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NEWSLETTER



                                          Contents



       1. Headlines                                                                 1

       2. News India                                                                2

       3. News China                                                                6

       4. News Japan                                                                9

       5. Editorial                                                                 12



  TT Consultants is an ISO-27001 and ISO-9001:2008 certified Intellectual Property Consulting
  firm providing services in over 20 countries worldwide to more than 500 Companies, universities
  and research institutes with several offices in three countries i.e. Taiwan, US and India and strong
  client base in US, Canada, Europe, Japan, Singapore, South Korea, Taiwan and India, we strive
  towards providing our clients global and world-class services.
  We provide patent litigation support, patent prosecution support, licensing support, patent
  acquisition support, technology transfer consulting, patent portfolio management and other legal
  support services to leading patent law firms, companies, universities, research institutes and
  intellectual property owners.
INDIA                           CHINA                               JAPAN   EDITORIAL

    HEADLINES INDIA

      India revokes Roche patent in new blow for Big Pharma
      India's Cipla cuts price of 3 more cancer drugs
      India Publishes Draft Guidelines f or Patenting Of TK and Biological Material
      India revokes patent on Merck's asthma drug
      'Amul' loses trademark battle against US giant in court
      ASSOCHAM suggest formation of National IPR Strategy Authority
      India scores lowest on intellectual property protection - index
      Patent laws key to drug innovation, argues report
      American Court rules against confidentiality for Cadila’s ‘in -house’ Indian
         counsel

    HEADLINES CHINA

     EPO and SIPO launch Chinese-English machine translation for patents
     Global IP Filings Continue to Grow, China Tops Global Patent Filings
     East Asia faces unique challenges, opportunities for stem cell innovation
     China’s new approach to renewable energy
      Light at the end of the tunnel: trademark squatting in China
      China Officially Recognizes Napa Valley Wines

    HEADLINES JAPAN

     Japan, China pay a high price
     Japan gives patent for Medgenics IFNa pump
     Astellas-UCB rheumatoid arthritis therapy wins marketing approval in Japan
     Bristol-Myers, Pfizer win approval for Eliquis in Japan
     Novartis future growth prospects secured by industry -leading pipeline
     Roche reports positive studies of MabThera given by subcutaneous injection
     Govt To Mandate Price Cuts On Popular Off -Patent Drugs

    EDITORIAL

     The prime solution - Invalidation search

© TT Consultants, 2012. All rights reserved – privileged and confidential
NEWS INDIA


                                           India revokes Roche patent in new blow for Big Pharma
                                                   The Intellectual Property Appellate Board (IPAB) cited a lack of
                                           evidence that the drug was any better than
         Patent Invalidation               existing treatments and its high price as
               Search                      reasons for the decision. Pegasys was the first
                                           medicine to win protection in 2006 under
    Lupin bags final approval
      We ‘scour the earth’                 India's new patent regime and the revocation
    from USFDA to market
      when it comes to                     will rekindle tensions between New Delhi and
    generic contraceptive
      searching for prior art              global drug makers worried by the country's
    tablets
      in order to invalidate a             tough stance.
       troublesome       patent.                 The decision follows another high-profile setback for the industry in
    If you use ‘Xerox’ the way
      We      have     helped              March, when India granted the first ever compulsory licence to domestic drug
    you use ‘zipper,’ our
      several US and Asian                 maker Natco (NATP.NS) to sell cheap copies of Bayer's (BAYGn.DE) cancer
    trademark could be left
      companies save huge                  drug Nexavar.
    wide open
      litigation   costs    by
                                           Read More>>                                                 Go to the top>>
    India announced highly
      uncovering
    Nationalprior arts. We
      useful Policy on
      have          Mandarin,
    Electronics 2012; wants to
    rival China and Korea
      Japanese                             India's Cipla cuts price of 3 more cancer drugs
      native         searching                    Cipla Ltd. -- one of India's largest generic-drug manufacturers--said
    AstraZeneca unveils
      capability. We are a                 Thursday it is cutting prices for three cancer medicines it sells in India by up
    antiplatelet drug Brilinta
      preferred choice for                 to 63%. Cipla is cutting prices of these cancer drugs to make them "affordable
    in India
      companies involved in                and accessible" for patients, Cipla Chairman Y.K. Hamied said in a statement.
    After India, now patent
      complex
                                                  The price of Erlocip, a generic version of Roche Holding AG
      litigation and have
    Indonesia introduces
                                           (RHHBY)'s lung-cancer treatment Tarceva, has been reduced by 63% across
    Patent Licenses for Joint
      represented many                     various strengths. Now 30 tablets of Erelocip 150 will cost 9,900 rupees
    Generic VersionsGroups
      Defense           of                 ($181) versus 27,000 rupees earlier. The prices of docetaxel--used in the
    Drugs in such cases to
      (JDGs)                               treatment of breast, lung and other cancers--and capecitabine have been
      identify relevant prior              halved, Cipla added in the statement.
      art for invalidating
                                           Read More>>                                                 Go to the top>>
      potentially dangerous
      patents.

                                           India Publishes Draft Guidelines for Patenting Of TK and
                                           Biological Material
                                                  The government of India has released a set of draft guidelines to be
                                           followed in the patenting of traditional knowledge and biological material.

                                                                                                               Page 2 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS INDIA


                                           Comments are due by 22 November. “It has been reported that the Indian
                                           Patent Office is granting patents on the use of traditional knowledge (TK) of
                                           India, particularly relating to the Ayurveda, Unani and Siddha systems of
       Patentability Search                medicine, etc. and patents have been granted on inventions related to
                                           biological resources obtained from India without taking adequate care to
  A thorough patentability                 observe the mandate of law,” the draft guidelines state.
  assessment search conducted
                                           The guidelines mention India’s primary role in a range of international policy
  on an exhaustive list of
                                           developments related to TK and genetic resources. Pending patent
  patent     and    non-patent             applications involving traditional knowledge are published on.
  databases.      We       offer
  innovative search reports                Read More>>                                                 Go to the top>>
  that come along with a key
  feature chart and many value
  additions offered by none                India revokes patent on Merck's asthma drug
  other in the industry. This
                                                  Indian Patents Office has revoked a patent for an asthma drug held by
  service is being extensively             US-based Merck & Co following a challenge
  used by the best research                from domestic pharma firm Cipla. In an order,
  institute of Asia, several               Assistant Controller of Patents & Designs T V
  national    universities    of           Madhusudhan revoked the patent on the
  Taiwan, top law firms in the             ground that it lacked invention.
  US and 5 fortune 500
                                                   "The sole process claim also in its
  companies to name a few.
                                           entirety is not inventive as the said claim does not describe any inventive
                                           feature," the order said. "In view of the above conclusion I hereby order that
                                           the patent bearing number 246328 is revoked," Madhusudhan said in his
                                           order.

                                                  Schering Corporation, which was later acquired by Merck & Co, had
                                           applied for patent of the asthma drug in February 2004, and the Indian Patents
                                           Office had granted the patent in March 2011. Cipla had challenged the patent.

                                           Read More>>                                                 Go to the top>>



                                           'Amul' loses trademark battle against US giant in court
                                                  The Gujarat High Court has refused to set aside an order which
                                           cancelled Amul's registration of its trademark 'TRIX', on which a US firm has
                                           claimed its right. In July this year, the Intellectual Property Appellate Board
                                           had directed Registrar of Trademarks to cancel Amul's registration of TRIX
                                           trademark.
                                                                                                              Page 3 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS INDIA

                                                   A Division Bench of Chief Justice Bhaskar Bhattacharya and Justice J
                                           B Pardiwala, in a recent judgement, dismissed the petition filed by Kaira
                                           District Cooperative Milk Producers Union Ltd, owner of Amul, seeking
                                           cancellation of trademark 'TRIX' registered in favour of US food giant
                                           General Mills.
       Freedom to Operate
             Search                        Read More>>                                                  Go to the top>>

       We      provide       a
       proactive       patent              ASSOCHAM suggest formation of National IPR Strategy
       study for mitigating
                                           Authority
       the risks involved                          Report by India Education bureau, New Delhi: The Associated
       before entering a                   Chambers of Commerce and Industry of India (ASSOCHAM) has suggested
       new jurisdiction and                establishment of National Intellectual Property Right (IPR) Strategy Authority
       have the capability                 to Department of Industrial Policy & Promotion (DIPP) in the context of fast
       to search in various                changing trade environment driven by global competition, innovation risks,
       geographies                         short product life cycle, rapid changes in technology involving huge
       including most of                   investments in Research & Development and human resource.
       the Asian countries
                                                  The proposed Authority should be aiming of aligning towards
       and some European
                                           achieving a target of 50,000 patent applications filed in India in 2015 and 1,
       countries.         Our              50,000 in 2020. Similar targets should also be set for filing of design and trade
       experienced                         mark applications.
       professionals
       perform an in-depth                 Read More>>                                                  Go to the top>>
       search and very
       closely examine the
       prior art vis-à-vis the             India scores lowest on intellectual property protection - index
       product       features.                     The index prepared for the group's Global Intellectual Property Center
       Claim charts are                    scored 11 countries on a point scale from
                                           zero to 25, with the United States receiving
       prepared         based
                                           the highest overall tally of 23.73 and
       upon the national
                                           Britain coming in second at 22.40.
       patent laws.
                                                   India was last with 6.24 points,
                                           reflecting its low scores in each of the five
                                           categories      examined      by     Pugatch
                                           Consilium, an international research and analysis firm that specializes in the
                                           knowledge economy. China was tenth with a score of 9.13, below Brazil with
                                           9.57 points and Russia with 11.17.
                                                   The new index is intended as a tool for U.S. policymakers to push for
                                           tough protections of U.S. copyrights, patents and trade secrets in free trade

                                                                                                                Page 4 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS INDIA

                                           agreements and other international talks.
                                                  The United States, with some of the strongest copyright, patent and
                                           trademark protections in the world, has a total stock of intellectual property
                                           valued at around $5.8 trillion.

       Structure Sequence                  Read More>>                                                Go to the top>>
             Search
      When you request a                   Patent laws key to drug innovation, argues report
      chemical structure/                         Pharmaceutical innovation in middle-income countries such as Brazil
      substructure search,                 and India could be boosted by stronger
      our domain specific                  enforcement of intellectual property laws and by
      searchers          with              building up research capacity, says a report.
      extensive experience
                                                   The report by global consultancy Charles
      perform          patent
                                           River Associates has identified the conditions
      searches and deliver                 required to encourage innovation in middle-
      insightful results for               income countries by evaluating government policies that promote investment
      compounds matching                   in local innovative activities in the biopharmaceutical field.
      the query structure,
      as well as for                              Commissioned by the International Federation of Pharmaceutical
      compounds                            Manufacturers & Associations (IFPMA) — an NGO representing the
                                           pharmaceutical, biotechnology and vaccine sectors — the document was
      containing the query
                                           released at the 26th IFPMA Assembly last month (31 October).
      structure as a subset
      (substructure) of a                  Read More>>                                                Go to the top>>
      larger structure.




                                                                                                             Page 5 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS CHINA

                                           EPO and SIPO launch Chinese-English machine translation
                                           for patents
                                                  Breaking new ground in providing access to the most comprehensive
        Patent Drafting &                  technological information, the European
                                           Patent Office (EPO) and the State Intellectual
           Illustrations
                                           Property Office of the People's Republic of
     A well drafted patent                 China (SIPO) today launched the Chinese-
     is the key to a strong                English component of the EPO's free
     patent and holds the                  automatic translation service Patent Translate.
     highest chances of                           As a result, the collections of the two largest languages in patents are
     being accepted by the                 now united as full-text documents on the same website through the EPO's
     National          Patent              global patent database, Espacenet, and linguistically accessible for innovators
     Office.              Our              from both regions using a single tool, Patent Translate. Under the new
     experienced           and             arrangement with SIPO, Espacenet has grown by 4 million Chinese language
     technically      trained
                                           Read More>>                                                 Go to the top>>
     professionals do a
     comprehensive
     understanding of the                  Global IP Filings Continue to Grow, China Tops Global Patent
     subject matter and use                Filings
     their        exceptional
     communication skills                         A new WIPO report shows that while the global economy continued to
                                           underperform, intellectual property (IP) filings worldwide kept growing
     to     elucidate       the
                                           strongly in 2011. It also finds that China’s patent office became the largest in
     invention and the draft
                                           the world, as measured by the number of patent applications received. Before
     is by default reviewed                2011, China already accounted for most filings of utility models (UMs),
     by an Indian Patent                   trademarks and industrial designs.
     Attorney. Further, the                       World Intellectual Property Indicators 2012 shows that patent filings
     draft is reviewed by                  worldwide grew by 7.8% in 2011, exceeding 7% growth for the second year
     respective          filing            in a row. Similarly, UM, industrial design and trademark filings increased by
     country           Patent              35%, 16% and 13.3%, respectively.
     Attorney.
                                           Read More>>                                                 Go to the top>>
     We have Illustrators
     who        are       well
     conversant with the                   East Asia faces unique challenges, opportunities for stem cell
     rules of USPTO, PCT                   innovation
     and other National                            Tension is the theme running through the new consensus statement
     Patent Offices.                       issued by the Hinxton Group, an international working group on stem cell
                                           research and regulation. Specifically, tension between intellectual property
                                           policies and scientific norms of free exchange, but also between eastern and

                                                                                                               Page 6 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS CHINA

                                           western cultures, national and international interests, and privatized vs.
                                           nationalized health care systems. The consensus, titled Statement on Data and
                                           Materials Sharing and Intellectual Property in Pluripotent Stem Cell Science
                                           in Japan and China, was released on the Hinxton Group's website on
                                           November 19, 2012.

       Patent & Trademark                  "China and Japan are among the world's leading nations in stem cell research,
          Filing in India                  but because of challenges distinct from western nations, they are dramatically
                                           underrepresented in terms of patents and licensing,"
            Our Indian IP
                                           Read More>>                                                 Go to the top>>
      Prosecution Partner –
         Talwar Advocates
      established since 1983,              China’s new approach to renewable energy
         handles patent and                        Chinese companies are using innovative business models to change the
      trademark filing in the              cost structures and capabilities
      Indian Patent Offices.               involved in delivering renewable
           The firm has the                energy technology. Through strategic
          infrastructure and               partnerships     with    technology-led
        resources to take on               companies in the US and Europe, they
         the whole range of                are rapidly reducing the cost of
      conventional and non-                production and effectively entering the
      conventional IP issues               value-added parts of the global
                                           technology economy.
           and offer clients
                                                   In the popular imagination, China’s industrial base is largely built on
           comprehensive
                                           agriculture and manufacturing. This is still generally true. Agriculture
       services in structuring
                                           employs an enormous proportion of the workforce and vast lands are
       and securing a patent               dedicated to the painstaking process of growing rice or harvesting wheat.
         portfolio. The firm
       possesses the distinct              Read More>>                                                 Go to the top>>
         advantage of filing
       Patents, Trademarks
                                           Light at the end of the tunnel: trademark squatting in China
         and PCT National
                                                  Trademark squatting has been a nightmare for many overseas
         Phase applications
                                           trademark owners for a long time, and more so in recent years. Our partner,
      electronically in Indian             Kenny Wong, published an article last month in Intellectual Property
            Patent Office.                 Magazine, titled "Kung fu trademark hustle", in which he says there are
                                           encouraging signs that we may be seeing light at the end of the tunnel.

                                           Following the Trademark Office, the Chinese judiciary has also openly
                                           acknowledged the problem. On December 3, the Beijing No. 1 Intermediate
                                           People's Court held a press conference to report on their study into "the cause,

                                                                                                               Page 7 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS CHINA

                                           characteristic and judicial response to trademark squatting". Vice president
                                           Chen Rui, a supervisor of intellectual property cases at the intermediate court
             Claim Chart                   and the leader of the task force, said that the courts should fully exert their
             Preparation                   judicial function by aiming to deter squatting activities when they interpret
                                           and apply the law.
      This search helps in
    Utah Hosts China-U.S.
                                           Read More>>                                                  Go to the top>>
    Intellectual the potential
      identifying Property
    Rights Roundtable
       infringers of a particular
                                           China Officially Recognizes Napa Valley Wines
    BSA: Global software
      patent portfolio. Over
    theft totaled $63.4 billion                    For more than a decade, Napa Valley vintners have been exporting
      the years, we have
    last year                              wine to China; and now, one of the most recognizable wine regions in the
       evolved an innovative               world will be the first acknowledged with Geographic Indication (GI) status in
    Court finds copyright of               China. Geographical indications are used in all countries to act as a
    Buddha designstrategy to
     and effective valid
                                           certification of authenticity. This is the first time that China has granted a GI
       identify       infringing           recognition to any wine region outside of its own borders.
    TechFaith Sues Samsung
      products/standards and
    for Patent Infringement                       “Being first speaks volumes to what people think about Napa Valley,”
       ascertaining          the           said Terry Hall of the Napa Valley Vintners. The Napa Valley Vintners
    In Search of 'Dexter':
                                           brokered the deal, working with the Chinese government for nearly 14 years.
    Why You Can't Buy This
      infringement.
                                           The new GI status step will help prevent Napa Valley knockoffs and
    Pirated DVDs in China a
      service is used by                   counterfeiting of labels and allow for consumer protection in China's rapidly
    Anymore                                growing market.
       leading semiconductor
       manufacturer and some               Read More>>                                                  Go to the top>>

       fortune 500 companies
       across the globe.




                                                                                                                Page 8 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS JAPAN


                                           Japan, China pay a high price
                                           Confirmation of the costly economic consequences of the continuing spat
            Patent Watch                   between Japan and China over who owns a tiny string of remote uninhabited
                                           rocky islets in the East China Sea came with the publication of Japan's
    The patent alert service is            September trade figures. They showed an unprecedented deficit of $7 billion
    for clients who wish to                as exports dropped by 10.3 percent, thanks to the global slowdown and to
    remain updated about the               Beijing's determination to teach Tokyo a lesson.
    latest patents filed in their
                                           Can China and Japan really be contemplating the madness of going to war
    preferred field of invention.
                                           over who owns this small real estate? Two months ago, most commentators
    It is a practical step taken by
                                           expressed confidence that the row would soon blow over, but it is continuing
    most of the companies who
                                           with new bellicose words, provocative actions and political tensions between
    desire to keep track of the            the once and future economic powers. New leaders settling in in Beijing dare
    new        and        improved         not risk being seen as weak, and Tokyo's nationalists will keep up the
    formulations and adjuvant              pressure. When and how will it end?
    relating to their field of
                                           Read More>>                                              Go to the top>>
    interest or in respect to a
    competitor's            patents.
    Accordingly, we endeavor               Japan gives patent for Medgenics IFNa pump
    to       observe         patents              Medgenics received a Notice of Allowance from the Japanese Patent
    continually and provide                and Trademark Office for key claims protecting the use of Medgenics'
    regular updates to our                 Infradure Biopump technology for the delivery of interferon alpha (IFNa).
    clients. Further, our search           Medgenics is developing Infradure as a new approach to provide sustained
    includes online product                and patient compliant interferon therapy to address unmet needs in the
    directory and other non                treatment of hepatitis B, C, and D.
    patent literature available.                  Similar claims protecting Medgenics' Infradure technology have been
                                           granted or allowed in other large Asian markets including, China, Korea and
                                           Australia. In addition, these countries have allowed broad claims to
                                           Medgenics protecting the core Biopump technology for production and
                                           delivery of proteins. Patents covering core Biopump technology for a
                                           genetically modified dermal micro-organ have already been granted to
                                           Medgenics in the US and in the EU.

                                           Read More>>                                              Go to the top>>


                                           Astellas-UCB rheumatoid arthritis therapy wins marketing
                                           approval in Japan
                                           Astellas Pharma and UCB have announced the marketing approval of Cimzia
                                           (certolizumab pegol) to treat rheumatoid arthritis (RA) in Japan. The
                                                                                                           Page 9 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS JAPAN


                                           Japanese Ministry of Health, Labor and Welfare has approved Cimzia as a
                                           200mg syringe for subcutaneous (s.c.) injection to treat adult RA patients who
                                           failed to respond to conventional treatment.

         Patent Landscape                  The only PEGylated Fc-free anti-TNF is designed in the form of a prefilled
             Analysis                      syringe that enables self-administration by RA patients. Adult patients can be
                                           administered with 400mg s.c. of certolizumab pegol at weeks zero, two and
      With the help of our                 four, subsequent to 200mg every two weeks, while 400mg every four weeks
      technical      experts,              s.c. can be considered for maintenance dosing.
      experienced      patent
      searchers and IP tools               Read More>>                                                Go to the top>>

      developed in-house, we
      have been able to                    Bristol-Myers, Pfizer win approval for Eliquis in Japan
      provide        valuable                     Bristol-Myers Squibb and Pfizer have announced the approval of
      reports to our clients.              Eliquis (apixaban) anticoagulant for the prevention of ischemic stroke and
      Our reports have                     systemic embolism in patients suffering from nonvalvular atrial fibrillation
      enabled         several              (NVAF) in Japan.
      technology companies
                                                   The Japanese approval of the anticoagulant is based on ARISTOTLE,
      across the world to
                                           the pivotal Phase 3 trial conducted in 18,201 NVAF patients, which assessed
      take important strategic             the safety and efficacy of ELIQUIS compared to warfarin.
      decisions. We have
      performed        patent                      A subanalysis of the ARISTOTLE study also established a similar
      landscape studies for                safety and efficacy profile of ELIQUIS in Japanese patients, compared to the
      one of the leading                   overall study. Bristol-Myers Squibb intercontinental region and Japan
      semiconductor                        executive vice president and chief financial officer Charles Bancroft said,
                                           "Today's approval of ELIQUIS is the result of our shared vision with Pfizer to
      companies in the US
                                           introduce a differentiated treatment option to reduce the burden of stroke in
      and a top LED
                                           patients with nonvalvular atrial fibrillation."
      manufacturer of Asia
      to name a few.                       Read More>>                                                Go to the top>>


                                           Novartis future growth prospects secured by industry-leading
                                           pipeline
                                                  Novartis has provided an update on its leading Research and
                                           Development (R&D) pipeline and plans for turning these assets into
                                           commercial success to provide the basis for continued growth of the Group
                                           through 2017. Continuing R&D productivity in the Pharmaceuticals Division
                                           has fueled an industry-leading pipeline with 139 projects in clinical
                                           development with more than 73 New Molecular Entities (NMEs) across a
                                           multitude of disease areas. Highlights include RLX030 and LCZ696 in heart

                                                                                                            Page 10 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
NEWS JAPAN

                                           failure as well as AIN457 in psoriasis and multiple sclerosis. In addition, the
                                           company will showcase a comprehensive early and late-stage pipeline of
                                           novel oncology compounds. "As a science-driven company, Novartis is
                                           focused on innovation to address unmet medical needs for patients around the
                                           world." said Joseph Jimenez, CEO of Novartis.

                                           Read More>>                                                 Go to the top>>

       Whitespace Analysis
                                           Roche reports positive studies of MabThera given by
          Our White Space                  subcutaneous injection
        analysis study comes                      Pivotal study data presented at ASH shows that subcutaneous
         in handy if you are               administration enables the delivery of MabThera over approximately 5
        looking at the future              minutes without compromising MabThera’s proven efficacy and safety
        of a new technology
                                                   Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results
       or looking to diversify
                                           from two studies which showed that a fixed dose of MabThera (rituximab) can
        into new avenues of                be administered subcutaneously (SC), potentially allowing patients to spend
           technology. We                  less time in infusion centers receiving their MabThera treatment. Specifically,
         compile and study                 the studies showed that SC injection resulted in non-inferior MabThera
         variety of literature             concentrations in the blood (pharmacokinetics; PK) compared with standard
            available for a                intravenous (IV) infusion. Overall, SC and IV adverse event (AE) profiles
          technology- filing               were similar and administration related reactions (ARR) were mostly of mild
       trends add up to our                to moderate intensity.
           analysis and we                 Read More>>                                                 Go to the top>>
               provide
         recommendations                   Govt to Mandate Price Cuts On Popular Off-Patent Drugs
          and an idea of the                        Off-patent name-brand drugs with continued high market shares will
             road ahead.                   face steep price cuts under a new rule to be introduced as soon as 2014 in an
                                           initiative to curb health care costs. Off-patent drugs typically lose market
                                           share to their cheaper generic counterparts. But in Japan, they tend to maintain
                                           a high share even after their patents expire, primarily due to the
                                           manufacturer's brand strength and stable supplies. As a result, generic
                                           products account for less than 30% of the Japanese drug market.
                                                    The new rule, endorsed Wednesday by a Health Ministry panel, will
                                           slash the prices of post-patent drugs if consumers are slow to shift to the
                                           generic equivalent. Details, such as the timing of the price cuts, will be
                                           discussed starting next year, with plans to implement the change as early as
                                           April 1, 2014.

                                           Read More>>                                                 Go to the top>>


                                                                                                              Page 11 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
EDITORIAL


                                           The prime solution - Invalidation search

        Technology Transfer/                       A shrinking global economy and rapid growth in emerging countries,
                                           infringement analysis has poised to become an essential tool for companies.
         Commercialization
                                           Patent troll, another concept which has emerged over the years, has further
      TT         Consultants       is      contributed in the rise of infringement cases.
                                                   “According to the U.S. Department of Commerce, there has been a
      working       with     several
                                           76% increase in claims for trademark and patent infringement in the past
      technology       companies           10 years.”
      on      patent       licensing,
                                           The prime solution - Invalidation search.
      technology/product                           Conducting a prior art search could be a daunting task for most people.
      commercialization, and               Only an experienced searcher equipped with professional tools and access to
                                           appropriate databases can perform a search to an adequate degree.
      know-how transfer. We
                                                   With 2000+ invalidation searches to its credit, TT Consultants
      have:                                distinguishes itself with innovative and detailed methodology. We 'scour the
                                           earth' when it comes to searching for prior art in order to invalidate a
       Established            India       troublesome patent. The non-exhaustive patent and non-patent databases
                                           employed by the companies include Questel Orbit, TI, Total Patents
           Business Desk for
                                           LexisNexis, KIPRIS, TIPO, CIPO, AUSPAT, Espacenet, PAJ, SIPO, IEEE,
           the         incubation          IP.com, Science Direct, Springer, Pubmed, NCBI, Scirus and many others.
           companies of several                    TT Consultants, with plenty of competitive IP services offering, has
                                           prior art searching leading the portfolio of the company. The company has
           national universities           gained victory by invalidation several potentially dangerous patents, helping
           of Taiwan                       companies coming out of Patent Trolls and thus, saving millions of dollars.
       Tie-ups with the best              Invalidation Search at TT Consultants
           research institutes in           Multilingual Searching: Through our East Asia presence in Taiwan, we
                                              have in-house Native Searchers from all technical backgrounds and
           Asia
                                              further, tie-ups with several native searchers/firms through which we
       Successfully                          provide Chinese (Traditional and Non Traditional), Taiwan, Japanese,
           commercialized                     French and German search capabilities.
                                            Detailed Methodology: We have a detailed list of SOPs that we adopt
           several products and               while conducting an invalidation search. Some of the brief SOPs include
           technologies           in          understanding of the subject patent, file wrapper review, patent webbing,
                                              inequitable conduct search, keyword and classification based search,
           various parts of the
                                              combinational search, citation analysis, inventor/assignee search, Native
           world.                             search and thorough Non-patent search. The project managers crosscheck
                                              the report quality and adherence to SOPs during the search. Further, the
                                              identified prior art references are verified (technical relevancy and other
                                              limitations such as date criteria, assignee, etc.) by the project manager

                                                                                                             Page 12 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
EDITORIAL


                                               before mapping it into the report.
                                              Inequitable conduct search: We offer Inequitable Conduct Search by
         Patent Acquisition                    default in all invalidation projects. Using sophisticated and innovative
              Services                         databases, we uncover priceless patents that were not reported to the one
     Patent Acquisition/ In-                   or the other patent office but were cited during prosecution in other
                                               countries and this can lead to an excellent settlement in your favor.
     Licensing
                                              Quick Turnaround: TT Consultants has been successful on several
     We work closely with our
                                               occasions by providing search results in a very short span of time.
     clients for acquiring the
                                               Normally, the turnaround time for our invalidation search is 6 working
     right patents at the right                days but if you are looking at a weekend turnaround, that’s achievable.
     value. The support ranges                Reports on Rolling Basis: The Company provides the additional facility
     from landscape, evaluating                for the client to receive the identified prior art as they are identified. This
     patent strength to gauging                lets the client to better analyze the probability of finding the most relevant
     enforcement value.                        prior arts.
                                              Additional Analysis: An additional analysis is a complete analysis of all
     Patent Out-Licensing
                                               the patents and prior arts studied during the search. The trends and pattern
     We help our clients to                    for filing and publication activity of various active assignees and inventors
     license their patents to the              are studied for the technology domain. This analysis is represented as
     right purchasers for the                  graphs and charts making the data easy to analyze.
     right value. This includes               No Stone Unturned search: A “No Stone Unturned Search” is an
     identifying    the      right             extended invalidation search conducted by a team of 4 resources for the
     buyers,         performing                duration of four weeks which can be further expedited based on the
     infringement analysis and                 client’s requirement. Further, native searches are performed as and when
     other important aspects.                  required. This gives a broad coverage to any relevant prior arts that may
                                               exist.

                                           Go to the top>>




                                                                                                                Page 13 of 13


© TT Consultants, 2013. All rights reserved – privileged and confidential
INDIA                             WASHINGTON DC                                           TAIWAN
                     Chandigarh                              TT Consultants LLC                             Tainan (Branch Office)
       Office 8, Tower B, 3rd Floor, D.L.F, I.T park       1701, Pennsylvania Avenue, NW,             Room 410, Technology Transfer & Business
             Chandigarh (U.T)-160101, India                    Washington DC. 20006                               Incubation Center,
                 Mobile: +91-9815006413                       Mobile: +1.347.284.6413                     National Cheng Kung University,
          Email: s.goel@ttconsultants.co.in                  Toll Free: +1.888.337.5234                 No. 1 University Road, Tainan City 701

                       Gurgaon                           Email: talwar@ttconsultants.co.in
         Unit number 252, 2nd floor, Tower B2,                                                                       Hsinchu
                                                                                                            Si-Soft Research Center, 1A2,
              Spaze I-Tech Park, Sector 49,
                                                                                                            Lising 1st Road, Hsinchu City
              Sohna Road, Gurgaon-122002                                                                     Landline: +886-6-2368814
                Mobile: +91-9876196354
        Email: n.mahajan@ttconsultants.co.in                                                          Email: a.srivastava@ttconsultants.co.in




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IP Newsletter: India Revokes Roche Patent, Cipla Cuts Cancer Drug Prices

  • 1.
  • 2. NEWSLETTER Contents 1. Headlines 1 2. News India 2 3. News China 6 4. News Japan 9 5. Editorial 12 TT Consultants is an ISO-27001 and ISO-9001:2008 certified Intellectual Property Consulting firm providing services in over 20 countries worldwide to more than 500 Companies, universities and research institutes with several offices in three countries i.e. Taiwan, US and India and strong client base in US, Canada, Europe, Japan, Singapore, South Korea, Taiwan and India, we strive towards providing our clients global and world-class services. We provide patent litigation support, patent prosecution support, licensing support, patent acquisition support, technology transfer consulting, patent portfolio management and other legal support services to leading patent law firms, companies, universities, research institutes and intellectual property owners.
  • 3. INDIA CHINA JAPAN EDITORIAL HEADLINES INDIA  India revokes Roche patent in new blow for Big Pharma  India's Cipla cuts price of 3 more cancer drugs  India Publishes Draft Guidelines f or Patenting Of TK and Biological Material  India revokes patent on Merck's asthma drug  'Amul' loses trademark battle against US giant in court  ASSOCHAM suggest formation of National IPR Strategy Authority  India scores lowest on intellectual property protection - index  Patent laws key to drug innovation, argues report  American Court rules against confidentiality for Cadila’s ‘in -house’ Indian counsel HEADLINES CHINA  EPO and SIPO launch Chinese-English machine translation for patents  Global IP Filings Continue to Grow, China Tops Global Patent Filings  East Asia faces unique challenges, opportunities for stem cell innovation  China’s new approach to renewable energy  Light at the end of the tunnel: trademark squatting in China  China Officially Recognizes Napa Valley Wines HEADLINES JAPAN  Japan, China pay a high price  Japan gives patent for Medgenics IFNa pump  Astellas-UCB rheumatoid arthritis therapy wins marketing approval in Japan  Bristol-Myers, Pfizer win approval for Eliquis in Japan  Novartis future growth prospects secured by industry -leading pipeline  Roche reports positive studies of MabThera given by subcutaneous injection  Govt To Mandate Price Cuts On Popular Off -Patent Drugs EDITORIAL  The prime solution - Invalidation search © TT Consultants, 2012. All rights reserved – privileged and confidential
  • 4. NEWS INDIA India revokes Roche patent in new blow for Big Pharma The Intellectual Property Appellate Board (IPAB) cited a lack of evidence that the drug was any better than Patent Invalidation existing treatments and its high price as Search reasons for the decision. Pegasys was the first medicine to win protection in 2006 under Lupin bags final approval We ‘scour the earth’ India's new patent regime and the revocation from USFDA to market when it comes to will rekindle tensions between New Delhi and generic contraceptive searching for prior art global drug makers worried by the country's tablets in order to invalidate a tough stance. troublesome patent. The decision follows another high-profile setback for the industry in If you use ‘Xerox’ the way We have helped March, when India granted the first ever compulsory licence to domestic drug you use ‘zipper,’ our several US and Asian maker Natco (NATP.NS) to sell cheap copies of Bayer's (BAYGn.DE) cancer trademark could be left companies save huge drug Nexavar. wide open litigation costs by Read More>> Go to the top>> India announced highly uncovering Nationalprior arts. We useful Policy on have Mandarin, Electronics 2012; wants to rival China and Korea Japanese India's Cipla cuts price of 3 more cancer drugs native searching Cipla Ltd. -- one of India's largest generic-drug manufacturers--said AstraZeneca unveils capability. We are a Thursday it is cutting prices for three cancer medicines it sells in India by up antiplatelet drug Brilinta preferred choice for to 63%. Cipla is cutting prices of these cancer drugs to make them "affordable in India companies involved in and accessible" for patients, Cipla Chairman Y.K. Hamied said in a statement. After India, now patent complex The price of Erlocip, a generic version of Roche Holding AG litigation and have Indonesia introduces (RHHBY)'s lung-cancer treatment Tarceva, has been reduced by 63% across Patent Licenses for Joint represented many various strengths. Now 30 tablets of Erelocip 150 will cost 9,900 rupees Generic VersionsGroups Defense of ($181) versus 27,000 rupees earlier. The prices of docetaxel--used in the Drugs in such cases to (JDGs) treatment of breast, lung and other cancers--and capecitabine have been identify relevant prior halved, Cipla added in the statement. art for invalidating Read More>> Go to the top>> potentially dangerous patents. India Publishes Draft Guidelines for Patenting Of TK and Biological Material The government of India has released a set of draft guidelines to be followed in the patenting of traditional knowledge and biological material. Page 2 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 5. NEWS INDIA Comments are due by 22 November. “It has been reported that the Indian Patent Office is granting patents on the use of traditional knowledge (TK) of India, particularly relating to the Ayurveda, Unani and Siddha systems of Patentability Search medicine, etc. and patents have been granted on inventions related to biological resources obtained from India without taking adequate care to A thorough patentability observe the mandate of law,” the draft guidelines state. assessment search conducted The guidelines mention India’s primary role in a range of international policy on an exhaustive list of developments related to TK and genetic resources. Pending patent patent and non-patent applications involving traditional knowledge are published on. databases. We offer innovative search reports Read More>> Go to the top>> that come along with a key feature chart and many value additions offered by none India revokes patent on Merck's asthma drug other in the industry. This Indian Patents Office has revoked a patent for an asthma drug held by service is being extensively US-based Merck & Co following a challenge used by the best research from domestic pharma firm Cipla. In an order, institute of Asia, several Assistant Controller of Patents & Designs T V national universities of Madhusudhan revoked the patent on the Taiwan, top law firms in the ground that it lacked invention. US and 5 fortune 500 "The sole process claim also in its companies to name a few. entirety is not inventive as the said claim does not describe any inventive feature," the order said. "In view of the above conclusion I hereby order that the patent bearing number 246328 is revoked," Madhusudhan said in his order. Schering Corporation, which was later acquired by Merck & Co, had applied for patent of the asthma drug in February 2004, and the Indian Patents Office had granted the patent in March 2011. Cipla had challenged the patent. Read More>> Go to the top>> 'Amul' loses trademark battle against US giant in court The Gujarat High Court has refused to set aside an order which cancelled Amul's registration of its trademark 'TRIX', on which a US firm has claimed its right. In July this year, the Intellectual Property Appellate Board had directed Registrar of Trademarks to cancel Amul's registration of TRIX trademark. Page 3 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 6. NEWS INDIA A Division Bench of Chief Justice Bhaskar Bhattacharya and Justice J B Pardiwala, in a recent judgement, dismissed the petition filed by Kaira District Cooperative Milk Producers Union Ltd, owner of Amul, seeking cancellation of trademark 'TRIX' registered in favour of US food giant General Mills. Freedom to Operate Search Read More>> Go to the top>> We provide a proactive patent ASSOCHAM suggest formation of National IPR Strategy study for mitigating Authority the risks involved Report by India Education bureau, New Delhi: The Associated before entering a Chambers of Commerce and Industry of India (ASSOCHAM) has suggested new jurisdiction and establishment of National Intellectual Property Right (IPR) Strategy Authority have the capability to Department of Industrial Policy & Promotion (DIPP) in the context of fast to search in various changing trade environment driven by global competition, innovation risks, geographies short product life cycle, rapid changes in technology involving huge including most of investments in Research & Development and human resource. the Asian countries The proposed Authority should be aiming of aligning towards and some European achieving a target of 50,000 patent applications filed in India in 2015 and 1, countries. Our 50,000 in 2020. Similar targets should also be set for filing of design and trade experienced mark applications. professionals perform an in-depth Read More>> Go to the top>> search and very closely examine the prior art vis-à-vis the India scores lowest on intellectual property protection - index product features. The index prepared for the group's Global Intellectual Property Center Claim charts are scored 11 countries on a point scale from zero to 25, with the United States receiving prepared based the highest overall tally of 23.73 and upon the national Britain coming in second at 22.40. patent laws. India was last with 6.24 points, reflecting its low scores in each of the five categories examined by Pugatch Consilium, an international research and analysis firm that specializes in the knowledge economy. China was tenth with a score of 9.13, below Brazil with 9.57 points and Russia with 11.17. The new index is intended as a tool for U.S. policymakers to push for tough protections of U.S. copyrights, patents and trade secrets in free trade Page 4 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 7. NEWS INDIA agreements and other international talks. The United States, with some of the strongest copyright, patent and trademark protections in the world, has a total stock of intellectual property valued at around $5.8 trillion. Structure Sequence Read More>> Go to the top>> Search When you request a Patent laws key to drug innovation, argues report chemical structure/ Pharmaceutical innovation in middle-income countries such as Brazil substructure search, and India could be boosted by stronger our domain specific enforcement of intellectual property laws and by searchers with building up research capacity, says a report. extensive experience The report by global consultancy Charles perform patent River Associates has identified the conditions searches and deliver required to encourage innovation in middle- insightful results for income countries by evaluating government policies that promote investment compounds matching in local innovative activities in the biopharmaceutical field. the query structure, as well as for Commissioned by the International Federation of Pharmaceutical compounds Manufacturers & Associations (IFPMA) — an NGO representing the pharmaceutical, biotechnology and vaccine sectors — the document was containing the query released at the 26th IFPMA Assembly last month (31 October). structure as a subset (substructure) of a Read More>> Go to the top>> larger structure. Page 5 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 8. NEWS CHINA EPO and SIPO launch Chinese-English machine translation for patents Breaking new ground in providing access to the most comprehensive Patent Drafting & technological information, the European Patent Office (EPO) and the State Intellectual Illustrations Property Office of the People's Republic of A well drafted patent China (SIPO) today launched the Chinese- is the key to a strong English component of the EPO's free patent and holds the automatic translation service Patent Translate. highest chances of As a result, the collections of the two largest languages in patents are being accepted by the now united as full-text documents on the same website through the EPO's National Patent global patent database, Espacenet, and linguistically accessible for innovators Office. Our from both regions using a single tool, Patent Translate. Under the new experienced and arrangement with SIPO, Espacenet has grown by 4 million Chinese language technically trained Read More>> Go to the top>> professionals do a comprehensive understanding of the Global IP Filings Continue to Grow, China Tops Global Patent subject matter and use Filings their exceptional communication skills A new WIPO report shows that while the global economy continued to underperform, intellectual property (IP) filings worldwide kept growing to elucidate the strongly in 2011. It also finds that China’s patent office became the largest in invention and the draft the world, as measured by the number of patent applications received. Before is by default reviewed 2011, China already accounted for most filings of utility models (UMs), by an Indian Patent trademarks and industrial designs. Attorney. Further, the World Intellectual Property Indicators 2012 shows that patent filings draft is reviewed by worldwide grew by 7.8% in 2011, exceeding 7% growth for the second year respective filing in a row. Similarly, UM, industrial design and trademark filings increased by country Patent 35%, 16% and 13.3%, respectively. Attorney. Read More>> Go to the top>> We have Illustrators who are well conversant with the East Asia faces unique challenges, opportunities for stem cell rules of USPTO, PCT innovation and other National Tension is the theme running through the new consensus statement Patent Offices. issued by the Hinxton Group, an international working group on stem cell research and regulation. Specifically, tension between intellectual property policies and scientific norms of free exchange, but also between eastern and Page 6 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 9. NEWS CHINA western cultures, national and international interests, and privatized vs. nationalized health care systems. The consensus, titled Statement on Data and Materials Sharing and Intellectual Property in Pluripotent Stem Cell Science in Japan and China, was released on the Hinxton Group's website on November 19, 2012. Patent & Trademark "China and Japan are among the world's leading nations in stem cell research, Filing in India but because of challenges distinct from western nations, they are dramatically underrepresented in terms of patents and licensing," Our Indian IP Read More>> Go to the top>> Prosecution Partner – Talwar Advocates established since 1983, China’s new approach to renewable energy handles patent and Chinese companies are using innovative business models to change the trademark filing in the cost structures and capabilities Indian Patent Offices. involved in delivering renewable The firm has the energy technology. Through strategic infrastructure and partnerships with technology-led resources to take on companies in the US and Europe, they the whole range of are rapidly reducing the cost of conventional and non- production and effectively entering the conventional IP issues value-added parts of the global technology economy. and offer clients In the popular imagination, China’s industrial base is largely built on comprehensive agriculture and manufacturing. This is still generally true. Agriculture services in structuring employs an enormous proportion of the workforce and vast lands are and securing a patent dedicated to the painstaking process of growing rice or harvesting wheat. portfolio. The firm possesses the distinct Read More>> Go to the top>> advantage of filing Patents, Trademarks Light at the end of the tunnel: trademark squatting in China and PCT National Trademark squatting has been a nightmare for many overseas Phase applications trademark owners for a long time, and more so in recent years. Our partner, electronically in Indian Kenny Wong, published an article last month in Intellectual Property Patent Office. Magazine, titled "Kung fu trademark hustle", in which he says there are encouraging signs that we may be seeing light at the end of the tunnel. Following the Trademark Office, the Chinese judiciary has also openly acknowledged the problem. On December 3, the Beijing No. 1 Intermediate People's Court held a press conference to report on their study into "the cause, Page 7 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 10. NEWS CHINA characteristic and judicial response to trademark squatting". Vice president Chen Rui, a supervisor of intellectual property cases at the intermediate court Claim Chart and the leader of the task force, said that the courts should fully exert their Preparation judicial function by aiming to deter squatting activities when they interpret and apply the law. This search helps in Utah Hosts China-U.S. Read More>> Go to the top>> Intellectual the potential identifying Property Rights Roundtable infringers of a particular China Officially Recognizes Napa Valley Wines BSA: Global software patent portfolio. Over theft totaled $63.4 billion For more than a decade, Napa Valley vintners have been exporting the years, we have last year wine to China; and now, one of the most recognizable wine regions in the evolved an innovative world will be the first acknowledged with Geographic Indication (GI) status in Court finds copyright of China. Geographical indications are used in all countries to act as a Buddha designstrategy to and effective valid certification of authenticity. This is the first time that China has granted a GI identify infringing recognition to any wine region outside of its own borders. TechFaith Sues Samsung products/standards and for Patent Infringement “Being first speaks volumes to what people think about Napa Valley,” ascertaining the said Terry Hall of the Napa Valley Vintners. The Napa Valley Vintners In Search of 'Dexter': brokered the deal, working with the Chinese government for nearly 14 years. Why You Can't Buy This infringement. The new GI status step will help prevent Napa Valley knockoffs and Pirated DVDs in China a service is used by counterfeiting of labels and allow for consumer protection in China's rapidly Anymore growing market. leading semiconductor manufacturer and some Read More>> Go to the top>> fortune 500 companies across the globe. Page 8 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 11. NEWS JAPAN Japan, China pay a high price Confirmation of the costly economic consequences of the continuing spat Patent Watch between Japan and China over who owns a tiny string of remote uninhabited rocky islets in the East China Sea came with the publication of Japan's The patent alert service is September trade figures. They showed an unprecedented deficit of $7 billion for clients who wish to as exports dropped by 10.3 percent, thanks to the global slowdown and to remain updated about the Beijing's determination to teach Tokyo a lesson. latest patents filed in their Can China and Japan really be contemplating the madness of going to war preferred field of invention. over who owns this small real estate? Two months ago, most commentators It is a practical step taken by expressed confidence that the row would soon blow over, but it is continuing most of the companies who with new bellicose words, provocative actions and political tensions between desire to keep track of the the once and future economic powers. New leaders settling in in Beijing dare new and improved not risk being seen as weak, and Tokyo's nationalists will keep up the formulations and adjuvant pressure. When and how will it end? relating to their field of Read More>> Go to the top>> interest or in respect to a competitor's patents. Accordingly, we endeavor Japan gives patent for Medgenics IFNa pump to observe patents Medgenics received a Notice of Allowance from the Japanese Patent continually and provide and Trademark Office for key claims protecting the use of Medgenics' regular updates to our Infradure Biopump technology for the delivery of interferon alpha (IFNa). clients. Further, our search Medgenics is developing Infradure as a new approach to provide sustained includes online product and patient compliant interferon therapy to address unmet needs in the directory and other non treatment of hepatitis B, C, and D. patent literature available. Similar claims protecting Medgenics' Infradure technology have been granted or allowed in other large Asian markets including, China, Korea and Australia. In addition, these countries have allowed broad claims to Medgenics protecting the core Biopump technology for production and delivery of proteins. Patents covering core Biopump technology for a genetically modified dermal micro-organ have already been granted to Medgenics in the US and in the EU. Read More>> Go to the top>> Astellas-UCB rheumatoid arthritis therapy wins marketing approval in Japan Astellas Pharma and UCB have announced the marketing approval of Cimzia (certolizumab pegol) to treat rheumatoid arthritis (RA) in Japan. The Page 9 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 12. NEWS JAPAN Japanese Ministry of Health, Labor and Welfare has approved Cimzia as a 200mg syringe for subcutaneous (s.c.) injection to treat adult RA patients who failed to respond to conventional treatment. Patent Landscape The only PEGylated Fc-free anti-TNF is designed in the form of a prefilled Analysis syringe that enables self-administration by RA patients. Adult patients can be administered with 400mg s.c. of certolizumab pegol at weeks zero, two and With the help of our four, subsequent to 200mg every two weeks, while 400mg every four weeks technical experts, s.c. can be considered for maintenance dosing. experienced patent searchers and IP tools Read More>> Go to the top>> developed in-house, we have been able to Bristol-Myers, Pfizer win approval for Eliquis in Japan provide valuable Bristol-Myers Squibb and Pfizer have announced the approval of reports to our clients. Eliquis (apixaban) anticoagulant for the prevention of ischemic stroke and Our reports have systemic embolism in patients suffering from nonvalvular atrial fibrillation enabled several (NVAF) in Japan. technology companies The Japanese approval of the anticoagulant is based on ARISTOTLE, across the world to the pivotal Phase 3 trial conducted in 18,201 NVAF patients, which assessed take important strategic the safety and efficacy of ELIQUIS compared to warfarin. decisions. We have performed patent A subanalysis of the ARISTOTLE study also established a similar landscape studies for safety and efficacy profile of ELIQUIS in Japanese patients, compared to the one of the leading overall study. Bristol-Myers Squibb intercontinental region and Japan semiconductor executive vice president and chief financial officer Charles Bancroft said, "Today's approval of ELIQUIS is the result of our shared vision with Pfizer to companies in the US introduce a differentiated treatment option to reduce the burden of stroke in and a top LED patients with nonvalvular atrial fibrillation." manufacturer of Asia to name a few. Read More>> Go to the top>> Novartis future growth prospects secured by industry-leading pipeline Novartis has provided an update on its leading Research and Development (R&D) pipeline and plans for turning these assets into commercial success to provide the basis for continued growth of the Group through 2017. Continuing R&D productivity in the Pharmaceuticals Division has fueled an industry-leading pipeline with 139 projects in clinical development with more than 73 New Molecular Entities (NMEs) across a multitude of disease areas. Highlights include RLX030 and LCZ696 in heart Page 10 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 13. NEWS JAPAN failure as well as AIN457 in psoriasis and multiple sclerosis. In addition, the company will showcase a comprehensive early and late-stage pipeline of novel oncology compounds. "As a science-driven company, Novartis is focused on innovation to address unmet medical needs for patients around the world." said Joseph Jimenez, CEO of Novartis. Read More>> Go to the top>> Whitespace Analysis Roche reports positive studies of MabThera given by Our White Space subcutaneous injection analysis study comes Pivotal study data presented at ASH shows that subcutaneous in handy if you are administration enables the delivery of MabThera over approximately 5 looking at the future minutes without compromising MabThera’s proven efficacy and safety of a new technology Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results or looking to diversify from two studies which showed that a fixed dose of MabThera (rituximab) can into new avenues of be administered subcutaneously (SC), potentially allowing patients to spend technology. We less time in infusion centers receiving their MabThera treatment. Specifically, compile and study the studies showed that SC injection resulted in non-inferior MabThera variety of literature concentrations in the blood (pharmacokinetics; PK) compared with standard available for a intravenous (IV) infusion. Overall, SC and IV adverse event (AE) profiles technology- filing were similar and administration related reactions (ARR) were mostly of mild trends add up to our to moderate intensity. analysis and we Read More>> Go to the top>> provide recommendations Govt to Mandate Price Cuts On Popular Off-Patent Drugs and an idea of the Off-patent name-brand drugs with continued high market shares will road ahead. face steep price cuts under a new rule to be introduced as soon as 2014 in an initiative to curb health care costs. Off-patent drugs typically lose market share to their cheaper generic counterparts. But in Japan, they tend to maintain a high share even after their patents expire, primarily due to the manufacturer's brand strength and stable supplies. As a result, generic products account for less than 30% of the Japanese drug market. The new rule, endorsed Wednesday by a Health Ministry panel, will slash the prices of post-patent drugs if consumers are slow to shift to the generic equivalent. Details, such as the timing of the price cuts, will be discussed starting next year, with plans to implement the change as early as April 1, 2014. Read More>> Go to the top>> Page 11 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 14. EDITORIAL The prime solution - Invalidation search Technology Transfer/ A shrinking global economy and rapid growth in emerging countries, infringement analysis has poised to become an essential tool for companies. Commercialization Patent troll, another concept which has emerged over the years, has further TT Consultants is contributed in the rise of infringement cases. “According to the U.S. Department of Commerce, there has been a working with several 76% increase in claims for trademark and patent infringement in the past technology companies 10 years.” on patent licensing, The prime solution - Invalidation search. technology/product Conducting a prior art search could be a daunting task for most people. commercialization, and Only an experienced searcher equipped with professional tools and access to appropriate databases can perform a search to an adequate degree. know-how transfer. We With 2000+ invalidation searches to its credit, TT Consultants have: distinguishes itself with innovative and detailed methodology. We 'scour the earth' when it comes to searching for prior art in order to invalidate a  Established India troublesome patent. The non-exhaustive patent and non-patent databases employed by the companies include Questel Orbit, TI, Total Patents Business Desk for LexisNexis, KIPRIS, TIPO, CIPO, AUSPAT, Espacenet, PAJ, SIPO, IEEE, the incubation IP.com, Science Direct, Springer, Pubmed, NCBI, Scirus and many others. companies of several TT Consultants, with plenty of competitive IP services offering, has prior art searching leading the portfolio of the company. The company has national universities gained victory by invalidation several potentially dangerous patents, helping of Taiwan companies coming out of Patent Trolls and thus, saving millions of dollars.  Tie-ups with the best Invalidation Search at TT Consultants research institutes in  Multilingual Searching: Through our East Asia presence in Taiwan, we have in-house Native Searchers from all technical backgrounds and Asia further, tie-ups with several native searchers/firms through which we  Successfully provide Chinese (Traditional and Non Traditional), Taiwan, Japanese, commercialized French and German search capabilities.  Detailed Methodology: We have a detailed list of SOPs that we adopt several products and while conducting an invalidation search. Some of the brief SOPs include technologies in understanding of the subject patent, file wrapper review, patent webbing, inequitable conduct search, keyword and classification based search, various parts of the combinational search, citation analysis, inventor/assignee search, Native world. search and thorough Non-patent search. The project managers crosscheck the report quality and adherence to SOPs during the search. Further, the identified prior art references are verified (technical relevancy and other limitations such as date criteria, assignee, etc.) by the project manager Page 12 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 15. EDITORIAL before mapping it into the report.  Inequitable conduct search: We offer Inequitable Conduct Search by Patent Acquisition default in all invalidation projects. Using sophisticated and innovative Services databases, we uncover priceless patents that were not reported to the one Patent Acquisition/ In- or the other patent office but were cited during prosecution in other countries and this can lead to an excellent settlement in your favor. Licensing  Quick Turnaround: TT Consultants has been successful on several We work closely with our occasions by providing search results in a very short span of time. clients for acquiring the Normally, the turnaround time for our invalidation search is 6 working right patents at the right days but if you are looking at a weekend turnaround, that’s achievable. value. The support ranges  Reports on Rolling Basis: The Company provides the additional facility from landscape, evaluating for the client to receive the identified prior art as they are identified. This patent strength to gauging lets the client to better analyze the probability of finding the most relevant enforcement value. prior arts.  Additional Analysis: An additional analysis is a complete analysis of all Patent Out-Licensing the patents and prior arts studied during the search. The trends and pattern We help our clients to for filing and publication activity of various active assignees and inventors license their patents to the are studied for the technology domain. This analysis is represented as right purchasers for the graphs and charts making the data easy to analyze. right value. This includes  No Stone Unturned search: A “No Stone Unturned Search” is an identifying the right extended invalidation search conducted by a team of 4 resources for the buyers, performing duration of four weeks which can be further expedited based on the infringement analysis and client’s requirement. Further, native searches are performed as and when other important aspects. required. This gives a broad coverage to any relevant prior arts that may exist. Go to the top>> Page 13 of 13 © TT Consultants, 2013. All rights reserved – privileged and confidential
  • 16. INDIA WASHINGTON DC TAIWAN Chandigarh TT Consultants LLC Tainan (Branch Office) Office 8, Tower B, 3rd Floor, D.L.F, I.T park 1701, Pennsylvania Avenue, NW, Room 410, Technology Transfer & Business Chandigarh (U.T)-160101, India Washington DC. 20006 Incubation Center, Mobile: +91-9815006413 Mobile: +1.347.284.6413 National Cheng Kung University, Email: s.goel@ttconsultants.co.in Toll Free: +1.888.337.5234 No. 1 University Road, Tainan City 701 Gurgaon Email: talwar@ttconsultants.co.in Unit number 252, 2nd floor, Tower B2, Hsinchu Si-Soft Research Center, 1A2, Spaze I-Tech Park, Sector 49, Lising 1st Road, Hsinchu City Sohna Road, Gurgaon-122002 Landline: +886-6-2368814 Mobile: +91-9876196354 Email: n.mahajan@ttconsultants.co.in Email: a.srivastava@ttconsultants.co.in Subscribe/Opt in If you wish to receive this Newsletter in future, please click here. Feedback/Suggestion We will be happy to know your feedback & suggestion on the same. Kindly send us an email with your feedback. Unsubscribe If you do not wish to receive this Newsletter in future, please click here, else just reply this mail with the word "Unsubscribe" in the subject of the mail. Disclaimer While every care has been taken in the preparation of this News Bulletin to ensure its accuracy at the time of publication, TT Consultants assumes no responsibility for any errors which despite all precautions, may be found herein. Neither this bulletin nor the information contained herein constitutes a contract or will form the basis of a contract. The material contained in this document does not constitute/substitute professional advice that maybe required before acting on any matter. *COPYRIGHT NOTICE:-© 2013, India. All Rights reserved with TT Consultants Go To Top >> © TT Consultants, 2013. All rights reserved – privileged and confidential