proprietary with full-spectrum control capability for the sort of crystal target structures of transmembrane-bound pathogenic agents typical of surgical site infections protein receptors to novel in silico de novo drug (SSIs), and will also negate much of the potential design of biomimetics: small molecule compounds for bacteria to develop a resistance due to the that mimic the activity of proteins.
unique biomimetic functionality of the PolyCidepolymer materials.
The company has recived patent protection for certain exclusively licensed intellectual property by SSIs are the number three cause of hospital- the issuance to the University of Pennsylvania a US acquired infections, often leading to serious patent, No. 7,590,517, entitled “Methods, Systems, complications and even death. Because 60% of and Computer Program Products for Computational SSIs are at the incision site, such antimicrobial Design of Amphiphilic Polymers.” This patent sutures with robust characteristics may go a long claims the underlying process and implementation way toward solving this problem in one fell swoop.
of two proprietary computational methodologies:PACE(TM) (Proteomic Assisted Computational Business Strategy
Engine) and GOLDYN(TM) (Global Optimizationof Long-time Dynamics force field), useful for the de PolyMedix has a combination of advanced anti- novo design of small molecule mimetics. It relates to infective and heptagonist lead product development the identification of stable conformations of programs, and a computational drug design polymers and polymer fragments (oligomers) by technology platform that is capable of generating computing force fields for the target compounds, and new products that can create a sustainable product then predicting their conformations using molecular pipeline. Havaing many products could provide several dynamics and configurational-biased simulations.
ways to generate revenues and minimize risk.
IPR BIOTECHNOLOGY
JUNE 2010
But as detailed functional studies have revealed SPECIAL FEATURE
the internal structure of some cis-regulatory modules,it is less clear whether much of the sequence lengththat is included in the relatively conserved sequences GENE DUPLICATION
must be located between, and not within, the known Introduction
transcription factor target sites. It is unlikely that base pairs located between the transcription factor and eukaryotes reflects the phenotypic version as target sites of cis-regulatory modules have sequence it affects the physiological mechanisms.
dependent function, and the mechanism thatconstrains evolutionary change within cis-regulatory to consist of repeated sequences. Such sequencesinclude noncoding DNA and also functional genes, Origin of Gene Duplications
as exemplified by the ubiquity of multigene families.
Gene duplication can involve large or small Multigene families consist of groups of similar genes regions of the genome. At one extreme, an entire that have arisen by duplication from a common genome can be duplicated. Several mechanisms can ancestral gene and that generally retain similar cause this to happen. Sometimes the paired functions. One of the best-known examples is the chromosomes fail to divide during meiosis, globin gene family. Around 600 million years ago, producing gametes with a full diploid complement of a duplication from an ancestral globin gene was chromosomes. Instead of two haploid gametes followed by divergence into genes encoding two fusing to restore the normal diploid number of types of functional protein: myoglobin, involved in chromosomes, two diploid gametes occasionally oxygen storage in muscles, and hemoglobin, fuse to produce an offspring with twice the responsible for oxygen transport in the blood.
number of normal chromosomes. This phenomenon Gene Families
is called autopolyploidy. A more commonpolyploidization event, allopolyploidy, involves hybridization between related species. If the important in all eukaryotes. About half of these analogous chromosomes of the two species are gene familes have more than five members.
somewhat dissimilar, they may not pair properly, Similarly, around 40 percent of the ∼35,000 known resulting in a doubling of the chromosome number or predicted proteins encoded by the human genome are encoded by genes belonging to genefamilies. A remarkable feature of some gene families is that even those with many thousands of members homologous recombination, a retrotranspostionevent, or duplication of entire chromosome leads may show a high level of nucleotide sequence to the duplication of a region of DNA containing a conservaion. However, the various copies generally gene. The significance of this process for evolutionary biology is that, unlike a single functional gene, which Whole genome analysis has demonstrated that is usually subject to purifying selection and thus the most important genes utilized in development has a slowed mutation rate, one copy of a duplicate are all shared across Bilateria. These genes are the set of genes is often freed from selective pressure, genes encoding transcriptional factors and allowing it to freely mutate. This is because with co-factors and elements of signaling systems.
two copies of a gene present, mutations in just one Differences in the repertoire of these genes, or of copy of the gene often have no deleterious effect genomically encoded protein domains, cannot on the organism; thus, the second copy to “explore” account for the differences in body plan amongst the sequence space by mutating randomly. The bilaterian animals, rather the causal explanation duplicate gene may either (a) acquire mutations for particular developmental pathways lies that lead to a gene with a novel function or (b) in the regulatory connections programmed in acquire deleterious mutations and become a IPR BIOTECHNOLOGY
JUNE 2010
For over100 years, gene duplication is believed device therefor and the like. In another aspect, the to play a major role in evolution. Susumu Ohno is one of present invention is related to a method for expressing the most famous developers of this theory in his classical a protein of interest instead of a native protein.
book “Evolution by gene duplication” (1970). Somehave argued the gene duplication is the most important On 25th May 2010 another Japanese scientists evolutionary force since the emergence of the team, Kadowaki, et al were awarded the US patent (No. 7,723,569), on ‘Method for producingubiquinone-10 in plant’. The invention relates to a method of producing ubiquinone-10 using a plant, uncommon. It is retrodicted that the entire yeast a transgenic plant for use in the production method, genome underwent duplication about 100 million and an expression cassette for use in the years ago. Plants are the most prolific genome production of the transgenic plant. Ubiquinone is a component of the electron transfer system and isa compound which has a quinone backbone with an isoprenoid (a naturally-occurring organic duplication event are called paralogs. Paralogs usually code for proteins with a different function diphosphate (IPP) having 5 carbon atoms).
and/or structure. This is different from orthologous Ubiquinone is a biological component as a coenzyme.
gene, which code for proteins with similar functions In animal and plants, it plays a physiological and but exist in different species. Orthologs are created biochemical important role. Vitamin-like substance is from a speciation event. It is important (but often known as an antioxidant substance. Therefore, hard) to differentiate between paralogs and orthologs according to the demand for a method of enhancing production of qubiquinone-10 using a transferred Genomic Microarrays Detect Duplications
plant, the present invention was launched.
Technologies such as genomic microarrays, also On 25th May 2010, US scientist won the US called array comparative genomic hybridization patent (No. 7,723,298) on ‘Cytokine receptor’. In the (array CGH), are used to detect chromosomal invention novel methods are disclosed for forming abnormalities, such as microduplications, in a high heterodimeric receptor complex with IL-28R and throughput fashion from genomic DNA samples.
CRF2-4. Ligand-binding receptor polypeptides In particular, DNA microarray technology can can be used to block ligand activity in vitro and in simultaneously monitor the expression levels of vivo. The invention also includes methods for thousands of genes across many treatments or experimental conditions, greatly facilitating theevolutionary studies of gene regulation after gene Davidson, et al of USA were awarded with the US patent (No. 7,720,614) on May 18, 2010 on‘Method for identification of cis-regulatory modules Patent Scenario
via computational analysis of single polynucleotidepolymorphisms (SNPs) and insertions/deletions (indels)’. The invention relates generally to and seventy seven (1077) US patents. Some of the gene regulatory networks and more specifically to significant patents are mentioned below:- identifying genomic sequences which function as Japanese scientist Kuroda won the US patent (No. 7,728,191) on June 01, 2010 entitled ‘Nucleicacid for reducing protein content in rice seed’. More US patent (No. 7,711,497) on ‘Method of specifically, the present invention is related to a identifying calcium-binding sites in gamma-crystallin method for reducing expression of a storage protein useful for management of cataract’ was granted to and for efficiently expressing a foreign protein, and an Yogendra Sharma et al of India. The present antisense construct, RNAi construct, composition, invention relates to a method of identifying calcium IPR BIOTECHNOLOGY
JUNE 2010
binding sites in gamma-crystallin useful in calcium- On January 19, 2010 Echeverri, et al got the based homeostasis for the management of cataract. The US patent (No. 7,648,827) on ‘Use of eukaryotic said method comprises steps of isolating gamma- genes affecting cell cycle control or cell cycle crystallin from eye lens, studying binding of progression for diagnosis and treatment of calcium to the isolated protein by both direct proliferative diseases’. The invention relates to the and indirect methods, identifying Greek key significant functional role of several C. elegans motif as calcium-binding sites of the protein genes and of their corresponding gene products gamma-crystallin with the said protein binding in cell cycle progression during cell division that 4-mol eq of calcium having dissociation constant could be identified by means of RNA-mediated interference (RNAi) and to the identification andisolation of functional orthologs of said genes US scientist Siegel, Donald L, was awarded the including all biologically functional derivatives US patent (No. 7,709,219) on May 4, 2010, on thereof. In particular, the invention relates to the use ‘Compositions and methods for detection of antibody of small interfering RNAs derived from said genes binding to cells’. The field of invention is generation of binding proteins. The invention includes Rh(D)binding proteins, including antibodies, and DNA The US patent (No. 7,642,345) was awarded encoding such proteins. Methods of generating such to Presnell, Scott R et al on January 5, 2010, entitled proteins and DNAs are also included.
‘Polynucleotides encoding human cytokine receptor’.
The invention relates generally to a new protein On April 20, 2010, US scientists Johnson, et al expressed by human cells. In particular, the were awarded with US patent (No. 7,700,100) on invention relates to a novel gene that encodes a ‘Fc.gamma.RIIB fusion proteins and compositions receptor, designated as “Zcytor16,” and to nucleic thereof’. The invention relates to molecules, acid molecules encoding Zcytor16 polypeptides, preferably soluble (i.e., not membrane bound) polypeptides, most preferably soluble fusionpolypeptides comprising the extracellular soluble US inventors Huang, Jing et al won the US patent regions of Fc.gamma.RIIB, derivatives and analogs thereof, and nucleic acids encoding same. Molecules ‘Methods for high throughput genotyping’’. The of the invention are particularly useful for the invention is related to methods of genotyping treatment, management, or prevention of or polymorphisms. The invention relates to computer amelioration of one or more symptoms of an systems, methods, and products for the analysis autoimmune disease, especially for ameliorating serum platelet deficiency associated with immune Conclusion
thrombocytopenic purpura. The invention providesmethods and compositions for enhancing the Gene and genome duplications provide a source therapeutic efficacy of standard, current or of genetic material for mutation, drift, and selection experimental therapies for an autoimmune disease to act upon, making new evolutionary opportunities by administering a molecule of the invention.
possible. As a result, many have argued that genomeduplication is a dominant factor in the evolution of On April 13, 2010, an Indian scientist Madan complexity and diversity. However, a clear Kumar Bhattacharyya won the US patent on ‘Rps-1- correlation between a genome duplication event .kappa. nucleotide sequence and proteins'. The and increased complexity and diversity is not patent No. is 7,696,410. This invention relates to apparent, and there are inconsistencies in the the purified and isolated family of Rps1-k disease patterns of diversity invoked to support this claim.
resistance genes, proteins encoded thereby and use Interestingly, several estimates of genome duplication of the same to confer, enhance or otherwise events in vertebrates are preceded by multiple modify resistance of soybean to plant pathogens, extinct lineages, resulting in pre-duplication gaps IPR BIOTECHNOLOGY
JUNE 2010
CLINICAL TRIALS
Laevo-Bambuterol Trial
Beike Biotechnology Awarded ISO 9001
Certification

Lotus Pharmaceuticals, Inc is an emerging developer, manufacturer and seller of medicines and Beike Biotechnology Co. Ltd., one of the world’s drugs in the People’s Republic of China (PRC).
leading biotechnology companies focusing on adult On April 2010, the company reported that its stem cell therapies, has been awarded ISO 9001 innovative asthama drug Laevo-Bambuterol.
certification by the International Organization for categorized as a Class 1 new drug, has received Standardization (“ISO”). This internationally approval from China’s State Food and Drug recognized designation signifies Beike has established Administration’s (SFDA) to commence clinical trials.
a Quality Management System (QMS) that complies Its pre-eclinical studies show that it is more effective and have lower toxicity than Bambuterol, (Beike Biotechnology, Apr 03, 2010) ORNL Small Business Award
(Lotus Pharmaceutical Inc, Apr 29, 2010) Neutralizable Anticoagulant
announced it has been awarded Oak Ridge National Endotis Pharma has reported the successful Laboratory's (ORNL) 2009 Small Business of the completion of Phase I clinical trials of neutralizable anticoagulant EP217609 and antidote avidin.
Frontier GeoSciences is an internationally EP217609 has a dual mechanism of action which recognized analytical, consulting, and advanced combines indirect factor Xa inhibition and direct research laboratory, specializing in the analysis of thrombin inhibition. EP217609 is the neutralizable trace metals or heavy metals in industrial, version of EP42675. The Phase I clinical programwas successfully completed in 108 healthy subjects.
environmental and consumer applications. For over EP217609’s pharmacodynamic and pharmacokinetic 18 years, the company has provided innovative profiles were predictable, with low inter-subject solutions and “gold standard” analytical services to variability. In a separate trial, avidin was well corporations and government entities throughout tolerated in 24 healthy subjects exposed to single, Oak Ridge National Laboratory (ORNL) is a multi-program science and technology laboratorymanaged for the US Department of Energy. Scientists Ventricular Assist System
and engineers at ORNL conduct basic and applied research and development to create scientific innovator of less invasive, miniaturized circulatory knowledge and technological solutions that strengthen support technologies that have revolutionised the the nation’s leadership in key areas of science; increase the availability of clean, abundant energy; company presented the results of the clinical data restore and protect the environment; and contribute at the annual meeting of the International Society of Heart and Lung Transplantation (ISHLT) held inChicago. The data includes all 50 patients enrolled According to Oak Ridge National Laboratory, in the company’s international clinical trial, as well the selection criteria for the 2009 Small Business as the first commercial patients. Survival rates were of the Year was based on excellence in contract identical between the commercial and clinical groups compliance, customer service, problem solving and commercial experience of HeartWare Verticular and most importantly, helping accomplish objectives (HeartWare International, Inc, Apr 24, 2010) IPR BIOTECHNOLOGY
JUNE 2010
the cohesin complex called Rec8. Also, Amon said that FINE TUNING
researchers had found that Rec8 cleavage waspromoted by phosphorylation, the addition ofchemical phosphate groups of Rec8.
This section attempts to fine-tune some basic Researchers also knew that cohesins release concepts on a subject of interest about which one chromosome pairs from one another’s embrace might have already heard of. The current issue quite differently during meiosis and mitosis. In features Protein Cohesins”. mitosis, cohesins release chromosomes along theirentire length simultaneously. However, in the initial Protein Cohesins
stage of meiosis, cohesins first release only the “arms” Introduction
of chromosomes, still holding the chromosomes Proteins called cohesins ensure that newly together at their central connection point, the copied chromosomes bind together, correctly centromere. Only in a second stage of meiosis that separate during cell division and are efficiently gives rise to haploid sperm or egg cells do repaired after DNA damage. Scientists at the centromeric cohesins become cleaved. This precisely Carnegie Institution have observed for the first time controlled centromeric “stickiness” is essential for that cohesins are needed in different concentrations the accurate segregation of sister chromatids into for their different functions. The research study was published on-line May 6 and on May 25, 2010 According to Amon, a deeper basic knowledge of print edition of ‘Current Biology'.
the mechanism of cohesin loss during meiosis could Earlier, the October 20, 1995 issue of ‘Cell' ultimately improve understanding of the origins of published the research work of scientists at the miscarriages and mental retardation due to mis- Whitehead Institute for Biomedical Research where they had discovered the glue-like protein in fruit flies that ensures proper partitioning of hereditary phosphorylation was not the only process essential material and could shed new light on the origin of for cohesin removal. Recombination, an exchange of some of the most common human birth defects, including Down syndrome. They described the new genetic diversity, was also needed for the protein as MEI-S332 and its role in sexual initial removal of cohesin from the chromosome reproduction. MEI-S332 is the first protein in any species shown to hold together chromosomes Their research work as published in 'Nature', until the exact moment in cell division when they represents a significant advance in understanding must separate to ensure proper development of the enzyme that phosphorylates Rec8, named eggs and sperms. After it, on May 2006 in the journal Polo kinase, because it more accurately identified Nature, the MIT (Massachusetts Institute of the specific sites on the Rec8 subunit that Polo Technology) scientists, led by Amon (investigator) of phosphorylates. Firm identification of such sites will Howard Hughes Medical Institute, revealed how enable more precise studies of the mechanism of glue like protein complexes release pairs of function of Rec8, and will also enable scientists to chromosomes at precisely the moment of meiosis, the identify other protein targets of Polo kinase.
specialized cell division process that produces spermsand eggs-enabling them to separate properly.
Conclusion
Cohensin Function
Proteins cohesins play a central role in meiosis.
mechanism of cohesin function has remained chromosome pair together until just the right moment sketchy, even though it plays a central role in meiosis.
during cell division. Bound together by cohesins, Researchers knew that an enzyme called separase chromosome pairs must organize themseves in snips apart cohesins, targeting a specific subunit of preparation for division before they can be relased.
IPR BIOTECHNOLOGY
JUNE 2010
IP Advocate Settles Legal Battle
LEGAL SCENE
In a move that positions IP Advocate for its next chapter as a champion of research translation, Gemzar Patent
Eli Lilly and Company announced that the US she has settled her long-standing legal battle with district court for the southern district of Indiana the University of Georgia Research Foundation has upheld the validity of the company’s compound patent on Gemzar® (gemcitabine HCl for injection).
The $20.2 million settlement ends a seven- This decision maintains Lilly’s US exclusivity for year dispute over a secret contract that UGARF entered with pharmaceutical company Allerganto market an ophthalmic formula, including According to senior vice-president and general cyclosporine, to alleviate chronic dry eye disease by counsel of Lilly, the Court’s rule to the validity of restoring normal tear function. Dr Kaswan’s Gemzar’s compound remains optimistic that asuccessful appeal of the Michigan dicision on the invention is marketed as Restasis®, and is one of Gemzar method-of-use patent will retain US exclusivity for Gemzar into 2013. Protection of intellectual property rights is extremely important to Johrson & Johnson Resolve Patent Litigation
The Johnson & Johnson company Ethicon These statements are based on management's Endo-Surgery, Inc., announced its agreement with current expectations, though actual results Hologic Inc. and its subsidiary Suros Surgical Systems Inc., settling litigation in Ohio and dismissing pending cases in Delaware. The disputes involvedpatents relating to Ethicon Endo-Surgery Infringement Case Against Boston
MAMMOTOME® Breast Biopsy System, and the OrbusNeich Medical, Inc, a designer, developer, Hologic ATEC and EVIVA biopsy devices. Under manufacturer and marketer of innovative medical the terms of the agreement, Ethicon Endo-Surgery devices for the treatment of cardiovascular diseases, will receive $12.5 million from Hologic.
announced that on March 23, 2010, the company As part of the settlement, Ethicon Endo-Surgery was granted US Patent No. 7,682,384 B2, entitled and Hologic will enter into a cross licensing “Stent with Helical Elements.” The patent relates to agreement, whereby Hologic will pay ongoing an expandable stent comprised of a plurality of royalties on the sales of ATEC and EVIVA hand helical segments. The company noted that it hasidentified unlicensed use by Boston Scientific pieces, and Ethicon Endo-Surgery will pay ongoing Corporation of certain technologies protected royalties on the sales of the MAMMOTOME® As the owner by assignment of all rights, title, The cases resolved were in trial in Ohio before and interest in the “Stent with Helical Elements”, US district court judge Barrett, and pending trial OrbusNeich believes that its previously announced in Delaware before US district court judge Farnan.
infringement claims against Boston Scientific in the (Ethicon Endo-Surgery, Inc., Feb 20, 2010) United States district court for the district ofMassachusetts , specifically related to the Boston Lower Court’s Ruling on Patent Claims
Scientific Liberte and TAXUS Liberte branded In November of 2007, Merck entered into an agreement to resolve state and federal myocardial newly granted patent. Accordingly, the company infarction and ischemic stroke personal injury claims filed with the court a motion to amend its filed or tolled by November 9, 2007. More than existing complaint against Boston Scientific.
99 percent of all eligible personal injury claimants (OrbusNeich Medical, Inc, Apr 14, 2010) enrolled in the program and the program is IPR BIOTECHNOLOGY
JUNE 2010
proceeding as scheduled with payments expected Nycomed’s Patent Invalid
On 28th April, 2010 the company announced Industries Ltd, announced that a jury returned a that it is disappointed with the US Supreme Court’s verdict in the US district court of New Jersey decision to affirm a lower court’s ruling on when the finding that Nycomed’s US Patent No. 4,758,579 statute of limitations began to run in a federal is not invalid. The New Jersey district court has securities class action against the company and reserved decision on the issue of what, if any, effect certain of its officers and directors. The effect of the to give to the jury’s determinations in connection ruling is to return the case to federal district court in with the obviousness-type double patenting defenses, which Teva has argued is to be decided by the The original suit, brought by investors, who allege court. A decision by the district court judge that the company made material mis-statements and independent of the jury's verdict would be omissions regarding the pain medication VIOXX®, sufficient to invalidate the patent.
was dismissed by the US district court for the (Teva Pharmaceutical Industries Ltd, Apr 24, district of New Jersey in 2007, on the ground that the claims were time-barred under the statute of Sadanta-Infocrossing Lawsuit
limitations. In 2008, however, a divided Court ofAppeals for the Third Circuit reversed the district Sandata Technologies, Inc., a leading nationwide court’s ruling. In May 2009, the Supreme Court provider of information technology solutions to the home healthcare and social services communities, andInfocrossing, Inc. announced the settlement of the patent infringement lawsuit between the two Novamont Patents Valid
companies. As part of the settlement, Infocrossingwill transfer its home healthcare agency business On April 16 , the Paris Law Court issued the consisting of time and attendance software and first-instance sentence in the case brought by services that capture time and attendance information Novamont against the German company Biotec and inputted by telephone as provided under the contracts certain companies of the French group Sphere, being assigned to Sandata and will stop offering respectively, the manufacturer and distributors of such services to home health care agencies in certain starch-based products which, it was alleged North America. The parties agreed to release all by Novamont, infringed its patents protecting first claims against each other, including Sandata’s claims for alleged infringement of Sandata’s The Court found two Novamont patents to be patents covering Automatic Number Identification.
fully valid and a third patent to be partially invalidwhile also finding that Novamont had not provided (Sandata Technologies, Inc, Mar 05, 2010) proof of the infringement. Not entering into the merit Takeda Settles Infringement Lawsuit
of the case, the court noted that the analyses on samples of the products of the summoned companies (Takeda) announced that it and its wholly had not been conducted in a two-party process.
owned subsidiary, Takeda Pharmaceuticals North Novamont greeted with satisfaction the fact that America, Inc. (TPNA), have completed settlement its important patents were considered valid and agreements with six out of eight defendants in patent remains convinced that they will be declared to have infringement litigation brought against these parties been infringed when it comes to examining the aspects in response to their Abbreviated New Drug of substance of the dispute. Novamont will therefore pursue with the greatest conviction itsactions against the infringement of its patents, and in (pioglitazone HCl) and ACTOplus met® (pioglitazone particular those currently pending before the concluded litigation with the sixth settling defendant.
(Pharmaceutical News, Apr 28, 2010) IPR BIOTECHNOLOGY

Source: http://www.witts.org/IPR_biotech/biotech-63-jun10.pdf

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