Protecting and Policing IPRs in China

March 11th, 2010

China has emerged as an important economy that enhances registration and enforcement of intellectual property rights (IPRs). China is renowned as the world’s factory, with the emergence of an affluent and growing middle-class.

The Chinese government has worked assiduously to develop and implement modern and streamlined IP legislation. The filing, examination and registration system for patents, trade marks, and registered designs in China, work well in comparison to IP offices in other countries.

Of the significant world economies, China is also unique in offering two avenues—administrative and judicial—for the enforcement of IPRs. A major issue facing the judicial enforcement system is the quantum of damages awarded to successful IP owners. At present, judicially awarded damages do not provide a sufficient deterrent to third party infringement. The comparatively low levels of damages awarded have been argued to be sufficiently small to tempt would-be infringers to take on an infringement lawsuit risk. Nevertheless, this is slowly changing, as more advanced mechanisms for calculating damages have become available, and actual damages awarded have increased.

Another important IP issue, especially for brand and copyright owners, is the seemingly entrenched custom of low cost copying driven by the pull of the local Chinese market. It cannot be denied that brand and copyright owners continue to face significant problems in China. To effect cultural change to improve this situation we need further concerted efforts at all levels of Chinese society—it will take generations.

The situation for patentees has, at least, improved in the last decade, and continues to improve. Some Chinese provinces have also introduced further IP protection measures like policing IPRs at trade shows and exhibitions.

Notwithstanding the persisting difficulties, it is imperative that, in any given infringement situation, IP owners work closely with experienced local counsel to develop an enforcement strategy that is most likely to prove effective. In particular, owners should determine whether damages or an injunction is the desired outcome. If an injunction only is required, the administrative (as opposed to the judiciary) enforcement procedure may be more suitable and cost-effective.  Owners should also determine whether other means of enforcement might prove effective.

Chinese Enforcement System

In 2007, thousands of IPR infringement cases were decided in the Chinese courts and by administrative procedures. Foreign IPR holders alone proceeded within the vicinity of 2,000 lawsuits. These are staggering numbers, even when compared to the US. Economic analysis suggests that foreign companies actually fare better in the Chinese IP courts, as opposed to China based companies. Law enforcement courts in major cities such as Beijing and Shanghai are gaining experience in IP-related activities. In addition, a special IP court has now been proposed to accept and hear civil, administrative and criminal cases related to IPRs.

However, in 2007, average damages awarded by the Chinese courts amounted only to $13,100 (only 15 percent of the actual damages sought). There is anecdotal evidence to suggest that IP owners under-claim damages, so as to avoid prejudicing the court’s inclination to injunct an infringer. Thus, until the quantum of damages that make would-be infringers to seriously reconsider copying or counterfeiting, certain IPR infringement will continue to be rife in China.

Chinese law does not have the provisions for common law-style discovery, leading to IPR owners experiencing difficulties in establishing losses. Also, because of the low margins infringers make account for profits that does not provide an adequate remedy or deterrent. In cases where the amount of damages cannot be ascertained, the People’s Court may make an order for damages not exceeding a modest $73,000 based on the factual matrix of individual cases, subject to the latest amendment of patent laws where the maximum amount of damages is doubled.

Though the case is seen as an anomaly, the largest ever successful damages claim was $44.3 million awarded to Chint Group in 2007. The trend in Chinese court is to award greater damages in IPR infringement matters, and this will get strengthened as more transparent accounting procedures and systems are adopted by the Chinese legislature.

Administrative Procedures

Compared to the Chinese court procedure, various administrative enforcement procedures available in China are fast, simple and cost-effective. The procedures are mainly employed to secure an injunction at a low-cost and within a short time frame. Decisions can be issued 3-6 months after case receipt, but can be as fast as five days, when accompanied by a raid action. The procedure can also be used to secure delivery, and destruction of goods and collateral materials.

Occasionally, it is possible to track down the source of infringed products using such administrative measures. It is also possible to request severe punishment for infringers, but more often modest fines are applicable. Sometimes the administrative action can provide a referral for a subsequent criminal action.

The administrative procedure cannot be used to secure damages, and administrative fines are typically quite small and thus ineffective to stop serious or repeat infringers.

Judicial Procedure

When compared to Western common law court procedures, the Chinese court procedure is still relatively fast and cost-effective. However, final hearings and decisions are not issued within the year (especially for cases where foreign parties are involved), and hotly contested cases can become protracted. Chinese judges are working assiduously to ensure fair and open trials. In addition, in the absence of discovery procedures, plaintiffs must employ pre-litigation investigation to try and uncover, develop and trap evidence. This can prove to be a risky and uncertain process and can result in destruction of valuable evidence. Care also needs to be taken to ensure jurisdictional control.

IP system in China

After 30 years of its ‘open door policy’, China has started to move from a manufacturing based to a knowledge-based economy and, in the process, has adopted improved IP laws, judicial processes and enforcement procedures. There have also been significant cultural shifts within Chinese society in the perception and recognition of intellectual property rights (IPRs).

Whilst Western governments and respected commentators continue to highlight remaining deficiencies in the Chinese IP system. The general improvement in the IP system is noteworthy and is moving in the right direction. Quantum of damages and a culturally-driven practice of counterfeiting well-known brands and copyright works remain as significant issues.

 

Mr Johnson Lam was appointed as a solicitor of the High Court of Hong Kong SAR in September 2005. He primarily assists in intellectual property matters. He has a special interest in China matters. He completed Master of Laws in China Laws, co-hosted by the City University of Hong Kong and the Remin University of China. He also assists in general litigation matters.

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DUPHAT 2010

March 10th, 2010

With the Pharmaceutical sector experiencing a revamp, DUPHAT 2010 is also reinvented to cater to the needs of a large segment of population of its target audience from UAE, GCC, Arab and Europe.

DUPHAT 2010 will provide an avenue for mutual interaction to discuss and deliberate the radical changes and advances in the Pharmaceutical discipline during a dynamic 3-day program embracing conference presentations, scientific workshops, technology exhibitions and poster presentations.

It is committed this year to new challenges affecting the pharmaceutical world. The gathering will therefore focus on the exchanges concerning various aspects in the science of pharmacy.

The 15th edition of DUPHAT as customary shall be held in collaboration with the Dubai Health Authority, Dubai, UAE and in association with Ministry of Health UAE, American Society of Health System Pharmacists (ASHP), European Federation for Pharmaceutical Sciences (EUFEPS), European Society of Clinical Pharmacists (ESCP), Society of Hospital Pharmacists of Australia (SPHA), International Association of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT), Canadian Pharmacists Association (CPhA), International Society for Pharmacoepidemiology (ISPE), Utrecht University, The Netherlands, European Society of Oncology Pharmacy (ESOP) and Monash University.

The scientific gathering will enable participants to come to grips with the experts in the field of pharmacy science with activities parallel to the conference resulting to long-term benefits and providing continuing medical education. The exhibition will reveal avant-garde technologies.

Event Name:
Dubai Pharmaceutical & Technologies Exhibition (DUPHAT)
Date:
15 - 17 March 2010
Venue:
Dubai International Convention & Exhibition Centre
City/State:
Dubai
Country:
United Arab Emirates

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Primary healthcare sector in China surges ahead

February 3rd, 2010
Primary healthcare facilities concept, better known as Community Health Centers (CHC) and Community Health Stations (CHS) in urban China, was first initiated in 1997, to address the rising public cries towards increasingly unaffordable and inaccessible healthcare at the tertiary care hospitals in the urban cities. Thus, the Chinese government began to shift its focus from purely large general hospitals development to primary community healthcare.

However, little emphasis or investment was made towards CHC and CHS development by the government, until the outbreak of Severe Acute Respiratory Syndrome (SARS) in 2003. The SARS incident exposed the weakness of the former hospital-centric China’s healthcare system, and highlighted the importance of developing good community-based public health and primary medical care by the Chinese government.
Under the directive of China’s Ministry of Health (MoH), CHC and CHS healthcare functions broadly encompasses two major areas, namely public health and primary medical care with major focus on six main service functions such as health education, disease prevention, health management, primary medical care, family planning, and rehabilitation.
The CHC and CHS function as a ‘gatekeeper’ for providing education and treatment for common and frequently occurring diseases, as per the traditional concept of a family physician. The focus is on disease prevention, early diagnosis, basic medical management and monitoring, rehabilitation and recovery, for everyone in the community.
According to China’s Ministry of Health (MoH), the establishment target is for every 30,000 to 100,000 urban population there will be a CHC to take care of their community medical needs, with each CHC ideally supported by several smaller CHS (as required), enabling the community under the CHC coverage to have access to medical treatment within 15 minutes of walking distance. For cities/districts where the city urban population is too sparse and with limited resources, CHC are generally not established. In these cases, the less equipped and basic CHS becomes the major primary healthcare establishment to serve the population.
Ever since the SARS incident, China’s CHC infrastructure has grown tremendously over the last four years at a CAGR of 37.5 percent, with CHC outpatient visits growing even faster, at a CAGR of 39.0 percent. Plagued by a financial burden from ballooning pensions and medical spending related to an increasing incidence of chronic diseases in a demographically aging population; pollution, smoking, dietary changes and lack of exercise as a result of increasing affluence; expensive costs of quality medical care for the general population; and unrelenting congestion situation at level 2 and 3 hospitals; the government has identified the community outreach intervention through CHC and CHS as the most cost-effective strategy to address this situation, supplemented by advanced medical care support from level 2 and 3 hospitals
.
The government is well aware that the current investment and infrastructure for CHC and CHS are highly inadequate to cope with the growing needs of the population. Hence, in the 2009 Healthcare Reform Plans announced by Mr Chen Zhu, the Health Minister of China, major emphasis was given for the development of primary healthcare in China, with an estimated budget allocation of $124 billion (RMB 850 billion) to be disbursed over the next three years, and a total of 3,700 CHCs to be established or upgraded in major cities across China. This include an estimated $600 million (RMB 4.1 billion) to be disbursed by the Central government for the setting up or upgrade of 2,400 CHCs in needy cities by 2011, and an additional $32.22 million (about RMB 220 million) to be allocated for the purchase of medical devices.
With such a strong government initiative and assured massive investments together with a clear focus on community-centric primary healthcare, CHC’s strong growth trend is expected to continue. Vast opportunities are available for suppliers and distributors who can position themselves well to serve the rapidly growing healthcare segment in China.
Mr Tan Shen Leng is the Associate Consultant with Clearstate, a niche healthcare consultancy based in Singapore. Clearstate offers strategic advisory and intelligence services to help medical devices, healthcare services, pharmaceutical and biotechnology firms understand their current and potential markets, implement pragmatic and innovative strategies to ultimately tap into new growth opportunities.

 

 

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All Eyes on Chinese healthcare market

January 25th, 2010
There are 1.3 billion people in China—seeking healthcare in what has become one of the strongest economies in the world. Over the next three years, China’s GDP is expected to grow between 7-9% per annum. The overall compound annual growth rate of the pharmaceutical market (2009-2013), for its part, is projected to be 24%, with the market reaching an estimated $73 billion by 2013 (at constant exchange rates).

Already China’s economy is the third largest in the world. Its foreign exchange reserve stands second to none. The government’s commitment to the health of its people is being demonstrated by a wide range of reform policies and an aggressive campaign to make smart use of new technologies. A close look at the forces at play argue—definitively—that now is the time for pharmaceutical companies to continue to accelerate the building of a sustainable presence in China.
Changing demographics and foundational growth
Consider, for example, the demographics of a population that is not only sizable but also aging and increasingly—perhaps due to more affluent, western-style lifestyles—beset by chronic diseases. An estimated 10% of the total Chinese population—130 million people—will be over 65 by 2015. More than 40 million are currently living with diabetes, while more than 100 million have been diagnosed with hypertension. New healthcare needs signal new treatment patterns, not to mention new opportunities for pharmaceutical companies to step in and make a difference.
The new demographics are fortunately happening at a time of economic prosperity. With demand for both quantity and quality of healthcare on the rise, rural and lower-tier cities are responding—using governmental support to ratchet up historically inadequate care centers with expanded services and capabilities.
Sustained economic development is foundational to growing healthcare expenditures; in China, healthcare spending CAGR (2006-2011) is expected to surge to 20%2. Rising levels of disposable income, meanwhile, are laying the groundwork for higher out-of-pocket expenditures for healthcare and pharmaceutical products.
Profound and fundamental healthcare reforms
Against the demographic and economic backdrop lie fundamental reforms that are rapidly changing the healthcare landscape. There is, for example, a concerted effort to expand the basic medical insurance system so that it might offer 90% of the population both insurance and increased medical benefits by 2011; over time, the system will be expanded to cover the whole of the population with even greater medical benefits.
A new National Essential Drug List (EDL) was published in August 2009 and is targeted to be enforced in 30% of Community Health Centers (CHCs) and rural areas by the end of 2009. The ultimate goal is to enforce the EDL across both urban and rural primary care facilities by 2020 and, in that way, to ensure affordable and good quality basic medicine is supplied for all.
At the same time, the pressure is on to build and upgrade the CHCs, the township health centers, and the county hospitals—and to train healthcare professionals to effectively staff the new environments. Much of this work is already under way, and more is planned throughout 2020.
The strengthening of the primary medical service is being driven by the roll out of numerous new programs designed to broaden access in rural areas and to build more primary care centers in urban areas to serve those with simple and basic diseases. Also on the agenda—though still a work in progress—are efforts to reform public hospitals to make them less reliant on profits from drugs.
Sizable investments are required to institute the kinds of reforms referenced here, and China has committed $125 billion over the next three years to finance the reform initiatives. Some 46% of that investment will go toward the provision of medical insurance and the implementation of the EDL in the primary health sector. Improving healthcare provision —the development of the rural infrastructure and the transformation of urban hospitals into secondary/tertiary care centers—will consume 47% of that budget, while the public health initiatives focused on disease prevention and the control of infectious diseases will be funded by the final 7%.
Real opportunities, pressing decisions
China has been an area of potential interest for years. Today, however, the opportunities are very real and only likely to continue to improve in the future. As China extends medical insurance to the vast numbers of its people, it becomes increasingly important that pharmaceutical companies decide whether to get their drugs onto the EDL and NDRL, since this may significantly affect the price and volume equations. They also need to develop strategies that effectively capitalize on China’s established preference for cost-effective generics as well as address demand for more trusted, effective brands.
At the same time, the rapidly developing healthcare infrastructure requires MNCs to carefully weigh geographic expansion strategies and to become deeply informed about the overall marketing environment. While generics are encouraged by the EDL due to their price benefits, it is often more effective for MNCs to focus on evidence-based, rational prescribing that stands on the principles of ethical sales models.
Third, with China’s public health initiatives increasingly focused on disease prevention, pharmaceutical companies with vaccine and preventive medicine capabilities should be taking aggressive steps to act on emerging opportunities.
Broadly speaking, healthcare policies will drive generics (including branded generics) through 2014, while the rising affluence of the Chinese population and the accelerated launch of innovative products by MNCs will drive the innovative sectors in specialty care and biotech.
In every case, MNCs must develop their strategies with an understanding that China is not by any stretch a uniform market, for while the national government establishes guidelines for health care policies, reimbursement lists, and pricing and drug purchase mechanisms, the local governments of each province are charged with interpreting and implementing those policies. Thus, key account teams must focus on all potential constituencies as they build their strategies.
Another key shape-shifter is the recent implementation of Integrated Medical Information Systems (IMIS) designed to drive efficiency, capture new data, and to enable the tighter oversight of all providers.
The Resident Health Record, for example, made its appearance in early 2009—an electronic document comprising basic personal and family information. In August 2009, the MoH published the Basic Structure and Data Standards for the Electronic Medical Record—a national standard that creates the framework for individual patient records that include inpatient, outpatient, and emergency medical information. Finally, under the umbrella of the Urban Employee Basic Medical Insurance Scheme, plans are under way to expand insurance cards and reimbursement records, and to integrate and standardize data.
For MNCs, then, the situation calls for strategies concerning price transparency, vigilance regarding growing regulatory checks for both approval and safety issues, and a thoughtful approach to clinical trial design so that products are clearly differentiated from their competitors.
Gauging (and capitalizing on) the future
China’s dynamic environment represents a significant bright spot in an era otherwise saturated with global uncertainty. Success, however, is never guaranteed, and those who wish to capitalize on China’s evolving landscape—not just powerhouse MNCs but also local players and smaller entrants—must effectively plan for and execute in three critical areas.
The first is geographic coverage and adaptation. Going deeper and wider into those cities, provinces, channels, and hospitals previously considered beyond economical reach is now an imperative. Hand-in-hand with that imperative is the need to enhance the field force and account management in order to optimize relationships with both the central government and the various provincial policy makers. In addition, marketing efforts must be resourced in a fashion that adapts to the changing, heterogeneous dynamic. A couple of MNCs and local companies have started to put into play a model that effectively runs China as separate geographical units. Other companies are carefully monitoring the success—or otherwise—of this approach.
The second key area concerns product portfolio strategy—having, in other words, a portfolio that intelligently reflects the market and is flexible enough to reshape itself in the face of dramatic changes while also reflecting the widely variant policies seen at the governmental and provincial levels. Brand managers must be adept at positioning and targeting products. Launch strategies must be finely tuned to reflect the particular dynamics of particular cities and regions.
The third key area relates to market access and pricing. There will be no substitute for a comprehensive understanding of each drug’s listing (and potential listing) on reimbursement drug lists; increased patient access will come at likely reduced prices, making the price-volume trade-offs a critical equation to master and to flex. Negotiation mechanisms, risk sharing programs that benchmarked developed markets are going to come into play for high priced drugs between local governments and the manufacturers. All of this means that optimizing product pricing strategies so as to align the portfolio with market conditions will likewise be a prerequisite to future success, as will the execution of sophisticated plans in negotiation mechanisms, support of tendering and supply chain management.
Authors
Jan-Willem Eleveld, VP Consulting & Services, APAC, Singapore 
David Twinberrow, GM, Business Line Management, APAC, Singapore
John Woo, GM, IMS, China

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Takeda, Pfizer to co-promote Actos in China

December 24th, 2009

Takeda Pharmaceutical and Pfizer have entered into an agreement under which Pfizer in China will co-promote Takeda’s Actos (pioglitazone HCl) with Tianjin Takeda Pharmaceuticals. The exclusive co-promotion agreement will build on the current sales capability for Actos in China by increasing the number of medical representat

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Forecast looks good for India pharma shows

December 3rd, 2009

Maarssen, The Netherlands, 9 November 2009: Momentum is building for the early December staging in Mumbai of the third CPhI India and second P-MEC India pharma ingredients, services and technologies event. A combined total of over 600 exhibitors from over 80 countries are expected at the Bombay Exhibition Centre for the 2009 events, being held on 1 - 3 December.

In addition to high quality exhibitors, the 2009 events include two new launches. BioPh India will focus on the convergence of technologies and business models in pharma and healthcare biotechnology - especially across the common interest areas of innovation, product development, clinical trials, manufacturing and supply logistics.

2009 also brings the debut of ICSE India, with emphasis on the very fast-growing outsourcing and contract services sector. The co-located additions of BioPh India and ICSE India to CPhI India and P-MEC India add impressive further depth and networking value to the combined events. The 2009 events will also be complemented by two major conferences.

CPhI India became the fourth member of the brand’s global event “family” in 2006 and was joined by P-MEC India in 2007. The combined exhibitions are the largest pharma services event in India and South Asia. Despite the recent global slowdown, Indian pharma has maintained standout growth rates, with a sector forecast to quadruple, from US $6.3bn. in 2005 to US $25bn. in 2015.

In their mid-2009 report, and underlining the important addition of ICSE India - E&Y/OPPI (Ernst & Young/Organisation of Pharmaceutical Producers of India - OPPI) noted that India’s outsourcing sector is growing at 43%, with drug discovery and development segment growing at 65% - well over three times the global average. India is targeting to become one of the top five innovator countries by 2020.

Growth will figure strongly in the major conferences complementing the exhibitions. These begin with the Indian Pharma Summit on Monday 30 November, focusing on: “The future of India Pharma - India Pharma Vision 2020″ addressing the issues, opportunities and challenges for India as an emerging global pharma hub.

The event will be chaired by Ashok Kumar, Secty. Dept. of Pharmaceuticals and co-chaired by Glenn Saldhana, Chairman, FICCI National Pharmaceuticals Committee & MD and CEO, Glenmark Pharmaceutiucals. Organisers are the Government of India’s new Department of Pharmaceuticals and UBM India Pvt. Ltd. Venue is the Mumbai Grand Hyatt.

Staged alongside the first two days of CPhI India, in the BioPh pavilion at the Bombay Exhibition Centre, Biosimilars India 2009 will cover a wide range of topics in 17 sessions across three half-day modules.

“India is now moving towards centrestage in world pharma, with its overall pharma market growing at better than 9% - and key segments much faster. CPhI and the co-located events are the natural meeting point that enables a high level of networking and business development across the academic, development, R&D, services and manufacturing communities”, said CPhI India Event Director Annemieke Timmers.

“With the BioPh India and ICSE India launches and a strong conference programme adding to a high level of pre-registrations, all our indications are that this year in Mumbai will see our strongest Indian events so far”, added ICSE, BioPh and P-MEC Event Director Haf Cennydd.

Key industry organisations supporting the exhibitions will include Pharmexcil - the Government of India’s pharmaceutical export promotion council; the Indian Drug Manufacturers Association (IDMA); the Organisation of Pharmaceutical Producers of India (OPPI) and the Bulk Drug Manufacturers Association (India) (BDMA).

The events are jointly organised by UBM International Media and sister company UBM India Pvt. Ltd. UBM International Media’s annual sister events for the pharma ingredients and services sector include Worldwide (Europe - October); Japan (April); China (June); and South America (August). For websites, see: www.wherepharmameets.com; www.cphiindia. com; www.pmec-india.com and www.bioph-online.com .

Contributed by Dawnrays Pharmaceuticals

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CPhI 2009: Madrid Launch for BioPh Marks Pharma and Biotech Convergence

October 19th, 2009

CPhI Worldwide and connected events - the global pharma ingredients and services community’s largest annual meeting - returns to Madrid on 12 - 15 October for its 20th staging.
The co-located ICSE contract services and P-MEC equipment and technology events are joined for 2009 under the Where Pharma Meets banner by the new, biotech-focused BioPh. The new platform markedly reflects the notable convergence of the pharma and biotech business models since Madrid first hosted CPhI in 2005.
Across the four events at Feria de Madrid, organisers UBM International Media expect a combined total approaching 1,700 exhibitors. First-time exhibitor bookings are 8% ahead of 2008. Significantly, CEO-level visitor pre-registrations are also up on last year.
One of several new features for 2009 is the all-new Pre-Show Seminar series on Monday 12 October, setting event context through the valuable insights of opinion leaders over a range of key sectors and topics.
Similarly, and returning after 2008’s highly successful launch, the Tuesday and Wednesday morning Breakfast Briefings team the European Fine Chemicals Group (EFCG) and Euromonitor International with the CPhI Conferences group to focus on industry-critical issues.
The year’s standout development - and the second event launched in Madrid after P-MEC in 2005 - is the debut of BioPh, Bio-solutions for Pharma.
BioPh marks the convergence of pharma and biotech business models in global healthcare - and the increasing bio-pharma partnerships in drug innovation, production and market delivery. The new exhibition is a timely link between the biotech innovation that increasingly drives pharma and the proven networking platform of CPhI for ingredients and production interests.
Within BioPh, UBM is teaming with PCM - Parque Scientifico de Madrid, a member of Enterprise Europe Network (EEN) - to offer a pharma and biotechnology “partnering” brokerage event at Feria de Madrid on Wednesday 14 October. (Stand 10A56)
Other highlights this year include the sixth staging of the annual CPhI Innovation Awards and the return of the popular Speakers’ Corner within both CPhI and ICSE.
UBM Pharma Portfolio Group Director Eliane van Doorn commented: “New event features this year reflect ongoing industry changes and the expanding role of healthcare biotechnology since CPhI’s first Madrid visit in 2005.
“They also mark our determination to add interest and value year-on-year for established and new audiences alike - building business value across events, conferences, networking opportunities and online.”
Regarding the business outlook she continued: “We expect the long run of year-over-year growth in visitor numbers for CPhI Worldwide to be interrupted for 2009. However, after the tough global business conditions since late 2008, we are now seeing more positive forecasts. There are better indicators for the global economy and also that the key emerging pharma markets of China, India and Russia will see returns to double-digit growth.”
For 2010, the Europe events are timed a week earlier, when the CPhI family will return to Paris-Nord Villepinte, on Tuesday 5 - Thursday 7 October. Paris last hosted the events in 2006.
Worldwide locations of annual sister events for the pharma sector hosted by UBM include Japan (April); China (June); South America - Argentina (August 2010) and India (November).See: www.wherepharmameets.com; www.cphi.com; www.icsexpo.com; www.bioph-online.com and www.p-mec.com.

SOURCE CPhI Worldwide

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Mr Venkatraman Ramakrishnan brings Nobel glory to India

October 8th, 2009

The Royal Swedish Academy of Sciences has decided to award the Nobel Prize in Chemistry for 2009 jointly to India born Mr Venkatraman Ramakrishnan, MRC Laboratory of Molecular Biology, Cambridge, UK; Mr Thomas A Steitz, Yale University and Ms Ada E Yonath, Weizmann Institute of Science, Israel; for their studies of the structure and function of the ribosome.

The researchers have shown that what the ribosome looks like and how it functions at the atomic level. They used a method called X-ray crystallography to map the position for each and every one of the hundreds of thousands of atoms that make up the ribosome.
 
An understanding of the ribosome’s innermost workings is important for a scientific understanding of life. This knowledge can be put to a practical and immediate use; many of today’s antibiotics cure various diseases by blocking the function of bacterial ribosomes. Without functional ribosomes, bacteria cannot survive. This is why ribosomes are such an important target for new antibiotics.
 
The three Laureates have all generated 3D models that show how different antibiotics bind to the ribosome. These models are now used by scientists in order to develop new antibiotics, directly assisting the saving of lives and decreasing humanity’s suffering.
 
Mr Venkatraman Ramakrishnan is a US citizen, born in 1952 in Chidambaram, Tamil Nadu, India. He did his PhD in Physics in 1976 from Ohio University, US. Currently, he is working as the senior scientist and group leader at Structural Studies Division, MRC Laboratory of Molecular Biology, Cambridge, UK.

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Orchid’s Piperacillin-Tazobactam ANDA gets FDA nod

September 16th, 2009

India-based pharma major, Orchid Chemicals & Pharmaceuticals has received approvals from the Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Piperacillin and Tazobactam in Injection form. These approvals cover Orchid’s generic equivalents in 2.25 g, 3.375 g and 4.5 g vial as well as 40.5 g (Pharmacy Bulk Package) dosage forms and strengths.

 
The FDA has also determined that Orchid is a ‘first applicant’ for the products and has accordingly granted 180-day generic drug exclusivity, under applicable provisions. Orchid would be launching these products in marketing and distribution partnership with Apotex in the US.
Mr K Raghavendra Rao, Managing Director, Orchid said, “This is a great milestone in our US Generics journey. We are not only the first generic product to be approved but also have been granted 180-days generic drug exclusivity. These approvals demonstrate Orchid’s world-class technological and regulatory skills. Given the premium nature of this life-saving antibiotic and our first generic status with exclusivity, we anticipate significant contribution to our revenues and profitability from this product in the ensuing quarters.”

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Sinovac’s H1N1 vaccine gets production license

September 4th, 2009

The State Food and Drug Administration (SFDA) has issued the production license to Chinese biopharmaceutical company, Sinovac, for the registration application of its H1N1 vaccine Panflu.1.

 
Following top-line results which showed that Panflu.1, Sinovac’s H1N1 vaccine, has a good safety and immunogenicity profile, the company announced the findings of an experts’ evaluation conference organized by the SFDA on August 30 and 31. The experts unanimously agreed that Sinovac’s H1N1 vaccine is suitable for all people from three to 60 years old on a single shot vaccination schedule.
 
Mr Weidong Yin, Chairman Sinovac, commented, “The approval of PANFLU.1, Sinovac’s H1N1 vaccine, is a significant milestone in the campaign for the prevention and control of the H1N1 virus. With the support of the Ministry of Health, State SFDA, Chinese Center for Disease Control and Prevention (China CDC), Sinovac was able to successfully and rapidly complete the clinical trials and registration process for the H1N1 vaccine. By leveraging our expertise in R&D, production and commercialization of human vaccines, we continue to execute our mission to provide top-quality vaccines to eliminate human diseases.”

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