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Journal of Intellectual Property Rights Vol 17, May 2012, pp 256-261
IPR News ─ General
countries are doubtful about the future of ACTA. Despite the rough ride, ACTA certainly is not yet EU Parliament’s draftsman urges ACTA rejection
dead. All EP committees still have to vote on the British MEP David Martin (rappoteur for EP respective opinions, and the plenary of the Committee on International Trade), in charge of Parliament is expected to vote in mid-June 2012 steering the Anti-Counterfeiting Trade Agreement (http://www.euractiv.com, http://www.ip-watch.org). (ACTA) through the European Parliament, recently said that he would urge lawmakers to reject the Kenya set to repeal controversial anti-counterfeit law
controversial treaty. He cited fears that the Agreement Kenya’s High Court has ordered a review of a could discourage generic drug supplies to developing controversial anti-counterfeit law enacted in 2008 on countries, and presented an outdated concept of the grounds that it could interfere with the supply of intellectual property. Mr Martin made the legitimate generic medicines to patients. The 2008 announcement following a three-hour debate on Anti-Counterfeiting Act has been under fire since ACTA in the European Parliament organized by the before it was passed with critics claiming that it was Socialist group. The event was streamed to up to too much of a blunt instrument to handle the 1,300 viewers online and prompted intense activity on complexities of the counterfeit and substandard Twitter. Besides, rapporteurs to two other committees medicines trade. The Act defined counterfeiting as an of the European Parliament (legal and industry and intellectual property breach of a protected good, trade) have also tabled reports on the plurilateral which can include ‘the manufacture, production, ACTA. While Socialist and Green MEPs have already packaging, re-packaging, labelling or making, voiced their opposition to ACTA, the overall position whether in Kenya or elsewhere, of any goods whereby of the Parliament is less clear. The Parliament’s those protected goods are imitated in such manner and approval is necessary to ratify the international to such a degree that those other goods are identical or agreement. The EU executive, which has referred substantially similar copies of the protected goods.’ ACTA to the European Court of Justice, invited In theory, this could encompass legitimate generic the Parliament not to vote until the court rules. copies of drugs that are on-patent anywhere overseas. The ACTA seems to have suffered further setback, Given that the vast majority of drug patents are not since now appears that the Group of 8 may have registered in developing countries like Kenya, there signalled a shift to a narrower approach on intellectual had been fears that enforcement of the Act could property rights at its recently concluded meeting. In a reduce the range of generic medicines available to ‘Non-paper on intellectual property rights protection’, doctors and their patients. That was acknowledged by by G8 leaders who met in Washington DC, there was the High Court, with Judge Mumbi Ngugi saying in a narrower focus on counterfeit products and drugs. her ruling that ‘the Act is vague and could undermine The non-paper, which is not part of the official access to affordable generic medicines since [it] statement of the G8 foreign ministers, proposes a failed to clearly distinguish between counterfeit and ‘G8 initiative to strengthen enforcement against generic medicines.’ counterfeiting and piracy’ (an integrated warning The High Court has called on Kenya’s Parliament system, stronger penalties and border seizure to review the Act and remove ambiguities that could possibilities), a ‘G8 initiative to support voluntary result in arbitrary seizures of generic medicines best practices for securing global supply chains’ and a under the pretext of fighting counterfeit drugs. The ‘G8 initiative to promote pharmaceutical drug safety.’ judgment also stated that IP rights should not override Voluntary cooperation in IPR protection through the the right to life and health. The judgment comes at a G8 moreover makes sense in the case that the G8 time when the World Health Organisation (WHO) is also struggling to contend with the controversy about A second important conclusion of the Controller is the conflation of IP and public health issues in the that the failure to meet demand adequately was partly area of what it refers to as substandard/spurious/ caused by the high price of the product, which made it falsely-labelled/falsified/counterfeit medical products unaffordable. While Natco’s counsel referred to research findings on reasonable estimates of R&D costs and the per capita incomes of the poor in Patent News
India to argue that the product was unreasonably priced, the judgment itself focussed on the issue of India’s first compulsory licence
unaffordability. Even when assessing this, the India’s long struggle to ensure access to affordable fundamental issue was not the fact that Nexavar was medicines for its people recently took an interesting being priced at around Rs 2.8 lakh for a month’s turn. In early March 2012, the Controller General of dosage of 120 tablets, when Cipla was supplying the Patents passed an order on an application filed drug at Rs 30,000 for a month’s treatment, and Natco by Natco Pharma, headquartered in Hyderabad, was promising the same quantum at Rs 8,800 if requesting a licence to produce an anti-cancer drug granted a licence. Rather, starting from the fact that (sorafenib tosylate), the patent for which is held by the sale of Nexavar over the previous four years was the German pharmaceuticals and chemicals giant only equivalent to a fraction of the public’s estimated Bayer. It produces and markets the drug under the requirement of this life-extending treatment, the brand name Nexavar, which is used in the treatment Controller General of Patents concluded that the drug of patients diagnosed as being in the advanced stages ‘was not bought by the public due to only one reason, of affliction with liver or kidney cancer. Having failed that is, its price was not reasonably affordable to to obtain a voluntary licence for manufacture them’. This is an important precedent, since it from Bayer, Natco had filed an application under lays down a condition for assessing affordability. If enough of a patented drug that is crucial for the Being the first in itself makes the Nexavar public is not being actually consumed, it must reflect judgment historic. But there is more to the judgment the fact that a significant share of patients are not able than its pioneering character. It is the grounds on to afford the drug at the price at which it can be sold. which the Controller of Patents accepted Natco’s That does warrant invoking the right to issue a application and rejected Bayer’s opposition that are also path-breaking. One important ground was the There are three points the judgment makes. assessment whether reasonable public requirement The first is that while importation rather than local was being met with regard to the supply of Nexavar manufacture is not a ground for forfeiture of a patent, through importation. Noting that: (i) over the years, a country may use the discretionary powers it has Bayer had imported the drug in volumes that could when framing patent legislation to make it a ground have treated only a small fraction (a little above 2 per for invoking the right to compulsory licensing. cent) of those who could be credibly assessed as Second, the understanding of working the patent in requiring the drug; (ii) that there were years in which the relevant conventions does not imply working the no imports were made; and, (iii) that the company patent on a ‘commercial scale’. And, finally but was relying only on the import route and not on local most importantly, ‘mere importation cannot amount to production to work the patent, the Controller General concluded that in a physical sense Bayer was not According to the judgment, ‘a patentee is obliged working the patent. It was not meeting the condition to contribute to the transfer and dissemination of the that ‘the reasonable requirements of the public with technology, nationally and internationally, so as respect to the patented invention’ were being to balance rights with obligations. A patentee can satisfied. He also rejected the argument that these achieve this by either manufacturing the product in circumstances with respect to supply of Nexavar had India or by granting a licence to any other person for to be judged in the context of the fact that manufacturing in India.’ This conclusion, if sustained, Cipla, another domestic generic pharmaceuticals is also a precedent with implications that go far manufacturer, has without licence been marketing sorafenib in India at a price much lower than that On these grounds the Controller of Patents issued an order giving Natco the right to manufacture and sell a generic version of sorafenib tosylate, subject universities and biotechnology organizations to patent to pricing it at Rs 8,800 for a monthly dose of genes or other biological facts and relationships, 120 tablets and the payment of 6 per cent royalty on which were deemed to be observations of natural the net sales to Bayer (http://www.frontline.in). processes rather than patentable inventions. The cases in question involved the Mayo Clinic v Prometheus, USPTO and UKIPO issue preliminary progress
in which the former successfully claimed that a report on worksharing initiative
diagnostic test using a drug metabolite to help with A joint report published by the UK Intellectual dosing could not be patented. Following that case, a Property Office (UKIPO) and the United States Patent case involving Myriad’s patents on two genes and Trademark Office (USPTO) reports that both associated with breast cancer and ovarian cancer was offices have been making efficient use of each other’s sent back to lower courts for consideration. This left work, which has led to an improvement in the quality the implication that the Court wanted the patents of patents being granted. The report also states that overturned using the reasoning from the Prometheus patent attorneys could speed up the patenting process case. It remains to be seen what effect those decisions by amending patent applications at both offices when will have on the pharmaceutical and in vitro Unlike the diagnostic and gene patenting cases, the investigate ways to reduce patent processing backlogs case decided in April 2012 will have an immediate in both countries. Through closer collaboration, both impact on the makers of generic and branded parties have improved the efficiency and quality of pharmaceuticals. The case in question is Caraco the patent examination process. This was achieved by Pharmaceuticals, a generics manufacturer, versus enabling patent examiners from each office to make Novo Nordisk, who patented and markets the drug greater use of each other’s work on commonly-filed Prandin, a blood glucose lowering treatment usually patent applications. Each office also surveyed its used in combination with metformin. The case examiners to assess their perceptions in using the revolves around a generic maker’s ability to introduce shared work products, and the results of this survey a generic drug for uses not indicated on the branded product’s label. In this case, Caraco argued that Mr John Alty, Chief Executive Officer of the Prandin is only indicated and patented for a single UKIPO, said that it highlighted their continued efforts use, as a treatment for type II diabetes in combination to maximize quality and efficiency savings via with metformin. However, it is approved for two worksharing. Mr David Kappos, Under Secretary of other uses - as a monotherapy and in combination Commerce for Intellectual Property and Director of the USPTO, said that the work-sharing effort The details of this case are very particular, but it represented a major step forward in the ongoing has broad implications for the pharmaceutical cooperation with the UKIPO, and showed good industry. In order to determine if the generic results. He added that more efficient and effective use application does not violate the issued patent, the of each other’s work would reduce the cost of doing FDA relies on a description of the patent, known as a business and help innovators move their products to use code, provided to the Agency by the originating market faster, with more predictability and certainty company. In this case, Caraco argued that Novo, in amendments to their patent descriptions filed after Caraco’s ANDA, had provided descriptions of the US Supreme Court clears the way for generic
Prandin patents that were vague and overly broad, patent challenges
effectively blocking the generic approval. The United States Supreme Court lately handed In the Supreme Court, this case boiled down to an down another decision affecting patent law in understanding of the intention of Congress when biotechnology. This decision follows a string of drafting Hatch-Waxman and related laws, and patent decisions during a Supreme Court session that interpretation of the specific wording. Although Novo has featured an unusually large number of cases had prevailed in Appeals Court by citing specific involving healthcare. In two separate decisions language of the relevant statutes, the Supreme Court earlier, the Court severely limited the ability of took a broader view and examined how Congress intended the generic challenge process to work. regulatory regime announced in 2011. Since then, Overall, the purpose of the relevant laws was to however, negotiations have stalled over who should encourage and speed-up the approval of generic bear the cost of the enforcement regime. Under the drugs. After the ruling, generic manufacturers will carriers’ anti-piracy regime, the code would be now be able to challenge the content of patent registered and enforced by a third-party regulator, descriptions and, if successful, ultimately force such as the Australian Communications and Media approval of the ANDA. Writing for the Court in a unanimous decision, Justice Elena Kagan chastised The Australian Federation Against Copyright Theft the FDA for using ambiguous or opaque guidelines (AFACT), which ran the case on the companies’ and forms that lend to the confusion surrounding behalf, said the ruling was a clear indication that patent decisions. She also encouraged Congress to act Australian copyright law was ill-equipped to deal with quickly to fix this problem in order to avoid excessive the online environment. The AFACT chief Neil Gane patent litigation (http://www.healthcarepackaging.com). said the situation would hinder the convergence of traditional entertainment and Internet business models, Copyright and Trademark News
pointing to increasing tension on copyright and access to content (http://www.theaustralian.com.au). Australia called on for piracy solution after
regulatory deadlock
US Supreme Court steps into copyright case
Copyright holders and Internet companies are The Supreme Court agreed to decide a copyright headed for a regulatory deadlock after the Australian case with important implications for the large and High Court recently cleared Internet service providers growing markets in discount and Internet sales. The of liability for peer-to-peer online movie piracy. The justices said they will hear an appeal from a Thai landmark ruling made clear to anti-piracy groups that student doing graduate work in the United States who they were extremely unlikely to get remedies to tried to make ends meet by re-selling textbooks that the problem from the legal system. Both the family and friends first purchased abroad. A jury telecommunications sector and content owners have awarded textbook publisher John Wiley & Sons supported calls for the federal government to step in US$ 600,000 after deciding that math graduate and provide a solution. However, the anti-piracy student, Supap Kirtsaeng, infringed on the company’s lobby and the telecommunications businesses want very different approaches from the federal The issue at the Supreme Court is whether US copyright protection applies to items that are made The High Court ruling cleared Perth-based iiNet of abroad, purchased abroad and then resold in the US movie industry claims that it had authorized without the permission of the manufacturer. The high infringement of copyright held by 34 companies when court split 4-4 when it tried to answer that question in its customers downloaded movies and television a case in 2010 involving Costco and Swiss watch programs. Legal experts said the ruling made it clear maker Omega. The high court has earlier ruled that that copyright holders would be able to hold ISPs copyright protections do not apply when the goods are liable for peer-to-peer online movie piracy only in made in the US, sold abroad and re-imported. This Earlier, the anti-piracy groups and carriers While studying for his undergraduate degree, including ISPs had been holding confidential Kirtsaeng arranged for family and friends living abroad negotiations overseen by the federal Attorney- to purchase textbooks and ship them to him. He resold General’s Department. However, despite the ruling, the copies on eBay. Eight textbooks sold by Kirtsaeng the Attorney-General’s Department is expected to were published by Wiley’s Asian subsidiary. The facilitate these discussions so that the industry company sued the student in federal court in continues to work together to find a range of solutions New York. eBay was among the outside parties urging the court to hear the case and decide it in Kirtsaeng’s The Communications Alliance, which has been favour. Federal judges have come to different negotiating on behalf of carriers and ISPs, has tried to conclusions about whether copyright law applies in secure agreement from content owners to test its co- Kirtsaeng’s and other cases (http://www.foxnews.com). Now sound can be protected in Canada
knee joint, eliminating exposure to radiation involved Everything from the roar of a motorcycle engine to in CT or MRI and the associated costs. Successful the sound of sizzling butter could eventually be knee replacement surgery entails soft-tissue trademarked in Canada. After a 20-year court battle, balancing, highly accurate implant positioning, the Canadian Intellectual Property Office is allowing and sizing. With the help of 3D modelling sounds to be trademarked. The decision — announced technology from Praxim, surgeons can have an in a recent CIPO ‘Practice Notice’ — was sparked by enhanced visualization and can better perform the US entertainment giant Metro Goldwyn Mayer, which specific procedures within the patient’s anatomy. applied in 1992 to trademark the lion’s roar heard at BoneMorphing enables surgeons to devise intra- the end of its movies. MGM and CIPO reached an operative surgical plan on the patient’s soft-tissues agreement that was recently approved by a Federal and ligament balancing, which is a major mandatory process prior to knee replacement surgery. Legal and marketing experts say the move by CIPO Designed to direct the surgical plan, the ART is a could eventually see everything from engine sounds robotic cutting guide known for its precision. ART to commercial jingles subject to trademark. However, enhances the surgeon’s potential to perform more there are others who feel that though not every accurate and safer bone cuts with minimal intra- application is going to get granted, there is certainly operative time and less complexity. With fewer going to be a rush of applications to test waters instruments involved in this procedure, optimization of logistics in hospitals will be improved and instrument processing costs will considerably be Gmail trademark dispute settled in Germany
Google has obtained control of the ‘Gmail’ trademark in Germany, according to the German Holovisions’ US patent for context-driven search
trademark office, and the legal battle for the related Holovisions has received US Pat No 8,161,073 for domain name is also over, according to Google. its context-driven search. Context-driven search When Google introduced Gmail in 2004, it quickly analyzes the semantic context for query phrases in ran into trademark trouble in the UK and Germany, web pages or other documents and clusters these where local companies asserted their rights to the sources into groups of results with similar meaning. Gmail trademark, forcing Google to rebrand its This provides results that are organized by query service there as Googlemail. phrase context. Search users no longer have to wade The UK case was settled in 2010, but the German through pages of results to pick out those entries case dragged on until the ‘Gmail’ trademark was that relate to the semantic context in which they transferred from the German company G-mail GmbH to Google on 13 April 2012, according to a transfer Present search engines do not produce search results filing posted by the German Patent and Trademark that are driven by the major contextual uses of a search Office (http://www.computerworlduk.com). input phrase. Accordingly, search results can be a jumble of different contextual meanings. This makes a Key Patents
user wade through pages of results (manually scanning titles, text snippets, and URLs) in order to pick out Patents for computer and robotic-assisted surgery
those entries that relate to the context for the phrase in platform
which the user is interested. Context-driven search Praxim received two patents from USPTO for their solves this problem in three steps. First, a person robotic-assisted surgery products and revolutionary provides an input phrase search query. Second, the computer platform.The first patent titled ‘System for search engine identifies sets of substantially-equivalent determining the position of knee prosthesis’ is related expanded phrases that are relevant to the input phrase. to Praxim’s BoneMorphing technology that supports Third, the search engine provides the person with set- knee replacement surgery. The second patent, titled specific summary information concerning these sets of ‘Guiding device for bone cutting’ recognizes substantially-equivalent expanded phrases. This three- step method provides search results that are driven, Based on BoneMorphing, surgeons can intra- consolidated, and summarized by search phrase context operatively construct a 3-D model of the patient’s IIT Delhi gets patent for fabric feel tester
the textile industry used the Kawabata Evaluation Indian Institute of Technology (IIT), Delhi has been System (KES), which apart from being very expensive, a granted patent for ‘fabric feel tester’, an innovative is a highly technical device which acted as a hurdle for product developed by the premier academic institute. extensive use by the industry. The new fabric feel The new device facilitates quality evaluation of the tester was would only cost Rs 150,000, compared to fabric on the industrial level at a much lower price. the price of Rs 15 million for the KES system Earlier, in order to evaluate the quality of their fabric,

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